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

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ClinicalTrials.gov Identifier: NCT04022772
Recruitment Status : Recruiting
First Posted : July 17, 2019
Last Update Posted : August 1, 2019
Sponsor:
Collaborators:
National Cancer Institute (NCI)
Genentech, Inc.
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Breast Carcinoma Other: Best Practice Other: Medical Chart Review Other: Quality-of-Life Assessment Other: Questionnaire Administration Procedure: Supportive Care Not Applicable

Detailed Description:

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 545 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Longitudinal Cohort Study of the Effect of an eHealth Support Program on Patient Reported Outcomes of Women With Breast Cancer
Actual Study Start Date : July 31, 2019
Estimated Primary Completion Date : February 28, 2021
Estimated Study Completion Date : February 28, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

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. 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.
Other: Medical Chart Review
Ancillary studies
Other Name: Chart Review

Other: Quality-of-Life Assessment
Ancillary studies
Other Name: Quality of Life Assessment

Other: Questionnaire Administration
Ancillary studies

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: Best Practice
Receive standard of care
Other Names:
  • standard of care
  • standard therapy

Other: Medical Chart Review
Ancillary studies
Other Name: Chart Review

Other: Quality-of-Life Assessment
Ancillary studies
Other Name: Quality of Life Assessment

Other: Questionnaire Administration
Ancillary studies




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04022772


Contacts
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Contact: Lori Williams 713-745-0844 loriwilliams@mdanderson.org

Locations
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United States, Texas
M D Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
Contact: Lori Williams    713-745-0844    loriwilliams@mdanderson.org   
Principal Investigator: Lori Williams         
Sponsors and Collaborators
M.D. Anderson Cancer Center
National Cancer Institute (NCI)
Genentech, Inc.
Investigators
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Principal Investigator: Lori Williams M.D. Anderson Cancer Center

Additional Information:
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Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT04022772     History of Changes
Other Study ID Numbers: 2018-0473
NCI-2019-03897 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
2018-0473 ( Other Identifier: M D Anderson Cancer Center )
P30CA016672 ( U.S. NIH Grant/Contract )
First Posted: July 17, 2019    Key Record Dates
Last Update Posted: August 1, 2019
Last Verified: July 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases