Prostate CancerNCT00954044
Exercising Together: An Intervention for Prostate Cancer Survivors and Spouses
A study testing Randomized Exercise Intervention in people with Prostate Cancer, run by Oregon Health and Science University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- Randomized Exercise Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 128 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2010to Jun 2011
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
- Currently residing with prostate cancer survivor
- Exclusion Criteria for prostate cancer survivor and Spouses:
Show all 10Show fewer
- 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
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
Oregon Health & Science University
Portland, Oregon, 97239
About this study
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.
- Conditions
- Prostate Cancer
- Being tested
- Randomized Exercise Intervention
- Keywords
- randomized clinical trial, prostate cancer, partnered exercise
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Randomized Exercise InterventionBehavioural
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.
Randomized Exercise InterventionBehavioural
Couples will continue doing their usual daily activities for 6 months
| Study group | Role | What they receive |
|---|---|---|
| Exercising Together | Experimental | Partnered progressive resistance exercise Receives: Behavioral: Randomized Exercise Intervention |
| Usual Care | Placebo comparator | Usual Care Control Receives: Behavioral: Randomized Exercise Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Physical function
Measured: baseline, 3, 6 months
Secondary outcomes (1)
Marital quality
Measured: 0,3,6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2009 (estimated)
- Study startJan 2010
- Primary completionMay 2011
- Study completionJun 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- More trials run by Oregon Health and Science UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 128 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oregon Health and Science University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kerri Winters, Oregon Health and Science University
- Investigators
- Kerri Winters-Stone, PhD, Principal investigator, Oregon Health & Science University-School of NursingJessica Dobek, MS, Study director, Oregon Health & Science University-School of Nursing
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00954044
- Sponsor's protocol ID
- 5366
- Status last verified
- Apr 2014
- First submitted
- 5 Aug 2009
- Last updated
- 11 Apr 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 24337765Winters-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.
PubMed 26715587
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exercising Together: An Intervention for Prostate Cancer Survivors and Spouses
- ClinicalTrials.gov ID
- NCT00954044
- Acronym / sponsor ID
- 5366
- Conditions
- Prostate Cancer
- Keywords
- randomized clinical trial, prostate cancer, partnered exercise
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 128 participants (actual)
- Lead sponsor
- Oregon Health and Science UniversityUniversity, hospital or other
- Study start
- Jan 2010
- Primary completion
- May 2011 (actual)
- Study completion
- Jun 2011 (actual)
- First posted
- 6 Aug 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Exercising Together | Experimental | Behavioral: Randomized Exercise InterventionPartnered progressive resistance exercise |
| Usual Care | Placebo comparator | Behavioral: Randomized Exercise InterventionUsual Care Control |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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
- Currently residing with prostate cancer survivor
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Randomized Exercise InterventionThe 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. | Behavioural | Exercising Together |
| Randomized Exercise InterventionCouples will continue doing their usual daily activities for 6 months | Behavioural | Usual Care |
Primary outcome
Physical function
Time frame: baseline, 3, 6 months
1 secondary outcome
Marital quality
Time frame: 0,3,6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Apr 2014.
- Results publication: PubMed 24337765Winters-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.
- Derived from this study: PubMed 26715587Winters-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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kerri Winters-Stone, PhD principal investigator
Oregon Health & Science University-School of Nursing
Jessica Dobek, MS study director
Oregon Health & Science University-School of Nursing
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Randomized Exercise Intervention in people with Prostate Cancer, run by Oregon Health and Science University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Apr 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Physical function (time frame: baseline, 3, 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00954044, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Apr 2014.