N/A
N=133
Exercise Intervention for LGBT Cancer Survivors
Neoplasms
Bottom Line
View on ClinicalTrials.gov: NCT02459769 ↗Enrolled (actual)
133
Serious AEs
0.8%
Results posted
Nov 2023
Primary outcome: Primary: Self-Reported Psychological Distress — 8.89; 6.96 score on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Exercise for Cancer Patients (Behavioral)
- Age
- Adult, Older Adult · 21+ yrs
- Sex
- All
- Sponsor
- University of Rochester
- Primary completion
- Feb 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Self-Reported Psychological Distress |
8.89; 6.96 | — |
| SECONDARY Biological Endpoints: Cortisol |
42.97; 59.20 | — |
| SECONDARY Biological Endpoints: Serum Amyloid A |
666.27; 968.26 | — |
| SECONDARY Biological Endpoints: C-reactive Protein |
860440.91; 133590.00 | — |
| SECONDARY Mechanistic Outcomes: Support |
39.46; 39.04 | — |
| SECONDARY Mechanistic Outcomes: Adherence |
12.57; 15.55 | — |
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.
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,
- Be 21 years of age or older,
- Give written informed consent.
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.
Data sourced from ClinicalTrials.gov (NCT02459769). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.