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

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.

Study Overview

• Status: Completed
• Conditions: Breast Carcinoma
• Intervention / Treatment: Other: Questionnaire Administration; Procedure: Supportive Care; Procedure: Supportive Care

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.

• Study Type: Interventional
• Enrollment (Actual): 419
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Texas
    • Houston, Texas, United States, 77030
      • M D Anderson Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• English speaking.
• Newly diagnosed women with a breast cancer diagnosis preparing to undergo chemotherapy for the first time.
• All chemotherapy treatment to be completed at the study institution.
• Access to electronic resources, defined for the purposes of this study as a mobile phone, a landline phone, a computer, or another device with the capacity to receive calls, texts, or e-mails.

Exclusion Criteria:

• Patients who have received previous chemotherapy treatment for cancer.
• Patients who are unable to verbalize (e.g. due to tracheostomy).
• Patients enrolled on Protocol 2016-0300, as these patients will be receiving proactive triage calls from nurses that could skew their symptom reporting.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group I (Pack Health Program); Patients participate in the Pack Health Program which includes up to 60 scheduled touch points via phone, text, email and a mobile application and weekly interaction with a health coach over 3 months. They 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.	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; Other Names: Therapy, Supportive
Active Comparator: Group II (standard of care support services); 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.	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; Other Names: Therapy, Supportive

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Impact of electronic (e)-health support program on patient reported outcomes	Measured with the National Institutes of Health Patient Reported Outcomes Measurement Information System (PROMIS) Global Health Scale. Summary statistics and box plots will be used to describe PROMIS scores by intervention arm and assessment time. A 2-sample t-test will be used to compare PROMIS scores at 3 months between intervention groups. Linear mixed effects models (LMMs) will be used to assess PROMIS scores over time. The models will include assessment time, intervention and baseline score as fixed effects and intercept as a random effect. Additional models will be created to include possible confounding covariates. PROMIS instrument scores will be reviewed and patients referred to the primary medical team if they score 1 on items 1-6, and 9, indicating poor health state and 4 or greater on items 8 and 10, indicating potential emotional distress or moderate to severe fatigue.	Baseline up to 3 months

Collaborators and Investigators

• Sponsor: M.D. Anderson Cancer Center
• Collaborators: National Cancer Institute (NCI)
• Investigators: Principal Investigator: Eileen Hacker, PHD, M.D. Anderson Cancer Center

Publications and helpful links

Helpful Links

• M D Anderson Cancer Center

Study record dates

Study Major Dates

• Study Start (Actual): May 19, 2017
• Primary Completion (Actual): August 7, 2023
• Study Completion (Actual): August 7, 2023

Study Registration Dates

• First Submitted: September 7, 2022
• First Submitted That Met QC Criteria: September 19, 2022
• First Posted (Actual): September 22, 2022

Study Record Updates

• Last Update Posted (Actual): August 14, 2023
• Last Update Submitted That Met QC Criteria: August 10, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms
• Other Study ID Numbers: 2016-0761 (Other Identifier: M D Anderson Cancer Center); NCI-2019-02645 (Registry Identifier: CTRP (Clinical Trial Reporting Program))

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No