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NCT03345264 · ClinicalTrials.gov registry record · NA
The Find Your PATHS (Pragmatic Assessment of a Tool to Help Survivors) to Sexual Health and Parenthood Study
A NA study of Cancer-related Problem/Condition and Fertility, sponsored by American Cancer Society.
- Completed
- Registry status
- NA
- Development phase
- 361
- Enrollment target
- 1
- Study location
NCT03345264 is a NA study of Cancer-related Problem/Condition and Fertility that has completed, run by American Cancer Society. The registered enrollment target is 361 participants, above the 78-participant average among 10 other Cancer-related Problem/Condition trials with a reported enrollment target (363% higher). The trial reports 1 study location across 1 state.
The verdict
NCT03345264, a NA study of Cancer-related Problem/Condition and Fertility, has completed, sponsored by American Cancer Society.
- COMPLETED
- Registry status
- NA
- Development phase
- 361 participants
- Enrollment target
- 1
- Study location
Study 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 uni
Conditions Studied
Interventions
- BEHAVIORAL Online, interactive self-help program
Study Locations (1)
Texas
- Will2Love, LLC - Houston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 361 participants |
| Start Date | 2017-10-02 |
| Est. Completion | 2018-12-11 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03345264
The ClinicalTrials.gov registry entry for NCT03345264 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 361 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 78-participant average among 10 other Cancer-related Problem/Condition trials with a reported enrollment target (363% higher). The listed sponsor is American Cancer Society, which has 2 total studies on file at ClinicalTrials.gov.
The record links to 3 conditions, with Cancer-related Problem/Condition appearing as the primary indexed condition, and to 1 intervention - of which Online, interactive self-help program is the first listed.
NCT03345264 reports 1 study location spanning 1 distinct geographic area - top geographies include Texas.
Frequently Asked Questions
What is clinical trial NCT03345264 about?
NCT03345264 is a clinical study titled "The Find Your PATHS (Pragmatic Assessment of a Tool to Help Survivors) to Sexual Health and Parenthood Study". 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...
What is the current status of trial NCT03345264?
This trial is currently completed. It is a NA study. The enrollment target is 361 participants. The study started on 2017-10-02. Estimated completion is 2018-12-11.
What conditions does trial NCT03345264 study?
This clinical trial studies the following conditions: Cancer-related Problem/Condition, Fertility, Sexuality.
What interventions are being tested in trial NCT03345264?
The interventions under investigation include: Online, interactive self-help program (BEHAVIORAL).
Who is sponsoring clinical trial NCT03345264?
This trial is sponsored by American Cancer Society, which has 2 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03345264 being conducted?
This trial has 1 study location across Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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