Neoplasms

Digestive System Diseases

All Conditions

Colorectal Neoplasms

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Colonic Diseases

Intestinal Diseases

Rectal Diseases

Patients who are identified by the IPHR as study participants will see an attractive link. In the Prefs arm, via question prompt lists, patients will first identify their CRCS preference using previously developed elicitation strategies.

Tailoring will be used to increase salience of information, motivation, communication, and action plans. We envision the Prefs+ arm in its entirety will be 5-7 minutes, but will depend on Phase I formative work. If the patient remains non-adherent, they will receive an e-mail reminder generated by the IPHR (specific text and frequency determined in Phase I). The Prefs content is identical to the preference portion of the Prefs+Barriers arm, which will allow us to assess the incremental benefit of addressing preferences only and the incremental benefit of addressing preferences and barriers.

Patients who are identified by the IPHR as study participants will see an attractive link. In the Prefs+Barriers arm, via question prompt lists, patients will first identify their CRCS preference using previously developed elicitation strategies, and subsequently based on their test preference determine their top 3 test-specific barriers/concerns in "real time".

Tailoring will be used to increase salience of information, motivation, communication, and action plans. We envision the Prefs+Barriers arm in its entirety will be 15-25 minutes, but will depend on Phase I formative work. If the patient remains non-adherent, they will receive an e-mail reminder generated by the IPHR (specific text and frequency determined in Phase I). The Prefs content is identical to the preference portion of the Prefs+Barriers arm, which will allow us to assess the incremental benefit of addressing preferences only and the incremental benefit of addressing preferences and barriers

The IPHR will be programmed so that where the IPHR-CRCS would normally present patients, who based on their demographics and health conditions, with content advising them to seek CRCS and links to third-party sites, they would instead be randomized to receive the usual care (IPHR-CRCS).

MyCRCS+Prefs

Patients who are identified by the IPHR as study participants will see an attractive link. In the Prefs+Barriers arm, via question prompt lists, patients will first identify their CRCS preference using previously developed elicitation strategies, and subsequently based on their test preference determine their top 3-5 test-specific barriers/concerns in "real time".

Tailoring will be used to increase salience of information, motivation, communication, and action plans. We envision the Prefs+Barriers arm in its entirety will be 15-25 minutes, but will depend on Phase I formative work. If the patient remains non-adherent, they will receive an e-mail reminder generated by the IPHR (specific text and frequency determined in Phase I). The Prefs content is identical to the preference portion of the Prefs+Barriers arm, which will allow us to assess the incremental benefit of addressing preferences only and the incremental benefit of addressing preferences and barriers.

MyCRCS+Prefs+Barriers

Resa M Jones, MPH, PhD

This study involves 3 phases that modifies current Interactive Preventative Health Record-Colorectal Cancer Screening (IPHR-CRCS) modules to address each patient's individual colorectal cancer screening (CRCS) knowledge, attitudes, preferences, and test-specific barriers. The study will engage patients, ages 50-75 years who are non-adherent to CRCS, to assess their CRCS test preferences and corresponding test-specific barriers in "real time". Based on patient characteristics (e.g. age, personal and family history, physician CRCS recommendation, CRCS test preferences, top test-specific barriers), tailored messages/videos will appear in the pop-up screens to address/reduce the top patient-reported, test-specific CRCS barriers while incorporating an action plan for CRCS adherence. The investigators hypothesize that modifying the IPHR-CRCS module to address each patient's individual CRCS knowledge, attitudes, preferences, and test-specific barriers will further increase CRCS.

An Interactive Preventive Health Record to Increase Colorectal Cancer Screening

Develop and pretest MyCRCS+, which focuses on integrating patient CRCS preferences and test-specific barriers in an interactive web-based intervention. Answer the question: What intervention content and reminder content, packaging and frequency are acceptable to patients?

