Smart-phone Health Coaching Intervention to Promote Maintenance of Exercise in Breast Cancer Survivors:Protocol

NCT02620735 | Completed

• 1 other identifier: 13-6157-DE
• Study Type: interventional
• Target: 114
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Neoplasms

Keywords

Exercise, health coaching, RCT, telehealth,

Outcome Measures

Primary Outcomes (5)

• Recruitment Rate

  Based on CONSORT criteria, a screening log enables data collection on eligible consented (pre- and post-initial screen) and non-recruited participants with reasons for non-recruitment recorded.

  Through study completion, average of 2 years

• Retention Rate

  To optimize retention and prevent attrition, stability (with some flexibility) is aimed for with group exercise in terms of class time/location, combined with careful selection and training of Health Coaches, short referral times

  Through study completion, average of 2 years

• Capture of Outcomes - proportion of participants from whom complete information is derived on clinical outcomes.

  As another major facet of feasibility, we assess the proportion of participants from whom complete information is derived on clinical outcomes, at which assessment time-points and then document rates of missing data. This outcome is measured in terms of frequency of completion not in the units of the measures themselves.

  through study completion, average of 2 years

• Treatment Implementation and Fidelity - length, number and quality of health coaching phone sessions

  For the experimental group, health coaching session lengths/numbers are recorded. The health coach will document use of health coaching techniques and tools, and the barriers identified. Use of the health coaching software is stored on the secure server and will be used to measure and analyze self-report and health coach activity.

  through study completion, average of 2 years

• Acceptability:Participants perceptions regarding their experience of the study and if they liked it

  To assess acceptability and inform future refinement, telephone interviews will be conducted with a purposefully selected sub-sample of experimental participants following intervention completion. The goal of the qualitative interviews is: 1) to explore participant perspectives of feasibility/acceptability of the health coaching intervention, and 2) to gain an understanding of specific experiences/attitudes among those successful and unsuccessful at PA maintenance PA. An interpretive description qualitative methodology will be used to meet this objective \[154\]. We will purposefully select participants, ensuring equal representation from participants who report exercise behavior has increased or decreased or stayed the same. We anticipate interviewing between 6-10 participants per group. A record of participation in the latter will be kept to distinguish these participants from those who were not chosen to participate. The semi-structured interviews will be 45-60 minutes in length.

  through study completion, average of 2 years

Secondary Outcomes (13)

• Change in Cardiorespiratory fitness - "VO2"(oxygen consumption) Peak (mlO2/kg/min)

  baseline, 12 week, and 36 weeks

• Change in exercise frequency - Leisure-Time Exercise Questionnaire (LTEQ)

  baseline, 12 week, and 36 weeks

• Change in body mass index (kg/m2)

  baseline, 12 week, and 36 weeks

• Change in waist circumference (WC) (cm)

  baseline, 12 week, and 36 weeks

• Change in quality of life - Functional Assessment of Cancer Therapy-Breast (FACT-B)

  baseline, 12 weeks, 36 weeks

Study Arms (2)

Exercise Only

ACTIVE COMPARATOR

Participants receive 12-weeks PA training (1x/week - 60 min) group sessions with a CEP/RKin, and a progressively structured home-based exercise program based on the American College of Sports Medicine (ACSM) guidelines.It combines aerobic-resistance exercise with flexibility training, and progresses towards increased in intensity and improved fitness. The goal is at least 150 min/week of moderate-intensity aerobic activity. Participants are also asked to complete 3-5 additional home-based sessions of aerobic, and resistance activities each week. Initial intensity is based on the performance of the exercises during a group session and is self-monitored via the 10-point rating of perceived exertion, with a prescribed training zone of 4-7.

Behavioral: Exercise Only

Exercise + iMOVE

EXPERIMENTAL

Participants will receive the same exercise program at the Exercise Only group + 1) one-on-one telephone-based counselling (10 x 30-minute telephone: weeks 1, 2, 3, 4, 5, 6, 8, and 12 (during the exercise program) and at weeks 20,28 (post-exercise program booster sessions)); 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. 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).

Device: Fit bit Device; Behavioral: Exercise Only; Behavioral: Connected Wellness HealthCoach Software; Behavioral: Health Coaching

Interventions

Fit bit Device DEVICE

Use of the fit bit flex for the duration of the study. Measures steps and sleep. Health Coaching

Exercise + iMOVE

Exercise Only BEHAVIORAL

12 week exercise program

Exercise + iMOVE; Exercise Only

Connected Wellness HealthCoach Software BEHAVIORAL

Use of the app on Smart-phones and an online platform. Measures the following factors: Mood, Pain, energy,exercise not picked up by Fit bit.

Exercise + iMOVE

Health Coaching BEHAVIORAL

10 over the phone health coaching sessions.

Exercise + iMOVE

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University Health Network, Toronto: lead
• Canadian Breast Cancer Foundation: collaborator

Study Sites (1)

ELLICSR, Toronto General Hospital 200 Elizabeth St.

Toronto, Ontario, M5G2C4, Canada

Location

Related Publications (1)

• 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.

  PMID: 28838886 DERIVED

MeSH Terms

Conditions

Breast Neoplasms; Motor Activity

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Behavior

Study Officials

• Jennifer M Jones, PhD

  University Health Network, Toronto

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 19, 2015
• First Posted: December 3, 2015
• Study Start: December 1, 2014
• Primary Completion: July 1, 2019
• Study Completion: July 1, 2019
• Last Updated: July 8, 2019

Record last verified: 2019-07

Locations

CA (1)