Clinical trial · Interventional
A Web-Based Tool to Improve Breast Cancer Survivorship
A Mindfulness-Based e-Health Intervention to Improve Medication Adherence Among Breast Cancer Survivors
- 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 examine the efficacy of a psychosocial eHealth intervention on the proposed primary outcomes, hormone therapy adherence and health related quality of life (HRQoL), in breast cancer survivors. The intervention components include mindfulness-based stress reduction, breast cancer knowledge, stress awareness and management, social support, and enhanced communication. The intervention will be delivered via an online application over an 8-week period. Participants are randomized into either an intervention application (described above) or a control application (health information and general health promotion strategies). Aside from having access to the online application for the recommended 8 weeks with weekly online focus groups, participation in this study includes four assessments: baseline (at the beginning of the research study), post-intervention (8 weeks after baseline), a 6-month follow-up and a 12-month follow-up.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Adherence to Hormone Therapy | — | UNRESOLVED | — |
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| Hormone Dependent Neoplasms | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| "Oncotool" Control (health +HT education) | Behavioral | — | UNRESOLVED |
| "OncoTool" Intervention (MBSR + HT education) | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Mindfulness-based stress reduction + Hormone Therapy Education
- interventionNames
- Behavioral: "OncoTool" Intervention (MBSR + HT education)
- type
- ACTIVE_COMPARATOR
- label
- Hormone Therapy Education + Overall Health Education
- interventionNames
- Behavioral: "Oncotool" Control (health +HT education)
Primary outcomes (4)
- measure
- Change in Self Reported Adherence to Hormone Therapy will be evaluated with the ARMS questionnaire.
- timeFrame
- T1 (prior to starting intervention), T2 (8 weeks post intervention), T3 (6 months post-intervention), T4 (12 months post intervention)
- description
- The ARMS (Adherence to Refills and Medications Scale) survey is a previously validated patient-report measure of barriers to medication adherence and adherence-related behavior.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. ≥ 18 years of age 2. English-speaking (6th grade reading level) as required to complete assessments 3. medical chart confirmed diagnosis of hormone-receptor positive non-metastatic breast cancer 4. Stages I-IIIa 5. completion of any combination of surgical, radiation, and chemotherapy treatment 6. willingness to be randomized into study 7. have initiated HT within the past 6 months as data in literature indicates that the overwhelming majority of women who initiated HT are still adherent within the first 4 months 8. first-time diagnosis of breast cancer 9. access to a computer or tablet with Internet capabilities Exclusion Criteria: 1. Visual, hearing, voice, or motor impairment that would prevent completion of study procedures 2. diagnosis of an unmanaged psychotic or psychiatric disorder (e.g., clinical depression, anxiety, or PTSD), bipolar disorder, dissociative disorder, or other diagnosis for which participation in this trial is either inappropriate or dangerous - this includes patients who have life-threatening illness (e.g., end-stage kidney disease) or diagnosis of a chronic disease that is associated with a major functional impairment (e.g., chronic severe pain, fibromyalgia) 3. Alzheimer's, dementia or history of stroke
References
Publications (0)
Data not yet available