Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

All Conditions

Rare Diseases

Uterine Cervical Neoplasms

Uterine Cervical Dysplasia

Uterine Neoplasms

Genital Neoplasms, Female

Urogenital Neoplasms

Uterine Cervical Diseases

Uterine Diseases

Genital Diseases, Female

Genital Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Cervical Intraepithelial Neoplasia

Culturally targeted behavioral and normative beliefs + knowledge/skills + salience + environmental constraints/barriers counseling

nontargeted behavioral and normative beliefs + knowledge/skills + salience + environmental constraints/barriers counseling

Clinical standard of care at time of study

Multiple component intervention based in the unified theory of behavior

Intervention

Partial intervention (full intervention minus cultural-specific component)

Active control

Carmen R Breitkopf, PhD

This project will examine whether a theory-based telephone intervention delivered by a nurse at the time women are informed of an abnormal Pap test result will increase adherence to follow-up recommendations.

Over 90% of deaths due to cervical cancer could be prevented with appropriate screening and treatment of precursor lesions. However, 20% to 70% of women in the United States who are told that their Papanicolaou (Pap) test was abnormal do not adhere to recommendations for follow-up care. This is a problem especially among minorities and women of lower socioeconomic status. The purpose of this part of the protocol is to test a theory-based intervention designed to improve adherence to follow-up among women who experience an abnormal Pap test. The intervention is a message, delivered over the telephone by a nurse, at the time Pap test results are given to patients. The investigators propose to randomize women who experience an abnormal Pap test to one of three groups: (1) targeted cultural belief + knowledge + importance message (intervention), (2) nontargeted belief + knowledge + importance (active control), or (3) standard care only (passive control). All three groups will receive standard care, which is to notify women by telephone of their abnormal results and provide instructions for follow-up. Women assigned to the intervention group also will receive a cultural belief component consistent with their racial/ethnic group, detailed information about follow-up procedures and the consequences of not returning for follow-up, and information regarding the importance of adhering to recommendations, particularly for "low grade" abnormalities. Women assigned to the active control group will receive a nontargeted belief component, plus procedural knowledge and a message on the importance of follow-up. Adherence to initial follow-up will be the primary outcome. Other behavioral outcomes, such as delayed care and completeness of care, also will be assessed over an 18-month interval by chart review. Additionally, the investigators will evaluate psychological outcomes including anxiety and distress. Finally, the investigators will examine the grade of abnormality (low versus high) as an effect modifier. The investigators anticipate that this research will result in an intervention that will improve several important behavioral and psychological outcomes related to abnormal Pap test results. The intervention is guided by a general integrative theoretical framework; therefore, this research will evaluate an intervention strategy that recognizes the importance of targeting culturally relevant beliefs about follow-up and key determinants of behavior (knowledge/skills, salience, environmental constraints) surrounding abnormal Pap test results. Ultimately, the objective of this research is to improve adherence to follow-up among low-income, minority women who are at particular risk of developing cervical cancer.

Intervention to Improve Follow-up of Abnormal Pap Test

Attendance at initial appointment to follow-up abnormal Pap test result

State Anxiety short form measure (6-item); higher scores =worse outcomes (i.e., higher self-reported anxiety levels)

National Cancer Institute (NCI)

The University of Texas Medical Branch, Galveston

Culturally targeted behavioral and normative beliefs + knowledge/skills + salience + environmental constraints/barriers counseling

Intervention: Multiple component intervention based in the unified theory of behavior

nontargeted behavioral and normative beliefs + knowledge/skills + salience + environmental constraints/barriers counseling

Active control: Partial intervention (full intervention minus cultural-specific component)

Active Control

Standard Care Only

Total

Age, Continuous

Sex: Female, Male

United States

Region of Enrollment

Dr. Carmen Radecki Breitkopf

Adherence to Initial Follow-up (Yes/no)

non-targeted behavioral and normative beliefs + knowledge/skills + salience + environmental constraints/barriers counseling

Active control: Partial intervention (full intervention minus cultural-specific component)

Only participants who completed the post-test over the telephone 7-14 following notification of the abnormal Pap test result were asked these questions.

State Trait Anxiety Inventory (STAI)-State Scale

Overall Study

Carcinoma

Carcinoma in Situ

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Device: Self-sampling swab from Eve Medical for collection of vaginal cells.

Device: Regular polyester swab for collection of vaginal cells.

Routine colposcopy sample collected by a physician.

The Eve collection system is a plastic device not much bigger than a tampon that is inserted in the vaginal cavity. A silicone brush is then swiped around the vagina to scrape a few vaginal cells for cervical cancer screening.

Eve Medical self-collection system©

Regular polyester swab for collection of vaginal cells.

cobas® PCR Female swab self-sampling

Physician-collected sampling

Eduardo Franco, DrPH

Mariam El-Zein, PhD

The proposed study seeks to compare the diagnostic performance of Human Papillomavirus (HPV) testing in self-collected samples via the Eve Medical self-collection system© (Eve) with standard physician-collected samples for the detection of cervical intraepithelial neoplasia grade 1 or worse (CIN1+) and cervical cancer among women referred for colposcopy. The performance of the Eve sample will also be compared with that of a second self-sample via a cobas® PCR Female swab.

Approximately 1000 adult women with an abnormal Pap test at the level of an atypical squamous cells of undetermined significance or worse squamous or glandular abnormality (i.e., ASCUS+) or an abnormal co-test (ASCUS+ and HPV-positive) result will be recruited over a period of 12 months via colposcopy clinics located at the Jewish General Hospital, St-Mary's Hospital, and the McGill University Health Centers (Royal Victoria Hospital).

