Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

All Conditions

Uterine Cervical Neoplasms

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

'Pap smear' arm: women are invited to participate in a preventive consultation. This consultation is followed by direct patient referral for Pap smear testing in a partner health facility.

'Self-collected vaginal swab for HPV testing + pap smear triage' arm : women are invited to participate in a preventive consultation. This consultation is followed by patient referral for Pap smear testing in a partner health facility if the HPV-HR test is positive.

A women who tests negative for HPV-HR can still be referred for further Pap smear testing, or can be referred for a gynaecological consultation for any other reason.

Women are invited to participate in a preventive consultation. Doctor of the World staff provides women with information in their mother tongue and uses visuals adressing cervical cancer, its causes and consequences and ways to prevent it.

This consultation is followed by direct patient referral for Pap smear testing in a partner health facility.

'Pap smear' arm

Women are invited to participate in a preventive consultation. Doctor of the World staff provides women with information in their mother tongue and uses visuals adressing cervical cancer, its causes and consequences and ways to prevent it.

This consultation is followed by patient referral for Pap smear testing in a partner health facility if the HPV-HR test is positive.

A women who tests negative for HPV-HR can still be referred for further Pap smear testing, or can be referred for a gynaecological consultation for any other reason.

'Self-collected vaginal swab for HPV testing + pap smear triage' arm

Philippe de Botton

Every year, in France, 3 000 women are diagnosed with cervical cancer, and 1 000 die each year. Recent studies highlighted regional, social and economical inequalities with respect to cervical cancer incidence.

In France, the pap-smear test is currently the reference test in order to screen for cervical cancer and neoplasia (CIN). Screening and treatment reduced the incidence and the mortality due to cervical cancer by half in the two last decades. That said, many women are still not reached by prevention programs, especially women living in precarious conditions. In 2013, Doctors of the World France estimated that almost 70% of women aged 25 to 65 years old visiting its medical facilities had never had of a pap-smear test.

The main study objectives are :

Primary objective

To compare the proportion of individuals with abnormal cytology across two screening strategies in order to determine which strategy detects a greater proportion of individuals with abnormal cytology.

These two strategies consist of a preventive consultation followed by:

1. Direct patient referral for Pap smear testing in a partner health facility ('Pap smear' study arm)
2. An invitation to perform a self-collected vaginal swab for HPV-HR testing followed by patient referral for Pap smear testing in a partner health facility if the HPV-HR test is positive\* ('self-collected vaginal swab for HPV-HR testing + Pap smear triage' study arm) \*A women who tests negative for HPV-HR can still be referred for further Pap smear testing, or can be referred for a gynaecological consultation for any other reason.

First of secondary objectives:

To evaluate the proportion of individuals who completed cervical cancer screening in each study arm in order to determine which strategy resulted in greater screening participation.

The above clarification of the study objectives and the related changes in the study protocole have been approved by the Comité de Protection des Personnes Ile de France IV.

Woman aged 25 to 65 years old met within one of Doctors of the World participating programs will be offered to attend a preventive consultation adressing sexual and reproductive health, and cervical cancer screening. Seven programs are taking part in this study (medical facilities and mobile health programs) in four french cities. Those programs aim to facilitate access to care for people who do not seek or have little access to health services and preventive health measures (lack of health insurance, living far from health services, knowing little about preventive health and how the health system works in France).

These two cervical screening strategies consist of a preventive consultation followed by:

1. Direct patient referral for Pap smear testing in a partner health facility ('Pap smear' study arm)
2. An invitation to perform a self-collected vaginal swab for HPV-HR testing followed by patient referral for Pap smear testing in a partner health facility if the HPV-HR test is positive\* ('self-collected vaginal swab for HPV-HR testing + Pap smear triage' study arm) \* A women who tests negative for HPV-HR can still be referred for further Pap smear testing, or can be referred for a gynaecological consultation for any other reason.

The inclusion of participants in one or the other study arm will be done through randomization. There will be 11 one-month periods during wich women are invited to perform a self-collected vaginal swab and 11 one-month periods during which women are directly referred to a partner health facility for Pap smear testing. Each one-month period with an invitation to perform a self-collected vaginal swab is followed by a one-month period with direct patient referral for Pap smear testing. The allocation of the starting period has been randomized for each participating program.

Doctors of the World staff who will be offering this preventive health consultation received a specific training adressing sexual and reproductive health topics, cervical screening and counseling approaches. Illustrated tools have been specially developed for this purpose. Professional translators will be sought when needed.

The two strategies consist of a preventive consultation followed by:

1. Direct patient referral for Pap smear testing in a partner health facility ('Pap smear' study arm)
2. An invitation to perform a self-collected vaginal swab for HPV-HR testing followed by patient referral for Pap smear testing in a partner health facility if the HPV-HR test is positive\* \* A women who tests negative for HPV-HR can still be referred for further Pap smear testing, or can be referred for a gynaecological consultation for any other reason.

