Sexual DisfunctionNCT02702453
True NTH Sexual Recovery Intervention for Prostate Cancer Survivors and Their Partners
A study testing website in people with Sexual Disfunction and Prostate Cancer, run by University of Michigan at 1 site in United States.
Trial summary
There is increasing evidence that sexual activity is associated with greater resilience and higher well-being in older adults. Even at a time of stress, and even during a late stage of illness, men and their partners turn to sexual intimacy to increase a sense of connection, comfort and support. Read more about this study
- Who is it for?
- Ages 18 years and older, men onlyHealthy volunteers can take part
- Conditions the study is for
- Sexual Disfunction, Prostate Cancer
- What is being tested?
- website
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 251 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2016to Nov 2019
- 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
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients diagnosed with localized prostate cancer who are about to receive definitive treatment with either radiation with or without ADT (androgen deprivation therapy) or prostatectomy AND who also have a spouse or been in a committed relationship with their partner for at least 6 months who is willing to participate in the study. Both parties are required to sign an informed consent, able to speak or read English, have reliable internet access,have their own e-mail address, or be willing to sign up for a new one, and must be 18 years of age or older. The participants must be consented at least two weeks prior to the start of treatment, so that participants will have enough time to complete a baseline survey and access the first module of the intervention.
Who cannot join
- Anyone unable to speak or read English, unwilling to sign an informed consent, under the age of 18, or people without internet access will be excluded from the study.
Trial locations and contacts
1 site in 1 country.
About this study
There is increasing evidence that sexual activity is associated with greater resilience and higher well-being in older adults. Even at a time of stress, and even during a late stage of illness, men and their partners turn to sexual intimacy to increase a sense of connection, comfort and support. The Sexual Recovery intervention seeks to address an unmet need of prostate cancer survivors and their partners who are at risk for poor mental health and decreased quality of life as a result of sexual dysfunction.
By using technology, the intervention will be widely accessible to survivors, the majority of whom do not currently have any access to sexual health expertise. The content and format of the intervention seeks to empower prostate cancer survivors and partners with knowledge and strategies to improve their sexual function, sexual confidence and their sexual relationship. The intervention begins prior to and continues following their definitive treatment. This may, in turn, improve mental health and quality of life.
In a broader sense, this intervention will be transferable. With appropriate modifications, it can become an accessible sexual health intervention for populations dealing with other cancers and chronic illnesses.
Read the detailed description
This proposal is innovative in a number of ways:
- The intervention is based on a full understanding of the complex nature of sexuality with its bio- (functional), psycho- (confidence), and social (relationship components). It incorporates modules that address each of these factors and their inter-dependencies.
- The intervention is sensitive to critical points in sexual recovery and to patient and partner preferences in the context of therapies for prostate cancer. The intervention acknowledges that there are certain time points at which concerns typically arise (e.g., when preparing for definitive treatment). The effectiveness of the intervention is increased by the use of tailoring linked to patient reported outcomes (e.g., decreased erectile function, increases in depression indices) and to patient/partner preferences.
- The intervention includes partners as equal stakeholders in the sexual recovery and legitimizes their needs for sexual fulfillment and support
- The intervention demonstrates a sensitivity to sexual orientation and cultural diversity
- The intervention is scalable and available at limited or no cost to prostate cancer survivors and their partners regardless of geographical location or system of care.
- Conditions
- Sexual Disfunction, Prostate Cancer
- Being tested
- website
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
websiteBehavioural
The intervention arm will consist of 12 modules, 8 of which are consistent with the trajectory of prostate cancer and its treatment. Four modules address aspects of the prostate cancer experience that are important for patients and partners as well as providers and are designed to optimize the goal of supporting patients and partners in their sexual recovery.
| Study group | Role | What they receive |
|---|---|---|
| Development and Testing | Experimental | Develop an online interactive, tailored intervention to address the needs of men and partners interested in sexual recovery after treatment for localized prostate cancer during the first 6 months after treatment. The intervention will undergo content testing through 4 focus groups with prostate cancer survivors and partners and usability testing with 5 survivors and partners Receives: Behavioral: website |
What is being measured
The primary outcome is the main question the study is designed to answer.
