Clinical trial NCT02620735: Smart-phone Health Coaching Intervention to Promote Maintenance of Exercise in Breast Cancer Survivors:Protocol
Official title: Innovative Smart-phone-enabled Health Coaching Intervention (iMOVE) to Promote Long-term Maintenance of Physical Activity Behavior in Breast Cancer Survivors: Study Protocol for a Feasibility Pilot Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Neoplasms
Keywords: Exercise, health coaching, RCT, telehealth,
Lead sponsor: University Health Network, Toronto
Sponsor class: OTHER
Collaborators: name: Canadian Breast Cancer Foundation
First posted: 2015-12-03
Enrollment: 114
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Recruitment Rate
timeFrame: Through study completion, average of 2 years
measure: Retention Rate
timeFrame: Through study completion, average of 2 years
measure: Capture of Outcomes - proportion of participants from whom complete information is derived on clinical outcomes.
timeFrame: through study completion, average of 2 years
measure: Treatment Implementation and Fidelity - length, number and quality of health coaching phone sessions
timeFrame: through study completion, average of 2 years
measure: Acceptability:Participants perceptions regarding their experience of the study and if they liked it
timeFrame: through study completion, average of 2 years
Secondary outcomes:
measure: Change in Cardiorespiratory fitness - "VO2"(oxygen consumption) Peak (mlO2/kg/min)
timeFrame: baseline, 12 week, and 36 weeks
measure: Change in exercise frequency - Leisure-Time Exercise Questionnaire (LTEQ)
timeFrame: baseline, 12 week, and 36 weeks
measure: Change in body mass index (kg/m2)
timeFrame: baseline, 12 week, and 36 weeks
measure: Change in waist circumference (WC) (cm)
timeFrame: baseline, 12 week, and 36 weeks
measure: Change in quality of life - Functional Assessment of Cancer Therapy-Breast (FACT-B)
timeFrame: baseline, 12 weeks, 36 weeks
measure: Change in indices of anxiety - Spielberger's State-Trait Anxiety Inventory-State (STAI-S)
timeFrame: baseline, 12 weeks, 36 weeks
measure: Change in state of depressive symptoms - The Center for Epidemiological Studies-Depression Scale Short Form (CESD-SF)
timeFrame: baseline, 12 weeks, 36 weeks
measure: Change in breast cancer related fatigue - Functional Assessment of Cancer Therapy-Fatigue (FACT-F) subscale
timeFrame: baseline, 12 weeks, 36 weeks
measure: Change in breast cancer related physical symptoms - The Breast Cancer Prevention Trial (BCPT) Symptoms Scale
timeFrame: baseline, 12 weeks, 36 weeks
measure: Change in fear of recurrence - Fear of Recurrence Questionnaire (FRQ)
timeFrame: baseline, 12 weeks, 36 weeks
measure: Group cohesion measure - Physical Activity Group Environment Questionnaire (PAGEQ)
timeFrame: 12 weeks
measure: Change in body fat percentage (%)
timeFrame: baseline, 12 weeks, 36 weeks
measure: Change in grip strength (kg of force)
timeFrame: baseline, 12 weeks, 36 weeks
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: ELLICSR, Toronto General Hospital 200 Elizabeth St.
state: Ontario
Study officials:
affiliation: University Health Network, Toronto
name: Jennifer M Jones, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Ritvo P, Obadia M, Santa Mina D, Alibhai S, Sabiston C, Oh P, Campbell K, McCready D, Auger L, Jones JM. 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.