Primary Malignant Brain TumorsNCT04171895
Communication Training for Caregivers In Advanced Care Planning
An observational study of Primary Malignant Brain Tumors and Advanced Care Planning, run by Memorial Sloan Kettering Cancer Center at 1 site in United States.
Trial summary
The purpose of this research study is to develop and test a new communication training to help caregivers communicate more effectively with their loved ones and healthcare professionals about advanced care planning. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Primary Malignant Brain Tumors, Advanced Care Planning
- What is being tested?
- Questionnaires, Communication training Part 1 (no longer recruiting) and Communication training Part II
- How many people
- 49 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Nov 2019to 22 Aug 2024
- Phase
- Observational
- 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
- Adult, Older adult
Study population: For Part 1 and 2 participants will be recruited from the MSK Brain Tumor Center (BTC), a multidisciplinary center comprised of faculty from Neurology, Neurosurgery, Radiation Oncology, Radiology and Psychiatry. The study team may also conduct approaches and recruitment over the phone, in situations where clinic recruitment may not be possible. After screening medical records for eligibility, study staff will email the treating clinician for approach approval, and will only proceed to reach out over phone if the clinician provides explicit permission.
Who may be able to join
- Part 1:
- Informal caregivers:
- Current self-reported informal cancer caregivers (IC) to a patient with a primary malignant brain tumor as per clinician judgment or as per EMR
- English fluency: Self-report by participant identifying English as the preferred language for healthcare, and self-reported degree of fluency as speaking English "Very well."
- age ≥ 18
- has access to a computer or smartphone with a webcam and internet connection
Show all 15Show fewer
- Patients:
- English-speaking as per EMR
- Able to provide informed consent, a determination that will be made in assistance with the patient's medical team.
- Part II:
- Informal caregivers:
- Current self-reported IC to an MSK patient with a (1) primary malignant brain tumor or (2) leptomeningeal metastasis of a solid tumor, as per clinician judgment or as per EMR.
- English fluency: Self-report by identifying English as the preferred language for healthcare, and self-reported degree of fluency as speaking English "Very well."
- Age >18 as per self report
- Access to a computer or smartphone with a webcam and internet connection as per self report
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
United States1 site
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
About this study
Official title: Communication Training for Caregivers to Promote Advanced Care Planning
The purpose of this research study is to develop and test a new communication training to help caregivers communicate more effectively with their loved ones and healthcare professionals about advanced care planning.
- Being tested
- Questionnaires, Communication training Part 1 (no longer recruiting), Enhanced usual care, Communication training Part II
- Keywords
- Communication training, 19-398
- Medical subject headings
- Brain Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QuestionnairesOther
Will be filled out before and after the training so investigators can evaluate the skills learned and how they can be used them in advanced care planning. Questionnaires will be available in both paper form and electronic via REDCap.
Communication training Part 1 (no longer recruiting)Other
1.5 hour Communication Training will be delivered through videoconferencing using the WebEx or Zoom platforms. The Training consists of a 30-minute lecture watched independently, and two modules (ACP Discussions with your Loved One and ACP Discussions with the Medical Team) completed as part of a virtual meeting. The lecture will be pre-recorded by Drs. Applebaum and Parker and will be sent via REDCap to ICs prior to the training to watch idependently. REDCap will log when ICs watch the lecture so that study staff know the participant has completed this aspect of the training. For the second part of the training ICs will participate in a virtual meeting for approximately 90 minutes of experiential role-play exercises where ICs will practice skills in simulated encounters with actors trained to play patients and HCPs.
Enhanced usual careOther
Participant will complete a survey on distress and receive feedback about distress and given a resource packet with support information and targeted referrals based on needs. The participant will also receive a physical or electronic copy of a book entitled "Cancer Caregiving A to Z" published by the American Cancer Society. At the conclusion of their participation in the study, EUC participants will be given access to the pre-training video and Advanced Care Planning forms sent to Communication Training participants.
Communication training Part IIOther
Part II The communication training developed in Part 1 will have two modules (ACP Discussions with your Loved One and ACP Discussions with the Medical Team) and consist of a 20-30 minute lecture and 90 minutes of experiential role-play exercises where ICs will practice skills in simulated encounters with actors trained to play patients and HCPs. Realistic scenarios were created and tailored according to ICs' reported concerns. After training, ICs will be coached through setting a SMART goal related to conducting ACP conversations, which emphasize Specific, Measurable, Attainable, Relevant and Time-bound steps that motivate and direct behavior change. Two weeks post training, a booster phone call will be made to ICs to check progress toward their SMART goal, address barriers with problem-solving and review skills as indicated.
| Study group | Role | What they receive |
|---|---|---|
| Enhanced Usual Care (EUC) | Not described Receives: Other: Questionnaires; Other: Enhanced usual care | |
| Communication Training | Not described Receives: Other: Questionnaires; Other: Communication training Part 1 (no longer recruiting); Other: Communication training Part II |
What is being measured
The primary outcome is the main question the study is designed to answer.
preliminary efficacy
Feasibility criteria will be met if the target number of participants (n=10) complete a training session within the planned timeframe.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2019
- Study start19 Nov 2019
- Primary completion22 Aug 2024
- Study completion22 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Primary Malignant Brain TumorsStudies of the same condition, open and under way.
