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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04106245
Recruitment Status : Recruiting
First Posted : September 26, 2019
Last Update Posted : July 23, 2020
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

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.

Condition or disease Intervention/treatment Phase
Prostate Carcinoma Behavioral: Behavioral Intervention Other: Survey Administration Not Applicable

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.

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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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer

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.
Behavioral: Behavioral Intervention
Participate in PACK Health
Other Names:
  • Behavior Conditioning Therapy
  • Behavior Modification
  • Behavior or Life Style Modifications
  • Behavior Therapy
  • Behavioral Interventions
  • Behavioral Modification
  • Behavioral Therapy
  • Behavioral Treatment
  • Behavioral Treatments

Other: Survey Administration
Complete survey




Primary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.



Information from the National Library of Medicine

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

Information from the National Library of Medicine

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


Contacts
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Contact: Lori Williams 713-792-1130 loriwilliams@mdanderson.org

Locations
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United States, Texas
M D Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
Contact: Lori Williams    713-792-1130      
Principal Investigator: Lori Williams         
Sponsors and Collaborators
M.D. Anderson Cancer Center
National Cancer Institute (NCI)
Investigators
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Principal Investigator: Lori Williams M.D. Anderson Cancer Center
Additional Information:
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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

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Prostatic Diseases