OncologyRESTOREDNCT05810987
Remote Education Strategies Training Oncology Residents for End-of-Life Discussions
A study testing RESTORE and Medical Interaction and Coaching in people with Oncology, run by McMaster University at 1 site in Canada.
Trial summary
Difficult conversations are common in oncology practice and patient-centered communication is essential to care for individuals with cancer. Within oncology training programs, communication training is mostly unstructured observation and feedback in the clinic and many learners receive inadequate training. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Oncology
- What is being tested?
- RESTORE and Medical Interaction and Coaching
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- 1 siteCanada
- Study dates
- 1 Mar 2023to 30 Aug 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Medical and radiation oncology residents and fellows at McMaster University, and medical oncology residents at the Universities of Ottawa and Toronto.
- Enrollment in a participating training program, ability to participate in study-related activities in English, access to internet and a video-enabled computer (either personal or institutional) to support study-related activities
Who cannot join
- Not enrolled in a participating training program
Trial locations and contacts
1 site in 1 country.
Canada1 site
Juravinski Cancer Centre - Hamilton Health Sciences
Hamilton, Ontario, L8V 5C2
About this study
Official title: Remote Education Strategies Training Oncology Residents for End-of-Life Discussions (The RESTORED Study)
Difficult conversations are common in oncology practice and patient-centered communication is essential to care for individuals with cancer. Within oncology training programs, communication training is mostly unstructured observation and feedback in the clinic and many learners receive inadequate training. Currently, educational resources are limited, and residents have indicated a desire for more education on end-of-life communication skills. A formal communication curriculum could fill a gap and help to standardize teaching and evaluation.
The overall goal of this study is to establish an effective communication skills curriculum for oncology residents that can be delivered remotely and that addresses difficult conversations with cancer patients. Through this preliminary study, we will explore the feasibility of a randomized controlled trial comparing different training experiences to understand how best to help oncology residents develop strong end-of-life communication skills.
Read the detailed description
Background:
Patient-centered communication is essential to care for individuals with cancer. High quality communication benefits patients, families, and clinicians. Proficiency in a variety of communication tasks is now a requirement within competency-based medical education (CBME) in Canada. Within oncology training programs, communication training is mostly unstructured observation and feedback in the clinic and many learners receive inadequate training. A formal communication curriculum could fill a gap and help to standardize teaching and evaluation, but current resources are limited.
Virtual care has been quickly adopted within oncology practice in the context of the COVID19 pandemic. This limits opportunities for direct observation of learners making assessment of communication skills more difficult. How best to teach communication skills in the context of virtual care is unclear. To mitigate current challenges, we will adapt two recognized educational tools, electronic learning modules (ELMs) and standardized patients (SPs), to create a novel virtual training strategy. Typically, SP skills sessions occur in person and effectiveness of SP encounters in a virtual care context has not been evaluated. Moreover, it is uncertain whether SPs are necessary for creation of psychological fidelity or improvement of transfer of communication skills. Thus, we aim to explore the relative impact of each component of a virtual communication curriculum. In this study, we will explore the feasibility of a randomized controlled trial comparing different training experiences.
Methods:
ELMs will be developed to teach communication skills for difficult conversations in oncology care. A framework for patient-centered communication and specific communication strategies will be introduced. Scenarios will be developed for virtual SP encounters related to each ELM. Virtual SP encounters will occur through the Zoom platform and include feedback from a remote faculty observer.
A randomized feasibility trial will be conducted. Consenting medical and radiation oncology residents in participating training programs (McMaster, University of Ottawa, University of Toronto) will be randomly assigned to complete the ELMs and virtual SP encounters (experimental arm) vs the ELMs alone (control arm). Video recorded simulated patient encounters will be conducted before and after the curricular activities. Recordings will be scored by trained assessors with multiple rating scales to evaluate communication skills of the learner. Standardized patients will also rate quality of physician communication with a patient-directed rating scale. This design will allow testing of our innovative educational interventions and exploration of the likelihood of success of a future RCT which will evaluate the impact of different training experiences. Outcome measures will include feasibility metrics such as recruitment, randomization, representativeness, adherence to intervention, and completeness of data collection. We will determine variance in scores on multiple rating scales within this study population to inform sample size of a future RCT. In addition, surveys completed pre- and post-intervention will assess change in self-efficacy rating and satisfaction with the learning experience.
