Effect of PACK Health Support Program on Patient Reported Outcomes in Patients With Breast Cancer

  • STATUS
    Recruiting
  • End date
    Feb 28, 2023
  • participants needed
    545
  • sponsor
    M.D. Anderson Cancer Center
Updated on 14 February 2022
cancer
carcinoma
breast cancer
carcinoma in situ
invasive breast cancer
ductal carcinoma in situ
ductal carcinoma

Summary

This trial studies the effect of an electronic health (eHealth) support program called PACK Health on patient reported health outcomes in patients with breast cancer. PACK Health monitors breast cancer patients' reported side effects and experience of care when receiving chemotherapy. Participating in the PACK Health coaching program may improve quality of life, decrease hospital admissions and improve overall health.

Description

PRIMARY OBJECTIVE:

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.

Details
Condition Breast Carcinoma, Breast Ductal Carcinoma In Situ, Invasive Breast Carcinoma, Recurrent Breast Carcinoma
Treatment questionnaire administration, quality-of-life assessment, medical chart review, Best Practice, Supportive Care
Clinical Study IdentifierNCT04022772
SponsorM.D. Anderson Cancer Center
Last Modified on14 February 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Able to read, speak and consent in English
Age 18 years and older
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
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

Exclusion Criteria

Male patients (due to the small number of male breast cancer patients treated annually)
Individuals for whom there is documentation of inability to provide consent in the medical record
Patients who were previously enrolled on protocol 2016-0761
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