Exercising Together During Radiation Treatment

OHSU Knight Cancer Institute

Status: Completed

Conditions: Prostate Carcinoma; Domestic Partnership; Spouse

Treatments: Other: Survey Administration; Behavioral: Exercise Intervention; Other: Questionnaire Administration

Study type: Interventional

Funder types: Other

Identifiers

NCT03418025

NCI-2018-00031 (Registry Identifier)

CPC-17135-L (Other Identifier)

STUDY00017367

IRB00017367 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 24 patients

Sex: All

Volunteers: Accepts 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)

Trial design

Primary purpose: Supportive Care

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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24 participants in 2 patient groups

Group I (Exercising Together program)

Experimental group

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.

Treatment:

Other: Survey Administration

Behavioral: Exercise Intervention

Other: Questionnaire Administration

Group II (pre and post testing)

Active Comparator group

Description:

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.

Treatment:

Other: Survey Administration

Other: Questionnaire Administration