NCT04022772

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

Longitudinal Cohort Study of the Effect of an eHealth Support Program on Patient Reported Outcomes of Women With Breast Cancer

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 287 (actual)
• Sponsor: M.D. Anderson Cancer Center · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Breast Carcinoma
• Breast Ductal Carcinoma In Situ
• Invasive Breast Carcinoma
• Recurrent Breast Carcinoma

Interventions

Type	Name	Description
OTHER	Best Practice	Receive standard of care
OTHER	Medical Chart Review	Ancillary studies
OTHER	Quality-of-Life Assessment	Ancillary studies
OTHER	Questionnaire Administration	Ancillary studies
PROCEDURE	Supportive Care	Participate in PACK Health program

Timeline

• Start date: 2019-07-31
• Primary completion: 2023-07-27
• Completion: 2023-07-27
• First posted: 2019-07-17
• Last updated: 2023-08-07

Locations

1 site across 1 country: United States