Analysis:
The proposed sample size is 40 (20 per arm). This is based on achieving a 95% confidence interval (CI) of 60 to 85% around an estimated recruitment proportion of 75%. The primary outcome will be whether feasibility metrics meet criteria for success. Descriptive statistics with corresponding 95% CIs will summarize recruitment, adherence to study procedures, satisfaction and self-efficacy rating. For assessment of video recorded virtual simulated patient encounters, correlations between scores from different rating scales will be performed using Pearson's coefficient. Inter-rater reliability for rating scales will be done using Cohen's Kappa.
Conclusions:
If criteria for success are met among feasibility outcomes, a national RCT will follow to evaluate impact of virtual SPs added to the ELM curriculum. These novel educational resources simulate virtual care, a new paradigm that will likely persist beyond the pandemic. This is a scalable intervention which may standardize and strengthen communication training among oncology residency programs across Canada.
- Conditions
- Oncology
- Being tested
- RESTORE, Medical Interaction and Coaching
- Keywords
- Communication, Serious Illness, Education, Palliative Care
- Medical subject headings
- Neoplasms, Communication
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RESTOREOther
Virtual educational curriculum organized into the following modules:
Module Specific Communication Strategies
- Introduction
- Preparing for and introducing a conversation [Consider personal bias /Building rapport /Ask permission]
- Assessing understanding [Avoid correcting /Open ended questions]
- Giving information [Give a warning shot /Using silence /Wish/worry/wonder]
- Explore goals [Reflective listening /Naming, validating emotion
- Summarizing and recommending a plan [Values-based recommendation /Aligning with goals /REMAP (Reframe, Expect emotion, Map goals, Align, Propose plan)]
Medical Interaction and CoachingBehavioural
Skills sessions with standardized patients (SPs) along with coaching feedback.
| Study group | Role | What they receive |
|---|---|---|
| ELMs and virtual SP encounters | Experimental | A virtual communication curriculum featuring electronic learning modules (ELMs) and skills sessions with standardized patients (SPs) along with coaching feedback. Receives: Other: RESTORE; Behavioral: Medical Interaction and Coaching |
| ELMs alone | Active comparator | A virtual communication curriculum featuring electronic learning modules (ELMs) only. Receives: Other: RESTORE |
What is being measured
The primary outcome is the main question the study is designed to answer.
COM-ON (Communication in Oncology) Checklist
Validated rating scale assessing general and specific communication skills in oncology. Items are rated on a five-point Likert scale ranging from 0 = ''Skill not demonstrated at all'' to 5 = ''Skill fully demonstrated'', with higher scores denoting higher quality communication.
Measured: 3 months
QQPPI (Questionnaire on the Quality of Physician-Patient Interaction)
Validated patient-facing rating scale of for quality of physician communication. Items are rated on a five-point Likert scale ranging from 1 = ''I do not agree'' to 5 = ''I fully agree'', with higher scores denoting higher quality communication.
Measured: 3 months
Assessment rubric for 'entrustable professional activities' (EPAs)
Medical interaction analysis rating scale as defined by the Royal College of Physicians and Surgeons of Canada. Items are rated on a five-point Likert scale ranging from 1 = ''I do not agree'' to 5 = ''I fully agree'', with higher scores denoting higher quality communication.
Measured: 3 months
Global rating scale
Overall rating scale of quality of physician communication. Items are rated on a five-point Likert scale ranging from 1 = ''I do not agree'' to 5 = ''I fully agree'', with higher scores denoting higher quality communication.
Measured: 3 months
Secondary outcomes (2)
End-of-Life Professional Caregiver Survey (EPCS)
Validated instrument assessing educational needs relating to palliative care for interprofessional members of the healthcare team. Items are rated on a five-point Likert scale ranging from 1 (lowest level of skill) to 5 (greatest level of skill), with higher scores denoting a higher level of skill.
Measured: 3 months
RESTORED Questionnaire
Participant satisfaction with training intervention. Items are rated on a five-point Likert scale ranging from 1 = ''I do not agree'' to 5 = ''I fully agree'', with higher scores denoting higher satisfaction.
