The Find Your PATHS (Pragmatic Assessment of a Tool to Help Survivors) to Sexual Health and Parenthood Study
Status: | Completed |
---|---|
Conditions: | Cancer, Cancer, Women's Studies |
Therapuetic Areas: | Oncology, Reproductive |
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 1/18/2019 |
Start Date: | October 2, 2017 |
End Date: | December 11, 2018 |
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.
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.
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
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