Cancer-related Problem/ConditionPATHSNCT03345264
The Find Your PATHS (Pragmatic Assessment of a Tool to Help Survivors) to Sexual Health and Parenthood Study
A study testing Online, interactive self-help program in people with Cancer-related Problem/Condition and Sexuality, run by American Cancer Society, Inc. at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cancer-related Problem/Condition, Sexuality, Fertility
- What is being tested?
- Online, interactive self-help program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 361 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Oct 2017to 11 Dec 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this 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, 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.
- Conditions
- Cancer-related Problem/Condition, Sexuality, Fertility
- Being tested
- Online, interactive self-help program
- Keywords
- Sexual Dysfunction, Fertility Disorders, Cancer
- Medical subject headings
- Sexuality, Sexual Dysfunction, Physiological, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Online, interactive self-help programBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Cancer patients, survivors, and partners | Experimental | Not described Receives: Behavioral: Online, interactive self-help program |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: Change from baseline to 3 months post consent
Secondary outcomes (3)
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
Measured: 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
Measured: 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
Measured: Change from baseline to 3 months post consent
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2017
- Study start2 Oct 2017
- Primary completion11 Sep 2018
- Study completion11 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cancer-related Problem/ConditionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 361 participants (actual)
Sponsor and investigators
- Lead sponsor
- American Cancer Society, Inc.
- Sponsor type
- University, hospital or other
- Collaborators
- Will2Love, LLC
- Responsible party
- Sponsor
- Investigators
- Tenbroeck Smith, Principal investigator, American Cancer Society, Inc.Leslie Schover, Principal investigator, Will2Love, LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03345264
- Sponsor's protocol ID
- PATHS IRB1094101
- Acronym
- PATHS
- Status last verified
- Jan 2019
- First submitted
- 13 Nov 2017
- Last updated
- 16 Jan 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Find Your PATHS (Pragmatic Assessment of a Tool to Help Survivors) to Sexual Health and Parenthood Study
- ClinicalTrials.gov ID
- NCT03345264
- Acronym / sponsor ID
- PATHS / PATHS IRB1094101
- Conditions
- Cancer-related Problem/Condition, Sexuality, Fertility
- Keywords
- Sexual Dysfunction, Fertility Disorders, Cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 361 participants (actual)
- Lead sponsor
- American Cancer Society, Inc.University, hospital or other
- Collaborators
- Will2Love, LLC
- Study start
- 2 Oct 2017 (actual)
- Primary completion
- 11 Sep 2018 (actual)
- Study completion
- 11 Dec 2018 (actual)
- First posted
- 17 Nov 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cancer patients, survivors, and partners | Experimental | Behavioral: Online, interactive self-help program |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Online, interactive self-help programParticipants 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. | Behavioural | Cancer patients, survivors, and partners |
Primary outcome
PROMIS® (Patient-Reported Outcomes Measurement Information System) Brief Sexual Profile v2 Male
Time frame: Change from baseline to 3 months post consent
Construct: Sexual function and satisfaction in men; Total Score Range: 0-33; Higher values represent a better outcome
PROMIS® (Patient-Reported Outcomes Measurement Information System) Brief Sexual Profile v2 Female
Time frame: Change from baseline to 3 months post consent
Construct: Sexual function and satisfaction in women; Total Score Range: 0-49; Higher values represent a better outcome
3 secondary outcomes
PROMIS® (Patient-Reported Outcomes Measurement Information System) Brief Anxiety Scale
Time frame: Change from baseline to 3 months post consent
PROMIS® (Patient-Reported Outcomes Measurement Information System) Brief Depression Scale
Time frame: Change from baseline to 3 months post consent
Abbreviated Dyadic Adjustment Scale-4
Time frame: Change from baseline to 3 months post consent
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jan 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tenbroeck Smith principal investigator
American Cancer Society, Inc.
Leslie Schover principal investigator
Will2Love, LLC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Online, interactive self-help program in people with Cancer-related Problem/Condition and Sexuality, run by American Cancer Society, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PROMIS® (Patient-Reported Outcomes Measurement Information System) Brief Sexual Profile v2 Male (time frame: Change from baseline to 3 months post consent). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jan 2019; AzTrials last refreshed its copy on 7 Nov 2026.