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Exercising Together: An Intervention for Prostate Cancer Survivors and Spouses

Primary Purpose

Prostate Cancer

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Randomized Exercise Intervention
Randomized Exercise Intervention
Sponsored by
Oregon Health and Science University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Prostate Cancer focused on measuring randomized clinical trial, prostate cancer, partnered exercise

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria For PCS:

  • Received treatment for histologically confirmed prostate cancer
  • Not currently undergoing radiation therapy or chemotherapy for prostate cancer
  • Currently residing with an identifiable spouse willing to participate
  • 60 years and older at enrollment

Inclusion Criteria for Spouses:

  • Currently residing with prostate cancer survivor

Exclusion Criteria for prostate cancer survivor and Spouses:

  • Current participation in moderate/vigorous intensity resistance training 2 or more hours per week
  • Cognitive difficulties that preclude answering the survey questions, participating in performance tests, or giving informed consent
  • Medical condition, movement or neurological disorder, or medication that contraindicates participation in resistance exercise
  • Unwillingness to be randomized

Sites / Locations

  • Oregon Health & Science University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Exercising Together

Usual Care

Arm Description

Partnered progressive resistance exercise

Usual Care Control

Outcomes

Primary Outcome Measures

Physical function

Secondary Outcome Measures

Marital quality

Full Information

First Posted
August 5, 2009
Last Updated
April 10, 2014
Sponsor
Oregon Health and Science University
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1. Study Identification

Unique Protocol Identification Number
NCT00954044
Brief Title
Exercising Together: An Intervention for Prostate Cancer Survivors and Spouses
Official Title
Exercising Together: An Intervention for Prostate Cancer Survivors and Spouses
Study Type
Interventional

2. Study Status

Record Verification Date
April 2014
Overall Recruitment Status
Completed
Study Start Date
January 2010 (undefined)
Primary Completion Date
May 2011 (Actual)
Study Completion Date
June 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Oregon Health and Science University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The purpose of this study is to explore the benefits of "Exercising Together"-a partnered strength training program for married couples coping with prostate cancer- on the physical and emotional health of prostate cancer survivors and their spouse and on marital quality.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer
Keywords
randomized clinical trial, prostate cancer, partnered exercise

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
128 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Exercising Together
Arm Type
Experimental
Arm Description
Partnered progressive resistance exercise
Arm Title
Usual Care
Arm Type
Placebo Comparator
Arm Description
Usual Care Control
Intervention Type
Behavioral
Intervention Name(s)
Randomized Exercise Intervention
Intervention Description
The Exercising Together training group will participate in 6 months of supervised, progressive partnered resistance exercise. Couples will participate in 2 exercise sessions a week for 6 months.
Intervention Type
Behavioral
Intervention Name(s)
Randomized Exercise Intervention
Intervention Description
Couples will continue doing their usual daily activities for 6 months
Primary Outcome Measure Information:
Title
Physical function
Time Frame
baseline, 3, 6 months
Secondary Outcome Measure Information:
Title
Marital quality
Time Frame
0,3,6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria For PCS: Received treatment for histologically confirmed prostate cancer Not currently undergoing radiation therapy or chemotherapy for prostate cancer Currently residing with an identifiable spouse willing to participate 60 years and older at enrollment Inclusion Criteria for Spouses: Currently residing with prostate cancer survivor Exclusion Criteria for prostate cancer survivor and Spouses: Current participation in moderate/vigorous intensity resistance training 2 or more hours per week Cognitive difficulties that preclude answering the survey questions, participating in performance tests, or giving informed consent Medical condition, movement or neurological disorder, or medication that contraindicates participation in resistance exercise Unwillingness to be randomized
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kerri Winters-Stone, PhD
Organizational Affiliation
Oregon Health & Science University-School of Nursing
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Jessica Dobek, MS
Organizational Affiliation
Oregon Health & Science University-School of Nursing
Official's Role
Study Director
Facility Information:
Facility Name
Oregon Health & Science University
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
24337765
Citation
Winters-Stone KM, Lyons KS, Bennett JA, Beer TM. Patterns and predictors of symptom incongruence in older couples coping with prostate cancer. Support Care Cancer. 2014 May;22(5):1341-8. doi: 10.1007/s00520-013-2092-0. Epub 2013 Dec 17.
Results Reference
result
PubMed Identifier
26715587
Citation
Winters-Stone KM, Lyons KS, Dobek J, Dieckmann NF, Bennett JA, Nail L, Beer TM. Benefits of partnered strength training for prostate cancer survivors and spouses: results from a randomized controlled trial of the Exercising Together project. J Cancer Surviv. 2016 Aug;10(4):633-44. doi: 10.1007/s11764-015-0509-0. Epub 2015 Dec 29.
Results Reference
derived

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Exercising Together: An Intervention for Prostate Cancer Survivors and Spouses

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