Participating women will undergo three cervical or cervicovaginal sampling techniques: 1) self-sampling using the Eve Medical self-collection system©; 2) self-sampling using a cobas® PCR Female swab; and 3) physician-collected sampling. The participants will also fill in a questionnaire on their experience with the convenience and acceptability of the Eve system, relative to the other two sampling approaches. The decision as to which self-sample is to be collected first will be dependent on randomization

HPV testing will be done using the cobas® 4800 HPV Test. The liquid medium of within the cobas® PCR CELL Collection Media with the provider collected sample and the cobas® PCR media with the two self-collected samples will be used to suspend the cellular material prior to HPV testing. We have made collaborative arrangements with Dr. Marcel Behr, Chief of the Department of Clinical Microbiology at the McGill University Health Centre for the HPV genotyping work.

Histology-confirmed CIN1+ will form the study outcome or case definition. Sensitivity, specificity, and predictive values (along with their respective 95% confidence intervals) will be calculated for each sample type to evaluate the clinical performance of the various sampling techniques. We will use CIN1+ as definition of disease but analyses will also be performed for more stringent definitions, e.g. CIN2+ or CIN3/cancer.

After the discovery that Human Papillomavirus (HPV) infection is the necessary cause of cervical cancer there have been much interest in the introduction of novel screening strategies involving HPV DNA testing \[1\]. HPV DNA testing was shown to have higher sensitivity in detecting cervical cancer and its precursors and greater reproducibility than Papanicolaou (Pap) cytology screening and has been therefore proposed as the primary screening method for the future. In high-income countries, cases of cervical cancer continue to develop among unscreened and under-screened women \[2\]. Factors discouraging women from attending routine screening include fear of pain or discomfort, lack of time or perceived inconvenience, cultural or religious concerns, and poor socioeconomic status \[3\]. For a screening program to be effective high coverage is essential and thus attendance is a critical requirement.

Because of the high sensitivity of molecular HPV testing to detect cervical cancer precursors there is great potential for screening coverage to be increased by inviting non-attendant to provide self-collected vaginal samples. Providing these women with a simple, convenient, and inexpensive means of self-testing may improve cervical screening participation \[3\]. Self-sampling is also an attractive approach to assist screening in poor countries, which typically do not have structured cervical cancer screening programs while having to bear the greatest burden of cervical cancer morbidity and mortality \[4\]. Self-sampling can also enhance the value of post-HPV vaccination surveillance by allowing a more efficient monitoring of HPV type distribution in populations. Finally, self-sampling represents a good research tool to assist prospective studies of genital HPV infection and natural history of cervical neoplasia.

Specifically for cervical cancer screening, it has been shown that self-collected cervicovaginal specimens from women who received proper instruction for collecting them yield HPV test results that are comparable to those in specimens collected by physicians \[5-8\]. Women also prefer self-sampling relative to clinician-provided samples, provided that they can be assured that they are told how to properly collect the sample \[8, 9\]. Although there is conceivably some loss of sensitivity and specificity in screening for cervical cancer in a specimen that is not directly collected from the ecto- and endo-cervix the overall accuracy of the HPV testing results (to identify presence of cervical precancerous lesions) is still superior to that of physician-collected Pap smears. Therefore, replacing a more anatomically-correct specimen (the one collected with direct visualization of the cervix by a primary healthcare provider) with one collected from the vagina (and thus diluted with exfoliated cells from a wider epithelial surface area) is compensated by the high sensitivity of the molecular screening approach \[6, 10, 11\]. Performance of screening seems also to be unaffected by storage and transport of the self-sample swabs, irrespective of whether they have been kept dry or transferred and resuspended into a liquid transport medium \[10, 12\].

A critical feature in enhancing women's acceptance and adherence with the self-sampling approach for cervical cancer screening and HPV surveillance studies is the convenience of the device used for collection. Dacron and polyester swabs are simple, common, and inexpensive. However, they are inconvenient and not isolated within a sheath that prevents contact of the sampling area with mucosal surfaces in the labia and vaginal opening. Ideally, sampling devices should be anatomically correct to facilitate insertion and the sampling surface that will retain the exfoliated cells should be protected from contact with the labia and lower vaginal mucosa while the device is inserted, with the objective of sampling cells that are mostly from the cervix and upper vaginal area.

HPV DNA testing using self-collected cervicovaginal specimens represents a promising strategy to increase cervical screening participation and thus reduce rates of cervical cancer in countries with established cervical screening programs. Furthermore, this approach can also greatly improve the coverage and quality of cervical cancer screening in developing countries, as well as in remote regions in developed countries, e.g., aboriginal populations in Northern Quebec and in First Nations territories. Facilitating and improving uptake of cervical cancer screening would save lives, reduce costs of treating invasive cancer and potentially reduce inequalities in avoidable mortality caused from cervical cancer.

(full protocol available upon request)

Cervical And Self-Sample In Screening Study

Cervical And Self-Sample In Screening (CASSIS) Study: Diagnostic Performance of Molecular HPV Testing With the Eve Medical Self-collection System© for Detecting Cervical Intraepithelial Neoplasia

Diagnostic accuracy (sensitivity and specificity with 95% confidence intervals, and predictive values will be determined for each sample type to evaluate the clinical performance of the various sampling techniques. The investigators hypothesize that the Eve sample will yield sensitivity and specificity results that are no worse than those with the physician-collected sample, while providing better or equivalent results than those with the self-sample based on the Cobas® PCR Female swab.

