Clinical trial NCT02702453: True NTH Sexual Recovery Intervention for Prostate Cancer Survivors and Their Partners
Official title: True NTH Sexual Recovery Intervention for Prostate Cancer Survivors and Their Partners
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sexual Disfunction
Prostate Cancer
Lead sponsor: University of Michigan
Sponsor class: OTHER
Collaborators: name: Emory University
name: Movember Foundation
name: Johns Hopkins University
name: Memorial Sloan Kettering Cancer Center
name: University of California, Los Angeles
name: University of North Carolina
First posted: 2016-03-08
Enrollment: 251
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: PROMIS (Patient-Reported Outcomes Measurement Information System) Sexual Satisfaction
timeFrame: 4 years
Secondary outcomes:
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
Study officials:
affiliation: University of Michigan
name: Daniela Wittmann, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.