Measured: Immediately after the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2023
- Study start1 Mar 2023
- Primary completion30 Aug 2024
- Study completion30 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OncologyStudies of the same condition, open and under way.
- More trials run by McMaster UniversityThe 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- Parallel Assignment
- Masking
- None (open label)
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- McMaster University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Oren Levine, MD, Principal investigator, McMaster University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05810987
- Sponsor's protocol ID
- 14948
- Acronym
- RESTORED
- Status last verified
- Jan 2025
- First submitted
- 28 Feb 2023
- Last updated
- 15 Jan 2025
- 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 15 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Remote Education Strategies Training Oncology Residents for End-of-Life Discussions (The RESTORED Study)
- ClinicalTrials.gov ID
- NCT05810987
- Acronym / sponsor ID
- RESTORED / 14948
- Conditions
- Oncology
- Keywords
- Communication, Serious Illness, Education, Palliative Care
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- McMaster UniversityUniversity, hospital or other
- Study start
- 1 Mar 2023 (actual)
- Primary completion
- 30 Aug 2024 (actual)
- Study completion
- 30 Aug 2024 (actual)
- First posted
- 13 Apr 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.
Difficult conversations are common in oncology practice and patient-centered communication is essential to care for individuals with cancer. Within oncology training programs, communication training is mostly unstructured observation and feedback in the clinic and many learners receive inadequate training. Currently, educational resources are limited, and residents have indicated a desire for more education on end-of-life communication skills. A formal communication curriculum could fill a gap and help to standardize teaching and evaluation.
The overall goal of this study is to establish an effective communication skills curriculum for oncology residents that can be delivered remotely and that addresses difficult conversations with cancer patients. Through this preliminary study, we will explore the feasibility of a randomized controlled trial comparing different training experiences to understand how best to help oncology residents develop strong end-of-life communication skills.
Detailed description
Background:
Patient-centered communication is essential to care for individuals with cancer. High quality communication benefits patients, families, and clinicians. Proficiency in a variety of communication tasks is now a requirement within competency-based medical education (CBME) in Canada. Within oncology training programs, communication training is mostly unstructured observation and feedback in the clinic and many learners receive inadequate training. A formal communication curriculum could fill a gap and help to standardize teaching and evaluation, but current resources are limited.
Virtual care has been quickly adopted within oncology practice in the context of the COVID19 pandemic. This limits opportunities for direct observation of learners making assessment of communication skills more difficult. How best to teach communication skills in the context of virtual care is unclear. To mitigate current challenges, we will adapt two recognized educational tools, electronic learning modules (ELMs) and standardized patients (SPs), to create a novel virtual training strategy. Typically, SP skills sessions occur in person and effectiveness of SP encounters in a virtual care context has not been evaluated. Moreover, it is uncertain whether SPs are necessary for creation of psychological fidelity or improvement of transfer of communication skills. Thus, we aim to explore the relative impact of each component of a virtual communication curriculum. In this study, we will explore the feasibility of a randomized controlled trial comparing different training experiences.
Methods:
ELMs will be developed to teach communication skills for difficult conversations in oncology care. A framework for patient-centered communication and specific communication strategies will be introduced. Scenarios will be developed for virtual SP encounters related to each ELM. Virtual SP encounters will occur through the Zoom platform and include feedback from a remote faculty observer.
A randomized feasibility trial will be conducted. Consenting medical and radiation oncology residents in participating training programs (McMaster, University of Ottawa, University of Toronto) will be randomly assigned to complete the ELMs and virtual SP encounters (experimental arm) vs the ELMs alone (control arm). Video recorded simulated patient encounters will be conducted before and after the curricular activities. Recordings will be scored by trained assessors with multiple rating scales to evaluate communication skills of the learner. Standardized patients will also rate quality of physician communication with a patient-directed rating scale. This design will allow testing of our innovative educational interventions and exploration of the likelihood of success of a future RCT which will evaluate the impact of different training experiences. Outcome measures will include feasibility metrics such as recruitment, randomization, representativeness, adherence to intervention, and completeness of data collection. We will determine variance in scores on multiple rating scales within this study population to inform sample size of a future RCT. In addition, surveys completed pre- and post-intervention will assess change in self-efficacy rating and satisfaction with the learning experience.
