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Quality of LifeOutPACENCT02321358

Trial of a Behavior Change Intervention to Increase Aerobic and Resistance Exercise and Quality of Life in Older Prostate and Breast Cancer Survivors

A study testing Two-time implementation intention, One-time implementation intention and Physical Activity Materials in people with Quality of Life and Physical Activity, run by Memorial University of Newfoundland 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

This trial is a three-armed randomized controlled trial which will explore the utility of an implementation intention intervention on aerobic and resistance exercise in older (60+) prostate and breast cancer survivors and improving quality of life. Read more about this study

Who is it for?
Ages 60 years and olderHealthy volunteers can take part
Conditions the study is for
Quality of Life, Physical Activity, Fatigue
What is being tested?
Two-time implementation intention, One-time implementation intention and Physical Activity Materials
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
30 participants
Where
1 siteCanada
Study dates
Sep 2014to Sep 2018
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 60 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 60 years old or older
  • Breast or prostate cancer survivor
  • Completed surgery, radiation and/or chemotherapy
  • Proficient in English
  • Living in the greater St. John's, NL area; participants are asked to meet researchers at the university
  • Have an interest in becoming more active or learning about physical activity

Who cannot join

  • Those with contraindications to exercise
  • Participants will be asked about other existing diseases and if they have been told by their doctor to avoid certain activities. Some may be asked to consult with physician before taking part

Trial locations and contacts

1 site in 1 country.

Canada1 site

  • School of Human Kinetics and Recreation

    St. John's, Newfoundland and Labrador, A1C 5S7

Other trials in Canada

About this study

Official title: Randomized Controlled Trial of a Behavior Change Intervention to Increase Aerobic and Resistance Exercise and Quality of Life in Older Prostate and Breast Cancer Survivors: The OutPACE Trial

This trial is a three-armed randomized controlled trial which will explore the utility of an implementation intention intervention on aerobic and resistance exercise in older (60+) prostate and breast cancer survivors and improving quality of life. It is expected that those in the experimental groups will report greater increases in their physical activity, resulting in greater improvements in their quality of life.

Read the detailed description

Recruitment

Potential participants will be contacted by the Newfoundland and Labrador Cancer registry. They will be given a brief explanation of the study will be asked to consent to a mail-out questionnaire from the registry. The questionnaire will contain a cover letter explaining the study in more detail along with informed consent. If the participant wishes to continue in the study, they will return the questionnaire to the research team, who will contact them from this point.

Participants will also be recruited through presentations at local support groups as well as advertisements in local papers and posters at local hospitals and recreation centers.

Power Analysis

According to G*Power a sample of 40 prostate and breast cancer survivors per group (n=120) is needed to detect a medium effect size (d= .50) on our primary outcome (i.e., PA) with a power of 0.80, at a p-level of 0.05. We expect a 20% attrition rate, based on previous research (McGowan, North, \& Courneya, 2013; Vallance, Courneya, Plotnikoff, Yasui, \& Mackey, 2007) therefore we will attempt to recruit a sample of 150 breast and prostate cancer survivors, which would allow for 50 participants per group.

Data Analysis

Analyses of covariance will be used to examine group differences on our primary outcome (i.e., PA minute/week) at month 1 and month 3, and secondary outcomes (e.g., QoL) at month 3. Additional analyses of covariance will be run to explore the group differences on sedentary behaviour, and light, moderate and vigorous minutes of activity/week at month 1 and month 3. Medical (e.g., comorbidities, months since diagnosis) and demographic (e.g., marital status, age, BMI) will be tested as possible moderators of PA behaviour change.

If we experience a large proportion of missing data multiple imputation techniques in SPSS will be used to replace missing values. Otherwise, a last outcome carried forward approach will be used.

The relationships between self-reported PA and QoL, and objectively measured PA and QoL in older breast and prostate cancer survivors will be explored. To examine this, differences in QoL between participants in the two PA categories (i.e., meeting PA guidelines and not meeting PA guidelines) will be tested using analysis of variance (ANOVA). These analyses will be repeated using analysis of covariance (ANCOVA) to control for the demographic and medical variables that had statistically significant associations with the QoL.