Participants will be asked to fill out a questionnaire consisting of 10 questions on ease of use, comfort, embarrassment, and clarity of instructions when using self-sampled cervicovaginal sampling such as the HerSwabTM and the female polyester swab as compared to the physician-collected sample. The investigators hypothesize similar patient satisfaction with the three sampling approaches.

McGill University

James McGill Professor in the Departments of Oncology and Epidemiology & Biostatistics, Director, Division of Cancer Epidemiology, and Chairman, Department of Oncology, at McGill University's Faculty of Medicine

Somali women who are randomized for Home based Vaginal Collection will be given a kit to perform the vaginal sample collection for HPV analysis, with detailed written instructions.

30 Somali women who are randomized for Standard Clinic Pap Group will be given a list of clinics that they can attend for cervical cancer screening using pap test. Follow-up will be done on test completion with the clinic at 3 months after enrollment.

Rahel Ghebre, M.D.

This proposal has been developed through collaboration between the University of Minnesota and New American Community Services (NACS), and the research design is based on a needs assessment conducted by the community partner. The investigators will test the hypotheses that women who are offered home vaginal bio-specimen collection will have higher rate of cervical cancer screening completion than that of women referred for clinic-based Pap test. All participants will be given identical education materials on cervical cancer screening and HPV, currently in use by the Minnesota Sage Program.

The trial will pilot text a protocol for home vaginal bio-specimen collection for human papillomavirus (HPV) testing for cervical cancer screening. The main objective is to estimate the successful screening completion rate among a sample of Somali women who have not undergone cervical cancer screening for three or more years. Women will be randomized to either home vaginal bio-specimen collection or referral to undergo a clinic-based Pap test.

Home based or clinic based HPV test (Pap) collection

Cervical Cancer Screening Project Part C

Minnesota Community Networks Center for Eliminating Cancer Disparities: Cervical Cancer Screening Project Part C Quantitative

The main outcome will be successful completion of cervical cancer screening by 3 months after enrollment. For the Home Vaginal Biospecimen Collection Group, completion is defined as return of the HPV DNA self-sampling kit by the patient, with a sample suitable for laboratory analysis. In the Clinic Pap Test Group, completion is defined by documentation of Pap test result.

University of Minnesota

Pharmaceutical Solutions

All Drugs and Chemicals

Anti-Infective Agents

Fenbendazole

Patients received colposcopy as per standard of care

Women will undergo colposcopy at 6 and 12 months after randomization. Those with CIN II will be managed according to standard of care. Those with CIN 1 6 months post randomization will have a second exam 6 months later and if still CIN I will have an exit colposcopy 6 months later.

All women in the Pap and HPV testing policies as well as all women in the colposcopy policy with CIN 1 after 2 exams will have an exit colposcopy 18 months after randomization. The exit colposcopy is a safeguard against the possibility of any false negatives in the follow up policies. The exit colposcopy will also establish the true numbers of CIN lesions in the 3 policies in order to determine their sensitivities and specificities. At the exit colposcopy,all will have an endocervical curettage,and either a minimum of 2 directed biopsies of any mucosal abnormality or in the event no abnormality is identified,2 random biopsies from the cervix.

Colposcopy

Women will receive Pap tests at 6 and 12 months after randomization. The Pap test will be prepared using the Thinprep® system which is the standard at Calgary Laboratory Services. Women with a Pap test result of malignant, HSIL, AIS, AGC, ASC-H, or LSIL-H (\>LSIL) at 6 or 12 months post randomization will be referred for colposcopic examination. Women with an ASC-US or LSIL result (\</=LSIL) will have a second follow up Pap test 6 months later (12 months post randomization). Those with a persistent result of ASC-US or LSIL or \>LSIL at 6 or 12 months will be referred for colposcopic examination. Outcome in the Pap policy is positive when the histopathology is \>/=CIN II. Results of \</=CIN I equal a negative outcome.

All other Pap test results will have an exit colposcopy 6 months later (18 months post randomization).

Pap test

Women will have an HPV test performed on a cervical scrape sample 12 months after randomization. Women with a positive result will be referred for colposcopy. Outcome in the HPV testing policy is positive when histopathology obtained at the colposcopic exam shows CIN II. All other results equal a negative outcome. HPV negative women will have an exit colposcopy 18 months post randomization. HPV testing will be performed using Cervista™HPV HR(Third Wave Technologies Inc./Hologic Inc, Madison, WI, USA).This HPV DNA test identifies 14 high risk types (16,18,31,33,35,39,45,51,52,56,58,59,66,68). Testing will be performed on the residual cervical scrape sample which is fixed in the PreservCyt® solution of the Thinprep® liquid based system(Hologic Inc, Marlborough, Ma, USA). Cervical samples may be held for up to 24 wks at room temperature before DNA extraction.This allows time for transportation without refrigeration.The samples will be sent by overnight express delivery to the laboratory.

HPV test

Gregg Nelson, MD, FRCSC, PhD

There is weak evidence supporting optimal follow-up of women with ASC-US or LSIL cytology found to have low grade disease or normal findings at initial colposcopy. Surveillance options include continued colposcopy, discharge with Pap testing, or HPV testing at 12 months. The investigators performed a pilot randomized controlled trial (RCT) comparing these 3 follow-up policies. Study objectives are to determine the feasibility of an RCT and to compare the incidence of \>/=HSIL in each of the arms by intention to treat principle.

