Exercise Intervention for LGBT Cancer Survivors

Neoplasms Clinical Trial

Official title:

Exercise Intervention for Lesbian, Gay, Bisexual, and Transgender (LGBT) Cancer Survivors and Caregivers

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02459769
• Other study ID #: 56965
• Status: Completed
• Phase: N/A
• Start date: August 15, 2015
• Est. completion date: February 22, 2021

Study information

• Verified date: February 2023
• Source: University of Rochester
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 140
• Est. completion date: February 22, 2021
• Est. primary completion date: February 22, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Neoplasms

Intervention

Behavioral:
• Exercise for Cancer Patients
a standardized, daily, 6 week, home-based, progressive exercise program

Locations

Country	Name	City	State
United States	University of Rochester	Rochester	New York

Sponsors (1)

Lead Sponsor	Collaborator
University of Rochester

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Self-Reported Distress Among Caregivers	Self-reported psychological distress among caregivers of LGBT cancer survivors was determined using the Profile of Mood States (POMS) total score. 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
Other	Biological Endpoints of Distress Among Caregivers	An exploratory aim is to determine the preliminary effect of EXCAP-PA versus survivor-only EXCAP©® on biological endpoints associated with distress among caregivers of LGBT cancer survivors: serum cortisol.	Assessed at 8 weeks
Primary	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	Biological Endpoints: Cortisol	The secondary aim is to determine the preliminary effect of EXCAP-PA versus survivor-only EXCAP©® on biological endpoints associated with distress: serum cortisol among LGBT cancer survivors.	Assessed at 8 weeks
Secondary	Biological Endpoints: Serum Amyloid A	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.	Assessed at 8 weeks
Secondary	Biological Endpoints: C-reactive Protein	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.	Assessed at 8 weeks
Secondary	Mechanistic Outcomes: Support	Social support from the care partner was measured with the Dyadic Support Questionnaire (DSQ) among LGBT cancer survivors. The DSQ is an 18-item survey based on four functions of social support (emotional, appraisal, instrumental, and informational support). Nine items measure received social support, that is, support provided by the partner. Items are anchored using a Likert scale ranging from 1 to 5 (from not at all to a great deal). Items were summed to create a scale for received support ranging from 9-45, with higher scores indicating more support.	Assessed at 8 weeks
Secondary	Mechanistic Outcomes: Adherence	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. The actigraph features a variable epoch length which can be set between 1 to 240 seconds. Software supplied by the manufacturer was used to determine number of minutes of moderate or higher activity during each assessment period.	Assessed at 8 weeks