The relationship between objectively measured PA and self-reported PA will be explored using a two-way mixed intraclass correlation coefficient to calculate the level of absolute agreement between the two types of measurements.

Being tested
Two-time implementation intention, One-time implementation intention, Sham Comparator, Physical Activity Materials
Keywords
Behavior Change, Objectively Measured Physical Activity, Survivorship
Medical subject headings
Motor Activity, Fatigue, Breast Neoplasms, Prostatic Neoplasms

What participants receive

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

  • Two-time implementation intentionBehavioural

    Will be given intervention and booster at six weeks

  • One-time implementation intentionBehavioural

    Will only be given the intervention once

  • Sham ComparatorBehavioural

    Canada's Food Guide for Healthy Eating will be provided. This contains a small amount of physical activity information.

  • Physical Activity MaterialsBehavioural

    Thera-Bands, instructional DVD and exercise handout, instructional stretching handout, CSEP Physical activity guidelines.

Study groups in NCT02321358
Study groupRoleWhat they receive
Two-time implementation intentionExperimentalGroup will receive physical activity materials along with the implementation intention intervention and a booster again six weeks following.
Receives: Behavioral: Two-time implementation intention; Behavioral: Physical Activity Materials
One-time implementation intentionActive comparatorGroup will receive physical activity materials along with the implementation intention intervention.
Receives: Behavioral: One-time implementation intention; Behavioral: Physical Activity Materials
Sham Comparator GroupSham comparatorGroup will receive Canada's Food Guide which contains a small amount of physical activity information.
Receives: Behavioral: Sham Comparator

What is being measured

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

  1. Change in Self-Reported Physical Activity

    Using Godin's Leisure Score Index, participants will be asked how much physical activity they took part in over the past seven days. Data from each time point will be analyzed and compared to determine change.

    Measured: Baseline, one month follow-up, three month follow-up

  2. Change in Objectively Measured Physical Activity

    Participants will wear an accelerometer (ActiGraph GT3X) for seven days to assess their activity. Data from each time point will be analyzed and compared to determine change.

    Measured: Baseline, one month follow-up, three month follow-up

Secondary outcomes (2)

  1. Change in Fatigue

    Will be assessed using the FACIT-F questionnaire. Data from each time point will be analyzed and compared to determine change.

    Measured: Baseline, one month follow-up, three month follow-up

  2. Change in Quality of Life

    Will be assessed using the short-form 36 scale (SF-36) and Functional Assessment of Cancer Therapy (FACT) questionnaire, specific to cancer type (FACT-Breast or FACT-Prostate). Data from each time point will be analyzed and compared to determine change.

    Measured: Baseline, one month follow-up, three month follow-up

Timeline

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

  1. First posted22 Dec 2014 (estimated)
  2. Study startSep 2014
  3. Primary completionSep 2018
  4. Study completionSep 2018

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
Factorial
Masking
Single blind
Who is masked
Participant
Enrolment
30 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02321358
Sponsor's protocol ID
20141338-HK
Acronym
OutPACE
Status last verified
Oct 2020
First submitted
8 Dec 2014
Last updated
22 Oct 2020
Results posted
No
Data monitoring committee
Yes

Publications

  • 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

  • Vallance JK, Courneya KS, Plotnikoff RC, Yasui Y, Mackey JR. Randomized controlled trial of the effects of print materials and step pedometers on physical activity and quality of life in breast cancer survivors. J Clin Oncol. 2007 Jun 10;25(17):2352-9. doi: 10.1200/JCO.2006.07.9988.

    PubMed 17557948

Questions about this trial

What is this clinical trial studying?

A study testing Two-time implementation intention, One-time implementation intention and Physical Activity Materials in people with Quality of Life and Physical Activity, run by Memorial University of Newfoundland 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 6 inclusion and 2 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 22 Oct 2020. 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. 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?

Change in Self-Reported Physical Activity (time frame: Baseline, one month follow-up, three month follow-up). The study lists 2 primary outcomes in all. 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 NCT02321358, 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 22 Oct 2020.

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