The Find Your PATHS (Pragmatic Assessment of a Tool to Help Survivors) to Sexual Health and Parenthood Study (PATHS)

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.

Study Overview

• Status: Completed
• Conditions: Fertility; Sexuality; Cancer-related Problem/Condition
• Intervention / Treatment: Behavioral: Online, interactive self-help program

• Study Type: Interventional
• Enrollment (Actual): 361
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Texas
    • Houston, Texas, United States, 77025
      • Will2Love, LLC

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Cancer patients, survivors, and partners

Behavioral: Online, interactive self-help program; Participants will receive access to the program, which provides: In-depth information specific to cancer sites and treatments, guidance on medical options for cancer-related sex or fertility problems, personalized goal-setting with progress tracking and relapse prevention, self-help exercises on overcoming sexual, relationship, and dating problems, videos of survivors' stories, and video vignettes with actors.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
PROMIS® (Patient-Reported Outcomes Measurement Information System) Brief Sexual Profile v2 Male	Construct: Sexual function and satisfaction in men; Total Score Range: 0-33; Higher values represent a better outcome	Change from baseline to 3 months post consent
PROMIS® (Patient-Reported Outcomes Measurement Information System) Brief Sexual Profile v2 Female	Construct: Sexual function and satisfaction in women; Total Score Range: 0-49; Higher values represent a better outcome	Change from baseline to 3 months post consent

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
PROMIS® (Patient-Reported Outcomes Measurement Information System) Brief Anxiety Scale	Construct: General anxiety level; Total Score Range: 0-16; Higher scores represent a worse outcome	Change from baseline to 3 months post consent
PROMIS® (Patient-Reported Outcomes Measurement Information System) Brief Depression Scale	Construct: Depressed Mood; Total Score Range: 0-16; Higher scores represent a worse outcome	Change from baseline to 3 months post consent
Abbreviated Dyadic Adjustment Scale-4	Construct: Relationship happiness; Total Score Range: 0-21; Higher scores represent a better outcome	Change from baseline to 3 months post consent

Collaborators and Investigators

• Sponsor: American Cancer Society, Inc.
• Collaborators: Will2Love, LLC
• Investigators: Principal Investigator: Tenbroeck Smith, American Cancer Society, Inc.; Principal Investigator: Leslie Schover, Will2Love, LLC

Publications and helpful links

Helpful Links

• PATHS Study Enrollment Instructions

Study record dates

Study Major Dates

• Study Start (Actual): October 2, 2017
• Primary Completion (Actual): September 11, 2018
• Study Completion (Actual): December 11, 2018

Study Registration Dates

• First Submitted: November 13, 2017
• First Submitted That Met QC Criteria: November 15, 2017
• First Posted (Actual): November 17, 2017

Study Record Updates

• Last Update Posted (Actual): January 16, 2019
• Last Update Submitted That Met QC Criteria: January 15, 2019
• Last Verified: January 1, 2019

More Information

Terms related to this study

• Keywords: Cancer; Sexual Dysfunction; Fertility Disorders
• Other Study ID Numbers: PATHS IRB1094101

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No