1. BACKGROUND In 2010 the estimated age standardized incidence and mortality rates for cancer of the uterine cervix in Canada were 7 and 2 per 100,000 women respectively. Squamous cell carcinoma is the most frequent type and arises from a premalignant squamous dysplasia called cervical intraepithelial neoplasia (CIN). There are 3 grades of CIN from I to III in order of increasing severity. A systematic review of 73 studies on the natural history of CIN, determined nearly 89% of CIN I regressed to normal or a benign lesion or persisted unchanged, and progression to CIN III occurred in 11% and to cancer in 1%. In contrast, CIN III and II had a greater malignant potential as 12% and 5% respectively progressed to cancer. The low incidence and mortality rates of cervical cancer are largely attributed to the availability of screening for CIN with the Pap test (Papanicolaou stained cervical smear) and the colposcopic management of cytologic abnormalities. While rates have plateaued in recent years, decreases are expected with additional improvements in Pap test performance and pre-colposcopy management of cytologic abnormalities. Changes to the post-colposcopy management of cytologic abnormalities could also improve the rates, but rigorous investigation of potential changes is lacking.

1.1 Management and outcome of cytological abnormalities The Bethesda System (TBS) is the recommended Pap test reporting terminology in Canada. TBS 2001 classifies results as negative for intraepithelial lesion or malignancy (NILM), or an epithelial cell abnormality. The latter includes 1) atypical squamous cells of undetermined significance (ASC-US), 2) atypical glandular cells (AGC), 3) low grade squamous intraepithelial lesion (LSIL), 4) atypical squamous cells, cannot exclude HSIL (ASC-H), 5) high-grade SIL (HSIL), 6) adenocarcinoma in situ (AIS), and 7) malignant.

Management of cytological abnormalities may involve colposcopic examination. The colposcope magnifies the cervix and allows directed biopsy of any visualized mucosal abnormality (impression). A repeat Pap test and tissue sampling of the endocervical canal (endocervical curettage; ECC) can also be carried out. CIN II, III and cancer diagnosed at the first colposcopy exam are considered to be incident disease undersampled by the referral Pap test (incident \>/=CIN II) 3. CIN II or higher detected within the subsequent 24 months is categorized as progressive disease. Some investigators however, also consider it incident disease that escaped earlier colposcopic detection and refer to incidentally detected and progressive CIN II or higher as cumulative CIN II (CIN 2+).

Approximately 1% of cytological results in the United States is an HSIL, 4.4 % is an ASCUS (atypical squamous cells of undetermined significance to include ASC-US and ASC-H) and 1.6% an LSIL. Canadian data is somewhat similar (Calgary Laboratory Services unpublished quality assurance data), Since upwards of 60-80% of HSIL is a CIN II/III colposcopic examination and treatment is appropriate so as to prevent cervical cancer. Uncertainty and controversy in regard to the outcome of ASC-US and LSIL existed until the completion of the ALTS (ASCUS and Low Grade Triage Study) randomized clinical trial. The trial determined 13% of the combined ASCUS and LSIL cohorts had an incident \>/=CIN II and an additional 8% progressed to CIN II/III. These results underscored the importance of managing low grade cytological abnormalities to prevent cervical cancer.

1.2 Pre-colposcopy management of ASC-US and LSIL Current management of ASC-US and LSIL in Canada is guided by the Clinical Practice Guidelines of the Society of Obstetricians and Gynecologists of Canada (SOGC) and the 2001 and 2006 guidelines of the American Society for Colposcopy and Cervical Pathology (ASCCP). Management options include referral to colposcopy after a single or double test result of ASC-US or LSIL or a single ASC-US result testing positive for HPV (Human Papilloma Virus) DNA (deoxyribonucleic acid). Management in Canada is mostly based on repeat Pap testing since HPV testing is not routinely available in every jurisdiction. For example, in Alberta, 2 years of repeat Pap testing carried out at 6-month intervals is the standard for an ASC-US or LSIL detected during routine screening and referral to colposcopy occurs when follow up Pap tests show persistence or progression.

1.3 Colposcopy management of ASC-US and LSIL Mucosal abnormalities of the cervix are biopsied and additional treatment is based on the histopathological results. Repeating the Pap test at colposcopy is of minimal value in the added detection of CIN II/III/cancer, and is not routinely performed. An ECC is recommended to sample disease in the endocervical canal. ASC-US and LSIL tests with incident \>/=CIN II are treated with ablation or excision, whereas those with \</=CIN 1 (benign/CIN I) are not treated.

1.4 Post-colposcopy management of ASC-US and LSIL The post colposcopy management of women referred with ASC-US or LSIL and who do not have incident \>/=CIN II is still uncertain. Management algorithms are available from the ASCCP despite the absence of strong evidence to support all of the recommendations. Amongst those with \</= CIN I at colposcopy, a repeat Pap test at 12 months is recommended if the women were referred with ASC-US and the HPV DNA status at colposcopy was unknown, and repeated at 6 and 12 months if they were referred with an HPV positive ASC-US or an LSIL. HPV DNA testing at 12 months is an option for those referred with an HPV positive ASC-US or an LSIL. Women would be referred back to colposcopy if the repeat Pap test was ASC-US or higher or the HPV DNA test was positive. The evidence was rated BII and BIII by the ASCCP which they defined as "moderate evidence for efficacy or only limited clinical benefit supports recommendation for use (B); based on evidence from at least one clinical trial without randomization, from cohort or case controlled analytic studies, or from multiple time series studies, or dramatic results from uncontrolled experiments (II); evidence from opinions of respected authorities based on clinical experience, descriptive studies, or reports of expert committees (III)".

