Clinical trial NCT03418025: Exercising Together During Radiation Treatment
Official title: Exercising Together: An Intervention for Couples Coping With Prostate Cancer During Radiation Treatment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Domestic Partnership
Prostate Carcinoma
Spouse
Lead sponsor: OHSU Knight Cancer Institute
Sponsor class: OTHER
Collaborators: name: Oregon Health and Science University
First posted: 2018-02-01
Enrollment: 24
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Feasibility
timeFrame: Up to 8 weeks post radiation treatment
measure: Physical function
timeFrame: Up to 8 weeks post-radiation treatment
measure: 400m walk Test
timeFrame: Up to 8 weeks post-radiation treatment
measure: Acceptability
timeFrame: Up to 8 weeks post-radiation treatment
measure: Depressive symptoms
timeFrame: Up to 8 weeks post-radiation treatment
measure: Anxiety
timeFrame: Up to 8 weeks post-radiation treatment
measure: Physical intimacy
timeFrame: Up to 8 weeks post-radiation treatment
measure: Strain
timeFrame: Up to 8 weeks post-radiation treatment
measure: Dyadic coping
timeFrame: Up to 8 weeks post-radiation treatment
measure: Exercise outside the exercise intervention
timeFrame: Up to 8 weeks post-radiation treatment
measure: Subjective evaluation of Exercising Together Program
timeFrame: Up to 8 weeks post-radiation treatment
Secondary outcomes:
Other outcomes:
Locations:
city: Portland
country: United States
facility: OHSU Knight Cancer Institute
state: Oregon
Study officials:
affiliation: OHSU Knight Cancer Institute
name: Kerri Winters-Stone
role: PRINCIPAL_INVESTIGATOR
References:
citation: Winters-Stone KM, Lyons KS, Beer TM, Skiba MB, Hung A. A pilot feasibility study of Exercising Together(c) during radiation therapy for prostate cancer: a dyadic approach for patients and spouses. Pilot Feasibility Stud. 2021 Dec 8;7(1):216. doi: 10.1186/s40814-021-00952-7.