search
Back to results

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

Primary Purpose

Prostate Carcinoma

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Behavioral Intervention
Survey Administration
Sponsored by
M.D. Anderson Cancer Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Prostate Carcinoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

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

Sites / Locations

  • M D Anderson Cancer Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Supportive care (PACK health coach, survey)

Arm Description

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.

Outcomes

Primary Outcome Measures

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.
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.
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.

Secondary Outcome Measures

Full Information

First Posted
September 25, 2019
Last Updated
August 1, 2023
Sponsor
M.D. Anderson Cancer Center
Collaborators
National Cancer Institute (NCI)
search

1. Study Identification

Unique Protocol Identification Number
NCT04106245
Brief Title
Effect of EHealth Coaching Program on Patient Reported Outcomes of Men With Prostate Cancer
Official Title
The Effect of an EHealth Coaching Program on Patient Reported Outcomes of Men With Prostate Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Completed
Study Start Date
December 4, 2019 (Actual)
Primary Completion Date
July 27, 2023 (Actual)
Study Completion Date
July 27, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
M.D. Anderson Cancer Center
Collaborators
National Cancer Institute (NCI)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Carcinoma

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
145 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Supportive care (PACK health coach, survey)
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Behavioral Intervention
Other Intervention Name(s)
Behavior Conditioning Therapy, Behavior Modification, Behavior or Life Style Modifications, Behavior Therapy, Behavioral Interventions, Behavioral Modification, Behavioral Therapy, Behavioral Treatment, Behavioral Treatments
Intervention Description
Participate in PACK Health
Intervention Type
Other
Intervention Name(s)
Survey Administration
Intervention Description
Complete survey
Primary Outcome Measure Information:
Title
Model trajectories of men who participate in eHealth program
Description
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.
Time Frame
Up to 3 months
Title
The number of emergency room visits
Description
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.
Time Frame
Baseline through day 90
Title
Number of hospital admissions
Description
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.
Time Frame
Baseline through day 90

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eileen Hacker, BS,PHD,RN
Organizational Affiliation
M.D. Anderson Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
M D Anderson Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States

12. IPD Sharing Statement

Links:
URL
http://www.mdanderson.org
Description
MD Anderson Cancer Center

Learn more about this trial

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

We'll reach out to this number within 24 hrs