Smart-phone Health Coaching Intervention to Promote Maintenance of Exercise in Breast Cancer Survivors:Protocol
Smart-phone Health Coaching Intervention to Promote Maintenance of Exercise in Breast Cancer Survivors:Protocol
While physical activity (PA) appears to play an important role in disease control and the
 promotion of long-term health and well-being of cancer survivors, the large majority of
 breast cancer survivors are not physically active. Addressing this problem requires exercise
 promotion and an additional method of supporting long term exercise adherence. In response,
 an innovative health coaching intervention which uses mobile technology (iMOVE) to promote
 long-term PA in breast cancer survivors (BrCa) was developed. Project description: 107
 inactive BrCa survivors will be randomized to receive a 12-week exercise program (CONTROL) OR
 a 12 week exercise program plus a concurrent health coaching program (iMOVE) consisting of
 telephone-based coaching sessions and interactive software delivered through a smart-phone
 and Fit-bit (wearable fitness technology) (INTERVENTION). Information on the feasibility and
 acceptability of the methods and intervention and examine the impact on fitness (primary),
 patient-reported, anthropometric, and physical (secondary) outcomes will be collected. Impact
 and relevance: PA has increasingly been identified as a modifiable factor that has the
 potential to impact cancer outcomes and improve quality of life. iMOVE is an innovative
 intervention with the potential to promote and maintain physical activity for breast cancer
 survivors. This study will be the first step in the evaluation of iMOVE and will help to
 determine whether a larger randomized controlled trial is needed.
In order to advance PA adoption and maintenance in BrCaS, an innovative health coaching
 intervention which uses mobile, wearable technologies (iMOVE) was developed. This pilot study
 will evaluate iMOVE and inform the design of a larger pragmatic randomized controlled trial
 (RCT).

 Main Hypotheses: 1) The study will be adequately recruit (>40%) and retain (>75%)
 participants, and 2) the intervention will be highly acceptable to participants and result in
 substantial sustained fitness improvements.

 Aims of the Pilot Study Aim 1: To evaluate feasibility of the methods employed as defined by
 a) ability to recruit >40% of those eligible; b) adequate retention, operationalized as
 6-month assessment completion by >75% of participants; c) adequate adherence, operationalized
 as ≥70% of intervention components completed.

 Aim 2: To evaluate acceptability feedback for the final refinement and optimization of the
 intervention.

 Aim 3: To determine preliminary intervention efficacy on fitness (primary) and on
 patient-reported, anthropometric and physical (secondary) outcomes.

 This pilot RCT enrolls inactive BrCa survivors (BrCaS) stratified by age (<55/> 55 yr) and
 adjuvant hormone therapy (AHT) exposure [AHT yes/AHT no]. Recruitment is undertaken at the
 Princess Margaret Cancer Centre (PM) while interventions occur at the Electronic Living
 Library for Cancer Survivorship Research (ELLICSR), the Cancer Survivorship and Wellness
 Centre at the Toronto General Hospital (TGH). Both PM and TGH are members of the University
 Health Network in Toronto, Ontario and research ethics board approval was obtained from the
 University Health Network (13-6157-DE).

 Patients, identified from weekly-generated clinic lists and chart reviews, are approached by
 a member of their clinical team and those interested meet with a research assistant who
 explains the study and screens for eligibility. Participants are also recruited by
 advertisement flyers located in common hospital areas. Eligibility is ascertained
 over-the-phone when possible, with written consent obtained in person prior to randomization.

 After participants complete baseline questionnaires and initial physiological assessments,
 stratification-related data (age, AHT status, eligibility ID) is emailed to a biostatistician
 in the Department of Biostatistics at PM who performs randomization and sends a Study ID with
 experimental or control group allocation.