Having had ≥1 test (i.e., fecal occult blood test, sigmoidoscopy, colonoscopy and barium enema) within the time frame specified for each procedure will count as adherent CRCS.

The four NCI-recommended CRCS history questions will be included on the self-report surveys. Respondents will identify the last time they had each test (i.e., fecal occult blood test, sigmoidoscopy, colonoscopy and barium enema). Having had ≥1 test within the time frame specified for each procedure will count as adherent CRCS.

We will track participants' use of the intervention and usual care arms to capture number of log-ins, pages viewed, length of view, links clicked. In addition to elucidating patients' uptake of intervention components, these data can indicate engagement for dose-response analyses or be examined as potential mediators. For Phase II, this data will allow us to assess the timing of intervention reminders to make a decision about what frequency is most appropriate so that we can modify before we begin the feasibility study (phase III).

Scales (e.g. Decisional conflict, intentions , self-efficacy, perceived susceptibility, worry, etc.) are included in the patient questionnaire, which have good psychometric properties.

A previously validated modality-specific colorectal cancer screening barrier instrument will be used. The FOBT-specific scale includes 19 questions relating to barriers for fecal occult blood test, and the colonoscopy-specific scale includes 21 questions relating barriers to colonoscopy. All items are measured on a 5-point Likert-type scale, with 5 representing greater barrier endorsement. Items are summated to create continuous scale scores (range: FOBT=19-95; colonoscopy=21-105).

Phase III is a feasibility study to determine among other things, implementation in the "real world" setting. The outcomes we propose to measure are defined by the RE-AIM model. Specifically, we selected four essential elements pertaining to the feasibility of fielding MyCRCS+: Reach, Effectiveness, Implementation, and Maintenance.

The patient survey will include key questions related to intervention reach and potential future implementation adaptations addressing patient awareness and perception of the practices' MyCRCS+ integration strategies.Surveys will assess: patients' awareness of MyCRCS+, how they learned about it, what they liked or disliked about how practices promoted and used MyCRCS+; to what extent they used the MyCRCS+, the factors that influenced use, facilitators and barriers to both using and acting on MyCRCS+ recommendations; anxiety and worry; and quality of life (QOL).

National Cancer Institute (NCI)

Virginia Commonwealth University

Temple University

Family caregivers were invited to meet in a group for 2 hours once a week for 3 weeks. Each meeting had a specific topic presented by a health care professional of the palliative care team (physician, nurse and social worker). The meetings addressed multi-dimensional issues in dialogue with the participants. A nurse acted as group leader and participated in all meetings. The intervention included both supportive and educational components. Each meeting began with a presentation based on a specific topic (palliative care, practical care and emotional reactions). This was followed by reflection and conversation, and finally a relaxation exercise

Psycho-educational

Health care systems are increasingly using outpatient care for patients with advanced cancer disease with complex needs, limited life expectancy, and need for palliative care. Family caregivers are centrally important, but are often insufficiently prepared for the caregiving role, and experience psychological distress and physical symptoms. We hypothesize that a psycho-educational intervention during ongoing palliative care will support family caregivers' wellbeing and decrease negative consequences of caregiving.

The intervention, which has been developed in steps through a series of studies based on theoretical, methodological, and empirical work, was delivered in a group format 2013-2014. Family caregivers were invited to meet in a group for 2 hours once a week for 3 weeks. Each meeting had a specific topic presented by a member of the palliative care team (physician, nurse, and social worker). The meetings addressed multi-dimensional issues in dialogue with the participants.

The overall aim of this ongoing project is to investigate short and long-term effects of the intervention delivered by health professionals at ten specialized palliative home care units. Multiple methods are now being used, including a randomized controlled trial (RCT). In total, 270 family caregivers have been requested to answer a questionnaire at four time points: at baseline, upon completion and again 2 months after completion of the intervention, and 6 months after the patient's death. The primary outcome variable is preparedness for caregiving, and the secondary outcome variables cover aspects of wellbeing including competence and reward, caregiver burden, health, anxiety and depressive symptoms, and grief. These data will be complemented with interviews.

