NCT00954044

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
128

participants targeted

Target at P50-P75 for not_applicable prostate-cancer

Timeline
Completed

Started Jan 2010

Shorter than P25 for not_applicable prostate-cancer

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 5, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 6, 2009

Completed
5 months until next milestone

Study Start

First participant enrolled

January 1, 2010

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2011

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2011

Completed
Last Updated

April 11, 2014

Status Verified

April 1, 2014

Enrollment Period

1.3 years

First QC Date

August 5, 2009

Last Update Submit

April 10, 2014

Conditions

Prostate Cancer

Keywords

randomized clinical trialprostate cancerpartnered exercise

Outcome Measures

Primary Outcomes (1)

  • Physical function

    baseline, 3, 6 months

Secondary Outcomes (1)

  • Marital quality

    0,3,6 months

Study Arms (2)

Exercising Together

EXPERIMENTAL

Partnered progressive resistance exercise

Behavioral: Randomized Exercise Intervention

Usual Care

PLACEBO COMPARATOR

Usual Care Control

Behavioral: Randomized Exercise Intervention

Interventions

Randomized Exercise InterventionBEHAVIORAL

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.

Exercising Together

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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
  • years and older at enrollment
  • Currently residing with prostate cancer survivor

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Oregon Health & Science University

Portland, Oregon, 97239, United States

Location

Related Publications (2)

  • 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.

    PMID: 24337765RESULT

  • 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.

    PMID: 26715587DERIVED

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital Diseases

Study Officials

  • Kerri Winters-Stone, PhD

    Oregon Health & Science University-School of Nursing

    PRINCIPAL INVESTIGATOR

  • Jessica Dobek, MS

    Oregon Health & Science University-School of Nursing

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

August 5, 2009

First Posted

August 6, 2009

Study Start

January 1, 2010

Primary Completion

May 1, 2011

Study Completion

June 1, 2011

Last Updated

April 11, 2014

Record last verified: 2014-04

Locations

US(1)