 Intervention Participants in the experimental and control conditions receive 12-weeks of PA
 training that includes once weekly group sessions with a certified exercise physiologist
 (CEP) and a registered kinesiologist (RKin), and a progressively structured, individualized
 home-based exercise program. The program is based on the American College of Sports Medicine
 (ACSM) guidelines and modeled after a successful, theory-based, mixed-modality program
 developed by Santa Mina et al. The individually-tailored exercise prescription combines
 aerobic-resistance exercise with flexibility training, and progresses under the CEP/RKin's
 guidance towards increases in intensity and improved fitness. Based on ACSM guidelines the
 goal is at least 150 minutes per week of moderate-intensity aerobic activity. Carefully
 calibrated increases in exercise volume over 12 weeks is intended to minimize injury risks
 and potential discouragement over variations in progress. Weekly group sessions of 60 minutes
 duration (including aerobic and resistance training) optimize social reinforcements.
 Participants are provided choices of days/times for the weekly supervised sessions.
 Participants are also asked to complete 3-5 additional home-based sessions of aerobic (e.g.
 brisk walking, cycling), and resistance activities (using elastic bands and body weight lift
 exercises) each week. Initial intensity is based on the performance of the exercises during a
 group session with the CEP/RKin and is self-monitored via the 10-point rating of perceived
 exertion, with a prescribed training zone of 4-7. Participants keep a weekly exercise log and
 review it at each face-to-face meeting with the CEP/RKin. All participants are provided with
 an exercise manual that includes exercise descriptions with instructive photographs, exercise
 safety guidelines, and stretching instructions. After all participants have been recruited
 and enrolled, semi-structured exit interviews will be completed with N = 25 participants at
 week # of the intervention.

 Experimental Group To promote adoption and maintenance of fitness and PA levels, experimental
 group participants are concurrently provided with a smart-phone-based health coaching
 intervention (iMOVE). iMOVE has three components: 1) one-on-one telephone-based counselling;
 2) supportive software on smart-phone devices (the HealthCoach program), 3) use of Fit-bit
 and corresponding software. The iMOVE intervention was designed to enhance sustained behavior
 change re: PA, integrating several elements under the terms smart-phone-based health
 coaching, and is based on multiple behavior-change theories, specifically Motivational
 Interviewing (MI); Cognitive Behavioral Therapy (CBT), TPB, TTM ; Social Learning Theory and
 Relapse Prevention Therapy. Once decisions to regularly exercise are made (TTM), participants
 elicit support from influential individuals (TPB-SLT) and undertake sessions that progress to
 higher fitness levels (SLT-progressive mastery). Participants are additionally supported by
 observations of peer progress and peer-familial social supports when disruptions in
 regularity occur (SLT - social modeling/social support). The careful monitoring of subjective
 states sensitizes subjects to regulatory effects (elevated mood, reduced fatigue), preparing
 them to confront adherence disruptions with a re-decision process (TTM) and re-mobilization
 (RPT-TTM). Instead of reacting with self-blame, temporary setbacks become prolapses such that
 trial-and-error learning builds future success (RPT). Consistently adherent behaviour
 ultimately includes non-adherent lapses and recoveries of effective routines (TTM-RPT). The
 theoretical constructs employed are based on promoting motivation and establishing: a)
 exercise self-efficacy, b) social support for exercise and c) positive exercise-induced
 feelings during the acute intervention (12 weeks) and post-exercise program period (6
 months).

