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Exercising Together During Radiation Treatment

Primary Purpose

Domestic Partnership, Prostate Carcinoma, Spouse

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Exercise Intervention

Questionnaire Administration

Survey Administration

About this trial

This is an interventional supportive care trial for Domestic Partnership

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

PATIENTS
Histologically confirmed prostate cancer (confirmed by self-report on Health History Questionnaire)
Scheduled to receive a course (5-8 weeks) of radiation treatment for prostate cancer at Oregon Health & Science University (OHSU) Department of Radiation Medicine (confirmed by self-report on Health History Questionnaire)
Currently residing with an identifiable spouse (or co-residing partner) willing to participate (confirmed by self-report on Health History Questionnaire)
SPOUSES
Currently residing with the prostate cancer patient (confirmed by self-report on Health History Questionnaire)

Exclusion Criteria:

Cognitive difficulties that preclude answering the survey questions or giving informed consent
Medical condition, movement or neurological disorder, or medication that contraindicates participation in resistance exercise (for patient: confirmed by email and/or Electronic Privacy Information Center [EPIC] by Dr. Hung; for spouse: must answer 'No' to exercise pre-participation screening questions (question #20 & #21) in Health History Questionnaire (HHQ); if spouse answers 'Yes' to either question they will be considered eligible upon physician clearance; the exercise pre-participation screening questions are based on the American College of Sports Medicine 2016 Exercise pre-participation screening criteria)
Currently participating in partnered strength training 2 or more times per week (confirmed by self-report on the Godin Leisure Time Exercise Questionnaire)

Sites / Locations

OHSU Knight Cancer Institute

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Group I (Exercising Together program)

Group II (pre and post testing)

Arm Description

Exercise Intervention. All participants complete questionnaires about their health status, physical activity habits and relationship with their spouse/partner and undergo four physical tests at baseline and at the end of the 5-8 week radiation treatment. The questionnaires are then completed one final time 8 weeks following the completion of radiation treatment. EXERCISING TOGETHER PROGRAM: Participants complete three exercise sessions (approximately 1 hour per session) per week over 5-8 weeks during radiation treatment. Participants also receive a DVD of a partnered strength training exercise program to continue on their own after radiation is completed.

Questionnaire Administration & Survey Administration. All participants complete questionnaires about their health status, physical activity habits and relationship with their spouse/partner and undergo four physical tests at baseline and at the end of the 5-8 week radiation treatment. The questionnaires are then completed one final time 8 weeks following the completion of radiation treatment.

Outcomes

Primary Outcome Measures

Feasibility

Will be determined as the number of couples who enroll out of those approached and the number of couples who opt to participate in Exercising Together versus to participate as controls. Will evaluate using descriptive statistics.

Physical function

Will be measured by the Physical Performance Battery (PPB), developed for the Established Populations for Epidemiologic Studies of the Elderly study. The PPB consists of three timed tests: 5 repeated chair stands, standing balance, and gait speed over 4 meters. Each test is scored 0 (unable) to 4, based on quartiles of performance, then scores are summed. Higher scores indicate better physical function.

400m walk Test

The 400m walk test is a self-paced, submaximal exercise test. Participants will be required to move as fast as they can along a 20m course, demarked by two cones, until they have completed 10 laps of the course (400m). The time taken to complete the test will be recorded.

Acceptability

Will be measured by the average attendance at classes over the course of his radiation therapy. This will be calculated as the total number of classes attended divided by the total possible they could attend over the course of radiation therapy. Attendance will be categorized by sessions couples attended together and those where only one partner attends. Will evaluate using descriptive statistics.

Depressive symptoms

Will be measured with the Center for Epidemiological Studies-Depression (CES-D) scale. Scores range from 0-60, with higher scores indicating > depressive symptomology.

Anxiety

Will be measured from the Symptom Checklist - 90 Anxiety Scale (SCL-90 ANX) which includes 10 items representing anxiety symptoms, scored on a 5 point scale ranging from 0 (not at all) to 4 (extremely).

Physical intimacy

Physical intimacy behavior of patient and spouse will be measured using the Physical intimacy behavior scale. Respondents are asked to report the frequency with which they engage in, initiate and avoid each of four affectionate and two sexual behaviors. Three scales assess the frequency, initiation and avoidance of affectionate and sexual behaviors.

Strain

Spouse strain will be measured with the role overload scale, which assesses the extent a spouse's time and energy are exhausted by demands of care for their partner.