('self-collected vaginal swab for HPV-HR testing + Pap smear' triage study arm)

Improving Access to Cervical Cancer Screening

Improving Access to Cervical Cancer Screening for Women Living in Precarious Conditions Met Within Doctors of the World Programs

Comparison of the proportion of women with abnormal cytology in each study arm

Comparison of the proportion of women who completed cervical screening in each study arm

Comparison of the proportion of women who acquired a specific set of knowledge before and after the preventive consultation, using the same five-item questionnaire

Comparisons of medical, socio-demographical and educational characteristics of women who completed screening with that of women who did not.

National Cancer Institute, France

Médecins du Monde

Skin and Connective Tissue Diseases

Blood and Lymph Conditions

Immune System Diseases

Rare Diseases

Breast Neoplasms

Lymphoma

Hodgkin Disease

Neoplasms by Histologic Type

Lymphoproliferative Disorders

Lymphatic Diseases

Immunoproliferative Disorders

Breast Diseases

Skin Diseases

Lymphosarcoma

Hodgkin Lymphoma

Bone Density Conservation Agents

Antineoplastic Agents

All Drugs and Chemicals

Tamoxifen

This study is a prospective, observational, longitudinal study assessing the prevalence of sexual dysfunction and distress in premenopausal and postmenopausal women with breast cancer. This study will also evaluate the severity, time course, and predictors of sexual dysfunction. Breast cancer patients and survivors will be administered surveys of comprehensive questionnaires related to sexual function. In the case that participants miss the follow up questionnaires, study staff may contact the patient by phone to request and record the patients" responses. The study staff may also mail the missed questionnaires to each patient.

This study is a prospective, observational, longitudinal study assessing the prevalence of sexual dysfunction and distress in premenopausal and postmenopausal women with Diffuse Large B-cell Lymphoma or Hodgkin's Lymphoma. This study will also evaluate the severity, time course, and predictors of sexual dysfunction. Lymphoma patients and survivors will be administered surveys of comprehensive questionnaires related to sexual function. In the case that participants miss the follow up questionnaires, study staff may contact the patient by phone to request and record the patients" responses. The study staff may also mail the missed questionnaires to each patient.

A survey including the Female Sexual Function Index (FSFI), the Modified Female Sexual Function Index (FSFI-M), the Modified Female Sexual Function Index Follow-Up (FSFI-M Follow-Up) the Sexual Activity Questionnaire (SAQ), the Female Sexual Distress Scale (FSDS-R), the Menopausal Symptom Check List (MSCL), Patient-reported Outcomes Measurement Information System Sexual Function Instrument (PROMIS-SF), Abbreviated Dyadic Adjustment Scale for Relationships (ADAS), Reproductive Health Survey-baseline (RHS-B). Reproductive Health Survey-followup and (RHS-F1)Reproductive Health Survey-followup (RHS-F2) will be conducted at the following intervals: baseline/before chemotherapy +/- 1 month, 3 months after baseline +/- 1 month, 6 months after baseline +/- 1 month, 1 year after baseline +/- 1 month, and at intervals during survivorship that include yearly for 5 years +/- 2 months.

surveys

Those patients receiving chemotherapy who consent to the optional blood draw will provide blood at baseline (before start of chemotherapy), 12 months after baseline (+/-1 month) and 24 months after baseline (+/-2 months). All patients in the subset of the premenopausal cohort receiving tamoxifen only will have required blood draws at baseline (before they begin taking tamoxifen), at 6 months post-baseline/start of tamoxifen (+/- 2 weeks), 12 months post-start of tamoxifen (+/-1 month) and 24 months post-start of tamoxifen (+/-2 months). We will ask these participants for blood draws on day 1, 2, 3 or 4 of their menses at baseline and 6 months post-baseline/start of tamoxifen and during months 1 through 5 post-baseline/start of tamoxifen.

Blood draw

Transvaginal ultrasounds are used to determine the number of antral follicles in each ovary. They will be performed to evaluate both the number and size of antral follicles of premenopausal women on Tamoxifen as antral follicle count is a good predictor of ovarian reserve and response. All patients in the subset of the premenopausal cohort receiving tamoxifen only will also have required transvaginal ultrasounds at baseline (before they begin taking tamoxifen) and at 6 months post-start of tamoxifen (+/- 2 weeks).

Transvaginal ultrasounds

Shari Goldfarb, MD

Jeanne Carter, MD

The purpose of this study is to see how cancer treatment affects sexual and reproductive function. The patient will also be asked to participate in blood draws to see if and how cancer treatment affects the ovaries and the ability to have children (fertility). These blood draws are optional and the patient can still participate in the questionnaire portion of the study even if they choose not to have their blood drawn.

Longitudinal Sexual and Reproductive Health Study of Women With Breast Cancer and Lymphoma

Before treatment and family building after treatment

Memorial Sloan Kettering Cancer Center

Infections

Respiratory Tract (Lung and Bronchial) Diseases

COVID-19

Coronavirus Infections

A tailored HPV education and professional skills intervention.

