Exercise Intervention for Lesbian, Gay, Bisexual, and Transgender (LGBT) Cancer Survivors and Caregivers
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Neoplasms
- Sponsor
- University of Rochester
- Enrollment
- 140
- Locations
- 1
- Primary Endpoint
- Self-Reported Psychological Distress
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
The purpose of this study is to test preliminary efficacy, as well as acceptability and feasibility, of a dyadic exercise intervention, the current study will randomize LGBT cancer survivors and their non-professional caregivers as dyads to either an individual or a dyadic Exercise for Cancer Patients (EXCAP) intervention. The primary outcome assessed will be psychological distress. Analyses will involve pre-post comparisons of outcomes across the study arms, testing the hypothesis that a 6 week, daily, dyadic exercise intervention will result in greater improvements in psychological distress than an individual intervention.
Detailed Description
The proposed randomized controlled trial aims to recruit 70 lesbian, gay, bisexual, and transgender (LGBT) cancer survivors who have completed treatment (surgery, radiation, or chemotherapy) within the past 24 months, so as to have a final, evaluable sample of 60 LGBT survivors after attrition. The proposed RCT will also recruit caregivers (broadly defined) of the above cancer survivors. Each recruited cancer survivor will be asked to name a person who they feel provided care (emotional, informational, tangible, etc.) during their cancer experience, with no further strictures placed on this relationship in terms of type or duration. The caregiver will be approached to participate in the RCT. Thus the sample will consist of 70 LGBT survivors (60 evaluable) and their caregivers (140 individuals total/120 evaluable). Recruitment and primary analyses will specifically target the LGBT cancer survivor. All data will be gathered from participants 21 years of age or older. Participants are cancer survivors who have completed treatments or caregivers of cancer survivors; both survivors and caregivers are able to read and understand English.
Investigators
Charles Kamen
Assistant Professor
University of Rochester
Eligibility Criteria
Inclusion Criteria
- •(Survivors): To be included in the study, cancer survivors must:
- •Have had a diagnosis of cancer (any cancer type excluding squamous and basal cell \[skin cancers\]) and have completed primary surgery, chemotherapy, and/or radiation (those on continued adjuvant treatment are still eligible),
- •Identify as lesbian, gay, bisexual, or transgender, or have a same-sex romantic partner,
- •Have a caregiver willing to participate in the study (defined as anyone who provided emotional support or tangible assistance during the survivors' cancer experience),
- •Be able to read English,
- •Be 21 years of age or older, and
- •Give written informed consent.
- •(Caregivers): Caregivers must:
- •Be nominated by a cancer survivor,
- •Be able to read English,
Exclusion Criteria
- •Have physical limitations (e.g., cardiorespiratory, orthopedic) contraindicating participating in a low- to moderate-intensity home-based walking and progressive resistance program and physical function testing, as assessed by their medical oncologist, their primary care physician, and/or the study medical monitor (or any of these three physicians' designees),
- •For caregivers, be currently undergoing active treatment for cancer.
Outcomes
Primary Outcomes
Self-Reported Psychological Distress
Time Frame: Assessed at 8 weeks
Self-reported psychological distress was measured with the Profile of Mood States (POMS) total score among LGBT cancer survivors. The POMS consists of 30 adjectives that subjects rate on a five-point scale with "1" = "Not at all" and "5" = "Extremely" to describe their moods over the past week. The total score can be calculated by adding the raw scores from tension, depression, anger, fatigue and confusion-focused items and then subtracting the vigour-focused items. This will give a value between -24 and 177, with higher scores indicating higher psychological distress.
Secondary Outcomes
- Biological Endpoints: Serum Amyloid A(Assessed at 8 weeks)
- Biological Endpoints: Cortisol(Assessed at 8 weeks)
- Mechanistic Outcomes: Adherence(Assessed at 8 weeks)
- Mechanistic Outcomes: Support(Assessed at 8 weeks)
- Biological Endpoints: C-reactive Protein(Assessed at 8 weeks)