Post-colposcopy management of ASC-US and LSIL in Canada is very variable and likely reflects the lack of strong evidence supporting the existing guidelines. Based on 102 survey responses from 252 Canadian colposcopists, 43% recommended discharge from colposcopy for ASC-US/LSIL negative for CIN, while 53% recommended repeat colposcopy. For ASCUS/LSIL positive for CIN I, 13% recommended discharge to Pap test follow-up, 65% recommended repeat colposcopy, and 16% recommended treatment. The number of follow up colposcopy exams was variable but there was at least one at 6 months and more often a second at 12 months. The survey highlighted a greater reliance on colposcopy as a standard of follow up care and a reluctance to discharge women for follow up with routine Pap tests performed in the primary care setting. Notably, no participant reported utilizing HPV DNA testing. The high (48%) level of survey participation and individual participant's comments attested to the community's interest in scientifically evaluating the best post-colposcopy management strategy for this clinical scenario.

1.4 Post-colposcopy management of ASC-US and LSIL negative for incident CIN II/III The ALTS trial was principally designed to assess the pre-colposcopy management of women with ASCUS or LSIL. Later, some of the trial data was used to test repeat cytology and HPV testing as post-colposcopy management options. Repeat colposcopy examination could not be measured as a management option. HPV testing at 12 months was found to be 92% sensitive for progression to \>/=CIN II amongst those with \</=CIN I at the initial colposcopy and would refer 55% of women back to colposcopy. The sensitivity compared very well with the 88% obtained with 2 follow up ASCUS Pap tests which however would refer slightly more (64%) women back to colposcopy. The sensitivity of a single colposcopy exam for cumulative CIN II is generally considered to be approximately 80% but may be closer to 55% based on recent data from the ALTS trial. Thus post colposcopy follow up with a single HPV test at 12 months or repeat Pap testing at 6 and 12 months may be equivalent to or more sensitive than follow up with 1 or even 2 colposcopy exams. However, a randomized trial is needed to prove this hypothesis and provide the evidence needed to change the current colposcopy dominated practice in Canada.

2 RESEARCH DESIGN This is a pilot randomized controlled trial performed at the Holy Cross Colposcopy Clinic of the Calgary Health Zone for the purpose of testing a randomized clinical trial which will be designed to test above-stated objectives. The pilot will test the recruitment, randomization, operational feasibility, and clinical outcomes. The pilot data will be added to the future full proposal of the clinical trial. Potential additional studies stemming from the clinical trial will include the evaluation of molecular determinants of outcome, e.g. persistence of specific HPV types, viral load and viral integration, analyses of temporal changes in behavioral factors, and cost effectiveness of the 3 arms.

3 RESEARCH METHODOLOGY 3.1 Pilot sample, enrolment and randomization

Usual colposcopic and pathology practices will be applied at the initial exam and a repeat Pap test will not be performed. After enrolment, baseline data will be extracted by the study team from the clinic charts, including date of the referral Pap test and result, date of the colposcopy exam, colposcopy impression, and cervical biopsy and ECC results. Those with \</=CIN I by impression and pathology will not be treated. These women will be randomized by RANDOMIZE.NET to one of the 3 follow up policies - colposcopy (considered standard of care), cytology or HPV testing (simulating discharge to community). A sticker will be added to the clinic charts describing the woman's policy.

All cervical disease identified at these referrals back to colposcopy will be managed in accordance with standard protocols.

4 DATA MANAGEMENT AND ANALYSIS 4.1 Data management All data collected by the research team will be collected in a de-identified fashion in the REDCap Software managed by University of Calgary. Data discrepancies will be reviewed by an independent third person. Data forms will be checked prior to data entry, and range and logic checks carried out regularly on entered data to ensure the quality of the data. Any results that appear to be out of range or do not comply with the logic checks will be checked with the hospital or clinic case notes and the woman and her clinician.

4.2 Data analysis Patient demographics and characteristics will be reported using descriptive statistics, and comparisons between the three arms will be done using the Chi-square test or Fisher's exact test for categorical variables and the Kruskal-Wallis test for continuous variables. For the primary outcome, the investigators will report the proportion of high risk disease along with the 95% confidence intervals, and compared the arms using relative risks and 95% confidence intervals, with the Colposcopy arm as the reference group. Sensitivity, specificity, positive predictive value, and negative predictive value will be calculated in each arm. SAS 9.3 (SAS Institute Inc., Cary, NC, USA) will be used for analyses. Non-inferiority of repeat Pap and HPV testing follow-up policies strategies, relative to colposcopy is hypothesized. Inferiority will be defined as the smallest relative disadvantage in sensitivity that would be of practical clinical interest. Investigators assume this margin to be less than 1% based on informal discussions with colposcopists in Calgary and in the absence of relevant publications.

Post Colposcopy Management of ASC-US and LSIL Pap Tests

Post Colposcopy Management of ASC-US and LSIL Pap Tests (PALS Trial): Pilot Study

Adherence will be defined as colposcopist performing the test the patient is randomized to and NOT performing a different test. Proportion of patients who had the correct test done over total number of patients being tested will be recorded.

