Clinical trial NCT02459769: Exercise Intervention for LGBT Cancer Survivors
Official title: Exercise Intervention for Lesbian, Gay, Bisexual, and Transgender (LGBT) Cancer Survivors and Caregivers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Neoplasms
Lead sponsor: University of Rochester
Sponsor class: OTHER
First posted: 2015-06-02
Enrollment: 140
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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.

Primary outcomes:
measure: Self-Reported Psychological Distress
timeFrame: Assessed at 8 weeks
Secondary outcomes:
measure: Biological Endpoints: Cortisol
timeFrame: Assessed at 8 weeks
measure: Biological Endpoints: Serum Amyloid A
timeFrame: Assessed at 8 weeks
measure: Biological Endpoints: C-reactive Protein
timeFrame: Assessed at 8 weeks
measure: Mechanistic Outcomes: Support
timeFrame: Assessed at 8 weeks
measure: Mechanistic Outcomes: Adherence
timeFrame: Assessed at 8 weeks
Other outcomes:
measure: Self-Reported Distress Among Caregivers
timeFrame: Assessed at 8 weeks
measure: Biological Endpoints of Distress Among Caregivers
timeFrame: Assessed at 8 weeks
Locations:
city: Rochester
country: United States
facility: University of Rochester
state: New York
Study officials:
affiliation: University of Rochester
name: Charles Kamen, PhD, MPH
role: PRINCIPAL_INVESTIGATOR
References: