Study Results
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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COMPLETED
NA
24 participants
INTERVENTIONAL
2017-11-01
2018-10-23
Brief Summary
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Detailed Description
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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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Study Design
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NON_RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
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.
Exercise Intervention
Undergo Exercise Together intervention
Questionnaire Administration
Ancillary studies
Survey Administration
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.
Questionnaire Administration
Ancillary studies
Survey Administration
Ancillary studies
Interventions
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Exercise Intervention
Undergo Exercise Together intervention
Questionnaire Administration
Ancillary studies
Survey Administration
Ancillary studies
Eligibility Criteria
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Inclusion Criteria
* 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
* 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)
ALL
Yes
Sponsors
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Oregon Health and Science University
OTHER
OHSU Knight Cancer Institute
OTHER
Responsible Party
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Kerri Winters
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
Countries
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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.
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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