Percentage of eligible patients will be calculated by counting the number of referrals to colposcopy with eligible cytology over total number of referrals; patient participation rate will be calculated by counting the number of eligible patients over number of patients consenting to participate in the study

Determine the incidence of \>/=HSIL (CIN 2/3) in the study population

University of Calgary

Standard care plus cognitive-affective barriers counseling delivered by phone , i.e., culturally-relevant/sensitive barrier-specific messages drawn from a pre-developed library designed to counsel individuals regarding their specific barriers to adherence

Standard care plus cognitive-affective barriers counseling delivered via mail-home print material

Cognitive-affective barriers (CAB) assessment delivered via phone; receipt of a notification letter from physician regarding abnormal Pap test result, need to undergo colposcopy, appointment date and clinic contact numbers; telephone confirmation and post-card appointment reminder

Culturally-relevant/sensitive barrier-specific messages drawn from a pre-developed library designed to counsel individuals regarding their specific barriers to adherence, e.g., by increasing risk-related knowledge, providing accurate outcome and self-efficacy expectancies, addressing health-related values and goals, moderating risk-related affect, or offering active plans and strategies to assist with self-regulation

Cognitive-affective barriers counseling

Culturally-relevant/sensitive barrier-specific messages drawn from a pre-developed library designed to counsel individuals regarding their specific barriers to adherence via brochure, e.g., by increasing risk-related knowledge, providing accurate outcome and self-efficacy expectancies, addressing health-related values and goals, moderating risk-related affect, or offering active plans and strategies to assist with self-regulation

Cognitive-affective barriers counseling via brochure

standard care

Suzanne M. Miller-Halegoua, Ph.D.

Objective: Previous studies have suggested that psycho-educational interventions delivered by telephone improve adherence to initial colposcopy after an abnormal Pap smear. To further explore strategies for enhanced follow-up to medical care recommendations, we studied the impact of a theory-guided cognitive-affective barriers counseling intervention, delivered at 2-4 weeks before the colposcopy appointment, for inner city women. The comprehensive telephone barriers intervention was compared to an enhanced comparison group and a group that received tailored print materials.

Methods: Participants (N = 211) were recruited through a colposcopy clinic and randomly assigned to: 1) telephone assessment of barriers to follow up adherence recommendations combined with tailored telephone barriers counseling; 2) telephone assessment combined with tailored barriers print brochure; or 3) telephone assessment with no barriers counseling. Participants were assessed at baseline, 1-week, 9 and 15 months post-colposcopy.

Objective: Previous studies have shown that theory-based, tailored telephone barriers counseling significantly improves adherence to a colposcopy appointment after an abnormal pap smear result among low-income, minority women. This study built on these research findings and explored the efficacy of a state-of-the-science telephone counseling intervention utilizing a more rigorous study design. This enhanced counseling intervention was tailored to individual's distinctive cognitive-affective barriers profile, as assessed by the Cognitive-Social Health Information Processing (C-SHIP) model-guided barriers assessment tool, and with counseling messages targeted to all five domains of individual's barriers to adherence. In addition, the current study design was improved in two ways. First, the comparison group in this current study was an enhanced one that received a notification letter, assessment of cognitive-affective barriers by telephone, and a telephone appointment reminder. Second, this study had a longer follow-up period to allow testing of the intervention effect beyond initial colposcopy adherence. The participants were followed for 15 months post-colposcopy so that participants' adherence to medical follow-up recommendations (if any) within the 12 months after initial colposcopy can be collected and studied. Adherence to medical follow-up at 6 months and 12 months was measured at 9 months and 15 months, respectively, to allow 3 months for rescheduling, attending, and recording of the appointment. Overall, this study tested whether an enhanced tailored telephone barriers counseling intervention improve adherence to medical follow-up after abnormal pap smear among low-income, minority women.

Methods:

METHODS Participants (211) were randomized to the following baseline conditions: a) standard care (SC), i.e., a cognitive-affective barriers (CAB) assessment delivered via phone, receipt of a notification letter from physician regarding abnormal Pap test result and need to undergo colposcopy, and also including appointment date and clinic contact numbers, plus telephone confirmation and post-card appointment reminder; b) SC plus CAB counseling delivered by phone (CAB-C -T), i.e., culturally-relevant/sensitive barrier-specific messages drawn from a pre-developed library designed to counsel individuals regarding their specific barriers to adherence, e.g., by increasing risk-related knowledge, providing accurate outcome and self-efficacy expectancies, addressing health-related values and goals, moderating risk-related affect, or offering active plans and strategies to assist with self-regulation; c) SC plus CAB counseling delivered via Mail-Home Print Material (CAB-C-P), which included exactly the same applicable messages as were delivered by phone, but in print form. The tailoring of messages to a participant's cognitive-affective barriers profile was based on the two barriers in each of the five Cognitive-Social Health Information Processing (C-SHIP) categories (a total of 10 messages) that she rated most important on a five-point scale. There were 23 cognitive-affective adherence barriers grouped into the following C-SHIP categories: 1) risk-related encodings/perceptions (i.e., purpose of colposcopy, presence and progression of HPV-related disease); 2) risk-related expectancies and beliefs (i.e., confidence in ability to keep appointment, fatalistic beliefs about cancer); 3) risk-related values and goals (i.e., maintaining modesty, importance of having children); 4) risk-related affect (i.e., worries about necessary procedures and/or progression of disease, concerns regarding fertility); and 5) risk-related self-regulation (i.e., remembering appointment, overcoming child-care or work-related conflicts, transportation difficulties, ability to manage any negative risk-related affect). With regard to assessments, they were conducted at the following time points: baseline, and 1-week, 9-month, and 15-month post-colposcopy and included the following: the CAB assessment; background variables, including demographic (e.g., gender, age, ethnicity, education, marital and employment status, household income, number of children); medical and screening history (e.g., cancer diagnosis, previous Pap smears and frequency; breast exams (self and clinical); mammograms and abnormal results; results of the index colposcopy and physician recommendations from medical records; a potential moderating dispositional variable, attentional style (Monitoring-Blunting Style Scale); potential mediating variables, including affective variables (Spielberger State-Trait Anxiety Inventory, the Center for Epidemiological Studies-Depression Scale), and cognitive-affective process variables (knowledge, risk perceptions, expectancies and beliefs, affect, values and goals, regulatory skills); outcome variables, including adherence to initial diagnostic colposcopy and to 6- and 12-months colposcopically-based follow-up diagnostic and medical management recommendations, and an intervention evaluation. All assessments used scales developed in previous research, except the Powe Fatalism Inventory used to assess fatalism and the Revised Impact of Events Scale used to assess affect (i.e., stress-related intrusive and avoidant thoughts). Assessed at baseline were background variables (except medical recommendations), the moderating variable, and all mediating variables. The cognitive-affective barriers were assessed only at baseline. Assessed at 1-week post-colposcopy and at the 9-month and 15 month follow-ups were all mediating variables (except the cognitive-affect barriers) and outcome variables. The medical recommendations were assessed only at the 1-week post-colposcopy. Medical history was also re-assessed at the 15-month follow-up relating to the interim period from baseline.

