Exercise Intervention for LGBT Cancer Survivors

NCT02459769 | Completed Results DMC

• 1 other identifier: 56965
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 1

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.

Conditions

Neoplasms

Outcome Measures

Primary Outcomes (1)

• Self-Reported Psychological Distress

  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.

  Assessed at 8 weeks

Secondary Outcomes (5)

• Biological Endpoints: Cortisol

  Assessed at 8 weeks

• Biological Endpoints: Serum Amyloid A

  Assessed at 8 weeks

• Biological Endpoints: C-reactive Protein

  Assessed at 8 weeks

• Mechanistic Outcomes: Support

  Assessed at 8 weeks

• Mechanistic Outcomes: Adherence

  Assessed at 8 weeks

Other Outcomes (2)

• Self-Reported Distress Among Caregivers

  Assessed at 8 weeks

• Biological Endpoints of Distress Among Caregivers

  Assessed at 8 weeks

Study Arms (2)

Dyadic Exercise Intervention

ACTIVE COMPARATOR

Progressive walking and resistance exercise treatment, prescribed to both cancer survivors and their caregivers (daily walking and 3 times/week resistance prescription for 6 weeks). Cancer survivor and caregiver are also asked to discuss ways they can support one another in a) remaining adherent to exercise, and b) dealing with stress, including LGBT-specific minority stress.

Behavioral: Exercise for Cancer Patients

Individual Exercise Intervention

OTHER

Progressive walking and resistance exercise treatment, prescribed solely to cancer survivors (daily walking and 3 times/week resistance prescription for 6 weeks). The caregiver is told not to change his/her exercise behavior in any way.

Behavioral: Exercise for Cancer Patients

Interventions

Exercise for Cancer Patients BEHAVIORAL

a standardized, daily, 6 week, home-based, progressive exercise program

Also known as: EXCAP

Dyadic Exercise Intervention; Individual Exercise Intervention

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• (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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Rochester: lead

Study Sites (1)

University of Rochester

Rochester, New York, 14642, United States

Location

MeSH Terms

Conditions

Neoplasms

Interventions

Exercise

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Results Point of Contact

• Title: Charles Kamen, PhD
• Organization: University of Rochester

charles_Kamen@urmc.rochester.edu

585-275-9958

Study Officials

• Charles Kamen, PhD, MPH

  University of Rochester

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: May 21, 2015
• First Posted: June 2, 2015
• Study Start: August 15, 2015
• Primary Completion: February 22, 2021
• Study Completion: February 22, 2021
• Last Updated: November 18, 2023
• Results First Posted: November 18, 2023

Record last verified: 2023-02

Locations

US (1)