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Prostate CancerPROMOTENCT01410656

Prostate Cancer Survivors Moving Toward Exercise (PROMOTE) Trial

A study testing Telephone Implementation Intention and Self-completed implementation intention in people with Prostate Cancer, run by University of Alberta at 1 site in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The primary purpose of the study is to determine the effects of an implementation intention intervention on physical activity (PA) behaviour in prostate cancer survivors. Secondary aims are to (a) compare the effects of a telephone-assisted implementation intention intervention against a self-administered… Read more about this study

Who is it for?
Ages 18 to 90 years, men onlyHealthy volunteers can take part
Conditions the study is for
Prostate Cancer
What is being tested?
Telephone Implementation Intention and Self-completed implementation intention
Could I receive a placebo?
No, everyone receives an active treatment
How many people
423 participants
Where
1 siteCanada
Study dates
May 2011to Sep 2012
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 to 90 years
  • Men only
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Prostate cancer survivors
  • at least 18 years old
  • proficient in English

Who cannot join

None listed.

Trial locations and contacts

1 site in 1 country.

Canada1 site
  • University of Alberta

    Edmonton, Alberta, T6G 2H9

Other trials in Canada

About this study

Official title: Prostate Cancer Survivors MOving Toward Exercise (PROMOTE) Trial

The primary purpose of the study is to determine the effects of an implementation intention intervention on physical activity (PA) behaviour in prostate cancer survivors. Secondary aims are to (a) compare the effects of a telephone-assisted implementation intention intervention against a self-administered implementation intention intervention and a standard recommendation group on physical activity behaviour and (b) document the effects of these interventions on quality of life (QoL), fatigue, symptom management, and physical functioning.

Hypotheses: Evidence exists that an implementation intention intervention can lead to significant improvements in PA levels and that regular PA has been shown to improve QoL, fatigue levels, manage symptoms and improve physical functioning in cancer survivors'. As such, the following hypotheses were generated: (1) prostate cancer survivors exposed to the researcher-assisted implementation intention intervention will have higher PA levels at the 1- and 3-month follow-ups compared to the self-completed implementation intention intervention and the standard recommendation group; (2) prostate cancer survivors in the researcher-assisted implementation intention intervention will show significant improvements in QoL, fatigue levels, symptom management, and physical functioning compared to the self-completed implementation intention intervention and the standard recommendation group at the 1- and 3-month follow-up; and (3) prostate cancer survivors in the self-completed implementation intention intervention will have higher PA levels, and better improvements in QoL, fatigue levels, symptom management, and physical functioning compared to the standard recommendation group at the 1- and 3-month follow-ups.

Read the detailed description

BACKGROUND:

Prostate cancer remains the most frequently diagnosed cancer among Canadian men, with an estimated 24,600 men being diagnosed in 2010. In Alberta specifically, roughly 2,500 men will be diagnosed with prostate cancer, and 440 men will die of the disease in 2010 (Canadian Cancer Society, 2011). Improvements in the treatment of prostate cancer has reduced tumour growth and improved survival rates, however, it has also been associated with significant negative changes in cancer survivors' quality of life, physical functioning, body fat percentage and fatigue levels that may persist for years following treatment. One behavioural strategy that has been consistently shown to combat these negative side effects and enhance psychosocial and physical well-being in prostate cancer survivors is physical activity. Unfortunately it has been established that physical activity levels decline significantly from pre-diagnosis to during treatment and may never regain pre-diagnosis levels; thus it is important to test novel, innovative and inexpensive ways to increase physical activity patterns in prostate cancer survivors.

PURPOSE:

The primary purpose of the study is to determine the effects of an implementation intention intervention on physical activity behaviour in prostate cancer survivors. Secondary aims are to (a) compare the effects of a telephone-assisted implementation intention intervention against a self-administered implementation intention intervention and a standard recommendation group on physical activity behaviour and (b) document the effects of these interventions on quality of life, fatigue, symptom management, and physical functioning.

METHODS:

A three-arm randomized controlled trial for prostate cancer survivors will be performed through the Alberta Cancer Registry. To obtain a sample of at least 300 participants, 1500 prostate cancer survivors will be contacted in the initial mail-out. Following the initial mail-out prostate cancer survivors agreeing to participate in the study will be randomized to one of the three conditions. All groups will receive a written physical activity recommendation, as well as the 2008 Physical Activity Guidelines. In addition to the physical activity materials, participants in the telephone-assisted and self-administered groups will be asked to complete an implementation intention intervention. Finally, the telephone-assisted group will receive a 10-20 minute telephone call to assist them with the completion of implementation intention intervention. Measures at baseline (i.e., initial mail-out) will include self-reported physical activity, demographic, health and medical factors, quality of life, fatigue, physical functioning. Follow-up at month 1 and 3 following the intervention will include self-reported physical activity, quality of life, fatigue and physical function measures.

SUMMARY:

This mail-out study will offer insight into the effects of an implementation intention intervention on physical activity levels in an understudied cancer population, and further explore the effect of physical activity as part of the usual care recommended for the treatment of prostate cancer on quality of life, fatigue and symptom management.

Conditions
Prostate Cancer
Being tested
Telephone Implementation Intention, Self-completed implementation intention
Keywords
Survivors
Medical subject headings
Prostatic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Telephone Implementation IntentionBehavioural

    Telephone implementation intention counseling

  • Self-completed implementation intentionBehavioural

    Self-administered implementation intention intervention

Study groups in NCT01410656
Study groupRoleWhat they receive
Standard PA RecommendationNo interventionReceived the standard physical activity recommendation.
Telephone Implementation IntentionExperimentalBehavioural Telephone Assisted Implementation Intention Intervention
Receives: Behavioral: Telephone Implementation Intention
Self-completed implementation intentionExperimentalSelf-administered implementation intention intervention.
Receives: Behavioral: Self-completed implementation intention

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in Physical activity Levels From Baseline to Month 1 and Month 3

    Measured by the Leisure score index. Looking for change in Physical Activity levels from baseline to month 1 and month 3 follow-ups.

    Measured: baseline, 1 month, 3 months

Secondary outcomes (2)
  1. Quality of life/ physical functioning

    Looking for change in the FACT-P and SF-36.

    Measured: baseline, 3 months

  2. fatigue

    Looking for change in the FACIT-F

    Measured: baseline, 3 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Aug 2011 (estimated)
  2. Study startMay 2011
  3. Primary completionSep 2012
  4. Study completionSep 2012

Resources

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
None (open label)
Enrolment
423 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01410656
Sponsor's protocol ID
RES-0006611
Acronym
PROMOTE
Status last verified
May 2018
First submitted
19 Jul 2011
Last updated
4 May 2018
Results posted
No
Data monitoring committee
No

Publications

  • McGowan EL, Fuller D, Cutumisu N, North S, Courneya KS. The role of the built environment in a randomized controlled trial to increase physical activity among men with prostate cancer: the PROMOTE trial. Support Care Cancer. 2017 Oct;25(10):2993-2996. doi: 10.1007/s00520-017-3798-1. Epub 2017 Jun 27.

    PubMed 28656468
  • McGowan EL, North S, Courneya KS. Randomized controlled trial of a behavior change intervention to increase physical activity and quality of life in prostate cancer survivors. Ann Behav Med. 2013 Dec;46(3):382-93. doi: 10.1007/s12160-013-9519-1.

    PubMed 23783829

Questions about this trial

What is this clinical trial studying?

A study testing Telephone Implementation Intention and Self-completed implementation intention in people with Prostate Cancer, run by University of Alberta at 1 site in Canada.

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 3 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 4 May 2018. 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 Canada. 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. 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?

Change in Physical activity Levels From Baseline to Month 1 and Month 3 (time frame: baseline, 1 month, 3 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 NCT01410656, 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 4 May 2018.

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