Facilitating Follow-Up Adherence for Abnormal Pap Smears

Adherence to initial diagnostic colposcopy will be assessed for each participant through tracking of clinic reports/patient medical records immediately post-colposcopy. Adherence will be measured dichotomously with patients who attend their initial appointment or who cancel their initial colposcopy appointment but reschedule within one month of their original date deemed adherent and eligible for follow-up assessments.

Adherence to 6- and 12-months colposcopically-directed recommendations and medical management over time will be assessed through medical chart review, as well as self-report, at 9- and 15-months post-index appointment. A 3-month grace period was selected to accommodate any clinic-based rescheduling and/or cancellation of appointments for procedures.

Temple University

Fox Chase Cancer Center

Skin and Connective Tissue Diseases

Breast Neoplasms

Unidas por Vida y Salud (United for Life and Health) prevention program

The control arm will not receive the Unidas por Vida y Salud (United for Life and Health) prevention program during the study analysis period (though, the control arm will receive the intervention after study has been completed).

The Unidas por Vida y Salud (United for Life and Health) prevention program is led by the El Paso Cancer and Chronic Disease Consortium (CCDC), the only Breast and Cervical Cancer Services (BCCS) provider in El Paso. This prevention program will use a well-integrated network of community organizations and health service providers to connect medically underserved women to services. To reach the most underserved women and increase preventive cancer screening and timely follow-up, diagnosis, and treatment, the multi-method approach uses evidence-based strategies, including face-to-face educational sessions led by promotoras (community health workers), client reminders, and provision of community-based navigation services to affordable and free screening services. The program also includes clinic-based navigation for those requiring diagnostics or treatment delivered by trained nurses and case workers.

Unidas por Vida y Salud prevention program

Maria E Fernandez

The purpose of this study is to develop, implement and evaluate a comprehensive breast and cervical cancer screening program designed to increase uptake of breast and cervical cancer screening among rarely and never-screened low-income women in El Paso County and to increase repeat screening among those currently overdue.

Unidas Por Vida y Salud: Increasing Breast and Cervical Cancer Screening in El Paso

Cancer Prevention Research Institute of Texas

The University of Texas Health Science Center, Houston

Professor

Gender-specific culturally tailored social-support informed educational intervention session.

Usual care with delayed intervention at the end of study.

The educational session consisted of a one-hour small group discussion (5-10 people). Gender-specific community health educators facilitated sessions for Pacific Islander women and for their spouses/significant others that included an educational video and other materials (brochure, calendar, and resource list). The video emphasized the importance of Pap testing for Pacific Islander women, and showed men supporting their women to get tested. Women's sessions provided basic information on cervical cancer and pap testing, and ended with verbal commitments and target screening dates by women to get screened. The men's education sessions contained similar information, with supplemental information on how to provide support for their wives to get tested and exercises on showing their support.

Sora Park Tanjasiri, DrPH

Lola Sablan-Santos

This community-based randomized trial tested the effects of a social support intervention to increase Chamorro, Samoan, and Tongan women's Pap test behavior and social support among their male spouses or significant others in Southern California.

The purpose of this five-year community-based randomized trial was to: 1) examine the Pap test decision making process in Pacific Islander women; 2) assess the role of social support within the decision making process; and 3) develop and test an intervention to increase Pap testing among Pacific Islander women, and support among their male spouses/significant others. The intervention was created utilizing a Multi-Attribute Utility model and social support theory resulting in gender-specific educational workshops consisting of a social support intervention that informed both Pacific Islander women and men about cervical cancer and the importance of Pap testing for Pacific Islander women, and aimed to increase social support among their male spouses/significant others.

A Pap Test Intervention to Enhance Decision Making Among Pacific Islander Women

After completion of each data collection activity, all program project datasets will be de-identified and then made available for secondary analysis on the California State University, Fullerton, Health Promotion Research Institute website. A consultant, who is experienced in large multi-site controlled trials, will assist with the protocols (in years 2 and 3) required for dataset documentation and distribution. Researchers will be able to access the data, documentation, and surveys by registering on the website, obtaining approval from the Health Promotion Research Institute steering committee, and downloading the files. Care will be taken to ensure that respondents cannot be identified from the information in the public-use dataset. The final dataset will be stripped of identifiers (i.e., individual respondent identifying information, such as names and phone numbers, will be removed) prior to release for sharing.

One question regarding whether the woman received a Pap test, among those who had not received one within the past 3 years at baseline

Six true/false questions regarding whether risk increases if woman has family history, smokes, has poor hygiene, spouse has many sex partners, had intercourse starting at early age, and has had more than one sex partner

Five agree/disagree questions regarding whether woman would undergo treatment if diagnosed with cervical cancer, would rather not know if she has cervical cancer, whether she believed there is not much she can do to prevent getting cervical cancer, whether cervical cancer is punishment from god, and whether she would feel less like a woman if she had cervical cancer.

