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

August 3, 2023 updated by: M.D. Anderson Cancer Center

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

287

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

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

  • 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
  • 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:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: GROUP I (PACK Health program)
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.
Other: Quality-of-Life Assessment
Ancillary studies
Other Names:
  • Quality of Life Assessment
Other: Questionnaire Administration
Ancillary studies
Other: Medical Chart Review
Ancillary studies
Other Names:
  • Chart Review
Procedure: Supportive Care
Participate in PACK Health program
Other Names:
  • Supportive Therapy
  • Symptom Management
  • Therapy, Supportive
Active Comparator: GROUP II (standard of care)
Patients receive standard of care support services over 6 months.
Other: Quality-of-Life Assessment
Ancillary studies
Other Names:
  • Quality of Life Assessment
Other: Questionnaire Administration
Ancillary studies
Other: Best Practice
Receive standard of care
Other Names:
  • standard of care
  • standard therapy
Other: Medical Chart Review
Ancillary studies
Other Names:
  • Chart Review

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patient reported outcomes on global physical and mental health
Time Frame: Up to 6 months
Measured by the National Institutes of Health (NIH) Patient Reported Outcomes Measurement Information System (PROMIS) Global Health Scale version (v.)1.2. PROMIS v1.2 raw scores will be converted to PROMIS v1.2 t-scores prior to any analyses. Because t scores can only be calculated if a participant answers all 10 items, multiple imputation techniques will be used to estimate the values for missing items. Prior to conducting multiple imputation, the data will first be examined to determine whether missing data are missing completely at random (MCAR), missing at random (MAR) or missing not at random (MNAR). Models will be created separately for physical and mental health. Testing will be 2-sided and conducted with a 0.05 level of statistical significance yielding a family wise Type I error rate of 0.10.
Up to 6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rate of emergency room visits and hospital admissions
Time Frame: From day 1 to day 180
A generalized linear mixed model using a log link function will be used to model the rate of emergency room visits and hospital admissions by intervention and time. The number of emergency room visits and hospital admissions will be recorded for each subject from day 1 through day 180 and summarized to correspond to inventory assessment periods.
From day 1 to day 180

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

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

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 31, 2019

Primary Completion (Actual)

July 27, 2023

Study Completion (Actual)

July 27, 2023

Study Registration Dates

First Submitted

July 15, 2019

First Submitted That Met QC Criteria

July 15, 2019

First Posted (Actual)

July 17, 2019

Study Record Updates

Last Update Posted (Actual)

August 7, 2023

Last Update Submitted That Met QC Criteria

August 3, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2018-0473 (Other Identifier: M D Anderson Cancer Center)
  • NCI-2019-03897 (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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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