Prostate CarcinomaNCT06016504
Adaptive Virtual Consultation Tool to Enhance Education and Understanding in Patients with Prostate Cancer
A study testing Health Education, Informational Intervention and Survey Administration in people with Prostate Carcinoma, run by Mayo Clinic at 1 site in United States.
Trial summary
This clinical trial aims to design and validate an adaptive virtual consultation tool (AVCT) for men with prostate cancer (PC). An AVCT utilizes health literacy assessments in combination with learning preferences and individual disease characteristics to provide focused and guided knowledge on PC tailored to the… Read more about this study
- Who is it for?
- Any age, men only
- Conditions the study is for
- Prostate Carcinoma
- What is being tested?
- Health Education, Informational 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
- 18 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Feb 2022to 9 Jul 2024
- 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 Any age
- Men only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- The participants in this study will be community dwelling, males with prostate cancer (PC) and their healthcare advocate, if applicable
- Proficiency in English is required
Who cannot join
- Mental incompetency to participate in the study and/or no treatment option due to other health reasons
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Development and Evaluation of an Adaptive Virtual Consultation Tool for Prostate Cancer Patients
This clinical trial aims to design and validate an adaptive virtual consultation tool (AVCT) for men with prostate cancer (PC). An AVCT utilizes health literacy assessments in combination with learning preferences and individual disease characteristics to provide focused and guided knowledge on PC tailored to the individual patient. Using an AVCT to enhance patient education may improve patient understanding and result in higher patient satisfaction with treatment decisions amongst men with PC.
Read the detailed description
PRIMARY OBJECTIVES:
- To develop an adaptive virtual consultation tool for PC (AVCT):
Ia. To incorporate and integrate the inputs from a diverse group of patients (including minorities), patient advocates, nursing, physicians and education experts in the design process for the adaptive consultation tool; Ib. Employ user centered iterative design approach to develop an adaptive learning tool on mobile devices that is tailored to individuals based on symptoms, health literacy, learning style, and disease specific characteristics.
II. To assess the feasibility, acceptability and usability of AVCT:
IIa. To validate the design approach and customization rules at the completion of the participatory design process using a convenience sample of subjects through assessment of system interaction logs and qualitative feedback from users on cognition, ease-of-use, usability and customization efficacy; IIb. To utilize the feasibility study results in (2a) to refine the interface, information presentation, and adaptive customization approach.
III. To determine the efficacy of AVCT using a small-scale comparative study:
IIIa. To design and execute a three arm comparative study consisting of adaptive virtual consultation, non-adaptive virtual consultation and standard-practice information-only control intervention and assess the comparative efficacy of the tool on the main outcome variable, satisfaction with health care episode; IIIb. To measure changes in other outcome variables at baseline, post-intervention, 3-month and 12-month duration; IIIc. To analyze the mediating influence of decision self-efficacy and a number of moderating factors including preference for decision-making participation and health literacy on outcome variables.
OUTLINE: Patients are randomized to 1 of 3 arms.
ARM 1: Patients participate in an adaptive virtual consultation on trial.
ARM 2: Patients participate in a non-adaptive virtual consultation on trial.
ARM 3: Patients receive information-only on trial.
After completion of study intervention, patients are followed up at 3- and 12-months post treatment decision.
- Conditions
- Prostate Carcinoma
- Being tested
- Health Education, Informational 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.
Health EducationBehavioural
Participate in an adaptive virtual consultation
Health EducationBehavioural
Participate in a non-adaptive virtual consultation
Informational InterventionOther
Given information-only
Survey AdministrationOther
Ancillary studies
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 (AVCT) | Experimental | Patients participate in an adaptive virtual consultation on trial. Receives: Behavioral: Health Education; Other: Survey Administration |
| Arm 2 (non-AVCT) | Active comparator | Patients participate in a non-adaptive virtual consultation on trial. Receives: Behavioral: Health Education; Other: Survey Administration |
| Arm 3 (information-only) | Active comparator | Patients receive information-only on trial. Receives: Other: Informational Intervention; Other: Survey Administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient satisfaction measured by post utilization surveys
Patient's satisfaction is to be measured by post utilization surveys using general Likert scale assessment tools.