The project has the potential to contribute knowledge about the development of support for family caregivers, not only in specialized palliative care but also in other contexts such as elderly care and general home care services.

Specific aims are to:

I) Determine the effects of the intervention upon completion, in relation to preparedness for caregiving, competence for caregiving, reward of II) Determine the effects of the intervention in a 2-month follow-up, in relation to preparedness for caregiving, competence for caregiving, reward of caregiving, health, anxiety, depressive symptoms, and caregiver burden III) Determine the effects of the intervention 6-month after the death of the patient, in relation to the family caregiver's health, anxiety, depressive symptoms and grief IV) Identify characteristics of family caregivers who do not respond to the intervention and describe support needs for these individuals V) Investigate associations between preparedness for caregiving (main outcome) and competence for caregiving, reward of caregiving, health, anxiety, depressive symptoms, caregiver burden and grief (secondary outcomes) VI) Evaluate intervention processes from the perspective of family caregivers and health care professionals VII) Investigate the influences of the caregiver intervention, for the patients with advanced cancer disease

A psycho-educational intervention was developed based on the theoretical framework of Andershed and Ternestedt relating to the principal support needs of family caregivers. The framework describes family caregivers' involvement in caregiving, and focuses on knowing, being and doing. Knowing is considered crucial for family caregivers, and is connected to an awareness of the nature of the caregiving role: knowing what to expect and what to do. Being is related to the management of one's own emotions and those of one's relative. Doing covers the practical care acts including a range of activities. It is assumed that insight will increase family caregivers' possibilities for making choices and for their involvement in caregiving.

The aim of the intervention is to increase family caregivers' feelings of preparedness for caregiving, to support their wellbeing, and to decrease negative consequences associated with caregiving. Preparedness refers to how ready family caregivers perceive they are for the tasks and demands of the caregiving role, such as providing physical care, providing emotional support and dealing with the stress of caregiving. It is suggested that preparedness could support wellbeing and protect against negative consequences in relation to caregiving. The intervention is delivered as a programme in a group format and its components, design, acceptability, feasibility and potential effects have been confirmed in a series of previous studies. During the development process, slight modifications concerning the content and structure have been done based on participant experiences.

Family caregivers were invited to meet in a group for 2 hours once a week for 3 weeks. Each meeting had a specific topic presented by a health care professional of the palliative care team (physician, nurse and social worker). The meetings addressed multi-dimensional issues in dialogue with the participants. A nurse acted as group leader and participated in all meetings. The intervention included both supportive and educational components. Each meeting began with a presentation based on a specific topic (palliative care, practical care and emotional reactions). This was followed by reflection and conversation, and finally a relaxation exercise

The intervention was conducted at ten specialized palliative home care units in the Greater Stockholm area. These settings provide palliative care mainly for patients with advanced cancer disease and complex needs and limited survival expectancy. The needs of the patients include symptom management, emotional and spiritual support, and assistance with personal nursing care.

All settings delivered 24-hours-a-day services and were staffed by multi-professional teams including physicians, nurses, social workers, occupational therapists and physiotherapists. The intervention was delivered altogether 21 times during 2013 and 2014. To ensure consistency, the content and structure of the intervention followed a manual that was developed in collaboration between researchers and staff. In order to strengthen this consistency, all team members involved in delivering the intervention participated in a 1-day workshop covering the theoretical basis of the intervention and how it should be conducted. In addition, several meetings between researchers and health care professionals were held pre-intervention, and during and after the intervention. The researchers also arranged meetings to give health care professionals from the various settings a chance to meet and share experiences related to delivering the intervention.

