Remote Exercise Maintenance With Health Coaching for Cancer Survivors

NCT04751305 | Completed

• 1 other identifier: HREBA.CC-19-0206
• Study Type: interventional
• Target: 39
• Locations: 1 country
• Sites: 2

Brief Summary

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

Conditions

Cancer Survivors

Keywords

mHealth; Health Coaching; Exercise; Online delivery

Outcome Measures

Primary Outcomes (22)

• Feasibility of Exercise Class Attendance (Cohort 1)

  Percentage of class attendance by all participants was assessed and deemed feasible if attendance was equal or above 70%.

  Beginning of exercise classes (week 1) until last day of exercise classes (week 8)

• Feasibility of Exercise Class Attendance (Cohort 2)

  Percentage of class attendance by all participants was assessed and deemed feasible if attendance was equal or above 70%.

  Beginning of exercise classes (week 1) until last day of exercise classes (week 12)

• Feasibility of Exercise Guidelines Adherence (Cohort 1)

  Percentage of participants meeting the exercise guidelines of 90 minutes of moderate to vigorous physical activity. 80% or higher adherence will be deemed feasible.

  Beginning of exercise classes (week 1) until last week of exercise classes (end of week 8)

• Feasibility of Exercise Guidelines Adherence (Cohort 2)

  Percentage of participants meeting the exercise guidelines of 90 minutes of moderate to vigorous physical activity. 80% or higher adherence will be deemed feasible.

  Beginning of exercise classes (week 1) until last week of exercise classes (end of week 12)

• Feasibility health coaching call completion (Cohort 1)

  Percentage of participants in the health coaching intervention completing all calls. 80% or higher completion will be deemed feasible.

  Beginning of exercise classes (week 1) until last week of exercise classes (week 8)

• Feasibility health coaching call completion (Cohort 2)

  Percentage of participants in the health coaching intervention completing all calls. 80% or higher completion will be deemed feasible.

  Beginning of exercise classes (week 1) until last week of exercise classes (week 12)

• Feasibility of Recruitment

  Percentage of participants signing up for the study over the eligible cancer survivors will be calculated. 50% or higher recruitment rate will be deemed feasible.

  Started about one month before study beginning and went until beginning of study (week 0)

• Fidelity of the health coaching intervention (Cohort 1)

  The fidelity of the health coaching intervention will be reported based on how close the intervention followed the protocol. Two sessions of each participant were randomly recorded (through envelope draw). After study completion a research assistant will analyze the recording with the health coaching protocol checklist. The research assistant will report percent agreement with the protocol (9 items for each health coaching session) and the time spent on each part of the health coaching call.

  Beginning of exercise classes (week 1) until last day of exercise classes (week 8)

• Fidelity of the health coaching intervention (Cohort 2)

  The fidelity of the health coaching intervention will be reported based on how close the intervention followed the protocol. Two sessions of each participant were randomly recorded (through envelope draw). After study completion a research assistant will analyze the recording with the health coaching protocol checklist. The research assistant will report percent agreement with the protocol (9 items for each health coaching session) and the time spent on each part of the health coaching call.

  Beginning of exercise classes (week 1) until last day of exercise classes (week 12)

• Fidelity of the exercise intervention (Cohort 1)

  The fidelity of the exercise intervention will be reported based on how close the intervention followed the protocol. The research coordinator joined each exercise class, reported on the class and compared the class structure to the exercise protocol checklist (4 items for each exercise class (including: Alterations to pre-class, warm-up, exercise circuits, cool-down, and post-class conversation)). Percent agreement between protocol and intervention across all classes will be reported. Additionally, the amount of times participants showed up late and the amount of times technical difficulties arose (including audio/video and log in complications) will be reported.

  Beginning of exercise classes (week 1) until last day of exercise classes (week 8)

• Fidelity of the exercise intervention (Cohort 2)

  The fidelity of the exercise intervention will be reported based on how close the intervention followed the protocol. The research coordinator joined each exercise class, reported on the class and compared the class structure to the exercise protocol checklist (4 items for each exercise class (including: Alterations to pre-class, warm-up, exercise circuits, cool-down, and post-class conversation)). Percent agreement between protocol and intervention across all classes will be reported. Additionally, the amount of times participants showed up late and the amount of times technical difficulties arose (including audio/video and log in complications) will be reported.

  Beginning of exercise classes (week 1) until last day of exercise classes (week 12)

• Feasibility of Study completion (Cohort 1)

  The attrition rate of the study was calculated as the percentage of dropouts out of all participants.

  Beginning of exercise classes (week 1) until last day of exercise classes (week 8)

• Feasibility of Study completion (Cohort 2)

  The attrition rate of the study was calculated as the percentage of dropouts out of all participants.

  Beginning of exercise classes (week 1) until last day of exercise classes (week 12)

• Feasibility of Assessment Completion (Questionnaire) (Cohort 1)

  Percentage of all assessments completed by all participants was assessed and deemed feasible if completion was equal or above 70%.

  Before study (week 0) and after study completion (Week 9)

• Feasibility of Assessment Completion (Questionnaire) (Cohort 2)

  Percentage of all assessments completed by all participants was assessed and deemed feasible if completion was equal or above 70%.

  Before study (week 0) and after study completion (Week 13)

• Feasibility of Assessment Completeness (Questionnaire) (Cohort 1)

  Percentage of all questions within the questionnaire answered by all participants was assessed and deemed feasible if completion was equal or above 70%.

