Exercising Together During Radiation Treatment

NCT ID: NCT03418025

Last Updated: 2020-10-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-11-01

Study Completion Date

2018-10-23

Brief Summary

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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

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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.

Conditions

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Domestic Partnership Prostate Carcinoma Spouse

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Group I (Exercising Together program)

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.

Group Type EXPERIMENTAL

Exercise Intervention

Intervention Type BEHAVIORAL

Undergo Exercise Together intervention

Questionnaire Administration

Intervention Type OTHER

Ancillary studies

Survey Administration

Intervention Type OTHER

Ancillary studies

Group II (pre and post testing)

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.

Group Type ACTIVE_COMPARATOR

Questionnaire Administration

Intervention Type OTHER

Ancillary studies

Survey Administration

Intervention Type OTHER

Ancillary studies

Interventions

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Exercise Intervention

Undergo Exercise Together intervention

Intervention Type BEHAVIORAL

Questionnaire Administration

Ancillary studies

Intervention Type OTHER

Survey Administration

Ancillary studies

Intervention Type OTHER

Eligibility Criteria

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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)
Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Oregon Health and Science University

OTHER

Sponsor Role collaborator

OHSU Knight Cancer Institute

OTHER

Sponsor Role lead

Responsible Party

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Kerri Winters

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Kerri Winters-Stone

Role: PRINCIPAL_INVESTIGATOR

OHSU Knight Cancer Institute

Locations

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OHSU Knight Cancer Institute

Portland, Oregon, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 34879873 (View on PubMed)

Other Identifiers

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NCI-2018-00031

Identifier Type: REGISTRY

Identifier Source: secondary_id

CPC-17135-L

Identifier Type: OTHER

Identifier Source: secondary_id

IRB00017367

Identifier Type: OTHER

Identifier Source: secondary_id

STUDY00017367

Identifier Type: -

Identifier Source: org_study_id

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