Effect of EHealth Coaching Program on Patient Reported Outcomes of Men With Prostate Cancer
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ClinicalTrials.gov Identifier: NCT04106245 |
Recruitment Status :
Recruiting
First Posted : September 26, 2019
Last Update Posted : July 23, 2020
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Condition or disease | Intervention/treatment | Phase |
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Prostate Carcinoma | Behavioral: Behavioral Intervention Other: Survey Administration | Not Applicable |
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.
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 532 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Supportive Care |
Official Title: | The Effect of an EHealth Coaching Program on Patient Reported Outcomes of Men With Prostate Cancer |
Actual Study Start Date : | December 4, 2019 |
Estimated Primary Completion Date : | September 30, 2020 |
Estimated Study Completion Date : | September 30, 2020 |

Arm | Intervention/treatment |
---|---|
Experimental: 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.
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Behavioral: Behavioral Intervention
Participate in PACK Health
Other Names:
Other: Survey Administration Complete survey |
- Model trajectories of men who participate in eHealth program [ Time Frame: Up to 3 months ]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 [ Time Frame: Baseline through day 90 ]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 [ Time Frame: Baseline through day 90 ]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.

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | Male |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04106245
Contact: Lori Williams | 713-792-1130 | loriwilliams@mdanderson.org |
United States, Texas | |
M D Anderson Cancer Center | Recruiting |
Houston, Texas, United States, 77030 | |
Contact: Lori Williams 713-792-1130 | |
Principal Investigator: Lori Williams |
Principal Investigator: | Lori Williams | M.D. Anderson Cancer Center |
Responsible Party: | M.D. Anderson Cancer Center |
ClinicalTrials.gov Identifier: | NCT04106245 |
Other Study ID Numbers: |
2018-0422 NCI-2019-05856 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) ) 2018-0422 ( Other Identifier: M D Anderson Cancer Center ) |
First Posted: | September 26, 2019 Key Record Dates |
Last Update Posted: | July 23, 2020 |
Last Verified: | December 2019 |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Prostatic Neoplasms Genital Neoplasms, Male Urogenital Neoplasms |
Neoplasms by Site Neoplasms Prostatic Diseases |