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
2 other identifiers
interventional
419
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started May 2017
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 19, 2017
CompletedFirst Submitted
Initial submission to the registry
September 7, 2022
CompletedFirst Posted
Study publicly available on registry
September 22, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 7, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
August 7, 2023
CompletedAugust 14, 2023
August 1, 2023
6.2 years
September 7, 2022
August 10, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
Impact of electronic (e)-health support program on patient reported outcomes
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 as fixed effects and intercept as a random effect. Additional models will be created to include possible confounding covariates. PROMIS instrument scores will be reviewed and patients referred to the primary medical team if they score 1 on items 1-6, and 9, indicating poor health state and 4 or greater on items 8 and 10, indicating potential emotional distress or moderate to severe fatigue.
Baseline up to 3 months
Study Arms (2)
Group I (Pack Health Program)
EXPERIMENTALPatients 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.
Group II (standard of care support services)
ACTIVE COMPARATORPatients receive standard of care support services with a telephone triage line available 5 days a week between 8 a.m. and 5 p.m.
Interventions
Ancillary studies
Participate in Pack Health, an electronic support program
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- M.D. Anderson Cancer Centerlead
- National Cancer Institute (NCI)collaborator
Study Sites (1)
M D Anderson Cancer Center
Houston, Texas, 77030, United States
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Eileen Hacker, PHD
M.D. Anderson Cancer Center
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 7, 2022
First Posted
September 22, 2022
Study Start
May 19, 2017
Primary Completion
August 7, 2023
Study Completion
August 7, 2023
Last Updated
August 14, 2023
Record last verified: 2023-08