This clinical trial develops and examines a mindfulness program intended to reduce distress for men with prostate cancer undergoing radical prostatectomy and their partners. Information gained from this trial may help future patients with prostate cancer and their partners manage potential stress related to undergoing radical prostatectomy.
Additional locations may be listed on ClinicalTrials.gov for NCT04727710.
See trial information on ClinicalTrials.gov for a list of participating sites.
PRIMARY OBJECTIVES:
I. To develop a couples-based group mindfulness intervention for men undergoing prostatectomy.
II. To evaluate the effectiveness of our mindfulness intervention on the reduction of distress for men undergoing prostatectomy and their partners using a pilot randomized controlled trial.
OUTLINE:
AIM 1: Participants attend stakeholder discussion over 2 hours for the development of mindfulness intervention. Discussion includes timing and types of distress that men and their partners experience when they undergo radical prostatectomy, approaches to mitigating this distress, what an ideal tool to help mitigate distress for men undergoing prostatectomy might look like, and what reaction men might have to this and if they think it would be useful.
AIM 2: Participants are randomized to 1 of 2 groups.
GROUP I: Participants receive usual care.
GROUP II: Participants receive an introduction to mindfulness and a series of short guided mediations focused on reducing distress.
Trial PhaseNo phase specified
Trial Typesupportive care
Lead OrganizationUniversity of Michigan Comprehensive Cancer Center
Principal InvestigatorLindsey Allison Herrel
