Clinical trial NCT04022772: Effect of PACK Health Support Program on Patient Reported Outcomes in Patients With Breast Cancer
Official title: Longitudinal Cohort Study of the Effect of an eHealth Support Program on Patient Reported Outcomes of Women With Breast Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Carcinoma
Breast Ductal Carcinoma In Situ
Invasive Breast Carcinoma
Recurrent Breast Carcinoma
Lead sponsor: M.D. Anderson Cancer Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2019-07-17
Enrollment: 287
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Patient reported outcomes on global physical and mental health
timeFrame: Up to 6 months
Secondary outcomes:
measure: Rate of emergency room visits and hospital admissions
timeFrame: From day 1 to day 180
Other outcomes:
Locations:
city: Houston
country: United States
facility: M D Anderson Cancer Center
state: Texas
Study officials:
affiliation: M.D. Anderson Cancer Center
name: Eileen Hacker, PHD
role: PRINCIPAL_INVESTIGATOR
References: