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Prostate Cancer Survivors MOving Toward Exercise (PROMOTE) Trial


Phase 3
18 Years
90 Years
Open (Enrolling)
Male
Prostate Cancer

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Trial Information

Prostate Cancer Survivors MOving Toward Exercise (PROMOTE) Trial


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.


Inclusion Criteria:



- Prostate cancer survivors

- at least 18 years old

- proficient in English

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Outcome Measure:

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

Outcome Description:

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

Outcome Time Frame:

baseline, 1 month, 3 months

Safety Issue:

No

Principal Investigator

Kerry S Courneya, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Alberta

Authority:

Canada: Ethics Review Committee

Study ID:

RES-0006611

NCT ID:

NCT01410656

Start Date:

May 2011

Completion Date:

November 2011

Related Keywords:

  • Prostate Cancer
  • Survivors
  • Prostatic Neoplasms

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