University of Michigan
Ann Arbor, Michigan, 48105, United States
NCT Number: NCT02702453
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.
Looking for future studies?
Notify Me18 year and older
Male
Interventional
Not applicable
Ann Arbor, Michigan, 48105, United States
This proposal is innovative in a number of ways:
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
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.
University of Michigan
Other
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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