Effect of EHealth Coaching Program on Patient Reported Outcomes of Men With Prostate Cancer

Prostate Carcinoma Clinical Trial

Official title:

The Effect of an EHealth Coaching Program on Patient Reported Outcomes of Men With Prostate Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04106245
• Other study ID #: 2018-0422
• Secondary ID: NCI-2019-0585620
• Status: Completed
• Phase: N/A
• Start date: December 4, 2019
• Est. completion date: July 27, 2023

Study information

• Verified date: August 2023
• Source: M.D. Anderson Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This trial studies the effect of an eHealth coaching program (PACK Health) on patient reported outcomes of men with prostate cancer. An electronic health support program may affect prostate cancer patients' reported side effects and outcomes of care.

Description:

PRIMARY OBJECTIVES:

I. To model the trajectory of patient reported outcomes (PROs), as measured by the National Institutes of Health (NIH) Patient Reported Outcomes Measurement Information System (PROMIS) Global Health Scale (version [v]1.2), among men newly diagnosed with prostate cancer who are engaged in either active surveillance or active treatment, while enrolled in an e-health coaching program.

Ia. To compare the trajectories of (PROs) between men who are engaged in either active surveillance or active treatment, while enrolled in an e-health coaching program.

SECONDARY OBJECTIVES:

I. To evaluate the effect of digital health coaching program on:

Ia. Physical and mental health of men newly diagnosed with prostate cancer as measured by the subscales of the PROMIS Global Health Scale (v 1.2).

Ib. The global health outcomes of men with prostate cancer who are in active treatment by active treatment type (i.e. surgery, radiation, chemotherapy, hormonal therapy, or a combination of these methodologies).

Ic. The symptom experience of men newly diagnosed with prostate cancer as measured by the MD Anderson Symptom Inventory (MDASI).

Id. The frequency of emergency room visits and hospital admissions for patients receiving treatment in the ambulatory setting.

II. 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 Expanded Prostate Cancer Index Composite for Clinical Practice (EPIC-CP).

OUTLINE:

Patients are contacted once weekly by a health coach by text message, phone call, email, or a mobile application, for 3 months. The total time interacting with the health coach is about 3.5-4.5 hours across the study. Patients also complete surveys over 30 minutes each time at baseline and every 30 days for 3 months.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 145
• Est. completion date: July 27, 2023
• Est. primary completion date: July 27, 2023
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Able to read, speak and consent in English

• Newly diagnosed (within 6 months of diagnosis) with prostate cancer

• 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 hospice care

• Individuals who have a prior diagnosis of prostate cancer

• Individuals for whom there is documentation of inability to provide consent in the medical record

Related Conditions & MeSH terms

• Prostate Carcinoma
• Prostatic Neoplasms

Intervention

Behavioral:
• Behavioral Intervention
Participate in PACK Health

Other:
• Survey Administration
Complete survey

Locations

Country	Name	City	State
United States	M D Anderson Cancer Center	Houston	Texas

Sponsors (2)

Lead Sponsor	Collaborator
M.D. Anderson Cancer Center	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Model trajectories of men who participate in eHealth program	Summary statistics and box plots will also be used to describe Patient Reported Outcomes Measurement Information System (PROMIS) (1.2) and other inventory scores and subscale scores by cohort and assessment time. A linear mixed effects model will be used to assess PROMIS (version 1.2) (and scores over time). The models will include assessment time, treatment and a treatment by time interaction as fixed effects and intercept as a random effect.	Up to 3 months
Primary	The number of emergency room visits	A generalized linear mixed model (GLMM) using a log link function will be used to model the number of emergency room visits. Generalized linear mixed Tobit models will be used if the data are found to be zero-inflated.	Baseline through day 90
Primary	Number of hospital admissions	A GLMM using a log link function will be used to model the number of emergency room visits. Generalized linear mixed Tobit models will be used if the data are found to be zero-inflated.	Baseline through day 90

External Links

•   MD Anderson Cancer Center