Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Breast Neoplasms

Group of participants receiving the RISE intervention

Group receiving no intervention in first 6 weeks.They will have the option of participating in the RISE program after their second assessment at week 6.

Intervention will consist of 3 sessions over 6 weeks. Each session will last 2 hours and be conducted with a clinical psychologist or medical social worker. The intervention content include psycho-education, communication training between the couple, and exercises to foster intimacy. A therapy manual will be developed to ensure program delivery fidelity. A folder with session summaries will be provided to the participants.The intervention content include psycho-education, communication training between the couple, and exercises to foster intimacy. A therapy manual will be developed to ensure program delivery fidelity. A folder with session summaries will be provided to the participants.

RISE

Irene Teo, Ph.D.

Fang Ting Pan, BS

Komal Tewani, MD

Irene Teo, PhD

Disturbances in marital intimacy and sexual health is one of the most underrated and undertreated problems in cancer survivorship. A review on unmet supportive care needs of cancer patients noted one third to more than half of patients reported support for sexual disturbances as an area of unmet need during and after treatment. Patients, whose sense of femininity and body image may be at risk, such as in the case of breast and gynaecologic cancers, may be more susceptible to such intimacy and sexual disturbances. According to a recent study conducted in Singapore, 25% of gynaecologic cancer patients reported dissatisfaction with their bodies and 19% reported feeling less sexually attractive. Unfortunately, there is paucity in formal resources for couples counselling within the oncology setting in Singapore. The current study seeks to investigate a pilot program called Renewing Intimacy and Sexuality (RISE), which consists of 3 sessions with female cancer patients and their spouses, and that combine components of psychosexual education, communication training and skills building. The reach, acceptability, implementation, and preliminary effectiveness of the RISE program will be assessed based on the RE-AIM framework for program planning. The overall aim of the research project is to establish evidence-based programs for cancer survivors to enhance their quality of life.

This is a multi-site, randomized controlled, pilot intervention study. Patients seen in outpatient clinics in the Department of Gynaecologic Oncology at KKH Women and Children's Hospital (KKH) and the breast team within the Division of Medical Oncology at National Cancer Centre (NCC) will be recruited to participate. Patients who meet pre-screen criteria will be invited to complete a self-report screener of marital and sexual well-being. Those who are eligible for the study and indicate interest will be contacted to participate in the RISE program. Study participants will sign an informed consent before being given a pre-treatment assessment and being randomized using an opaque, sealed envelope system to receive either (i) the RISE program or (ii) Standard Care. Those in the Standard Care group will have the option of participating in the RISE program after their second pre-treatment assessment to ensure all participants are given the opportunity to receive the program. Randomization is stratified by cancer (i.e., gynaecologic vs breast) and occur in permuted blocks. At the end of participation in the RISE program, all participants will be given a post-treatment assessment. Spouse of the participants will be invited to participate in the study. Those who agree will complete a pre-treatment survey similar to the patient participant and attend the 3 sessions with the patient, and complete a post-treatment assessment similar to the patient's.

The RISE Intervention consists of 3 sessions which will last 2 hours each and be conducted with a clinical psychologist or medical social worker with experience with couples counseling. The intervention content include psycho-education, communication training between the couple, and exercises to foster intimacy. A therapy manual will be developed to ensure program delivery fidelity. A folder with session summaries will be provided to the participants.

Marital Satisfaction and Sexual Health of Female Cancer Patients in Singapore

Renewing Intimacy and Sexuality (RISE): A Pilot Program to Support Marital Intimacy and Sexual Health of Female Cancer Patients in Singapore

Measured by proportion of those who enrol to those who are eligible to participate.

Measured by participant rated satisfaction with the program using the Client Satisfaction Questionnaire

Measured by participant's willingness to pay for the program.

Obtained by conducting semi-structured interviews with participants at program completion.

Measured by change in relationship well-being using the Dyadic Adjustment Scale-10

Duke-NUS Graduate Medical School

Assistant Professor

Digestive System Diseases

Colorectal Neoplasms

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Colonic Diseases

Intestinal Diseases

Rectal Diseases

Educational Intervention via DVD: In this arm of the intervention participants watch a tailored interactive DVD program and answer questions posed by the DVD program.

Educational Intervention-DVD \& Telephone based Navigation: In this arm of the intervention participants watch a TIDVD and are called by a patient navigator.

Educational Intervention via brochure: In this arm of the intervention participants receive brochures that explain and provide information and encouragement for cancer screening.

Educational Intervention via brochure:

In this arm of the educational intervention the participant receives brochures

Educational Intervention via brochure

Educational Intervention via DVD: In this arm of the educational intervention the participant receive a tailored interactive DVD to watch

Educational Intervention via DVD

Educational Intervention via Telephone-Based Navigation: In this arm of the educational intervention the participant receives a tailored interactive DVD to watch and telephone calls from a patient navigator

Educational Intervention-DVD & Telephone Based Navigation

Electra Paskett, PhD

Victoria Champion, PhD

This randomized clinical trial studies how well a tailored interactive digital versatile disc (DVD) with or without patient navigation works in improving screening rates in rural women for breast cancer, cervical cancer or colorectal cancer. A tailored interactive DVD and patient navigation may help rural women to learn more about cancer screening and to better understand the results.

PRIMARY OBJECTIVES:

I. Compare the effectiveness of a tailored and interactive DVD (TIDVD) versus (vs.) TIDVD + telephone-based patient navigation (PN) intervention (TIDVD + PN) vs. usual care (UC), to increase guideline-based cancer screening rates at 12 months post randomization for breast cancer (BC), cervical cancer (CC), and colorectal cancer (CRC) among 1058 women age 50 to 74 living in rural northwest Ohio and northeast Indiana.

II. Compare the cost effectiveness of the TIDVD and the TIDVD + PN intervention vs. UC, for adherence to each screening outcome or combination of screening tests.

OUTLINE: Patients are randomized to 1 of 3 arms.

Arm I: Patients watch a tailored interactive DVD program and answer questions posed by the DVD program.

Arm II: Patients engage in TIDVD and PN.

Arm III: Patients receive brochures that explain and provide encouragement for cancer screening.

After completion of the study, patients are followed up at 2 and 12 months.

Rural Interventions for Screening Effectiveness

Comparative Effectiveness of Interventions to Improve Screening Among Rural Women

These data will only be used to characterize/compare the group individual to those who are eligible and agree to participate; with those who are ineligible and will not be shared after the completion of the study with other researchers.

Will be tested initially with pair-wise chi-square tests. Binary logistic regression analysis will be used to compare the two interventions and the UC group on the binary dependent variable (adherence), while adjusting for any potentially confounding covariates. The models will be controlled for any demographic covariate (e.g., age, education) for which the randomized groups differ significantly at baseline using a liberal significance level of 0.20 to achieve conservative adjustment. As a sensitivity analysis, multiple imputation will be used to impute the adherence outcome for participants.

Cost-effectiveness analysis (CEA) implies a comparison of whether the cost per unit of outcome in one situation exceeds that in another. Unless the outcome measures are comparable, this is not possible. Will be able to examine outcomes of the interventions and the UC group (participants who up to date with all three cancer screening guidelines at 12 month follow-up). CEA will consist of measuring the incremental cost of achieving the observed incremental outcomes, but not a cost-effectiveness ratio in standard terms.

In the model implemented in this study, the patient navigators spend full time in that activity. Thus, the costs of implementation are straightforward and obtainable. Even though the navigator is full-time, data were collected concerning broad categories of time use through a structured time log so that the cost of specific components (e.g., arranging transportation) can be estimated more accurately. A developed Participant Encounter Form and a Tracking Log of Direct Participant Contacts were used to provide the majority of this information.

National Cancer Institute (NCI)

Ohio State University Comprehensive Cancer Center

Principal Investigator

TIDVD: In this arm of the intervention participants watch a tailored interactive DVD program and answer questions posed by the DVD program.

Arm I Tailored and Interactive Digital Versatile Disc (DVD) (TIDVD)

TIDVD,PN: In this arm of the educational intervention the participant receives a tailored interactive DVD to watch and telephone calls from a patient navigator

Arm II TIDVD and Patient Navigation (PN) (TIDVD, PN)

UC: In this arm of the intervention participants receive brochures that explain and provide information and encouragement for cancer screening.

Arm III Usual Care (UC)

Educational Intervention via DVD: In this arm of the intervention participants watch a tailored interactive DVD program and answer questions posed by the DVD program.

Educational Intervention via DVD: Educational Intervention via DVD: In this arm of the educational intervention the participant receive a tailored interactive DVD to watch

ARM I (TIDVD)

Educational Intervention-DVD \& Telephone based Navigation: In this arm of the intervention participants watch a TIDVD and are called by a patient navigator.

Educational Intervention-DVD \& Telephone Based Navigation: Educational Intervention via Telephone-Based Navigation: In this arm of the educational intervention the participant receives a tailored interactive DVD to watch and telephone calls from a patient navigator

ARM II (TIDVD, PN)

Educational Intervention via brochure: In this arm of the intervention participants receive brochures that explain and provide information and encouragement for cancer screening.

Educational Intervention via brochure: Educational Intervention via brochure:

In this arm of the educational intervention the participant receives brochures

ARM III (UC)

Total

Age at consent

Nineteen participants (7 TIDVD, 5 TIDVD,PN, 7 UC) who enrolled and participated in the program were determined to be ineligible through additional cancer screening information obtained via exit medical record review. Two participants in the TIDVD,PN Arm withdrew and asked that their data not be used. Exit medical record data was unable to be obtained for one Usual Care participant. These 22 were excluded from analyses.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Marital Satisfaction and Sexual Health of Female Cancer Patients in Singapore	NCT03420547	Gynecologic Can... Breast Cancer	RISE	21 Years - 100 Years	Duke-NUS Graduate Medical School
Rural Interventions for Screening Effectiveness	NCT02795104	Breast, Cervica...	Educational Int... Educational Int... Educational Int...	50 Years - 74 Years	Ohio State University Comprehensive Cancer Center
Rural Interventions for Screening Effectiveness	NCT02795104	Breast, Cervica...	Educational Int... Educational Int... Educational Int...	50 Years - 74 Years	Ohio State University Comprehensive Cancer Center
Rural Interventions for Screening Effectiveness	NCT02795104	Breast, Cervica...	Educational Int... Educational Int... Educational Int...	50 Years - 74 Years	Ohio State University Comprehensive Cancer Center

Spots Global Cancer Trial Database for rise

Every month we try and update this database with for rise 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 rise

Every month we try and update this database with for rise 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 rise 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.