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

NCT02321358 | Completed DMC

• 1 other identifier: 20141338-HK
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Quality of Life; Physical Activity; Fatigue; Breast Cancer; Prostate Cancer

Keywords

Behavior Change; Objectively Measured Physical Activity; Survivorship

Outcome Measures

Primary Outcomes (2)

• 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.

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

• 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.

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

Secondary Outcomes (2)

• Change in Fatigue

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

• Change in Quality of Life

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

Study Arms (3)

Two-time implementation intention

EXPERIMENTAL

Group will receive physical activity materials along with the implementation intention intervention and a booster again six weeks following.

Behavioral: Two-time implementation intention; Behavioral: Physical Activity Materials

One-time implementation intention

ACTIVE COMPARATOR

Group will receive physical activity materials along with the implementation intention intervention.

Behavioral: One-time implementation intention; Behavioral: Physical Activity Materials

Sham Comparator Group

SHAM COMPARATOR

Group will receive Canada's Food Guide which contains a small amount of physical activity information.

Behavioral: Sham Comparator

Interventions

Two-time implementation intention BEHAVIORAL

Will be given intervention and booster at six weeks

Two-time implementation intention

One-time implementation intention BEHAVIORAL

Will only be given the intervention once

One-time implementation intention

Sham Comparator BEHAVIORAL

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

Sham Comparator Group

Physical Activity Materials BEHAVIORAL

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

One-time implementation intention; Two-time implementation intention

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Memorial University of Newfoundland: lead
• Mitacs: collaborator

Study Sites (1)

School of Human Kinetics and Recreation

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

Location

Related Publications (2)

• 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.

  PMID: 23783829 BACKGROUND

• 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.

  PMID: 17557948 BACKGROUND

MeSH Terms

Conditions

Motor Activity; Fatigue; Breast Neoplasms; Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Behavior; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Genital Neoplasms, Male; Urogenital Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Officials

• Erin L McGowan, Ph.D

  Assistant Professor

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: December 8, 2014
• First Posted: December 22, 2014
• Study Start: September 1, 2014
• Primary Completion: September 1, 2018
• Study Completion: September 1, 2018
• Last Updated: October 22, 2020

Record last verified: 2020-10

Locations

CA (1)