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Remote Exercise Maintenance With Health Coaching for Cancer Survivors

U

University of Calgary

Status

Completed

Conditions

Cancer Survivors

Treatments

Behavioral: Online delivered Exercise Classes
Behavioral: Health Coaching

Study type

Interventional

Funder types

Other

Identifiers

NCT04751305
HREBA.CC-19-0206

Details and patient eligibility

About

The feasibility of an online maintenance exercise program for cancer survivors supported by health coaching.

Full description

Purpose: The primary aim of this proposed mixed-methods study is to determine the feasibility of implementing a home-based exercise program with the support of telephone-based health coaching (HC). The secondary aim is to test the effectiveness of the program on physical activity (PA) levels, psychosocial well-being, and physical functioning.

Background: Cancer is the leading cause of death in Canada, and one in two Canadians will be diagnosed with cancer in their lifetime. Cancer treatments can prolong life, however it is often at the expense of a multitude of negative symptoms and side-effects that diminish quality of life (QOL). Exercise is one of the most effective and safe options among non-pharmaceutical interventions to manage the psychological and physiological side effects of cancer. Despite the known benefits, PA levels amongst cancer survivors are low. The main barriers to exercise in cancer survivors include lack of time, treatment-related side effects, and fatigue. One factor used to address these potential barriers is to have flexibility in programming, including varying sites for delivery of programs (centre vs home). While there is a preference towards home-based programs, adherence and maintenance rates are generally lower compared to group-based programs.

Rationale: Home-based programs can address the preferences of cancer survivors and potential barriers of exercise, such as access and lack of time. However, there is a need to increase adherence in a home-based program setting.

Objectives/ Research Question: The primary outcome measure of this pilot study is feasibility, while the secondary outcome measures include PA levels, physical functioning, and patient reported outcomes (PRO). We hypothesize that a home-based exercise program, designed to promote self-efficacy and supported by HC, will be maintained, and will improve physical activity levels, self-efficacy in managing the additional burden of isolation, and symptom management, such as chronic fatigue and QOL. The data collected will be used to inform the implementation of a home-based maintenance exercise program.

Research Plan: Assessments of the two intervention arms 1) online group maintenance classes (tapered sessions, 2x/wk for first 2 weeks; 1x/wk for remaining 6 weeks); and 2) online group maintenance classes (same tapered format) with HC (1x/week for approximately 30 minutes) will occur at baseline and post intervention. The first wave of the intervention was run from May until July 2020 for 8 weeks and the second wave was run from September until December 2020 for 12 weeks. Feasibility is the primary outcome measure, including recruitment rate (% who participate from those eligible), assessment completion, safety (adverse event reporting), attendance to remote maintenance classes, HC call completion, and attrition rates. Secondary outcomes include PROs of fatigue, loneliness, stress, social support, self-efficacy, QOL, and PA levels; and measures of physical functioning. Fatigue will be assessed using the FACIT-F. Social support will be assessed through the OSSS-3. Stress and loneliness will be assessed with the PSS and ULS-6 respectively. Self-efficacy will be assessed with a modified barrier SE scale and QOL with the FACT-general questionnaire. PA levels will be monitored objectively through weekly PA levels recorded with an accelerometer, and pre-/post intervention with the self-reported GLTEQ. Physical functioning assessments will be conducted remotely with a clinical exercise physiologist. Semi-structured interviews conducted post-intervention will focus on feasibility, including participant satisfaction, barrier management, pros/cons to the home-setting, value of the health coaching support, and facilitators to maintaining PA levels.

Significance: Exercise improves physical and psychological symptom burden from cancer treatment and enhances QOL. During COVID necessitated social isolation, a feasible and effective home-based exercise program may increase the capacity of cancer survivors to engage in regular physical activity.

Enrollment

39 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Being 18 years or older
  • Diagnosed with Cancer within the last 3 years
  • Passed Physical Activity Readiness Questionnaire + (PAR-Q+)
  • Completed at an ACE baseline class
  • Have access to a computer, laptop, iPad or Tablet with a video camera (with the Zoom app installed)
  • Have access to an internet connection strong enough to support a live video broadcast

Exclusion criteria

  • Active infections at the time of enrollment
  • Enteral tube feeding/parenteral nutrition
  • Mechanical or functional bowel obstruction due to any cause
  • Cognitive impairment
  • non-English speaking
  • Neuromusculoskeletal issues that impede participation

Trial design

Primary purpose

Supportive Care

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

39 participants in 2 patient groups

ACE Remote Maintenance Program with Health Coaching
Experimental group
Description:
The participants received online delivered (over zoom) group based exercise classes (2x/wk for first 2 weeks; 1x/wk for the remaining weeks) followed by a 15 minute post workout social session. Participants also received a PDF of a home-based exercise program with embedded videos and a Garmin Vivosmart4 activity tracker. The accelerometer is not intended to be an active part of the intervention but is used to gather an objective measure of PA levels. Additionally, the health coaching intervention received weekly zoom calls that were focused on being participant-centered, built on a coach participant relationship, and included participant-determined goals, a self-discovery process to find solutions, patient accountability, and education.
Treatment:
Behavioral: Health Coaching
Behavioral: Online delivered Exercise Classes
Only ACE Remote Maintenance Program
Active Comparator group
Description:
The participants received online delivered (over zoom) group based exercise classes (2x/wk for first 2 weeks; 1x/wk for the remaining weeks) followed by a 15 minute post workout social session. Participants also participants received a PDF of a home-based exercise program with embedded videos and a Garmin Vivosmart4 activity tracker. The accelerometer is not intended to be an active part of the intervention but is used to gather an objective measure of PA levels.
Treatment:
Behavioral: Online delivered Exercise Classes

Trial contacts and locations

2

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Data sourced from clinicaltrials.gov

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