Both patients and family caregivers were included in the study. The inclusion criteria for patients were: being in receipt of palliative care, and having a limited life expectancy that was nevertheless assumed to be \>5 weeks. Patients were not included in active data collection, but were asked to consent to the use of specific information from their medical record, including diagnosis and illness duration. Patients were also asked for approval for and preferences of which family caregiver(s) were to be asked to participate in the study. The inclusion criteria for family caregivers were: being ≥18 years old, and being able to understand and speak Swedish. All participants were consecutively approached by health care professionals and received written study information from the researchers. Family caregivers who agreed to participate were randomized to either the intervention or a control group (i.e. standard care).

In total, 270 family caregivers have been included and have been requested to answer a questionnaire to determine the effects of the intervention at four time points: at baseline, upon completion, 2 month after completion of the intervention and 6 months after the patient's death.

Inclusion and baseline assessment was completed in March 2014 with an end of intervention delivery in April 2014. The 2-month follow-up assessments for these participants were completed in June 2014. The long-term assessment may be extended since its timing is dependent on the time of death of the patient. All data collection will, however, be finalized by December 2015. Data has been collected from family caregivers, patients and health care professionals in order to evaluate the intervention and its influences as well as intervention delivery

To determine the effects of the intervention, participant assessments are made at four time points: before randomization (i.e. at baseline), upon completion of the intervention, 2 months after the intervention and 6 months after the patient's death

The questionnaire includes background characteristics such as age, sex, living conditions, level of education, relationship with the patient, marital status, financial situation, morbidity, and health care needs. It also includes scales with documented validity and reliability. The primary outcome variable is measured using the Preparedness for Caregiving Scale (PCS). The secondary outcome variables are measured using the Caregiver Competence Scale (CCS), Reward of Caregiving Scale (RCS), Caregiver Burden Scale (CBS), Health Index (HI), and Hospital Anxiety and Depression Scale (HADS). Social support is measured using the Multidimensional Scale of Perceived Social Support (MSPSS), grief is measured using the Anticipatory Grief Scale (AGS) \& Texas Revised Inventory of Grief (TRIG)), and background data are assessed to identify characteristics for family caregivers who will not respond to the intervention

Interviews have been conducted with the aim to evaluate intervention processes from the perspective of family caregivers and describe influences for patients. With the aim of describing the need for support among family caregivers who do not respond to the intervention, interviews are being planned. Focus group interviews have been conducted with the aim to evaluate the intervention processes from the perspective of care professionals. The number of participants for experiential explorative studies were based on sampling principles for qualitative methods and included: 19 interviews with family caregivers 25 Health care professionals. Approximately 20 interviews with family caregivers who do not respond to the intervention will be held.

Data analysis To secure the statistical power for the regression analyses, sample size calculations were made. A sample of 110 would be sufficiently large to detect a medium effect size.

Descriptive statistics, χ2 statistics for categorical variables, and Student's t-test (unpaired) for continuous data (or equivalent non-parametric tests) were used to describe the characteristics of the participants and to compare the intervention and control group at baseline. Due to violations of the assumption of independence multiple linear regression analysis based on robust variance estimates was conducted to test the short and longer-term effects of the intervention (at baseline, upon completion of the intervention and two months following the intervention) and 6 months after the patient's death.

Participants from the intervention group will be categorized into those who demonstrate improvement and those who do not and descriptive statistics will be used to identify characteristics associated with this distinction. Age, sex, living conditions, educational level, relation to the patient, marital status, financial situation, morbidity, health care needs, social support, and anticipatory grief will be included as predictor variables.

Multiple linear regression analyses will be used to investigate the association between study outcome variables.

Analyses of interviews and focus group data were conducted with interpretive descriptive analysis during data Collection.

Ethical considerations A guiding ethical principle is not to harm the study participants, whether they participate in the intervention or in the control group. We have considered that answering the questionnaire and participating in the interviews may be associated with strong emotions. In addition, we have considered the stressful situation for caregivers. For this reason, the written and oral information emphasizes the voluntary nature of participation and the right to withdraw from the study at any time point. Ethics approval for the project and the extended project has been obtained from the regional ethical review board in Stockholm (2012/377-31, 2012/2191-32, 2013/934-32).

