Clinical trial · Interventional
A Study of Delivering a Mindfulness App Intervention to Accompany Supportive Care Among Women With Breast Cancer
Delivering an Intervention to Accompany Supportive Care
- 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 investigators are conducting a web-based study to explore the use of a mindfulness app to improve quality of life among women with breast cancer. Eligible participants will be asked to provide informed consent to participate and submit a data authorization form to obtain information from the app at the end of the project. This 12-week project will randomly assign participants to one of two groups: Group 1 (AMT) will receive the mindfulness app right away; Group 2 (WC) will receive the mindfulness app at the end of 12 weeks. All participants will receive a welcome email with group designation. Participants assigned to Group 1 (AMT) will also receive app download instructions and pass code. Group 1 will be asked to complete the app's first 10-minute mindfulness exercise, at minimum. Participants assigned to Group 2 (WC) will be notified that they will receive app download instructions and pass code at the end of 12 weeks. Regardless of group assignment, all participants will be asked to complete web-based survey assessments 4 different times throughout the study (baseline, week 5, week 9, 12-week follow up). The surveys will be related to quality of life, mindfulness, mobile technology, health literacy, and chronic pain. To encourage participation, a member of the study team will send out weekly check-in emails. Once all data has been collected, app developers will provide the investigators with app data for each participant, including times accessed, length of time using app. This information will help the investigators observe which app characteristics are most useful, as well as the optimal amount of time needed to obtain benefit from the app. The investigators goals are to understand how using the mindfulness app compares to not using the mindfulness app. The investigators will also observe whether the app contributes to participants' quality of life. The investigators also want to understand more about how women use health apps overall. This information may inform issues related to delivery of app-based health interventions among women with breast cancer.
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 Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| App-based Mindfulness Training | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- App-based Mindfulness Training
- description
- 12 week mindfulness training delivered remotely through mobile app
- interventionNames
- Behavioral: App-based Mindfulness Training
- type
- NO_INTERVENTION
- label
- Waitlist Control
- description
- No intervention provided during study period. 12 week mindfulness training will be delivered through mobile app once all study assessments have been completed
Primary outcomes (1)
- measure
- Change in breast cancer-related quality of life scores
- timeFrame
- Change from baseline FACT-B scores at 12 weeks
- description
- Measured by the Functional Assessment of Cancer Therapy-Breast (FACT-B)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 25 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: 1. Female 2. Age ≥ 25 3. Breast cancer diagnosis within past 5 years 4. Willing to provide locator information for follow-up contact 5. Reliable internet access 6. Ownership of smartphone or tablet with following specifications: wireless capability, running on iOS or Android operating system, current software (4.4 Android; 8.0 iOS or later), and adequate memory to run the mindfulness app (43M Android; 30.2M iOS). Exclusion Criteria: 1. Unfamiliar with mobile phones/tablets, including ability to download and register mindfulness app 2. Become unable to participate in a fully app and web-based intervention trial 3. Unwilling to complete online questionnaires 4. Unwilling to use personal phone/tablet to test intervention
References
Publications (7)
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- BACKGROUNDBrady MJ, Cella DF, Mo F, Bonomi AE, Tulsky DS, Lloyd SR, Deasy S, Cobleigh M, Shiomoto G. Reliability and validity of the Functional Assessment of Cancer Therapy-Breast quality-of-life instrument. J Clin Oncol. 1997 Mar;15(3):974-86. doi: 10.1200/JCO.1997.15.3.974. PMID 9060536
- BACKGROUNDBrown KW, Ryan RM. The benefits of being present: mindfulness and its role in psychological well-being. J Pers Soc Psychol. 2003 Apr;84(4):822-48. doi: 10.1037/0022-3514.84.4.822. PMID 12703651
- BACKGROUNDNorman CD, Skinner HA. eHEALS: The eHealth Literacy Scale. J Med Internet Res. 2006 Nov 14;8(4):e27. doi: 10.2196/jmir.8.4.e27. PMID 17213046
- BACKGROUNDHaun J, Noland-Dodd V, Varnes J, Graham-Pole J, Rienzo B, Donaldson P. Testing the BRIEF health literacy screening tool. Federal Practitioner 26(12): 24-31, 2009.