Clinical trial NCT03345264: The Find Your PATHS (Pragmatic Assessment of a Tool to Help Survivors) to Sexual Health and Parenthood Study
Official title: The Find Your PATHS (Pragmatic Assessment of a Tool to Help Survivors) to Sexual Health and Parenthood Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cancer-related Problem/Condition
Sexuality
Fertility
Keywords: Sexual Dysfunction
Fertility Disorders
Cancer
Lead sponsor: American Cancer Society, Inc.
Sponsor class: OTHER
Collaborators: name: Will2Love, LLC
First posted: 2017-11-17
Enrollment: 361
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: Concerns with sexual health and fertility are common among cancer patients, survivors and their partners. Literature reviews suggest that over 60% of survivors have reproductive health problems yet fewer than 20% get professional help. This study will test the uptake, use and effectiveness of online, interactive self-help programs for men and women with cancer. Participants in the study will receive up to 6 months of access to the self-help programs without charge. Navigation through the programs can be personalized by setting goals and following links to the most relevant information. The programs cover all cancer sites and common treatments, explaining sexual and fertility side effects. Programs also include step-by-step cognitive behavioral self-help exercises, guidance on available medical treatment options, decision aids, and video stories with actual survivors as well as vignettes with actors. Information for same-sex couples is included. Programs include suggestions on how partners can work together to cope with sexual or fertility issues.

The primary hypothesis is that participants will report improvements in sexual function and satisfaction from baseline to 3-month follow-up. Secondary hypotheses will investigate whether more extensive use of the program is associated with better outcomes (dose-response effect) and whether the intervention also improves secondary outcomes such as anxiety, depression, relationship satisfaction, and seeking medical help. Analyses from the data will investigate how many people who are informed of the study decide to participate (uptake), as well as how often participants visit the program and which parts are used most. Both the male and female programs have previously been shown to help cancer survivors and partners in published clinical trials.

Participants will be encouraged to invite a sexual partner to join the study, but that will be optional. Partners will be able to be linked for statistical analysis through their unique study identification numbers. Participants' use of the websites will be electronically tracked and compared with questionnaire outcome measures. Outcome measures include online, self-report questionnaires completed at baseline and 3-month follow-up. At 6-month follow-up, participants will complete 2 online ratings of the helpfulness of the programs. Privacy and security are carefully protected. The entire website meets standards for HIPAA (Health Insurance Portability and Accountability Act). Questionnaires are identified with study numbers rather than names or email addresses. Once the study data are analyzed, the list linking participant identifying information (names, email) and study numbers will be destroyed. Any publications resulting from the study will discuss group data and will not contain any information that could be used to identify an individual participant.


Eligibility criteria: Inclusion Criteria:

* Has had a diagnosis of cancer or is the intimate partner of a cancer patient/survivor
* Has a concern or wants to learn more about cancer-related issues with sexuality or fertility
* Has a way to access the website and questionnaires on the internet

Exclusion Criteria:

* Younger than age 18
* Does not read and understand English well enough to use the website independently
* Does not live in the United States
* Potential participant has already subscribed to the male or female self-help program

Primary outcomes:
measure: PROMIS® (Patient-Reported Outcomes Measurement Information System) Brief Sexual Profile v2 Male
timeFrame: Change from baseline to 3 months post consent
measure: PROMIS® (Patient-Reported Outcomes Measurement Information System) Brief Sexual Profile v2 Female
timeFrame: Change from baseline to 3 months post consent
Secondary outcomes:
measure: PROMIS® (Patient-Reported Outcomes Measurement Information System) Brief Anxiety Scale
timeFrame: Change from baseline to 3 months post consent
measure: PROMIS® (Patient-Reported Outcomes Measurement Information System) Brief Depression Scale
timeFrame: Change from baseline to 3 months post consent
measure: Abbreviated Dyadic Adjustment Scale-4
timeFrame: Change from baseline to 3 months post consent
Other outcomes:
Locations:
city: Houston
country: United States
facility: Will2Love, LLC
state: Texas
Study officials:
affiliation: American Cancer Society, Inc.
name: Tenbroeck Smith
role: PRINCIPAL_INVESTIGATOR
affiliation: Will2Love, LLC
name: Leslie Schover
role: PRINCIPAL_INVESTIGATOR
References: