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NCT05549687 · ClinicalTrials.gov registry record · NA
E-Health Support Program (PACK Health Program) in Supporting Patient Reported Symptoms in Newly Diagnosed Patients With Breast Cancer
A NA study, sponsored by M.D. Anderson Cancer Center.
- Completed
- Registry status
- NA
- Development phase
- 419
- Enrollment target
NCT05549687: Completed NA study, sponsored by M.D. Anderson Cancer Center.
NCT05549687 is a NA study that has completed, run by M.D. Anderson Cancer Center. The registered enrollment target is 419 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (70% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05549687, a NA study, has completed, sponsored by M.D. Anderson Cancer Center.
- COMPLETED
- Registry status
- NA
- Development phase
- 419 participants
- Enrollment target
Study Summary
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.
Primary Outcome
Measured with the National Institutes of Health Patient Reported Outcomes Measurement Information System (PROMIS) Global Health Scale. Summary statistics and box plots will be used to describe PROMIS scores by intervention arm and assessment time. A 2-sample t-test will be used to compare PROMIS scores at 3 months between intervention groups. Linear mixed effects models (LMMs) will be used to assess PROMIS scores over time. The models will include assessment time, intervention and baseline score
Interventions
- OTHER Questionnaire Administration
- PROCEDURE Supportive Care
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 419 participants |
| Start Date | 2017-05-19 |
| Est. Completion | 2023-08-07 |
| Phase | NA |
What the finished NCT05549687 record still lists
NCT05549687 is an interventional study that assigns participants to a tested intervention. The registered 419 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (70% lower).
The record links to 0 conditions, and to 2 interventions - of which Questionnaire Administration is the first listed.
NCT05549687 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05549687 about?
NCT05549687 is a clinical study titled "E-Health Support Program (PACK Health Program) in Supporting Patient Reported Symptoms in Newly Diagnosed Patients With Breast Cancer". 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 ...
What is the current status of trial NCT05549687?
This trial is currently completed. It is a NA study. The enrollment target is 419 participants. The study started on 2017-05-19. Estimated completion is 2023-08-07.
What interventions are being tested in trial NCT05549687?
The interventions under investigation include: Questionnaire Administration (OTHER), Supportive Care (PROCEDURE).
Who is sponsoring clinical trial NCT05549687?
This trial is sponsored by M.D. Anderson Cancer Center, which has 2,692 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05549687's enrollment target sits among peer trials
419 240th of 2000 higher than 1,761 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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