CancerNCT06222242
mychoiceTM Implementation With Medical Oncology Patients
A study testing mychoiceTM in people with Cancer, run by Fox Chase Cancer Center at 1 site in United States.
Trial summary
This is a pragmatic, non-randomized mixed-methods evaluation study designed to evaluate the feasibility and acceptability of delivering the mychoiceTM tool to new Medical Oncology patients as well as to more deeply explore its value to patients in their discussion with their provider about clinical trials as a… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer
- What is being tested?
- mychoiceTM
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Jun 2023to Jun 2025
- 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
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 years of age or over
- Able to speak and read English
- Medical Oncology patients who have had their initial visit
- Have a cell phone number and/or an email in the electronic medical record
Who cannot join
- Doesn't not speak or read English
- Patients who do not have a cancer diagnosis
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Fox Chase Cancer Center
Philadelphia, Pennsylvania, 19111
Linda Fleisher, PhD, MPH, (215) 728-4066, linda.fleisher@fccc.edu
Zoe Landau, MPH, 215-728-5893, zoe.landau@fccc.edu
About this study
Official title: mychoiceTM Implementation in a Real World Clinical Environment - Delivery and Effectiveness
This is a pragmatic, non-randomized mixed-methods evaluation study designed to evaluate the feasibility and acceptability of delivering the mychoiceTM tool to new Medical Oncology patients as well as to more deeply explore its value to patients in their discussion with their provider about clinical trials as a treatment option over the course of their oncology treatment (Effectiveness).
Read the detailed description
This is a pragmatic, non-randomized mixed-methods evaluation study designed to evaluate the feasibility and acceptability of delivering the mychoiceTM tool to new Medical Oncology patients as well as to more deeply explore its value to patient in their discussion with their provider about clinical trials as a treatment option over the course of their oncology treatment (Effectiveness).
Our goal is to focus this study with patients who have had their first Medical Oncology Appointment based on a nightly EMR feed. The mychoiceTM link (currently mychoice.kevindurr.com, but will change to mychoice.templehealth.org prior to study launch) will be sent to patients through a REDCap feed where they can review the mychoice tool and voluntarily answer a short 5 question quality improvement (QI) survey about their experience with mychoiceTM. The survey will include a question about their willingness to be contacted regarding the more in-depth effectiveness study. This survey data will only be evaluated at an aggregate level and used for process improvement purposes.
The effectiveness study will be conducted with patients who have used mychoiceTM and have agreed to be contacted by Fox Chase Research Staff as indicated in their response to one of the questions in the QI survey. Our goal is to conduct follow-up with those patients who used mychoiceTM to evaluate the impact of the tool on patients' perceived preparedness to discuss clinical trials with their physician and insights into this decision-making process over six-months during their treatment. In addition, we will assess provider and system barriers and facilitators to implementation of mychoice in real world settings to guide future dissemination and implementation.
There are three levels of evaluation questions in this project and specific aims related to each.
- Can an evidence-based digital health tool designed to promote discussion about clinical trial participation (mychoiceTM) be easily provided to patients in real time, and will this dissemination approach be acceptable to patients and providers? (Aim 1)
- For a sub-set of these patients who use the tool and express interest in participating in a follow-up study evaluation, does the tool positively impact their preparation for a discussion about clinical trials participation across their cancer treatment trajectory? (Aim 3. What are the factors (based on Implementation Research frameworks - RE-AIM and Consolidated Framework Implementation Research) that influence the implementation of mychoiceTM in a real world setting that can guide future dissemination and implementation.
Therefore, the aims of this pragmatic, non-randomized, mixed-methods study is to assess the feasibility, acceptability (Aim 1) and effectiveness of the mychoiceTM preparatory tool for patients (Aim 2).
- Conditions
- Cancer
- Being tested
- mychoiceTM
- Keywords
- cancer
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mychoiceTMBehavioural
mychoiceTM is an online, educational tool designed to help prepare patients for a conversation with their provider about clinical trials as a treatment option. It consists of text, animations, and videos of real cancer patients sharing their experience with clinical trials. It is not meant to be a recruitment tool, but rather a preparatory tool to promote shared decision making between patients and providers.
| Study group | Role | What they receive |
|---|---|---|
| mychoiceTM intervention | Experimental | Single arm study - all participants receive mychoiceTM Receives: Behavioral: mychoiceTM |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility to disseminate the mychoice tool to patients
Assess the feasibility of disseminating the mychoiceTM preparatory tool to all Medical Oncology patients and the acceptability (measured by recommendation to other patients. Patient feasibility will focus on the proportion of patients who receive the mychoiceTM tool and open the web-based intervention (goal 50%).
Measured: 24 months
Acceptability
Patient acceptability will be measured for those patients who complete a voluntary, anonymous, feedback survey. Patients will rate how much they would recommend the navigation intervention to other patients on a scale of 1 to 5. Acceptability threshold would be met with a mean score of 3.5 or higher across all patients (aggregated data) who complete the feedback form (QI).
Measured: 24
Effectiveness
Assess the effectiveness and value of the mychoiceTM tool on patients' preparation for the discussion about clinical trials through baseline and 4 monthsurveys and interviews with a selected sample at 2 months. The primary outcome will be to measure the effectiveness of the tool using a modified Ottawa Preparation Scale (PrepDM, 1-5 scale) addressing the effectiveness of the tool to prepare for a discussion with their provider. Based on our previous randomized trial, benchmark for success is mean score of 3.5 or higher across all patients enrolled on the PrepDM measures (or a total score of 62.5).
Measured: 24 months
Secondary outcomes (1)
Implementation Factors
We will assess implementation factors (both barriers and facilitators) at the provider and institutional levels, through review of implementation notes from planning and implementation meetings, as well as study notes using a coding form based on the domains of the Consolidated Framework for Implementation Research and distribute post-launch provider surveys.
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jan 2024
- Study start7 Jun 2023
- Primary completionJun 2025 (estimated)
- Study completionJun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies of the same condition, open and under way.
- More trials run by Fox Chase 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
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fox Chase Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- Genentech, Inc.
- Responsible party
- Principal investigator, Linda Fleisher, Fox Chase Cancer Center
- Investigators
- Linda Fleisher, PhD, MPH, Principal investigator, Fox Chase Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06222242
- Sponsor's protocol ID
- 23-8003
- Status last verified
- Jan 2024
- First submitted
- 8 Dec 2023
- Last updated
- 24 Jan 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- mychoiceTM Implementation in a Real World Clinical Environment - Delivery and Effectiveness
- ClinicalTrials.gov ID
- NCT06222242
- Acronym / sponsor ID
- 23-8003
- Conditions
- Cancer
- Keywords
- cancer
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Fox Chase Cancer CenterUniversity, hospital or other
- Collaborators
- Genentech, Inc.
- Study start
- 7 Jun 2023 (actual)
- Primary completion
- Jun 2025 (estimated)
- Study completion
- Jun 2025 (estimated)
- First posted
- 24 Jan 2024 (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 is a pragmatic, non-randomized mixed-methods evaluation study designed to evaluate the feasibility and acceptability of delivering the mychoiceTM tool to new Medical Oncology patients as well as to more deeply explore its value to patients in their discussion with their provider about clinical trials as a treatment option over the course of their oncology treatment (Effectiveness).
Detailed description
This is a pragmatic, non-randomized mixed-methods evaluation study designed to evaluate the feasibility and acceptability of delivering the mychoiceTM tool to new Medical Oncology patients as well as to more deeply explore its value to patient in their discussion with their provider about clinical trials as a treatment option over the course of their oncology treatment (Effectiveness).
Our goal is to focus this study with patients who have had their first Medical Oncology Appointment based on a nightly EMR feed. The mychoiceTM link (currently mychoice.kevindurr.com, but will change to mychoice.templehealth.org prior to study launch) will be sent to patients through a REDCap feed where they can review the mychoice tool and voluntarily answer a short 5 question quality improvement (QI) survey about their experience with mychoiceTM. The survey will include a question about their willingness to be contacted regarding the more in-depth effectiveness study. This survey data will only be evaluated at an aggregate level and used for process improvement purposes.
The effectiveness study will be conducted with patients who have used mychoiceTM and have agreed to be contacted by Fox Chase Research Staff as indicated in their response to one of the questions in the QI survey. Our goal is to conduct follow-up with those patients who used mychoiceTM to evaluate the impact of the tool on patients' perceived preparedness to discuss clinical trials with their physician and insights into this decision-making process over six-months during their treatment. In addition, we will assess provider and system barriers and facilitators to implementation of mychoice in real world settings to guide future dissemination and implementation.
There are three levels of evaluation questions in this project and specific aims related to each.
- Can an evidence-based digital health tool designed to promote discussion about clinical trial participation (mychoiceTM) be easily provided to patients in real time, and will this dissemination approach be acceptable to patients and providers? (Aim 1)
- For a sub-set of these patients who use the tool and express interest in participating in a follow-up study evaluation, does the tool positively impact their preparation for a discussion about clinical trials participation across their cancer treatment trajectory? (Aim 3. What are the factors (based on Implementation Research frameworks - RE-AIM and Consolidated Framework Implementation Research) that influence the implementation of mychoiceTM in a real world setting that can guide future dissemination and implementation.
Therefore, the aims of this pragmatic, non-randomized, mixed-methods study is to assess the feasibility, acceptability (Aim 1) and effectiveness of the mychoiceTM preparatory tool for patients (Aim 2).
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| mychoiceTM intervention | Experimental | Behavioral: mychoiceTMSingle arm study - all participants receive mychoiceTM |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 18 years of age or over
- Able to speak and read English
- Medical Oncology patients who have had their initial visit
- Have a cell phone number and/or an email in the electronic medical record
Key exclusion criteria (2 listed)
- Doesn't not speak or read English
- Patients who do not have a cancer diagnosis
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 |
|---|---|---|
| mychoiceTMmychoiceTM is an online, educational tool designed to help prepare patients for a conversation with their provider about clinical trials as a treatment option. It consists of text, animations, and videos of real cancer patients sharing their experience with clinical trials. It is not meant to be a recruitment tool, but rather a preparatory tool to promote shared decision making between patients and providers. | Behavioural | mychoiceTM intervention |
Primary outcome
Feasibility to disseminate the mychoice tool to patients
Time frame: 24 months
Assess the feasibility of disseminating the mychoiceTM preparatory tool to all Medical Oncology patients and the acceptability (measured by recommendation to other patients. Patient feasibility will focus on the proportion of patients who receive the mychoiceTM tool and open the web-based intervention (goal 50%).
Acceptability
Time frame: 24
Patient acceptability will be measured for those patients who complete a voluntary, anonymous, feedback survey. Patients will rate how much they would recommend the navigation intervention to other patients on a scale of 1 to 5. Acceptability threshold would be met with a mean score of 3.5 or higher across all patients (aggregated data) who complete the feedback form (QI).
Effectiveness
Time frame: 24 months
Assess the effectiveness and value of the mychoiceTM tool on patients' preparation for the discussion about clinical trials through baseline and 4 monthsurveys and interviews with a selected sample at 2 months. The primary outcome will be to measure the effectiveness of the tool using a modified Ottawa Preparation Scale (PrepDM, 1-5 scale) addressing the effectiveness of the tool to prepare for a discussion with their provider. Based on our previous randomized trial, benchmark for success is mean score of 3.5 or higher across all patients enrolled on the PrepDM measures (or a total score of 62.5).
1 secondary outcome
Implementation Factors
Time frame: 24 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jan 2024.
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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.
Linda Fleisher, PhD, MPH principal investigator
Fox Chase 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 mychoiceTM in people with Cancer, run by Fox Chase 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 4 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 24 Jan 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Linda Fleisher, PhD, MPH ((215) 728-4066, linda.fleisher@fccc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility to disseminate the mychoice tool to patients (time frame: 24 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 24 Jan 2024.