Clinical trial · Interventional
Self-monitoring Activity: a Randomized Trial of Game-oriented Applications
Self-monitoring Activity: a Randomized Trial of Game-oriented Applications (SMARTGOAL)
NCT02341235CI-TRIAL-00079319SMARTGOALcompletedN/AResults postedClinicalTrials.gov clinicaltrialsProvenance
- 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)
The purpose of this study is to compare an enhanced intervention that includes narrative and game components to a standard intervention that only targets self-monitoring. These approaches will be tested among postmenopausal breast cancer survivors who are sedentary and overweight.
Conditions
Conditions (2)
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 Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| Obesity | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Game intervention | Behavioral | — | UNRESOLVED |
| Standard intervention | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Game intervention
- description
- Participants will receive narrative-based games on a mobile device and telephone counseling (weekly for the first 12 weeks, then once per month until 6 months)
- interventionNames
- Behavioral: Game intervention
- type
- ACTIVE_COMPARATOR
- label
- Standard intervention
- description
- Participants will receive an electronic activity monitor with a mobile device and telephone counseling (weekly for the first 12 weeks, then once per month until 6 months)
- interventionNames
- Behavioral: Standard intervention
Primary outcomes (1)
- measure
- Change in Minutes Per Day of Physical Activity
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 45 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: 1. Age between 45 and 75 years old 2. Report a breast cancer diagnosis no more than 10 years prior to enrollment 3. Cessation of menses for 12 months or more 4. Able to read and understand English 5. Able to read words in standard applications on a mobile device 3-4" large 6. Able to walk for exercise 7. Able to find transportation to the study location 8. Willing to use a mobile device provided by the study to participate (or to use one of their own) 9. Willing to be randomized to either group Exclusion Criteria: 1. Currently pregnant or nursing 2. Surgery in the past six months 3. Chemotherapy or radiation treatment in the past six months 4. Evidence of disease recurrence 5. Participant is active (90 minutes of moderate-vigorous intensity activity per week or more) 6. BMI is under 25 kg/m2 or over 35 kg/m2 7. Report a heart condition, chest pain during periods of activity or rest, loss of consciousness, etc. on the Physical Activity Readiness Questionnaire (PAR-Q), unless cleared by their physician 8. Participant reports hospitalization within the past year due to psychiatric problem(s) 9. Report current symptoms of alcohol or substance dependence 10. Plans to move away from the Galveston-Houston area or to be out of town for more than 1 week during the study period 11. Stroke, hip fracture, hip or knee replacement, or spinal surgery in the past 6 months 12. Report a history of severe orthopedic complications that would prevent optimal participation in the physical activities prescribed (e.g., severe arthritis, leg amputations, etc.) 13. Clinical judgment concerning safety 14. Lost more than 5% body weight in the previous 6 months 15. Currently participating in a physical activity or weight loss program 16. Current smoker 17. Participant already uses an electronic activity monitor (we will ask them to stop) 18. Another member of the household is a participant or staff member on this trial
References
Publications (1)
- DERIVEDLyons EJ, Baranowski T, Basen-Engquist KM, Lewis ZH, Swartz MC, Jennings K, Volpi E. Testing the effects of narrative and play on physical activity among breast cancer survivors using mobile apps: study protocol for a randomized controlled trial. BMC Cancer. 2016 Mar 9;16:202. doi: 10.1186/s12885-016-2244-y. PMID 26960972