PROMIS (Patient-Reported Outcomes Measurement Information System) Sexual Satisfaction
The primary outcome is PROMIS (Patient-Reported Outcomes Measurement Information System) Sexual Satisfaction. Basing power calculation on the average adjusted score (50) and standard deviation (10) provided in the PROMIS scoring, anticipating Sexual Satisfaction scores for the intervention group vs control group to be 50 vs 45, using a two-tailed t-test, power of 80%, and significance level of 0.05, it is expected this study will recruit 128 patients and 128 partners.
Measured: 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2016 (estimated)
- Study startMar 2016
- Primary completionNov 2019
- Study completionNov 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Sexual DisfunctionStudies of the same condition, open and under way.
- More trials run by University of MichiganThe sponsor's other registered studies.
- 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
- 251 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Collaborators
- Emory University, Movember Foundation, Johns Hopkins University, Memorial Sloan Kettering Cancer Center, University of California, Los Angeles, University of North Carolina
- Responsible party
- Principal investigator, Daniela Wittmann, University of Michigan
- Investigators
- Daniela Wittmann, PhD, Principal investigator, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02702453
- Sponsor's protocol ID
- HUM00107048
- Status last verified
- Jan 2020
- First submitted
- 3 Mar 2016
- Last updated
- 22 Jan 2020
- Results posted
- No
Publications
Wittmann D, Mehta A, Northouse L, Dunn R, Braun T, Duby A, An L, Arab L, Bangs R, Bober S, Brandon J, Coward M, Dunn M, Galbraith M, Garcia M, Giblin J, Glode M, Koontz B, Lowe A, Mitchell S, Mulhall J, Nelson C, Paich K, Saigal C, Skolarus T, Stanford J, Walsh T, Pollack CE. TrueNTH sexual recovery study protocol: a multi-institutional collaborative approach to developing and testing a web-based intervention for couples coping with the side-effects of prostate cancer treatment in a randomized controlled trial. BMC Cancer. 2017 Oct 2;17(1):664. doi: 10.1186/s12885-017-3652-3.
PubMed 28969611
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- True NTH Sexual Recovery Intervention for Prostate Cancer Survivors and Their Partners
- ClinicalTrials.gov ID
- NCT02702453
- Acronym / sponsor ID
- HUM00107048
- Conditions
- Sexual Disfunction, Prostate Cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 251 participants (actual)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Collaborators
- Emory University, Movember Foundation, Johns Hopkins University, Memorial Sloan Kettering Cancer Center, University of California, Los Angeles, University of North Carolina
- Study start
- Mar 2016
- Primary completion
- Nov 2019 (actual)
- Study completion
- Nov 2019 (actual)
- First posted
- 8 Mar 2016 (estimated)
- 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.
There is increasing evidence that sexual activity is associated with greater resilience and higher well-being in older adults. Even at a time of stress, and even during a late stage of illness, men and their partners turn to sexual intimacy to increase a sense of connection, comfort and support. The Sexual Recovery intervention seeks to address an unmet need of prostate cancer survivors and their partners who are at risk for poor mental health and decreased quality of life as a result of sexual dysfunction.
By using technology, the intervention will be widely accessible to survivors, the majority of whom do not currently have any access to sexual health expertise. The content and format of the intervention seeks to empower prostate cancer survivors and partners with knowledge and strategies to improve their sexual function, sexual confidence and their sexual relationship. The intervention begins prior to and continues following their definitive treatment. This may, in turn, improve mental health and quality of life.
In a broader sense, this intervention will be transferable. With appropriate modifications, it can become an accessible sexual health intervention for populations dealing with other cancers and chronic illnesses.