Fifteen items from the RAND Medical Outcomes Study (MOS) social support survey that use a 4-point likert scale (none, some, a lot, all the time) regarding how much the woman can count on husband to: listen, provide info, give advice, can confide, advice is wanted, can share private worries, will give suggestions, is understanding, can help if bedridden, can take to doctor, can prepare meals, can help with daily chores, shows love, makes women feel wanted, and hugs.

Number of women who reported scheduling a Pap test, among women who had not received a Pap test within the past 3 years at baseline

California State University, Fullerton

Community health workers (CHWs) assess women's breast and/or cervical cancer screening needs and deliver behavioral education designed to increase breast and/or cervical cancer screening. After completing the education, CHWs provide women with clinic referrals to local and affordable screening services. Participants also are offered telephone-delivered navigation support, which focuses on helping women overcome logistic and personal barriers to accessing screening services.

Community health workers (CHWs) assess women's breast and/or cervical cancer screening needs and deliver print materials to women describing cancer screening guidelines.

Community health workers (or promotoras) will deliver the CLS program either in face-to-face and/or group sessions to all women within 2 months of the baseline interview. Each session will last approximately 1 to 2 hours, and will include CLS materials adapted for this study.At the conclusion of the CLS program, promotoras will provide information about local and affordable providers delivering low-cost or free breast and cervical cancer screening services. Should a woman require follow-up for abnormal results, referrals will be given to programs,which provides assistance accessing cancer diagnostic and treatment services. Two weeks after delivering the education component of the CLS program, promotoras will call women to provide any further assistance needed. During these follow-up calls promotoras will provide on-going navigation support to women in need of mammography and Pap test screening

CLS Intervention

This control arm will receive only usual practice care (print education) and will not receive the CLS intervention. They may receive the intervention after the study has been completed

No CLS intervention

Lara Savas

The primary purpose of this study is adapt the Cultivando la Salud (CLS) intervention for a new community and priority population and to train community health workers (promotoras) from the Prosalud promotora program to implement the adapted CLS breast and cervical cancer screening program. The adaptation and delivery of the CLS intervention program focuses on meeting the needs and supporting of CHWs and Hispanic/Latina women in the Greater Houston Area. Finally, this study aims to evaluate the process and effect of the adapted CLS program (renamed Salud en Mis Manos (SEMM) on increasing mammography and cervical cancer screening.

CHWs identify women in the community in need of breast and/or cervical cancer screening. Based on their screening needs, they invite women to participate in the CLS behavioral intervention. Women are randomized to intervention and usual care comparison (delayed intervention) groups. After women are consented to participate in the study, the study team administers the baseline survey. After the baseline survey is administered, the CLS-adapted intervention (renamed Salud en Mis Manos), is delivered to participants randomized to the intervention group. After the follow-up survey is administered to the participants, women in the comparison group are offered the CLS (SEMM) intervention.

Using a Lay Health Worker Program to Increase Breast and Cervical Cancer Screening in Low-Income Hispanic Women

Using an Evidence-based Lay Health Worker Program to Increase Breast and Cervical Cancer Screening in Low-Income Hispanic Women in Houston

Outcomes based on self-report on follow-up survey

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Intervention to Improve Follow-up of Abnormal Pap Test	NCT00575510	Cervical Cancer	Intervention Active control	18 Years - 55 Years	The University of Texas Medical Branch, Galveston
Cervical And Self-Sample In Screening Study	NCT02397252	Cervical Cancer Intraepithelial...	Eve Medical sel... cobas® PCR Fema... Physician-colle...	-	McGill University
Cervical Cancer Screening Project Part C	NCT01575444	Cervical Cancer		25 Years - 70 Years	University of Minnesota
Post Colposcopy Management of ASC-US and LSIL Pap Tests	NCT03466710	Cervical Cancer...	Colposcopy Pap test HPV test	18 Years -	University of Calgary
Facilitating Follow-Up Adherence for Abnormal Pap Smears	NCT01561326	Uterine Cervica...	Cognitive-affec... Cognitive-affec... standard care	18 Years -	Fox Chase Cancer Center
Cervical Cancer Screening Project Part C	NCT01575444	Cervical Cancer		25 Years - 70 Years	University of Minnesota
Unidas Por Vida y Salud: Increasing Breast and Cervical Cancer Screening in El Paso	NCT04397744	Breast Cancer Cervical Cancer	Unidas por Vida...	21 Years - 64 Years	The University of Texas Health Science Center, Houston
A Pap Test Intervention to Enhance Decision Making Among Pacific Islander Women	NCT03064581	Cervical Cancer	Intervention	21 Years - 65 Years	California State University, Fullerton
A Pap Test Intervention to Enhance Decision Making Among Pacific Islander Women	NCT03064581	Cervical Cancer	Intervention	21 Years - 65 Years	California State University, Fullerton
Unidas Por Vida y Salud: Increasing Breast and Cervical Cancer Screening in El Paso	NCT04397744	Breast Cancer Cervical Cancer	Unidas por Vida...	21 Years - 64 Years	The University of Texas Health Science Center, Houston
Using a Lay Health Worker Program to Increase Breast and Cervical Cancer Screening in Low-Income Hispanic Women	NCT04426019	Breast Cancer Cervical Cancer	CLS Interventio... No CLS interven...	21 Years -	The University of Texas Health Science Center, Houston

Spots Global Cancer Trial Database for pap test

Every month we try and update this database with for pap test cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for pap test

Every month we try and update this database with for pap test cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for pap test cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.