Smartphone-Enabled Health Coaching Intervention (iMOVE) to Promote Long-Term Maintenance of Physical Activity in Breast Cancer Survivors: Protocol for a Feasibility Pilot Randomized Controlled Trial

Paul Ritvo; Maya Obadia; Daniel Santa Mina; Shabbir Alibhai; Catherine Sabiston; Paul Oh; Kristin Campbell; David McCready; Leslie Auger; Jennifer Michelle Jones

doi:10.2196/resprot.6615

Smartphone-Enabled Health Coaching Intervention (iMOVE) to Promote Long-Term Maintenance of Physical Activity in Breast Cancer Survivors: Protocol for a Feasibility Pilot Randomized Controlled Trial

JMIR Res Protoc. 2017 Aug 24;6(8):e165. doi: 10.2196/resprot.6615.

Authors

Paul Ritvo^{1

2}, Maya Obadia³, Daniel Santa Mina^{3

4}, Shabbir Alibhai^{5

6}, Catherine Sabiston⁴, Paul Oh^{7

8}, Kristin Campbell⁹, David McCready^{10

11}, Leslie Auger¹², Jennifer Michelle Jones^{3

13}

Affiliations

¹ School of Kinesiology and Health Science, York University, Toronto, ON, Canada.
² Department of Psychology, University of Toronto, Toronto, ON, Canada.
³ Cancer Rehabilitation and Survivorship Program, Princess Margaret Cancer Centre, University Health Network, Toronto, ON, Canada.
⁴ Kinesiology and Physical Education, University of Toronto, Toronto, ON, Canada.
⁵ General Internal Medicine, University Health Network, Toronto, ON, Canada.
⁶ Department of Medicine, University of Toronto, Toronto, ON, Canada.
⁷ Cardiovascular Prevention and Rehabilitation Program, Toronto Rehabilitation Institute, University Health Network, Toronto, ON, Canada.
⁸ Pharmacology and Toxicology, University of Toronto, Toronto, ON, Canada.
⁹ Department of Physical Therapy, University of British Columbia, Vancouver, BC, Canada.
¹⁰ Surgical Oncology, University Health Network, Toronto, ON, Canada.
¹¹ Division of Surgery, University of Toronto, Toronto, ON, Canada.
¹² Kinesiology Program, University of Guelph-Humber, Toronto, ON, Canada.
¹³ Department of Psychiatry, University of Toronto, Toronto, ON, Canada.

Abstract

Background: Although physical activity has been shown to contribute to long-term disease control and health in breast cancer survivors, a majority of breast cancer survivors do not meet physical activity guidelines. Past research has focused on promoting physical activity components for short-term breast cancer survivor benefits, but insufficient attention has been devoted to long-term outcomes and sustained exercise adherence. We are assessing a health coach intervention (iMOVE) that uses mobile technology to increase and sustain physical activity maintenance in initially inactive breast cancer survivors.

Objective: This pilot randomized controlled trial (RCT) is an initial step in evaluating the iMOVE intervention and will inform development of a full-scale pragmatic RCT.

Methods: We will enroll 107 physically inactive breast cancer survivors and randomly assign them to intervention or control groups at the University Health Network, a tertiary cancer care center in Toronto, Canada. Participants will be women (age 18 to 74 years) stratified by age (55 years and older/younger than 55 years) and adjuvant hormone therapy (AHT) exposure (AHT vs no AHT) following breast cancer treatment with no metastases or recurrence who report less than 60 minutes of preplanned physical activity per week. Both intervention and control groups receive the 12-week physical activity program with weekly group sessions and an individualized, progressive, home-based exercise program. The intervention group will additionally receive (1) 10 telephone-based health coaching sessions, (2) smartphone with data plan, if needed, (3) supportive health tracking software (Connected Wellness, NexJ Health Inc), and (4) a wearable step-counting device linked to a smartphone program.

Results: We will be assessing recruitment rates; acceptability reflected in selective, semistructured interviews; and enrollment, retention, and adherence quantitative intervention markers as pilot outcome measures. The primary clinical outcome will be directly measured peak oxygen consumption. Secondary clinical outcomes include health-related quality of life and anthropometric measures. All outcome measures are administered at baseline, after exercise program (month 3), and 6 months after program (month 9).

Conclusions: This pilot RCT will inform full-scale RCT planning. We will assess pilot procedures and interventions and collect preliminary effect estimates.

Trial registration: ClinicalTrials.gov NCT02620735; https://clinicaltrials.gov/ct2/show/NCT02620735 (Archived by WebCite at https://clinicaltrials.gov/ct2/show/NCT02620735).

Keywords: RCT; breast neoplasm; exercise; health coaching; telehealth.

©Paul Ritvo, Maya Obadia, Daniel Santa Mina, Shabbir Alibhai, Catherine Sabiston, Paul Oh, Kristin Campbell, David McCready, Leslie Auger, Jennifer Michelle Jones. Originally published in JMIR Research Protocols (http://www.researchprotocols.org), 24.08.2017.

Associated data

ClinicalTrials.gov/NCT02620735