True NTH Sexual Recovery Intervention for Prostate Cancer Survivors and Their Partners

NCT02702453 | Completed

• 1 other identifier: HUM00107048
• Study Type: interventional
• Target: 251
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Sexual Disfunction; Prostate Cancer

Outcome Measures

Primary Outcomes (1)

• 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.

  4 years

Study Arms (1)

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

Behavioral: website

Interventions

website BEHAVIORAL

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.

Development and Testing

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Michigan: lead
• Emory University: collaborator
• Movember Foundation: collaborator
• Johns Hopkins University: collaborator
• Memorial Sloan Kettering Cancer Center: collaborator
• University of California, Los Angeles: collaborator
• University of North Carolina: collaborator

Study Sites (1)

University of Michigan

Ann Arbor, Michigan, 48105, United States

Location

Related Publications (1)

• 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.

  PMID: 28969611 DERIVED

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Officials

• Daniela Wittmann, PhD

  University of Michigan

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 3, 2016
• First Posted: March 8, 2016
• Study Start: March 1, 2016
• Primary Completion: November 1, 2019
• Study Completion: November 1, 2019
• Last Updated: January 22, 2020

Record last verified: 2020-01

Locations

US (1)