 The telephone-based health coaching portion of iMOVE includes 10 x 30-minute telephone calls
 with a trained health coach scheduled at weeks 1, 2, 3, 4, 5, 6, 8, and 12 (during the
 exercise program) and at weeks 20 and 28 (post-exercise program booster sessions). The calls
 focus on the assessment of motivation, promotion of self-efficacy and collaborative problem
 solving. Telephone based counselling provides several advantages over face-to-face
 counselling, notably the potential for multi-regional population access given the telephone
 is a widely available communication medium that requires no travel by users or providers. The
 focus of is on assessing motivation, promoting self-efficacy and mutual problem solving to
 promote PA maintenance. The selected schedule provides support while building autonomy and
 independent motivation. The primary approach used by the health coaches is MI and CBT. MI is
 a collaborative, person-centered counselling method that elicits and strengthens motivation
 for behaviour-change by resolving ambivalence. MI has demonstrated effectiveness in
 increasing PA in cancer survivors and other chronic conditions and some MI-related effects
 have been shown to endure for two years post-intervention. Whenever self-efficacy appears
 impeded by distorted cognitions, CBT principles are applied, particularly to positively
 affect mood fluctuations. Distorted cognitions prevent enactment of health-behaviors and can
 drive unhealthy behaviors. With CBT, distorted cognitions can be modified, preventing or
 ameliorating associated negative emotional responses. Telephone-based interventions have been
 effective and acceptable to BrCa patients and useful in delivering MI-type/CBT interventions,
 include Diabetes health coaching study. As common with MI and CBT interventions, a handbook
 was created, which includes global objectives per session with relevant clinical tools that
 health coaches use to navigate sessions. An agenda for each session is facilitated by the
 health coach based on patient goals, activity, and motivation as collected by the software
 (between-sessions) and during sessions. Health coaches with a counselling background in MI
 and CBT and experience working with BrCa populations, receive clinical supervision by a
 Registered Psychologist and a Motivational Interviewing Network of Trainers (MINT) certified
 trainer. Fidelity of the intervention is assessed by routine review of implementation
 fidelity.

 In addition to the scheduled telephone-based sessions, participants interact with the
 HealthCoach software via smart-phone. This software, previously successfully tested with
 participants diagnosed with type II diabetes, is tailored for BrCa. It provides participants
 with specific health tips (delivered by video and verbally), and the ability to track PA,
 nutrition, pain and psychological well being (mood, energy); it also supports goal setting
 (with selective automatic daily/hourly reminders). All entries into the software are
 time-stamped, allowing for graph creation over time which combines multiple trackers,
 enabling participants and health coaches to see how health indicators change in relation to
 active health practices. The use of the software's capabilities of initiating contact with
 the health coach via text messaging will be quantified and recorded. When a patient texts
 their health coach via the app the health coach records the number of times contacts takes
 place and text message content. Confirmation of the text message will be provided but will
 direct the patient to discuss the matter further during the next phone session. Any content
 that indicates a medical or emergency need will be dealt with immediately and contact with
 the patient will be made.

 The use of the Fit-bit flex provides another way to help participants remain adherent to PA
 routines. Its real time feedback on activity (lights on device indicate % completion of the
 pre-set 10000 step goal), as well connectivity to the Connected Wellness platform allows the
 participant and the Health Coach to jointly explore how PA achieved by walking is being
 integrated into the participants life. It has a simple display of 5 LED lights which indicate
 the number of steps taken daily, and it vibrates to indicate that pre-set goals of 10000
 steps have been reached. The lights also indicate battery level. The Fit-bit Flex includes a
 specialized universal series bus (USB) charger; with a battery charge that lasts for five to
 seven days, and takes one to two hours to charge. The tracker measures steps taken, and
 combines it with user data to calculate distance walked, calories burned, and activity
 duration-intensity. It also measures sleep quality by tracking periods of restlessness, how
 long it takes the wearer to fall asleep, and how long they are actually asleep. The Fit-bit
 has its own app which the user can use to monitor their own activity.
Inclusion Criteria:

 -  Within 2 years of completion of adjuvant therapy, with the exception of hormone
 therapy, for early stage (0-IIIA) BrCa

 -  Baseline participation of < 60 min of weekly pre-planned PA

 -  Physician permission for moderate PA participation 4)Able to read and write English

 -  Able to attend in-person exercise training sessions and physiologic assessments at
 prescribed intervals.

 Exclusion Criteria:

 -  Plans to join a weight-loss or exercise program within 9 months)

 -  Current pregnancy or planned pregnancy within 9 months)

 -  Planned surgery during study; 4) not willing to be randomized.