Clinical trial · Interventional
Smart-phone Health Coaching Intervention to Promote Maintenance of Exercise in Breast Cancer Survivors:Protocol
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Neoplasms | Breast Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Connected Wellness HealthCoach Software | Behavioral | — | UNRESOLVED |
| Exercise Only | Behavioral | — | UNRESOLVED |
| Fit bit Device | Device | — | UNRESOLVED |
| Health Coaching | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Exercise Only
- description
- 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.
- interventionNames
- Behavioral: Exercise Only
- type
- EXPERIMENTAL
- label
- Exercise + iMOVE
- description
- 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).
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
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.
References
Publications (1)
- DERIVEDRitvo 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