Ignite Creation Date:
2024-05-06 @ 10:46 AM
Last Modification Date:
2024-10-26 @ 12:35 PM
Study NCT ID:
NCT03345264
Status:
COMPLETED
Last Update Posted:
2019-01-16
First Post:
2017-11-13
Brief Title:
The Find Your PATHS Pragmatic Assessment of a Tool to Help Survivors to Sexual Health and Parenthood Study
Sponsor:
American Cancer Society Inc
Organization:
American Cancer Society Inc
Study Overview
Official Title:
The Find Your PATHS Pragmatic Assessment of a Tool to Help Survivors to Sexual Health and Parenthood Study
Status:
COMPLETED
Status Verified Date:
2019-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PATHS
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
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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None