Prostate CarcinomaNCT04106245
Effect of EHealth Coaching Program on Patient Reported Outcomes of Men With Prostate Cancer
A study testing Behavioral Intervention and Survey Administration in people with Prostate Carcinoma, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Carcinoma
- What is being tested?
- Behavioral Intervention and Survey Administration
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 145 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Dec 2019to 27 Jul 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of an EHealth Coaching Program on Patient Reported Outcomes of Men With Prostate Cancer
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.
Read the detailed description
PRIMARY OBJECTIVES:
- 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:
- 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
- Being tested
- Behavioral Intervention, Survey Administration
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Behavioral InterventionBehavioural
Also called Behavior Conditioning Therapy, Behavior Modification, Behavior or Life Style Modifications, Behavior Therapy
Participate in PACK Health
Survey AdministrationOther
Complete survey
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Behavioral Intervention; Other: Survey Administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Model trajectories of men who participate in eHealth program
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.
Measured: Up to 3 months
The number of emergency room visits
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.
Measured: Baseline through day 90
Number of hospital admissions
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.
Measured: Baseline through day 90
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2019
- Study start4 Dec 2019
- Primary completion27 Jul 2023
- Study completion27 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate CarcinomaStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 145 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Eileen Hacker, BS,PHD,RN, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04106245
- Sponsor's protocol ID
- 2018-0422
- Other IDs
- NCI-2019-05856, 2018-0422
- Status last verified
- Aug 2023
- First submitted
- 25 Sep 2019
- Last updated
- 3 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of an EHealth Coaching Program on Patient Reported Outcomes of Men With Prostate Cancer
- ClinicalTrials.gov ID
- NCT04106245
- Acronym / sponsor ID
- 2018-0422
- Conditions
- Prostate Carcinoma
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 145 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 4 Dec 2019 (actual)
- Primary completion
- 27 Jul 2023 (actual)
- Study completion
- 27 Jul 2023 (actual)
- First posted
- 26 Sep 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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:
- 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 design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Supportive care (PACK health coach, survey) | Experimental | Behavioral: Behavioral Intervention, Other: Survey AdministrationPatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Behavioral InterventionAlso: Behavior Conditioning Therapy, Behavior Modification, Behavior or Life Style Modifications, Behavior TherapyParticipate in PACK Health | Behavioural | Supportive care (PACK health coach, survey) |
| Survey AdministrationComplete survey | Other | Supportive care (PACK health coach, survey) |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2023.
- MD Anderson Cancer CenterLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eileen Hacker, BS,PHD,RN principal investigator
M.D. Anderson Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Behavioral Intervention and Survey Administration in people with Prostate Carcinoma, run by M.D. Anderson Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Model trajectories of men who participate in eHealth program (time frame: Up to 3 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Aug 2023.