Descriptive statistics will be used to summarize the data at each study time point. For all the measures collected at multiple time points, generalized linear equations (GEE) will be used to evaluate the effect of treatment and time adjusting for usage pattern.
Measured: 3-month post treatment decision
Patient satisfaction measured by post utilization surveys
Patient's satisfaction is to be measured by post utilization surveys using general Likert scale assessment tools.
Descriptive statistics will be used to summarize the data at each study time point. For all the measures collected at multiple time points, generalized linear equations (GEE) will be used to evaluate the effect of treatment and time adjusting for usage pattern.
Measured: 12-month post treatment decision
Health outcomes for cancer recurrence using PSA
Measured by Prostate specific antigen ( PSA )
Measured: Baseline
Health outcomes for urinary function using IPSS
Measured using International Prostate symptom score (IPSS)
Measured: Baseline
Health outcomes for sexual function using SHIM score
Measured using Sexual Health inventory for men (SHIM) score
Measured: Baseline
Health outcomes for cancer recurrence using PSA
Measured by Prostate specific antigen ( PSA )
Measured: 3-month post treatment decision
Health outcomes for urinary function
Measured using International Prostate symptom score (IPSS)
Measured: 3-month post treatment decision
Health outcomes for sexual function
Measured using Sexual Health inventory for men (SHIM) score
Measured: 3-month post treatment decision
Health outcomes for cancer recurrence using PSA
Measured by Prostate specific antigen ( PSA )
Measured: 12-months post treatment decision
Health outcomes for urinary function
Measured using International Prostate symptom score (IPSS)
Measured: 12-months post treatment decision
Health outcomes for sexual function
Measured using Sexual Health inventory for men (SHIM) score
Measured: 12-months post treatment decision
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2023
- Study start10 Feb 2022
- Primary completion9 Jul 2024
- Study completion9 Jul 2024
Why it stopped: Low/slow accrual
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 Mayo ClinicThe 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mitchell Humphreys, Mayo Clinic
- Investigators
- Mitchell R. Humphreys, M.D., Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06016504
- Sponsor's protocol ID
- 21-002955
- Other IDs
- NCI-2022-09812, 21-002955
- Status last verified
- Oct 2024
- First submitted
- 1 Aug 2023
- Last updated
- 22 Oct 2024
- 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 22 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development and Evaluation of an Adaptive Virtual Consultation Tool for Prostate Cancer Patients
- ClinicalTrials.gov ID
- NCT06016504
- Acronym / sponsor ID
- 21-002955
- Conditions
- Prostate Carcinoma
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Low/slow accrual
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 10 Feb 2022 (actual)
- Primary completion
- 9 Jul 2024 (actual)
- Study completion
- 9 Jul 2024 (actual)
- First posted
- 29 Aug 2023 (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 clinical trial aims to design and validate an adaptive virtual consultation tool (AVCT) for men with prostate cancer (PC). An AVCT utilizes health literacy assessments in combination with learning preferences and individual disease characteristics to provide focused and guided knowledge on PC tailored to the individual patient. Using an AVCT to enhance patient education may improve patient understanding and result in higher patient satisfaction with treatment decisions amongst men with PC.
Detailed description
PRIMARY OBJECTIVES:
- To develop an adaptive virtual consultation tool for PC (AVCT):
Ia. To incorporate and integrate the inputs from a diverse group of patients (including minorities), patient advocates, nursing, physicians and education experts in the design process for the adaptive consultation tool; Ib. Employ user centered iterative design approach to develop an adaptive learning tool on mobile devices that is tailored to individuals based on symptoms, health literacy, learning style, and disease specific characteristics.
II. To assess the feasibility, acceptability and usability of AVCT:
IIa. To validate the design approach and customization rules at the completion of the participatory design process using a convenience sample of subjects through assessment of system interaction logs and qualitative feedback from users on cognition, ease-of-use, usability and customization efficacy; IIb. To utilize the feasibility study results in (2a) to refine the interface, information presentation, and adaptive customization approach.
III. To determine the efficacy of AVCT using a small-scale comparative study:
IIIa. To design and execute a three arm comparative study consisting of adaptive virtual consultation, non-adaptive virtual consultation and standard-practice information-only control intervention and assess the comparative efficacy of the tool on the main outcome variable, satisfaction with health care episode; IIIb. To measure changes in other outcome variables at baseline, post-intervention, 3-month and 12-month duration; IIIc. To analyze the mediating influence of decision self-efficacy and a number of moderating factors including preference for decision-making participation and health literacy on outcome variables.
