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Exercise Intervention for LGBT Cancer Survivors

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ClinicalTrials.gov Identifier: NCT02459769
Recruitment Status : Recruiting
First Posted : June 2, 2015
Last Update Posted : December 6, 2019
Sponsor:
Information provided by (Responsible Party):
Charles Kamen, University of Rochester

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.

Condition or disease Intervention/treatment Phase
Neoplasms Behavioral: Exercise for Cancer Patients Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 140 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Exercise Intervention for Lesbian, Gay, Bisexual, and Transgender (LGBT) Cancer Survivors and Caregivers
Study Start Date : August 2015
Estimated Primary Completion Date : April 2020
Estimated Study Completion Date : July 2020


Arm Intervention/treatment
Active Comparator: Dyadic Exercise Intervention
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
a standardized, daily, 6 week, home-based, progressive exercise program
Other Name: EXCAP

Individual Exercise Intervention
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
a standardized, daily, 6 week, home-based, progressive exercise program
Other Name: EXCAP




Primary Outcome Measures :
  1. Self-Reported Psychological Distress [ Time Frame: 4 years ]
    The primary aim of this study is to determine the preliminary effect of EXCAP with Partner Assistance (EXCAP-PA) versus survivor-only EXCAP©® on self-reported psychological distress (Profile of Mood States [POMS] total score) among LGBT cancer survivors.


Secondary Outcome Measures :
  1. Biological Endpoints: Cortisol [ Time Frame: 4 years ]
    The secondary aim is to determine the preliminary effect of EXCAP-PA versus survivor-only EXCAP©® on biological endpoints associated with distress: markers of hypothalamic-pituitary-adrenal axis functioning (cortisol) among LGBT cancer survivors.

  2. Biological Endpoints: Serum amyloid A [ Time Frame: 4 years ]
    The secondary aim is to determine the preliminary effect of EXCAP-PA versus survivor-only EXCAP©® on biological endpoints associated with distress: markers of early inflammation serum amyloid A (SAA) among LGBT cancer survivors.

  3. Biological Endpoints: C-reactive protein [ Time Frame: 4 years ]
    The secondary aim is to determine the preliminary effect of EXCAP-PA versus survivor-only EXCAP©® on biological endpoints associated with distress: markers of C-reactive protein (CRP) among LGBT cancer survivors.

  4. Mechanistic Outcomes: Support [ Time Frame: 4 years ]
    We also aim to determine the preliminary effect of EXCAP-PA versus survivor-only EXCAP©® on social support from the care partner (Dyadic Support Questionnaire [DSQ]) among LGBT cancer survivors.

  5. Mechanistic Outcomes: Adherence [ Time Frame: 4 years ]
    We also aim to determine the preliminary effect of EXCAP-PA versus survivor-only EXCAP©® on social support from the care partners intervention adherence (actigraphy) among LGBT cancer survivors.


Other Outcome Measures:
  1. Self-Reported Distress Among Care Partners [ Time Frame: 4 years ]
    An exploratory aim is to determine the preliminary effect of EXCAP-PA versus survivor-only EXCAP©® on self-reported psychological distress (POMS Total) among care partners of LGBT cancer survivors.

  2. Biological Endpoints of Distress Among Care Partners [ Time Frame: 4 years ]
    An exploratory aim is to determine the preliminary effect of EXCAP-PA versus survivor-only EXCAP©® on biological endpoints associated with distress among care partners of LGBT cancer survivors.



Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02459769


Contacts
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Contact: Nicole M Murray, MS 5852764638 nicole_murray@urmc.rochester.edu

Locations
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United States, New York
University of Rochester Recruiting
Rochester, New York, United States, 14642
Contact: Charles Kamen, PhD    585-275-9958    charles_kamen@urmc.rochester.edu   
Contact: Nicole Murray, MS    585-276-4638    nicole_murray@urmc.rochester.edu   
Principal Investigator: Chalres Kamen, PhD         
Sponsors and Collaborators
University of Rochester
Investigators
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Principal Investigator: Charles Kamen, PhD, MPH University of Rochester

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Responsible Party: Charles Kamen, Assistant Professor, University of Rochester
ClinicalTrials.gov Identifier: NCT02459769    
Other Study ID Numbers: 56965
First Posted: June 2, 2015    Key Record Dates
Last Update Posted: December 6, 2019
Last Verified: December 2019