Significance and clinical relevance The Project is based on an RCT design contributing to high evidence value results. It was hypothesized that a psycho-educational intervention delivered by health care professionals during ongoing palliative care would support family caregivers of patients with advanced cancer disease, sustain their wellbeing and decrease the negative consequences of caregiving. The project will expand the knowledge about short and long-term effects as well as intervention processes and influences of the intervention from the perspective of family caregivers, health care professionals and patients. The studies can thereby prepare for implementing the intervention in clinical settings. The intervention was planned, designed and conducted in cooperation with the health care professionals who were responsible for its delivery at ten specialized palliative home care units. This will further facilitate implementation of the intervention and research results - not only at the study settings, but also at other specialized palliative home care units. The RCT design should enhance the generalizability of the results and make the intervention applicable to implement as a tool in clinical practice. The project also has the potential to generate results that will contribute to the development of support for family caregivers in other contexts, for example elderly care and general home care services. Overall, the project has a potential to contribute to the body of knowledge about intervention development, delivery, and evaluation during ongoing palliative care.

Effects of a Psycho-educational Intervention for Family Caregivers in Palliative Care

The PCS is designed to measure caregivers' perceived readiness to provide care in real time. It consists of eight items answered on a five-point Likert-type response scale ranging from 'not at all prepared' (0) to 'very well prepared' (4) with a total score ranging from 0-32.

TRIG measures complicated grief on a 5 Point likert type scale ranging from 1 (Completely true) to 5 (Completely false).

Karolinska Institutet

Linnaeus University

Lund University

Ersta Sköndal University College

PhD, lecturer in Palliative Care

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Infections

Carcinoma

Uterine Cervical Neoplasms

Virus Diseases

Papilloma

Neoplasms, Squamous Cell

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

All Drugs and Chemicals

Vaccines

Participants were mailed a brochure describing the 4 recommended adolescent vaccines (HPV, meningococcal, tetanus diptheria acellular pertussis (TDAP), and influenza) 1-2 weeks before a clinic visit

* HPV-vaccine specific brochure mailed before clinic visit
* Telephone recalls after visit for those who complete pre-clinic survey and decline the vaccine
* Telephone reminders for those who complete the pre-clinic survey and are late for receiving the 2nd and/or 3 doses

HPV brochure, recall, reminders

General Adolescent Vaccine Brochure

Jasmin A Tiro, PhD

This randomized controlled trial is designed to evaluate whether a behavioral intervention that includes three components: 1) reminder letters and education materials delivered before the clinic visit, 2) telephone recalls after the visit for those who originally decline the vaccine, and 3) telephone reminders for those who miss the 2nd and/or 3rd doses, increases 1 and 3 dose coverage of the human papillomavirus (HPV) vaccine series among adolescent girls attending four Parkland primary care clinics in Dallas county.

Hypothesis 1: Investigators expect higher 1 dose HPV vaccine coverage among patients in the Intervention group than those in the General Adolescent Vaccine Brochure group.

Hypothesis 2: Investigators expect significantly higher 1 dose HPV vaccine coverage among patients in the Intervention group who initially declined the vaccine than those in the General Adolescent Vaccine Brochure group who initially declined.

Hypothesis 3: Investigators expect significantly higher 3 dose HPV vaccine coverage among the Intervention group than those in the General Adolescent Vaccine Brochure group.

The primary research goal is to implement and evaluate evidence-based intervention strategies targeted to adolescent girls and their parents that stimulate patient demand for the human papillomavirus (HPV) vaccine and compliment provider-directed strategies already employed by Parkland clinics.

The project has three specific aims:

* Aim 1. Determine if a mailed packet with an invitation letter and educational material (HPV-specific or general brochure about all recommended adolescent vaccines) delivered prior to clinic visit, increases 1 dose coverage of the HPV vaccine series.
* Aim 2. Determine if a telephone recall delivered 2 weeks after the clinic visit, increases 1 dose coverage among parent-patient dyads who decline the vaccine during the clinic visit.
* Aim 3. Determine if telephone reminders to those overdue for Dose 2 or 3 of the HPV vaccine series, increase 3 dose coverage of the series.

Phase 1 - Cognitive interviews: To ensure the usability and cultural appropriateness of all project materials, investigators will conduct 40 in-person, cognitive interviews with parents of female patients ages 11-18 attending Parkland clinics.

Phase 2 - Randomized controlled trial. Investigators will select and invite 1200 families whose daughter has an upcoming appointment at one of four Parkland clinic sites. Eligible patients will be randomized to either the Intervention group or the General Adolescent Vaccine Brochure group. The Intervention group participants will be mailed a packet containing an invitation letter to join the study and HPV vaccine-specific educational materials; General Adolescent Vaccine Brochure group participants will be mailed a packet with educational materials on all four of the recommended adolescent vaccines (HPV, meningococcal, TDAP, and influenza). A few days after the packet has been sent, a research assistant will call participants to verify that the letter was received and assess interest in completing a pre-clinic visit survey.

Participants who agree to fill out the in-clinic survey will be asked to come to their clinic appointment 40 minutes early to obtain verbal informed consent from the parent and verbal assent from the adolescent female patient. Then, the parent will complete a 20-30 minute survey about the HPV vaccine and interactions with their daughter's provider. The daughter will complete a short survey that asks about use of social media and health concerns.

Intervention group participants who complete the in-clinic survey are also eligible to receive telephone recalls and reminders. If the Intervention group parent refused the vaccine during the initial clinic visit, a telephone recall will be delivered after 2 weeks offering to schedule an immunization-only appointment. If the Intervention group participant misses the 2nd and/or 3rd doses, telephone reminders will be delivered. For participants who complete the in-clinic survey and are randomized to the General Adolescent Vaccine Brochure group, parents who refused will be contacted after 2 weeks to assess attitudes and intentions toward the HPV vaccine.

Participants in both the Intervention and General Adolescent Vaccine Brochure group will have their medical record reviewed to assess HPV vaccine outcomes, receipt of the other three recommended adolescent vaccines, and contact with the clinic during the 12 months following randomization.

Ancillary Analyses

The investigators will perform stratified analyses and multivariate logistic regression modeling to examine whether certain subgroups were more likely initiate and complete the series (e.g, vaccine uptake might vary by characteristics such as preferred language, race/ethnicity, patient age, or parent educational status). The Investigators will use similar methods to also examine our data for confounding, for example, if initiation differs by clinic site. If no interactions are found (e.g., outcome estimates are similar for different subgroups), the investigators will report summary chi-square tests that only adjust for potential confounders.

The investigators will also use the dates that patients received the 1st, 2nd, and 3rd HPV doses to run a time-to-recurrent event analysis. The investigators will model the completion of the 3-dose series as recurrent event data, 72; 73 with event times from intervention to Dose 1, Dose 1 to 2, and Dose 2 to 3. A proportional means model will be constructed with the outcome being the recurrent events, and the variables of interest including intervention group assignment, sociodemographic, clinic site, knowledge, and attitudes. A significant intervention indicator effect will conclude that the intervention generally shortens the time between initiation and receipt of all doses.