OUTLINE: Patients are randomized to 1 of 3 arms.
ARM 1: Patients participate in an adaptive virtual consultation on trial.
ARM 2: Patients participate in a non-adaptive virtual consultation on trial.
ARM 3: Patients receive information-only on trial.
After completion of study intervention, patients are followed up at 3- and 12-months post treatment decision.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Arm 1 (AVCT) | Experimental | Behavioral: Health Education, Other: Survey AdministrationPatients participate in an adaptive virtual consultation on trial. |
| Arm 2 (non-AVCT) | Active comparator | Behavioral: Health Education, Other: Survey AdministrationPatients participate in a non-adaptive virtual consultation on trial. |
| Arm 3 (information-only) | Active comparator | Other: Informational Intervention, Other: Survey AdministrationPatients receive information-only on trial. |
Who may qualify
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- The participants in this study will be community dwelling, males with prostate cancer (PC) and their healthcare advocate, if applicable
- Proficiency in English is required
Key exclusion criteria (1 listed)
- Mental incompetency to participate in the study and/or no treatment option due to other health reasons
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 |
|---|---|---|
| Health EducationParticipate in an adaptive virtual consultation | Behavioural | Arm 1 (AVCT) |
| Health EducationParticipate in a non-adaptive virtual consultation | Behavioural | Arm 2 (non-AVCT) |
| Informational InterventionGiven information-only | Other | Arm 3 (information-only) |
| Survey AdministrationAncillary studies | Other | Arm 1 (AVCT), Arm 2 (non-AVCT), Arm 3 (information-only) |
Primary outcome
Patient satisfaction measured by post utilization surveys
Time frame: 3-month post treatment decision
Patient's satisfaction is to be measured by post utilization surveys using general Likert scale assessment tools. Descriptive statistics will be used to summarize the data at each study time point. For all the measures collected at multiple time points, generalized linear equations (GEE) will be used to evaluate the effect of treatment and time adjusting for usage pattern.
Patient satisfaction measured by post utilization surveys
Time frame: 12-month post treatment decision
Patient's satisfaction is to be measured by post utilization surveys using general Likert scale assessment tools. Descriptive statistics will be used to summarize the data at each study time point. For all the measures collected at multiple time points, generalized linear equations (GEE) will be used to evaluate the effect of treatment and time adjusting for usage pattern.
Health outcomes for cancer recurrence using PSA
Time frame: Baseline
Measured by Prostate specific antigen ( PSA )
Health outcomes for urinary function using IPSS
Time frame: Baseline
Measured using International Prostate symptom score (IPSS)
Health outcomes for sexual function using SHIM score
Time frame: Baseline
Measured using Sexual Health inventory for men (SHIM) score
Health outcomes for cancer recurrence using PSA
Time frame: 3-month post treatment decision
Measured by Prostate specific antigen ( PSA )
Health outcomes for urinary function
Time frame: 3-month post treatment decision
Measured using International Prostate symptom score (IPSS)
Health outcomes for sexual function
Time frame: 3-month post treatment decision
Measured using Sexual Health inventory for men (SHIM) score
Health outcomes for cancer recurrence using PSA
Time frame: 12-months post treatment decision
Measured by Prostate specific antigen ( PSA )
Health outcomes for urinary function
Time frame: 12-months post treatment decision
Measured using International Prostate symptom score (IPSS)
Health outcomes for sexual function
Time frame: 12-months post treatment decision
Measured using Sexual Health inventory for men (SHIM) score
Results and safety
The study was stopped early (reason given: Low/slow accrual). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Oct 2024.
- Mayo Clinic Clinical TrialsLink 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.
Mitchell R. Humphreys, M.D. principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Health Education, Informational Intervention and Survey Administration in people with Prostate Carcinoma, run by Mayo Clinic 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 2 inclusion and 1 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: stopped early, as of the sponsor's last update on 22 Oct 2024. 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 was stopped early (reason given: Low/slow accrual). Results are not available in the source record.
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?
Patient satisfaction measured by post utilization surveys (time frame: 3-month post treatment decision). The study lists 11 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 22 Oct 2024.