NCT05549687

E-Health Support Program (PACK Health Program) in Supporting Patient Reported Symptoms in Newly Diagnosed Patients With Breast Cancer

Randomized Control Trial of the Effect of an E-Health Support Program on Patient Reported Outcomes of Women Newly Diagnosed With Breast Cancer

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 419 (actual)
• Sponsor: M.D. Anderson Cancer Center · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This trial studies how well an electronic (e)-health support program, called the PACK Health Program, supports patient reported symptoms in newly diagnosed patients with breast cancer. PACK Health offers a symptom management program involving both interpersonal interaction, as well as e-modules for patients diagnosed with cancer to better manage pain, fatigue, depression, anxiety, and to navigate care more effectively through e-health coaching and tools. Participating in the PACK Health Program may support breast cancer patients' reported side effects and experience of care during chemotherapy treatment and may ultimately improve overall health.

Detailed description

PRIMARY OBJECTIVE: 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

• Breast Carcinoma

Interventions

Type	Name	Description
OTHER	Questionnaire Administration	Ancillary studies
PROCEDURE	Supportive Care	Participate in Pack Health, an electronic support program
PROCEDURE	Supportive Care	Access to telephone triage line for support care services

Timeline

• Start date: 2017-05-19
• Primary completion: 2023-08-07
• Completion: 2023-08-07
• First posted: 2022-09-22
• Last updated: 2023-08-14

Locations

1 site across 1 country: United States