General/publicly available educational materials on HPV and communication skills.

The provider education and professional skills intervention will involve audio and visual content and will be delivered in the English language.

Tailored HPV Education and Professional Skills Intervention Group

The general provider education intervention will involve audio and visual content and will be delivered in the English language.

General HPV Education and Communication Skills Control Group

Kristin Gosselink, PhD

Eva M Moya, PhD, LMSW

Burrell College Office of Research and Sponsored Programs

Border Biomedical Research Center

UTEP Institutional Review Board

Gabriel A Frietze, PhD

Margie M Padilla, PharmD

Jacob Martinez, PhD, RN

Jacquelin Cordero, LMSW

Healthcare providers (HCP) serving the El Paso U.S.-Mexico Border Region will be recruited to compare educational and professional skills interventions focused on the human papillomavirus (HPV). Our hypothesis is that improving provider knowledge and communication strategies about HPV and its vaccine will reduce hesitancy and increase uptake and completion among the populations they serve.

A sample of emerging \[in training\] and current \[in practice\] health professionals from the El Paso U.S.-Mexico Border Region will be recruited to participate in a human papillomavirus (HPV) educational and professional skills intervention. Hypothesis: improving provider knowledge and communication strategies about HPV and its vaccine will reduce hesitancy and increase uptake and completion among eligible individuals through a tailored multi-media intervention to strengthen providers' ability to discuss HPV and vaccination in an informed and culturally competent manner, and increase subsequent provider recommendations.

A parallel trial design will be used to examine the effectiveness of a tailored HPV education and professional skills intervention. Emerging and current healthcare providers will be randomly assigned to one of two conditions: 1) treatment condition in which they will receive a tailored Education and Professional Skills Intervention, and 2) control condition in which they will receive general, publicly available information about HPV and communication skills. Participants will then be followed over time and the responses will be compared between groups.

* Participants \[blinding\]: participants will be randomly assigned to treatment and control groups, they will not be made aware of other participant's receipt of treatment or control materials. Participants will be asked not to discuss this project outside of the intervention; delivery of the intervention or other educational materials will be virtual, limiting the ability of participants to interact with one another during the study.
* Outcome assessor \[blinding\]: to reduce bias in the implementation and assessment of the clinical trial, participant information and pre-post survey responses will be maintained separately from the assignment and delivery of the intervention.

Healthcare Provider Human Papillomavirus Education and Professional Skills Intervention

Implementing Innovative and Strategic Approaches to Prevent and Mitigate the Deleterious Effects of HPV Across the Lifespan of Hispanics of Mexican Origin: Healthcare Provider Intervention

Collected deidentified individual participant data (IPD), all IPD that underlie results in a publication.

8-item HCP Practices scale (HCP vaccine recommendations, HCP screening recommendations, HCP communication practices) scored on a Likert scale from Never (1) to Always (5)

9-item HPV Vaccine Attitudes scale (perceived safety, perceived harm, perceived effectiveness) scored on a Likert scale from Strongly disagree (1) to Strongly agree (5)

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Improving Access to Cervical Cancer Screening	NCT03118258	Uterine Cervica...	'Pap smear' arm 'Self-collected...	25 Years - 65 Years	Médecins du Monde
Longitudinal Sexual and Reproductive Health Study of Women With Breast Cancer and Lymphoma	NCT01788839	Breast Cancer Lymphoma Hodgkin's Lymph...	surveys Blood draw Transvaginal ul...	18 Years -	Memorial Sloan Kettering Cancer Center
Healthcare Provider Human Papillomavirus Education and Professional Skills Intervention	NCT05120869	Health Personne... Health Knowledg...	Tailored HPV Ed... General HPV Edu...	18 Years - 65 Years	University of Texas, El Paso
Improving Access to Cervical Cancer Screening	NCT03118258	Uterine Cervica...	'Pap smear' arm 'Self-collected...	25 Years - 65 Years	Médecins du Monde
Improving Access to Cervical Cancer Screening	NCT03118258	Uterine Cervica...	'Pap smear' arm 'Self-collected...	25 Years - 65 Years	Médecins du Monde
Healthcare Provider Human Papillomavirus Education and Professional Skills Intervention	NCT05120869	Health Personne... Health Knowledg...	Tailored HPV Ed... General HPV Edu...	18 Years - 65 Years	University of Texas, El Paso
Longitudinal Sexual and Reproductive Health Study of Women With Breast Cancer and Lymphoma	NCT01788839	Breast Cancer Lymphoma Hodgkin's Lymph...	surveys Blood draw Transvaginal ul...	18 Years -	Memorial Sloan Kettering Cancer Center
Longitudinal Sexual and Reproductive Health Study of Women With Breast Cancer and Lymphoma	NCT01788839	Breast Cancer Lymphoma Hodgkin's Lymph...	surveys Blood draw Transvaginal ul...	18 Years -	Memorial Sloan Kettering Cancer Center

Spots Global Cancer Trial Database for sexual and reproductive health