This trial examines behavioral and psychological determinants in prostate cancer survivors for the improvement of quality of life. Living after having prostate cancer often means dealing with long term side effects like sexual and urinary problems, pain and fatigue. Side effects may lead to other personal issues such as negative self views and problems with intimate relationships. The purpose of this study is to look at changes in the way patients feel, think about things, and communicate and relate to others and changes in their health.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT04545021.
PRIMARY OBJECTIVES:
I. In prostate cancers (PC) survivors, evaluate the association between Science of Behavior Change (SOBC) measures (i.e., self-regulation domain: behavioral inhibition and activation [BIS/BAS], emotion regulation, self-regulation; interpersonal/ social processes domain: couple coercion; and stress domain: mindfulness awareness), and neuroimmune regulation, symptom burden and health-related quality of life (HRQoL).
II. In PC survivors, evaluate whether participation in culturally-adapted cognitive behavioral stress and self-management (CCBSM) relative to cognitive-behavioral stress and self management (CBSM), has a greater impact on SOBC measures.
III. In PC survivors, test whether intervention-associated changes in SOBC measures are associated with lower ecological momentary assessment (EMA)-based sympathetic nervous system (SNS) and hypothalamic pituitary adrenocortical (HPAC) activity, better mood and greater social engagement (i.e., EMA measures).
IV. In PC survivors, test whether the association between SOBC measures, and neuroimmune regulation, symptom burden and HRQoL are explained via changes in the EMA measures.
V. Evaluate whether SOBC measures in patients & spouses/partners.
VI. Evaluate whether intervention associated changes in SOBC and EMA measures in patients are associated with better dyadic adjustment and HRQoL in both patients and spouses/partners.
OUTLINE:
Patients and spouses/partners participate in SOBC psychosocial measures consisting of interviews over 30 minutes about how patients and spouses/partners react and cope with stress, and how satisfied they are in their relationship at baseline, 4 months, and 6 months. Patients also undergo collection of EMA data via wristwatch and cellphone applications for 4 consecutive days at baseline, mid-point of intervention, and at 4 and 6 months. Participants also undergo collection of saliva samples for 2 consecutive days at baseline, 4 months, and 6 months.
Trial PhaseNo phase specified
Trial Typesupportive care
Lead OrganizationUniversity of Miami Miller School of Medicine-Sylvester Cancer Center
Principal InvestigatorFrank J. Penedo