Secondary Analyses

The investigators will conduct the following secondary analyses to evaluate whether parents who receive the intervention have greater HPV vaccine knowledge, information seeking, and PAPM stage progression compared to parents receiving usual care. Among those who consented for additional contact and completed pre-clinic and follow-up surveys, the investigators will explore associations among intervention assignment and intermediate factors including parents' HPV vaccine knowledge, attitudes, perceived risk, information-seeking, and HPV vaccine decisional stage. Descriptive statistics will be calculated and outliers identified. A correlation matrix will be run to check for multicollinearity (strong correlations between intermediate factors). The investigators will run univariate and multivariate logistic regression models to determine whether intervention assignment is associated with greater knowledge of the HPV vaccine, more positive attitudes toward and information seeking about the HPV vaccine, and PAPM stage progression.

To explore generalizability to all safety-net patients in the clinics, the investigators will compute t tests or chi-square tests and examine whether patients who 1) decline to participate or 2) do not consent for reminder and recall intervention components differ from those randomized with respect to variables available in the EMR (patient demographics, health care utilization patterns, clinic visit characteristics).

An Intervention Promoting HPV Vaccination in Safety-net Clinics

Receipt of 1 or more doses of the HPV vaccine during 12-month study period

Receipt of 3 doses of the HPV vaccine during the 12 month study period

Cancer Prevention Research Institute of Texas

Parkland Health and Hospital System

University of Texas Southwestern Medical Center

Colonic Neoplasms

Herbal and Botanical

Cola

Patients randomized to the intervention group will use CRIS. Then intervention group patients and their physicians will receive a tailored printout generated by the CRIS recommending risk-appropriate colorectal testing and ways to overcome perceived barriers to testing. A member of the research team will hand the patient a printout and will deliver the other printout to the physician.

Patients randomized to the comparison group will use CRIS, but receive a non-tailored standard information about multiple types of cancer screening (e.g., content from an American Cancer Society cancer screening brochure) while physicians receive standard electronic chart prompts indicating the patients were age-eligible but not currently adherent for colorectal cancer screening.

A screening baseline for the true no-contact group will be established by conducting a retrospective chart review for patients who did not receive an invitation to participate in this study. The same randomization procedure will be used as the comparison and intervention groups. The purpose is to conduct analysis with the comparison and intervention group to see if individuals who participate in CRIS have a higher screening rate for colorectal cancer compared to the non-contact group.

The Cancer Risk Intake System (CRIS) is a tablet-based program through which patients answer detailed questions about their colorectal cancer risk prior to an appointment. Tailoring algorithms in CRIS generate printed information for patients and their physicians summarizing their risk factors and matching them with guideline-based screening options.

Tailored Printout

Celette S Skinner, PhD

This study will adapt and test a touch-screen computer program to evaluate cancer risk and provide patient-tailored recommendations for appropriate risk-based testing. This individually tailored intervention delivered right at the point of primary care and just prior to the office visit, can be a helpful and non-obstructive adjunct to clinical care.

The primary aim of this project is to test whether a tailored intervention promoting risk-appropriate cancer testing results increases participation compared with a simple non-tailored reminder or no reminder. The trial is designed to determine the extent to which the Cancer Risk Intake System (CRIS) facilitates (1) participation in risk-appropriate colorectal cancer testing, as documented by electronic medical record audit; (2) patient receipt of risk-appropriate colorectal cancer testing recommendations from their physicians, as documented by electronic medical record audit; and (3) changes in patients' intent to participate in risk-appropriate colorectal cancer testing, as documented by patient report.

The Family and Community Medicine and General Internal Medicine clinic databases will be used to identify potentially eligible patients with upcoming scheduled appointments. Because physicians will be the unit of random assignment, patients will be coded before study invitation as potential participants in the intervention or the comparison group. A random sample of eligible intervention and comparison group patients will be selected for contact. Identified patients will be mailed letters from the practices and signed by their physicians requesting their participation. The letters will describe a "study of beliefs and practices about cancer prevention and early detection" and will provide a toll-free number to refuse contact. One week after the mailing, patients who have not called to refuse contact will be called by study staff to explain the study, verify eligibility and, if the patient agrees, to arrange an in-person meeting at the clinic 30 minutes prior to their appointment. These calls will be made by trained research assistants who will follow standard calling protocols. After consent, participants will complete the computerized data collection (CRIS) immediately prior to a scheduled primary-care appointment. Intervention group patients and their physicians will receive a printout recommending risk-appropriate colorectal testing and ways to overcome perceived barriers to testing. A member of the research team will hand the patient his or her printout and will deliver the other printout to the physician. Comparison group patients and physicians will receive non-tailored printouts that are simple reminders about testing.

