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.
Recruiting
N/A
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.
| Name | Type | Description | Interventions |
|---|---|---|---|
| Supportive care (PACK health coach, survey) | Experimental | 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. |
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 |
| 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. |
| Phase: | N/A |
| Primary Purpose: | Interventional |
| Overall Status: | Recruiting |
| Lead Sponsor: | M.D. Anderson Cancer Center |
July 23, 2020
