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

Prostate Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02702453
• Other study ID #: HUM00107048
• Status: Completed
• Phase: N/A
• Start date: March 2016
• Est. completion date: November 2019

Study information

• Verified date: January 2020
• Source: University of Michigan
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 251
• Est. completion date: November 2019
• Est. primary completion date: November 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms
• Sexual Disfunction

Intervention

Behavioral:
• website
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.

Locations

Country	Name	City	State
United States	University of Michigan	Ann Arbor	Michigan

Sponsors (7)

Lead Sponsor	Collaborator
University of Michigan	Emory University, Johns Hopkins University, Memorial Sloan Kettering Cancer Center, Movember Foundation, University of California, Los Angeles, University of North Carolina

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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