Houston, Texas 77030


Purpose:

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


Study summary:

PRIMARY OBJECTIVES: 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 MDASI to MDASI-Br. II. To evaluate the effect of an eHealth coaching program on physical and mental health of women with a first-time diagnosis of 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, with or email for 3 months. Following the first 3 months of the program, study participants will then receive at least one touch point weekly between months 4-6 of their study enrollment, with additional engagement and frequency according to each patient's preference. GROUP II: Patients receive standard of care support services over 6 months.


Criteria:

Inclusion Criteria: - Able to read, speak and consent in English. - Individuals with a first time diagnosis of breast cancer 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 who are terminally ill, defined as individuals identified by their physician as likely having 6 months or less to live, or those individuals transitioned to comfort measures only (meaning only supportive care measures without curative focused treatment). - Individuals who have undergone treatment for previous diagnoses of breast cancer. - 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.


NCT ID:

NCT04022772


Primary Contact:

Principal Investigator
Lori Williams
M.D. Anderson Cancer Center

Lori Williams
Phone: 713-745-0844
Email: loriwilliams@mdanderson.org


Backup Contact:

N/A


Location Contact:

Houston, Texas 77030
United States

Lori Williams
Phone: 713-745-0844
Email: loriwilliams@mdanderson.org

Site Status: Recruiting


Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

Modifications to this listing: Only selected fields are shown, please use the link below to view all information about this clinical trial.


Click to view Full Listing

If you would like to be contacted by the clinical trial representative please fill out the form below.