Dyadic coping

Two types of dyadic coping will be measured. Active engagement assesses the extent to which the survivor (SVR) and spouse view their partner's active involvement and joint problem-solving. Participants respond to five items using a Likert scale from 1 (never) to 5 (very often). Higher scores indicate higher levels of perceived active engagement. Protective buffering assesses the extent to which the SVR and spouse view their partner's use of hiding concerns and denying worries. Participants respond to six items using a Likert scale from 1 (never) to 5 (very often). Higher scores indicate higher levels of perceived protective buffering.

Exercise outside the exercise intervention

Will measure outside activity with the Modified Godin Leisure-Time Exercise Questionnaire (GLTEQ). This survey, reported in average minutes per week over the past month, will be broken down into four categories: mild effort (minimal effort), moderate exercise (not exhausting), and strenuous exercise (heart beats rapidly), as well as resistance (weight bearing exercise). The questionnaire will be scored three different ways, to better capture different aspects of PA: 1) total activity = vigorous + moderate + mild + resistance 2) physical activity guidelines = moderate + (vigorous x 2) 3) moderate + vigorous.

Subjective evaluation of Exercising Together Program

For couples who opt to participate in Exercising Together will also ask them to fill out a survey asking about their experience in the program. They will be asked to rate their overall experience in the exercise classes using a 1 to 10 likert scale with 1 being poor and 10 being exceptional as well as indicate how much they agree or disagree with perceptions of the class.

Secondary Outcome Measures

Full Information

NCT ID

NCT03418025

First Posted

January 24, 2018

Last Updated

October 6, 2020

Sponsor

OHSU Knight Cancer Institute

Collaborators

Oregon Health and Science University

1. Study Identification

Unique Protocol Identification Number

NCT03418025

Brief Title

Exercising Together During Radiation Treatment

Official Title

Exercising Together: An Intervention for Couples Coping With Prostate Cancer During Radiation Treatment

Study Type

Interventional

2. Study Status

Record Verification Date

October 2020

Overall Recruitment Status

Completed

Study Start Date

November 1, 2017 (Actual)

Primary Completion Date

May 18, 2018 (Actual)

Study Completion Date

October 23, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

OHSU Knight Cancer Institute

Collaborators

Oregon Health and Science University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

This pilot clinical trial studies how well the Exercising Together program works in helping couples cope with radiation treatment for prostate cancer. Treatments for cancer can cause side effects for the patient, such as fatigue, add stress for the spousal caregiver, and put strain on the marital relationship. The Exercising Together program is designed to promote teamwork and emotional intimacy during exercise, which itself can help manage fatigue and stress for the patient and spouse, and may facilitate communication between partners about day-to-day energy, abilities, and motivation.

Detailed Description

PRIMARY OBJECTIVE: I. Determine the feasibility and acceptability of offering the Exercising Together program to couples during the time when men are undergoing an 8 week radiation treatment regimen. SECONDARY OBJECTIVES: I. Examine the efficacy of partnered strength training on objective physical function, self-report function, symptoms and intimacy in both the patient and his spouse. OUTLINE: All participants complete questionnaires about their health status, physical activity habits and relationship with their spouse/partner and undergo four physical tests at baseline and at the end of the 5-8 week radiation treatment. The questionnaires are then completed one final time 8 weeks following the completion of radiation treatment. EXERCISING TOGETHER PROGRAM: Participants complete three exercise sessions (approximately 1 hour per session) per week over 5-8 weeks during radiation treatment. Participants also receive a digital video disc (DVD) of a partnered strength training exercise program to continue on their own after radiation is completed. After completion of the supervised exercise program, participants are followed up at 8 weeks.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Domestic Partnership, Prostate Carcinoma, Spouse

7. Study Design

Primary Purpose

Supportive Care

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

24 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Group I (Exercising Together program)

Arm Type

Experimental

Arm Description

Arm Title

Group II (pre and post testing)

Arm Type

Active Comparator

Arm Description

Intervention Type

Behavioral

Intervention Name(s)

Exercise Intervention

Intervention Description

Undergo Exercise Together intervention

Intervention Type

Other

Intervention Name(s)

Questionnaire Administration

Intervention Description

Ancillary studies

Intervention Type

Other

Intervention Name(s)

Survey Administration

Intervention Description

Ancillary studies

Primary Outcome Measure Information:

Title

Feasibility

Description

Time Frame

Up to 8 weeks post radiation treatment

Title

Physical function

Description

Time Frame