  Before study (week 0) and after study completion (Week 9)

• Feasibility of Assessment Completeness (Questionnaire) (Cohort 2)

  Percentage of all questions within the questionnaire answered by all participants was assessed and deemed feasible if completion was equal or above 70%.

  Before study (week 0) and after study completion (Week 13)

• Feasibility of Assessment Completion (Physical functioning assessment) (Cohort 1)

  Percentage of all assessments completed by all participants was assessed and deemed feasible if completion was equal or above 70%.

  Before study (week 0) and after study completion (Week 9)

• Feasibility of Assessment Completion (Physical functioning assessment) (Cohort 2)

  Percentage of all assessments completed by all participants was assessed and deemed feasible if completion was equal or above 70%.

  Before study (week 0) and after study completion (Week 13)

• Feasibility of Assessment Completion (Accelerometer) (Cohort 1)

  Percentage of days accelerometer was worn as intended was assessed and deemed feasible if completed wear time days were equal or above 70% of overall study days. The accelerometer wearing time was calculated as following: a day was counted if the accelerometer was worn for more than 10 hours, the percentage of days worn over the overall days of the study was calculated.

  Throughout the study from week 4 (due to COVID related delivery delays) until end of week 8

• Feasibility of Assessment Completion (Accelerometer) (Cohort 2)

  Percentage of days accelerometer was worn as intended was assessed and deemed feasible if completed wear time days were equal or above 70% of overall study days. The accelerometer wearing time was calculated as following: a day was counted if the accelerometer was worn for more than 10 hours, the percentage of days worn over the overall days of the study was calculated.

  Throughout the study from week 1 until end of week 12

• Semi-Structured Interview (Feasibility)

  Include participant satisfaction, barrier management, pros/cons to the home-setting, value of the health coaching support, and facilitators to maintaining PA levels.

  Post-intervention (week 9 (first wave) or week 13 (second wave))

Secondary Outcomes (29)

• Physical Activity Minutes Per Week (objective) (Cohort 1)

  Throughout the study from week 4 (due to COVID related delivery delays) until end of week 8

• Physical Activity Minutes Per Week (objective) (Cohort 2)

  Throughout the study from week 1 until end of week 12

• Physical Activity Minutes Per Week (subjective) (Cohort 1)

  Before study (week 0) and after study completion (Week 9)

• Physical Activity Minutes Per Week (subjective) (Cohort 2)

  Before study (week 0) and after study completion (Week 13)

• Body Composition (Cohort 1)

  Before study (week 0) and after study completion (Week 9)

Study Arms (2)

ACE Remote Maintenance Program with Health Coaching

EXPERIMENTAL

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.

Behavioral: Health Coaching; Behavioral: Online delivered Exercise Classes

Only ACE Remote Maintenance Program

ACTIVE COMPARATOR

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.

Behavioral: Online delivered Exercise Classes

Interventions

Health Coaching BEHAVIORAL

The weekly health coaching (HC) calls were structured to be participant-centered, built on a coach participant relationship, and include participant-determined goals, a self-discovery process to find solutions, patient accountability, and education. Before each HC call, the participants received a short questionnaire on fatigue, QOL, stress, loneliness, and social support which enabled tailoring the HC call to the individual. Educational topics are discussed in the following order: Goal Setting, Monitoring Behaviour, Barrier Management, Social Support, Stress Management, Adapting the Program, Self-Compassion, Sleep \& Nutrition, Reflection, Health Media, Remote Resources, and Maintaining Motivation. However, the order of the educational topics can be adjusted based on the specific participants' needs each week. At the half-way point of the intervention, the participant provided feedback on the HC calls, ensuring optimization of HC impact.

ACE Remote Maintenance Program with Health Coaching

Online delivered Exercise Classes BEHAVIORAL

The group based remote exercise program was delivered over the Zoom application (2x/wk for first 2 weeks; 1x/wk for the remaining weeks). Classes were one hour long with a ten minute warm up, 40 minute strength and conditioning focused exercise circuits, and a ten minute stretch. Each class was followed by additional time to provide participants with an opportunity to interact with each other, fostering social support.

ACE Remote Maintenance Program with Health Coaching; Only ACE Remote Maintenance Program

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Calgary: lead

Study Sites (2)

Faculty of Kinesiology University of Calgary

Calgary, Alberta, T2N 1N4, Canada

Location

Health and Wellness Lab, University of Calgary

Calgary, Alberta, T2N 1N4, Canada

Location

Related Publications (1)

• Eisele M, Pohl AJ, McDonough MH, McNeely ML, Ester M, Daun JT, Twomey R, Culos-Reed SN. The online delivery of exercise oncology classes supported with health coaching: a parallel pilot randomized controlled trial. Pilot Feasibility Stud. 2023 May 12;9(1):82. doi: 10.1186/s40814-023-01316-z.

  PMID: 37173764 DERIVED

MeSH Terms

Conditions

Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: The certified exercise physiologists (CEP) instructing the exercise classes were unaware of the intervention each participant was assigned to. The CEP administering the physical functioning assessment was unaware of the participants intervention and was not the participants exercise class instructor.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: At the beginning of the remote ACE maintenance program participants are randomized into either the exercise only group or the exercise with additional health coaching group.

Study Record Dates

• First Submitted: January 13, 2021
• First Posted: February 12, 2021
• Study Start: May 27, 2020
• Primary Completion: December 11, 2020
• Study Completion: December 11, 2020
• Last Updated: February 12, 2021

Record last verified: 2020-12

Locations

CA (2)