Bridging the Gap: Incorporating Exercise Evidence Into Clinical Practice in Breast Cancer Care in Ontario

NCT03087461 | Completed

• 1 other identifier: HamiltonHSC-JS
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

Brief Summary

Breast cancer (BC) and its treatments lead to numerous side effects that affect a person's life for years after treatment has ended. Research shows that regular exercise limits many of these side effects. However, less than 30% of BC survivors regularly exercise due to many barriers that include patients being unaware of the benefits of exercise, health professionals facing institutional, personal, and patient-related barriers to promoting exercise, and a lack of knowledge translation (KT) strategies within cancer institutions that focus on accessible exercise interventions and education by physiotherapists. For this project, a pilot study is needed as the first step in order to assess process and resource variables before implementation of a large-scale intervention. The primary objective of this pilot trial is to assess the feasibility of conducting a larger trial to evaluate the effects of a novel KT intervention using exercise and self-management versus usual care among BC survivors. The secondary objective is to determine preliminary estimates of effects of the KT intervention of exercise plus self-management (SM) program versus usual care on (a) levels of exercise knowledge and behaviour, (b) health related quality of life and (c) resource utilization, among BC survivors over a four month period.

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (3)

• Study Recruitment Rate: percentage of eligible patients recruited

  A recruitment log will be kept, detailing reasons for non-participation.

  Baseline

• Intervention Retention Rate: percentage of consented participants who completed the intervention

  Attendance will be tracked on the feasibility data collection sheet and reasons for non-participation on scheduled intervention days will be documented using an adherence log

  Post-intervention (2 months post baseline)

• Intervention Adherence Rate: percentage of total intervention sessions attended

  Attendance will be tracked on the feasibility data collection sheet and reasons for non-participation on scheduled intervention days will be documented using an adherence log

  Post-intervention (2 months post baseline)

Secondary Outcomes (6)

• Health related quality of life

  Baseline, post intervention (2 months post baseline), 2 and 4 month follow up (post intervention completion)

• Exercise knowledge

  Baseline, post intervention (2 months post baseline), 2 and 4 month follow up (post intervention completion)

• Exercise behaviour

  Baseline, post intervention (2 months post baseline), 2 and 4 month follow up (post intervention completion)

• Health status

  Baseline, post intervention (2 months post baseline), 2 and 4 month follow up (post intervention completion)

• Use of health care services

  Baseline, post intervention (2 months post baseline), 2 and 4 month follow up (post intervention completion)

Study Arms (2)

Intervention Group

EXPERIMENTAL

The intervention group will receive a multi-component KT intervention. This will include exercise and self-management components. The exercise intervention will involve a moderate intensity aerobic exercise program, using recumbent bikes, delivered within the cancer institution. Participants will take part in the 30-minute sessions 8 times. The intervention will be supervised by a physiotherapist (PT) educated in cancer rehabilitation. The SM component will include educational modules created by a PT. Participants will view these 30 minute modules prior to each exercise intervention, over the same 8 sessions.

Behavioral: Exercise and self-management

Usual Care

NO INTERVENTION

Control group receiving usual care (no exercise or self-management education within the institution).

Interventions

Exercise and self-management BEHAVIORAL

The intervention will include aerobic exercise and self-management education using technology.

Intervention Group

Eligibility Criteria

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

You may qualify if:

• Community-dwelling, English-speaking women, over 18 years, who are currently undergoing chemotherapy for Stage 1-3 BC and have been cleared by their oncologist to participate in moderate intensity aerobic exercise

You may not qualify if:

• Participants will be excluded from the study if they have another chronic disease, cognitive impairment or injury that prevents them from participating independently in moderate intensity exercise

Sponsors & Collaborators

• Hamilton Health Sciences Corporation: lead

Study Sites (1)

McMaster University

Hamilton, Ontario, L8S1C7, Canada

Location

Related Publications (1)

• Smith-Turchyn J, Richardson J, Tozer R, McNeely M, Thabane L. Bridging the gap: incorporating exercise evidence into clinical practice in breast cancer care. Support Care Cancer. 2020 Feb;28(2):897-905. doi: 10.1007/s00520-019-04897-9. Epub 2019 Jun 5.

  PMID: 31168711 DERIVED

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Exercise; Self-Management

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Rehabilitation; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Jenna Smith-Turchyn, PT, PhD(c)

  McMaster University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD Candidate

Study Record Dates

• First Submitted: March 7, 2017
• First Posted: March 22, 2017
• Study Start: June 1, 2017
• Primary Completion: March 1, 2018
• Study Completion: October 1, 2018
• Last Updated: February 22, 2019

Record last verified: 2019-02

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)