The investigators will also establish a true no-contact control by conducting a retrospective chart review for randomly selected patients who did not receive an invitation to participate in the study. This no-contact control will establish a baseline screening rate. The investigators will then conduct analysis with the comparison and intervention group to see if individuals who participate in CRIS have a higher screening rate for colorectal cancer compared to the non-contact group. These additional data will help us better assess study Aims 1 and 2.

Facilitating Risk-Appropriate Colorectal Cancer Testing - Testing the Cancer Risk Intake System (CRIS)

Mixed-effects logistic regression model. Group assignment = main independent variable. Physician = random cluster effect.

Binary outcome values:

* Participation in any risk-appropriate CRIS-recommended test.
* Either no testing or participation in a non-recommended test (e.g., stool-based test for an individual whose risk profile indicated need for colonoscopy).

For patients assigned to the:

* Intervention group (i.e., tailored printout).
* Comparison group (i.e., non-tailored printout).

Mixed-effects logistic regression model. Group assignment = main independent variable. Physician = random cluster effect.

Binary outcome values:

* Participation in any testing.
* No participation in testing within 12 months.

For patients assigned to the:

* Intervention group (i.e., tailored printout).
* Comparison group (i.e., non-tailored printout).

Mixed-effects logistic regression model. Group assignment = main independent variable. Physician = random cluster effect. Age and gender = covariates.

Difference between patients assigned to:

* Use CRIS (i.e., intervention group = tailored printout and comparison group = non-tailored printout).
* True no-contact control group.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
An Interactive Preventive Health Record to Increase Colorectal Cancer Screening	NCT01885351	Colorectal Canc...	MyCRCS+Prefs MyCRCS+Prefs+Ba...	50 Years - 75 Years	Temple University
Effects of a Psycho-educational Intervention for Family Caregivers in Palliative Care	NCT02482415	Cancer	Psycho-educatio...	18 Years -	Ersta Sköndal University College
An Intervention Promoting HPV Vaccination in Safety-net Clinics	NCT01729429	Human Papilloma...	HPV brochure, r... General Adolesc...	11 Years - 18 Years	University of Texas Southwestern Medical Center
Facilitating Risk-Appropriate Colorectal Cancer Testing - Testing the Cancer Risk Intake System (CRIS)	NCT02368236	Colorectal Neop... Colonic Neoplas...	Tailored Printo...	25 Years - 75 Years	University of Texas Southwestern Medical Center
An Interactive Preventive Health Record to Increase Colorectal Cancer Screening	NCT01885351	Colorectal Canc...	MyCRCS+Prefs MyCRCS+Prefs+Ba...	50 Years - 75 Years	Temple University
An Intervention Promoting HPV Vaccination in Safety-net Clinics	NCT01729429	Human Papilloma...	HPV brochure, r... General Adolesc...	11 Years - 18 Years	University of Texas Southwestern Medical Center
Effects of a Psycho-educational Intervention for Family Caregivers in Palliative Care	NCT02482415	Cancer	Psycho-educatio...	18 Years -	Ersta Sköndal University College
Facilitating Risk-Appropriate Colorectal Cancer Testing - Testing the Cancer Risk Intake System (CRIS)	NCT02368236	Colorectal Neop... Colonic Neoplas...	Tailored Printo...	25 Years - 75 Years	University of Texas Southwestern Medical Center

Spots Global Cancer Trial Database for intervention studies