Analysis:
The proposed sample size is 40 (20 per arm). This is based on achieving a 95% confidence interval (CI) of 60 to 85% around an estimated recruitment proportion of 75%. The primary outcome will be whether feasibility metrics meet criteria for success. Descriptive statistics with corresponding 95% CIs will summarize recruitment, adherence to study procedures, satisfaction and self-efficacy rating. For assessment of video recorded virtual simulated patient encounters, correlations between scores from different rating scales will be performed using Pearson's coefficient. Inter-rater reliability for rating scales will be done using Cohen's Kappa.
Conclusions:
If criteria for success are met among feasibility outcomes, a national RCT will follow to evaluate impact of virtual SPs added to the ELM curriculum. These novel educational resources simulate virtual care, a new paradigm that will likely persist beyond the pandemic. This is a scalable intervention which may standardize and strengthen communication training among oncology residency programs across Canada.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Parallel Assignment
| Arm | Type | Receives |
|---|---|---|
| ELMs and virtual SP encounters | Experimental | Other: RESTORE, Behavioral: Medical Interaction and CoachingA virtual communication curriculum featuring electronic learning modules (ELMs) and skills sessions with standardized patients (SPs) along with coaching feedback. |
| ELMs alone | Active comparator | Other: RESTOREA virtual communication curriculum featuring electronic learning modules (ELMs) only. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Medical and radiation oncology residents and fellows at McMaster University, and medical oncology residents at the Universities of Ottawa and Toronto.
- Enrollment in a participating training program, ability to participate in study-related activities in English, access to internet and a video-enabled computer (either personal or institutional) to support study-related activities
Key exclusion criteria (1 listed)
- Not enrolled in a participating training program
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 |
|---|---|---|
| RESTOREVirtual educational curriculum organized into the following modules: Module Specific Communication Strategies 1. Introduction 2. Preparing for and introducing a conversation [Consider personal bias /Building rapport /Ask permission] 3. Assessing understanding [Avoid correcting /Open ended questions] 4. Giving information [Give a warning shot /Using silence /Wish/worry/wonder] 5. Explore goals [Reflective listening /Naming, validating emotion 6. Summarizing and recommending a plan [Values-based recommendation /Aligning with goals /REMAP (Reframe, Expect emotion, Map goals, Align, Propose plan)] | Other | ELMs alone, ELMs and virtual SP encounters |
| Medical Interaction and CoachingSkills sessions with standardized patients (SPs) along with coaching feedback. | Behavioural | ELMs and virtual SP encounters |
Primary outcome
COM-ON (Communication in Oncology) Checklist
Time frame: 3 months
Validated rating scale assessing general and specific communication skills in oncology. Items are rated on a five-point Likert scale ranging from 0 = ''Skill not demonstrated at all'' to 5 = ''Skill fully demonstrated'', with higher scores denoting higher quality communication.
QQPPI (Questionnaire on the Quality of Physician-Patient Interaction)
Time frame: 3 months
Validated patient-facing rating scale of for quality of physician communication. Items are rated on a five-point Likert scale ranging from 1 = ''I do not agree'' to 5 = ''I fully agree'', with higher scores denoting higher quality communication.
Assessment rubric for 'entrustable professional activities' (EPAs)
Time frame: 3 months
Medical interaction analysis rating scale as defined by the Royal College of Physicians and Surgeons of Canada. Items are rated on a five-point Likert scale ranging from 1 = ''I do not agree'' to 5 = ''I fully agree'', with higher scores denoting higher quality communication.
Global rating scale
Time frame: 3 months
Overall rating scale of quality of physician communication. Items are rated on a five-point Likert scale ranging from 1 = ''I do not agree'' to 5 = ''I fully agree'', with higher scores denoting higher quality communication.
2 secondary outcomes
End-of-Life Professional Caregiver Survey (EPCS)
Time frame: 3 months
RESTORED Questionnaire
Time frame: Immediately after the intervention
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 15 Jan 2025.
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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.
Oren Levine, MD principal investigator
McMaster University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing RESTORE and Medical Interaction and Coaching in people with Oncology, run by McMaster University at 1 site in Canada.
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: finished, as of the sponsor's last update on 15 Jan 2025. 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 Canada. 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?
COM-ON (Communication in Oncology) Checklist (time frame: 3 months). The study lists 4 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 15 Jan 2025.