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

NCT ID: NCT04106245

Last Updated: 2023-08-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 145 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-12-04
• Study Completion Date: 2023-07-27

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.

Conditions

Prostate Carcinoma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Supportive care (PACK health coach, survey)

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.

Group Type: EXPERIMENTAL

Behavioral Intervention

Intervention Type: BEHAVIORAL

Participate in PACK Health

Survey Administration

Intervention Type: OTHER

Complete survey

Interventions

Behavioral Intervention

Participate in PACK Health

Intervention Type: BEHAVIORAL

Survey Administration

Complete survey

Intervention Type: OTHER

Other Intervention Names

Behavior Conditioning Therapy; Behavior Modification; Behavior or Life Style Modifications; Behavior Therapy; Behavioral Interventions; Behavioral Modification; Behavioral Therapy; Behavioral Treatment; Behavioral Treatments

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

M.D. Anderson Cancer Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Eileen Hacker, BS,PHD,RN

Role: PRINCIPAL_INVESTIGATOR

M.D. Anderson Cancer Center

Locations

M D Anderson Cancer Center

Houston, Texas, United States

Countries

United States

Related Links

http://www.mdanderson.org

MD Anderson Cancer Center

Other Identifiers

NCI-2019-05856

Identifier Type: REGISTRY

Identifier Source: secondary_id

2018-0422

Identifier Type: OTHER

Identifier Source: secondary_id

2018-0422

Identifier Type: -

Identifier Source: org_study_id