Detailed description
This proposal is innovative in a number of ways:
- The intervention is based on a full understanding of the complex nature of sexuality with its bio- (functional), psycho- (confidence), and social (relationship components). It incorporates modules that address each of these factors and their inter-dependencies.
- The intervention is sensitive to critical points in sexual recovery and to patient and partner preferences in the context of therapies for prostate cancer. The intervention acknowledges that there are certain time points at which concerns typically arise (e.g., when preparing for definitive treatment). The effectiveness of the intervention is increased by the use of tailoring linked to patient reported outcomes (e.g., decreased erectile function, increases in depression indices) and to patient/partner preferences.
- The intervention includes partners as equal stakeholders in the sexual recovery and legitimizes their needs for sexual fulfillment and support
- The intervention demonstrates a sensitivity to sexual orientation and cultural diversity
- The intervention is scalable and available at limited or no cost to prostate cancer survivors and their partners regardless of geographical location or system of care.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Development and Testing | Experimental | Behavioral: websiteDevelop an online interactive, tailored intervention to address the needs of men and partners interested in sexual recovery after treatment for localized prostate cancer during the first 6 months after treatment. The intervention will undergo content testing through 4 focus groups with prostate cancer survivors and partners and usability testing with 5 survivors and partners |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients diagnosed with localized prostate cancer who are about to receive definitive treatment with either radiation with or without ADT (androgen deprivation therapy) or prostatectomy AND who also have a spouse or been in a committed relationship with their partner for at least 6 months who is willing to participate in the study. Both parties are required to sign an informed consent, able to speak or read English, have reliable internet access,have their own e-mail address, or be willing to sign up for a new one, and must be 18 years of age or older. The participants must be consented at least two weeks prior to the start of treatment, so that participants will have enough time to complete a baseline survey and access the first module of the intervention.
Key exclusion criteria (1 listed)
- Anyone unable to speak or read English, unwilling to sign an informed consent, under the age of 18, or people without internet access will be excluded from the study.
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 |
|---|---|---|
| websiteThe intervention arm will consist of 12 modules, 8 of which are consistent with the trajectory of prostate cancer and its treatment. Four modules address aspects of the prostate cancer experience that are important for patients and partners as well as providers and are designed to optimize the goal of supporting patients and partners in their sexual recovery. | Behavioural | Development and Testing |
Primary outcome
PROMIS (Patient-Reported Outcomes Measurement Information System) Sexual Satisfaction
Time frame: 4 years
The primary outcome is PROMIS (Patient-Reported Outcomes Measurement Information System) Sexual Satisfaction. Basing power calculation on the average adjusted score (50) and standard deviation (10) provided in the PROMIS scoring, anticipating Sexual Satisfaction scores for the intervention group vs control group to be 50 vs 45, using a two-tailed t-test, power of 80%, and significance level of 0.05, it is expected this study will recruit 128 patients and 128 partners.
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 22 Jan 2020.
- Derived from this study: PubMed 28969611Wittmann D, Mehta A, Northouse L, Dunn R, Braun T, Duby A, An L, Arab L, Bangs R, Bober S, Brandon J, Coward M, Dunn M, Galbraith M, Garcia M, Giblin J, Glode M, Koontz B, Lowe A, Mitchell S, Mulhall J, Nelson C, Paich K, Saigal C, Skolarus T, Stanford J, Walsh T, Pollack CE. TrueNTH sexual recovery study protocol: a multi-institutional collaborative approach to developing and testing a web-based intervention for couples coping with the side-effects of prostate cancer treatment in a randomized controlled trial. BMC Cancer. 2017 Oct 2;17(1):664. doi: 10.1186/s12885-017-3652-3.
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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.
Daniela Wittmann, PhD principal investigator
University of Michigan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing website in people with Sexual Disfunction and Prostate Cancer, run by University of Michigan 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 1 inclusion and 1 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 22 Jan 2020. 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) Sexual Satisfaction (time frame: 4 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02702453, which also lists 1 linked publication.
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 22 Jan 2020.