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

NCT04022772 | Completed

• 2 other identifiers: 2018-0473NCI-2019-03897
• Study Type: interventional
• Target: 287
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Breast Carcinoma; Breast Ductal Carcinoma In Situ; Invasive Breast Carcinoma; Recurrent Breast Carcinoma

Outcome Measures

Primary Outcomes (1)

• Patient reported outcomes on global physical and mental health

  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 Outcomes (1)

• Rate of emergency room visits and hospital admissions

  From day 1 to day 180

Study Arms (2)

GROUP I (PACK Health program)

EXPERIMENTAL

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: Medical Chart Review; Other: Quality-of-Life Assessment; Other: Questionnaire Administration; Procedure: Supportive Care

GROUP II (standard of care)

ACTIVE COMPARATOR

Patients receive standard of care support services over 6 months.

Other: Best Practice; Other: Medical Chart Review; Other: Quality-of-Life Assessment; Other: Questionnaire Administration

Interventions

Best Practice OTHER

Receive standard of care

Also known as: standard of care, standard therapy

GROUP II (standard of care)

Medical Chart Review OTHER

Ancillary studies

Also known as: Chart Review

GROUP I (PACK Health program); GROUP II (standard of care)

Quality-of-Life Assessment OTHER

Ancillary studies

Also known as: Quality of Life Assessment

GROUP I (PACK Health program); GROUP II (standard of care)

Questionnaire Administration OTHER

Ancillary studies

GROUP I (PACK Health program); GROUP II (standard of care)

Supportive Care PROCEDURE

Participate in PACK Health program

Also known as: Supportive Therapy, Symptom Management, Therapy, Supportive

GROUP I (PACK Health program)

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

M D Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

• M D Anderson Cancer Center

MeSH Terms

Conditions

Breast Neoplasms; Carcinoma, Intraductal, Noninfiltrating

Interventions

Practice Guidelines as Topic; Standard of Care; Palliative Care

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Breast Carcinoma In Situ; Carcinoma in Situ; Neoplasms, Ductal, Lobular, and Medullary

Intervention Hierarchy (Ancestors)

Guidelines as Topic; Quality Assurance, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation; Quality Indicators, Health Care; Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Eileen Hacker, PHD

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 15, 2019
• First Posted: July 17, 2019
• Study Start: July 31, 2019
• Primary Completion: July 27, 2023
• Study Completion: July 27, 2023
• Last Updated: August 7, 2023

Record last verified: 2023-08

Locations

US (1)