Effect of PACK Health Support Program on Patient Reported Outcomes in Patients With Breast Cancer
NCT ID: NCT04022772
Last Updated: 2023-08-07
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
287 participants
INTERVENTIONAL
2019-07-31
2023-07-27
Brief Summary
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Detailed Description
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I. To evaluate the effect of an eHealth coaching program on the self-reported global health of women with breast cancer, as measured by the National Institutes of Health (NIH) Patient Reported Outcomes Measurement Information System (PROMIS) Global Health Scale version (v.) 1.2.
SECONDARY OBJECTIVES:
I. To evaluate the effect of an eHealth coaching program on the symptom experience of women with breast cancer as measured by the MD Anderson Symptom Inventory-Breast (MDASI-Br).
II. To evaluate the effect of an eHealth coaching program on physical and mental health of women diagnosed with breast cancer as measured by the subscales of the PROMIS Global Health Scale v 1.2.
III. To evaluate the effect of an eHealth coaching program on the symptom experience and global health outcomes of women by:
IIIa. Disease stage. IIIb. Active treatment type (i.e. surgery, radiation, chemotherapy, hormonal therapy, immunotherapy or a combination of these methodologies).
IIIc. Time since diagnosis. IV. To evaluate the effect of an eHealth coaching program on the frequency of emergency room visits and hospital admissions for patients receiving treatment in the ambulatory setting.
V. To evaluate the relationship between financial toxicity, as measured by the Consumer Score for Financial Toxicity (COST), and quality of life, as measured by the Functional Assessment of Quality of Life-Breast (FACT-B).
OUTLINE: Patients are randomized to 1 of 2 groups.
GROUP I: 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.
GROUP II: Patients receive standard of care support services over 6 months.
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 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.
Medical Chart Review
Ancillary studies
Quality-of-Life Assessment
Ancillary studies
Questionnaire Administration
Ancillary studies
Supportive Care
Participate in PACK Health program
GROUP II (standard of care)
Patients receive standard of care support services over 6 months.
Best Practice
Receive standard of care
Medical Chart Review
Ancillary studies
Quality-of-Life Assessment
Ancillary studies
Questionnaire Administration
Ancillary studies
Interventions
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Best Practice
Receive standard of care
Medical Chart Review
Ancillary studies
Quality-of-Life Assessment
Ancillary studies
Questionnaire Administration
Ancillary studies
Supportive Care
Participate in PACK Health program
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* Individuals for whom there is documentation of inability to provide consent in the medical record.
* Patients who were previously enrolled on protocol 2016-0761.
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-2019-03897
Identifier Type: REGISTRY
Identifier Source: secondary_id
2018-0473
Identifier Type: OTHER
Identifier Source: secondary_id
2018-0473
Identifier Type: -
Identifier Source: org_study_id
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