Clinical Trials /

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

NCT04106245

Description:

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.

Related Conditions:
  • Prostate Carcinoma
Recruiting Status:

Recruiting

Phase:

N/A

Trial Eligibility

Document

Title

  • 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

Clinical Trial IDs

  • ORG STUDY ID: 2018-0422
  • SECONDARY ID: NCI-2019-05856
  • SECONDARY ID: 2018-0422
  • NCT ID: NCT04106245

Conditions

  • Prostate Carcinoma

Purpose

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.
    

Trial Arms

NameTypeDescriptionInterventions
Supportive care (PACK health coach, survey)ExperimentalPatients 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.

    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
          
    Maximum Eligible Age:N/A
    Minimum Eligible Age:18 Years
    Eligible Gender:Male
    Healthy Volunteers:No

    Primary Outcome Measures

    Measure:Model trajectories of men who participate in eHealth program
    Time Frame:Up to 3 months
    Safety Issue:
    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.

    Details

    Phase:N/A
    Primary Purpose:Interventional
    Overall Status:Recruiting
    Lead Sponsor:M.D. Anderson Cancer Center

    Last Updated

    July 21, 2020