Exercise Intervention for LGBT Cancer Survivors

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02459769

Enrollment

140

Registered

2015-06-02

Start date

2015-08-15

Completion date

2021-02-22

Last updated

2023-11-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Neoplasms

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.

Interventions

BEHAVIORALExercise for Cancer Patients

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

SUPPORTIVE_CARE

Masking

SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

21 Years to No maximum

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	Time frame	Description
Self-Reported Psychological Distress	Assessed at 8 weeks	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.

Secondary

Measure	Time frame	Description
Biological Endpoints: Cortisol	Assessed at 8 weeks	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.
Biological Endpoints: Serum Amyloid A	Assessed at 8 weeks	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.
Biological Endpoints: C-reactive Protein	Assessed at 8 weeks	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.
Mechanistic Outcomes: Support	Assessed at 8 weeks	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.
Mechanistic Outcomes: Adherence	Assessed at 8 weeks	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.

Other

Measure	Time frame	Description
Self-Reported Distress Among Caregivers	Assessed at 8 weeks	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.
Biological Endpoints of Distress Among Caregivers	Assessed at 8 weeks	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.

Countries

United States

Participant flow

Participants by arm

Arm	Count
Dyadic Exercise Intervention for LGBT Cancer Survivors 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 survivors and caregivers 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. Exercise for Cancer Patients: a standardized, daily, 6 week, home-based, progressive exercise program	32
Individual Exercise Intervention for LGBT Cancer Survivors 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. Exercise for Cancer Patients: a standardized, daily, 6 week, home-based, progressive exercise program	31
Dyadic Exercise Intervention for Caregivers 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 survivors and caregivers 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. Exercise for Cancer Patients: a standardized, daily, 6 week, home-based, progressive exercise program	32
Individual Caregivers-No Intervention A caregiver is defined as any individual whom the cancer survivor nominates as having provided emotional support or tangible assistance without pay during the survivor's cancer experience. No restriction will be placed on caregivers in terms of relationship with the cancer survivor; they can be family members, friends, romantic partners, or community members	31
Total	126

Withdrawals & dropouts

Period	Reason	FG000	FG001	FG002	FG003
Overall Study	Lost to Follow-up	1	0	1	0
Overall Study	Withdrawal by Subject	7	4	8	5

Baseline characteristics

Characteristic	Individual Exercise Intervention for LGBT Cancer Survivors	Total	Individual Caregivers-No Intervention	Dyadic Exercise Intervention for LGBT Cancer Survivors	Dyadic Exercise Intervention for Caregivers
Age, Continuous	55.5 years	55.7 years	54.5 years	56.3 years	56.7 years
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants	3 Participants	1 Participants	2 Participants	0 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	31 Participants	123 Participants	30 Participants	30 Participants	32 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) Asian	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) Black or African American	0 Participants	4 Participants	0 Participants	2 Participants	2 Participants
Race (NIH/OMB) More than one race	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) White	31 Participants	122 Participants	31 Participants	30 Participants	30 Participants
Region of Enrollment United States	31 Participants	126 Participants	31 Participants	32 Participants	32 Participants
Sex/Gender, Customized Female	18 Participants	83 Participants	19 Participants	23 Participants	23 Participants
Sex/Gender, Customized Male	13 Participants	41 Participants	11 Participants	8 Participants	9 Participants
Sex/Gender, Customized Transgender Female	0 Participants	1 Participants	0 Participants	1 Participants	0 Participants
Sex/Gender, Customized Transgender Male	0 Participants	1 Participants	1 Participants	0 Participants	0 Participants
Sexual Orientation Bisexual	0 Participants	1 Participants	0 Participants	1 Participants	0 Participants
Sexual Orientation Heterosexual or Straight	0 Participants	6 Participants	5 Participants	0 Participants	1 Participants
Sexual Orientation Lesbian or Gay	31 Participants	117 Participants	26 Participants	30 Participants	30 Participants
Sexual Orientation Other	0 Participants	2 Participants	0 Participants	1 Participants	1 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk	EG002 affected / at risk	EG003 affected / at risk
deaths Total, all-cause mortality	3 / 32	2 / 31	1 / 32	1 / 31
other Total, other adverse events	0 / 32	0 / 31	0 / 32	0 / 31
serious Total, serious adverse events	1 / 32	0 / 31	0 / 32	0 / 31

Outcome results

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.