Clinical trial · Interventional
E-Health Support Program (PACK Health Program) in Supporting Patient Reported Symptoms in Newly Diagnosed Patients With Breast Cancer
Randomized Control Trial of the Effect of an E-Health Support Program on Patient Reported Outcomes of Women Newly Diagnosed 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 how well an electronic (e)-health support program, called the PACK Health Program, supports patient reported symptoms in newly diagnosed patients with breast cancer. PACK Health offers a symptom management program involving both interpersonal interaction, as well as e-modules for patients diagnosed with cancer to better manage pain, fatigue, depression, anxiety, and to navigate care more effectively through e-health coaching and tools. Participating in the PACK Health Program may support breast cancer patients' reported side effects and experience of care during chemotherapy treatment and may ultimately improve overall health.
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 Carcinoma | Breast Carcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 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 the Pack Health Program which includes up to 60 scheduled touch points via phone, text, email and a mobile application and weekly interaction with a health coach over 3 months. They also have access to standard of care support services at MD Anderson including a telephone triage line 5 days a week between 8 a.m. and 5 p.m.
- interventionNames
- Other: Questionnaire Administration
- Procedure: Supportive Care
- type
- ACTIVE_COMPARATOR
- label
- Group II (standard of care support services)
- description
- Patients receive standard of care support services with a telephone triage line available 5 days a week between 8 a.m. and 5 p.m.
- interventionNames
- Other: Questionnaire Administration
- Procedure: Supportive Care
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * English speaking. * Newly diagnosed women with a breast cancer diagnosis preparing to undergo chemotherapy for the first time. * All chemotherapy treatment to be completed at the study institution. * Access to electronic resources, defined for the purposes of this study as a mobile phone, a landline phone, a computer, or another device with the capacity to receive calls, texts, or e-mails. Exclusion Criteria: * Patients who have received previous chemotherapy treatment for cancer. * Patients who are unable to verbalize (e.g. due to tracheostomy). * Patients enrolled on Protocol 2016-0300, as these patients will be receiving proactive triage calls from nurses that could skew their symptom reporting.
References
Publications (0)
Data not yet available