Clinical trial · Interventional
Effect of PACK Health Support Program on Patient Reported Outcomes in Patients With Breast Cancer
Longitudinal Cohort Study of the Effect of an eHealth Support Program on Patient Reported Outcomes of Women With Breast Cancer
- 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)
This trial studies the effect of an electronic health (eHealth) support program called PACK Health on patient reported health outcomes in patients with breast cancer. PACK Health monitors breast cancer patients' reported side effects and experience of care when receiving chemotherapy. Participating in the PACK Health coaching program may improve quality of life, decrease hospital admissions and improve overall health.
Conditions
Conditions (4)
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 Carcinoma | Breast Carcinoma | ONTOLOGY_EXACT | 0.98 |
| Breast Ductal Carcinoma In Situ | Breast Ductal Carcinoma In Situ | ONTOLOGY_EXACT | 0.98 |
| Invasive Breast Carcinoma | Invasive Breast Carcinoma | ONTOLOGY_EXACT | 0.98 |
| Recurrent Breast Carcinoma | Breast Carcinoma | CURATED_BROADER | 0.78 |
Interventions
Interventions (5)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Best Practice | Other | — | UNRESOLVED |
| Medical Chart Review | Other | — | UNRESOLVED |
| Quality-of-Life Assessment | Other | — | UNRESOLVED |
| Questionnaire Administration | Other | — | UNRESOLVED |
| Supportive Care | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- GROUP I (PACK Health program)
- description
- Patients participate in PACK Health program consisting of weekly contact with an assigned health coach via text message, phone call, and email for 3 months. After 3 months, patients continue to be contacted by the health coach at least once monthly for an additional 3 months.
- interventionNames
- Other: Medical Chart Review
- Other: Quality-of-Life Assessment
- Other: Questionnaire Administration
- Procedure: Supportive Care
- type
- ACTIVE_COMPARATOR
- label
- GROUP II (standard of care)
- description
- Patients receive standard of care support services over 6 months.
- interventionNames
- Other: Best Practice
- Other: Medical Chart Review
- Other: Quality-of-Life Assessment
- Other: Questionnaire Administration
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Age 18 years and older * Able to read, speak and consent in English. * Individuals with a diagnosis of: * First time diagnosis of invasive breast cancer, * Ductal carcinoma in situ (DCIS), * Recurrent breast cancer off all therapy prior to recurrence * Currently starting or undergoing active treatment * Internet access via smart phone, tablet, a computer, or another device with the capacity to receive calls, texts, or e-mails, as well as the electronic study assessments. Exclusion Criteria: * Male patients (due to the small number of male breast cancer patients treated annually). * Individuals for whom there is documentation of inability to provide consent in the medical record. * Patients who were previously enrolled on protocol 2016-0761.
References
Publications (1)
- DERIVEDWhisenant M, Williams LA, Dains JE, Brassil KJ, Fellman B, Urbauer DL, Isaac T, Shelton V, Burton BS, Hacker E. The Effect of a Digital Health Coaching Program on Patient-Reported and Healthcare Utilization Outcomes of Women With Breast Cancer. Oncol Nurs Forum. 2026 Jan 5;53(1):1-14. doi: 10.1188/26.ONF.e26535242. PMID 41586740