The Breast Cancer & Physical Activity Level (BC-PAL) Pilot Study

NCT03564899 | Completed

• 1 other identifier: BC-PAL
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

Brief Summary

The Breast Cancer \& Physical Activity Level (BC-PAL) pilot study is a randomized controlled pilot trial aimed at evaluating whether total physical activity levels, health-related fitness and patient reported outcomes are improved by promoting different intensities of physical activity participation within a home-based setting, and whether these improvements are maintained over the long-term, in inactive breast cancer survivors.

Conditions

Breast Cancer Survivorship

Keywords

Breast cancer; Survivorship; Physical activity intervention; Activity trackers; Sedentary time

Outcome Measures

Primary Outcomes (1)

• Change in sedentary time, light intensity physical activity time and moderate-vigorous intensity physical activity time (hours/day)

  Measured with accelerometry over seven days

  Baseline, 12 weeks (end of intervention) and 24 weeks (end of follow-up period)

Secondary Outcomes (6)

• Change in body weight (kg)

  Baseline, 12 weeks (end of intervention) and 24 weeks (end of follow-up period)

• Change in height (cm)

  Baseline, 12 weeks (end of intervention) and 24 weeks (end of follow-up period)

• Change in waist and hip circumference (cm)

  Baseline, 12 weeks (end of intervention) and 24 weeks (end of follow-up period)

• Change in body composition (fat and lean mass in kg)

  Baseline, 12 weeks (end of intervention) and 24 weeks (end of follow-up period)

• Change in cardiorespiratory fitness (VO2max)

  Baseline, 12 weeks (end of intervention) and 24 weeks (end of follow-up period)

Other Outcomes (5)

• Change in sleep quality (scale of 0 to 21)

  Baseline, 12 weeks (end of intervention) and 24 weeks (end of follow-up period)

• Change in health-related quality of life (scale of 0 to 100)

  Baseline, 12 weeks (end of intervention) and 24 weeks (end of follow-up period)

• Change in breast cancer-specific quality of life (scale of 0 to 28)

  Baseline, 12 weeks (end of intervention) and 24 weeks (end of follow-up period)

Study Arms (3)

control

NO INTERVENTION

Receive no physical activity intervention (maintain baseline physical activity participation)

Lighter intensity physical activity

EXPERIMENTAL

Receive an intervention of 300 minutes/week of physical activity at an intensity of 40-60% of heart rate reserve for 12 weeks.

Behavioral: Lighter intensity physical activity intervention

Higher intensity physical activity

ACTIVE COMPARATOR

Receive an intervention of 150 minutes/week of physical activity at an intensity of 60-80% of heart rate reserve for 12 weeks.

Behavioral: Higher intensity physical activity intervention

Interventions

Lighter intensity physical activity intervention BEHAVIORAL

Prescription of 300 minutes/week of physical activity at an intensity of 40-60% of heart rate reserve

Lighter intensity physical activity

Higher intensity physical activity intervention BEHAVIORAL

Prescription of 150 minutes/week of physical activity at an intensity of 60-80% of heart rate reserve

Higher intensity physical activity

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histologically-confirmed Stage I-III breast cancer diagnosis
• Completion of adjuvant treatment (chemotherapy, radiation therapy and surgery) except for hormone therapy
• Females ≥18 years of age
• Currently living in the Calgary area and able to meet with study staff at the Holy Cross Center on at least six occasions (twice as baseline, 12- and 24-weeks)
• Currently inactive (accumulating ≤ 60 minutes of moderate-vigorous intensity physical activity/week and ≤ 10,000 steps/day)
• Ability to undertake a physical activity program \[assessed by an Exercise Physiologist with the Physical Activity Readiness Questionnaire (PAR-Q+)\].

You may not qualify if:

• Deemed too active (accumulating on average ≥ 60 minutes of moderate-vigorous intensity physical activity/week and ≥ 10,000 steps/day)
• Being away from Calgary or not able to attend testing sessions/be contacted by study staff for \> 4 consecutive weeks during the intervention period.

Sponsors & Collaborators

• AHS Cancer Control Alberta: lead
• University of Calgary: collaborator

Study Sites (1)

The Rehabilitation, Exercise and Complementary (REACH) center within the Holy Cross Center

Calgary, Alberta, T2S 3C3, Canada

Location

Related Publications (2)

• McNeil J, Fahim M, Stone CR, O'Reilly R, Courneya KS, Friedenreich CM. Adherence to a lower versus higher intensity physical activity intervention in the Breast Cancer & Physical Activity Level (BC-PAL) Trial. J Cancer Surviv. 2022 Apr;16(2):353-365. doi: 10.1007/s11764-021-01030-w. Epub 2021 Mar 22.

  PMID: 33754246 DERIVED

• McNeil J, Brenner DR, Stone CR, O'Reilly R, Ruan Y, Vallance JK, Courneya KS, Thorpe KE, Klein DJ, Friedenreich CM. Activity Tracker to Prescribe Various Exercise Intensities in Breast Cancer Survivors. Med Sci Sports Exerc. 2019 May;51(5):930-940. doi: 10.1249/MSS.0000000000001890.

  PMID: 30694978 DERIVED

MeSH Terms

Conditions

Breast Neoplasms; Sedentary Behavior

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Behavior

Study Officials

• Christine Friedenreich, PhD

  CancerControl Alberta

  PRINCIPAL INVESTIGATOR

• Jessica McNeil, PhD

  CancerControl Alberta

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Participants are randomized, using a 1:1:1 allocation, into one of three groups: 1) the control group (no physical activity intervention), 2) the lighter intensity physical activity intervention or 3) the higher intensity physical activity intervention.

Study Record Dates

• First Submitted: May 29, 2018
• First Posted: June 21, 2018
• Study Start: February 13, 2017
• Primary Completion: July 31, 2018
• Study Completion: December 31, 2018
• Last Updated: January 12, 2021

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)