E-Health Support Program (PACK Health Program) in Supporting Patient Reported Symptoms in Newly Diagnosed Patients With Breast Cancer
NCT ID: NCT05549687
Last Updated: 2023-08-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
419 participants
INTERVENTIONAL
2017-05-19
2023-08-07
Brief Summary
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Detailed Description
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I. To examine the impact of an e-health support program on patient reported outcomes.
SECONDARY OBJECTIVES:
I. To evaluate the effect of e-health support program in comparison with standard of care support services, on the symptom experience of patients receiving chemotherapy in the ambulatory setting.
II. To evaluate the effect of e-health support program in comparison with standard of care support services, on the satisfaction of patients receiving chemotherapy in the ambulatory setting.
III. To evaluate the effect of e-health support program, in comparison with standard of care support services, on the frequency of emergency room visits and hospital admissions for patients receiving chemotherapy in the ambulatory setting.
OUTLINE: Patients are randomized to 1 of 2 groups.
GROUP I: Patients participate in the PACK Health Program which includes up to 60 scheduled touch points via phone, text, email and a mobile application, as well as weekly interaction with a health coach over 3 months. Patients 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: 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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
NONE
Study Groups
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Group I (Pack Health Program)
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.
Questionnaire Administration
Ancillary studies
Supportive Care
Participate in Pack Health, an electronic support program
Group II (standard of care support services)
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.
Questionnaire Administration
Ancillary studies
Supportive Care
Access to telephone triage line for support care services
Interventions
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Questionnaire Administration
Ancillary studies
Supportive Care
Participate in Pack Health, an electronic support program
Supportive Care
Access to telephone triage line for support care services
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 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.
18 Years
FEMALE
No
Sponsors
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National Cancer Institute (NCI)
NIH
M.D. Anderson Cancer Center
OTHER
Responsible Party
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Principal Investigators
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Eileen Hacker, PHD
Role: PRINCIPAL_INVESTIGATOR
M.D. Anderson Cancer Center
Locations
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M D Anderson Cancer Center
Houston, Texas, United States
Countries
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Related Links
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M D Anderson Cancer Center
Other Identifiers
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NCI-2019-02645
Identifier Type: REGISTRY
Identifier Source: secondary_id
2016-0761
Identifier Type: OTHER
Identifier Source: secondary_id
2016-0761
Identifier Type: -
Identifier Source: org_study_id
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