- More trials run by Memorial Sloan Kettering 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 49 participants (actual)
Sponsor and investigators
- Lead sponsor
- Memorial Sloan Kettering Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Allison Applebaum, PhD, Principal investigator, Memorial Sloan Kettering Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04171895
- Sponsor's protocol ID
- 19-398
- Status last verified
- Aug 2024
- First submitted
- 19 Nov 2019
- Last updated
- 26 Aug 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 26 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Communication Training for Caregivers to Promote Advanced Care Planning
- ClinicalTrials.gov ID
- NCT04171895
- Acronym / sponsor ID
- 19-398
- Keywords
- Communication training, 19-398
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 49 participants (actual)
- Lead sponsor
- Memorial Sloan Kettering Cancer CenterUniversity, hospital or other
- Study start
- 19 Nov 2019 (actual)
- Primary completion
- 22 Aug 2024 (actual)
- Study completion
- 22 Aug 2024 (actual)
- First posted
- 21 Nov 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.
The purpose of this research study is to develop and test a new communication training to help caregivers communicate more effectively with their loved ones and healthcare professionals about advanced care planning.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Enhanced Usual Care (EUC) | – | Other: Questionnaires, Other: Enhanced usual care |
| Communication Training | – | Other: Questionnaires, Other: Communication training Part 1 (no longer recruiting), Other: Communication training Part II |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- For Part 1 and 2 participants will be recruited from the MSK Brain Tumor Center (BTC), a multidisciplinary center comprised of faculty from Neurology, Neurosurgery, Radiation Oncology, Radiology and Psychiatry. The study team may also conduct approaches and recruitment over the phone, in situations where clinic recruitment may not be possible. After screening medical records for eligibility, study staff will email the treating clinician for approach approval, and will only proceed to reach out over phone if the clinician provides explicit permission.
Key inclusion criteria (15 listed)
- Current self-reported informal cancer caregivers (IC) to a patient with a primary malignant brain tumor as per clinician judgment or as per EMR
- English fluency: Self-report by participant identifying English as the preferred language for healthcare, and self-reported degree of fluency as speaking English "Very well."
- age ≥ 18
- has access to a computer or smartphone with a webcam and internet connection
- English-speaking as per EMR
Key exclusion criteria (1 listed)
- None
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 |
|---|---|---|
| QuestionnairesWill be filled out before and after the training so investigators can evaluate the skills learned and how they can be used them in advanced care planning. Questionnaires will be available in both paper form and electronic via REDCap. | Other | Communication Training, Enhanced Usual Care (EUC) |
| Communication training Part 1 (no longer recruiting)1.5 hour Communication Training will be delivered through videoconferencing using the WebEx or Zoom platforms. The Training consists of a 30-minute lecture watched independently, and two modules (ACP Discussions with your Loved One and ACP Discussions with the Medical Team) completed as part of a virtual meeting. The lecture will be pre-recorded by Drs. Applebaum and Parker and will be sent via REDCap to ICs prior to the training to watch idependently. REDCap will log when ICs watch the lecture so that study staff know the participant has completed this aspect of the training. For the second part of the training ICs will participate in a virtual meeting for approximately 90 minutes of experiential role-play exercises where ICs will practice skills in simulated encounters with actors trained to play patients and HCPs. | Other | Communication Training |
| Enhanced usual careParticipant will complete a survey on distress and receive feedback about distress and given a resource packet with support information and targeted referrals based on needs. The participant will also receive a physical or electronic copy of a book entitled "Cancer Caregiving A to Z" published by the American Cancer Society. At the conclusion of their participation in the study, EUC participants will be given access to the pre-training video and Advanced Care Planning forms sent to Communication Training participants. | Other | Enhanced Usual Care (EUC) |
| Communication training Part IIPart II The communication training developed in Part 1 will have two modules (ACP Discussions with your Loved One and ACP Discussions with the Medical Team) and consist of a 20-30 minute lecture and 90 minutes of experiential role-play exercises where ICs will practice skills in simulated encounters with actors trained to play patients and HCPs. Realistic scenarios were created and tailored according to ICs' reported concerns. After training, ICs will be coached through setting a SMART goal related to conducting ACP conversations, which emphasize Specific, Measurable, Attainable, Relevant and Time-bound steps that motivate and direct behavior change. Two weeks post training, a booster phone call will be made to ICs to check progress toward their SMART goal, address barriers with problem-solving and review skills as indicated. | Other | Communication Training |
Primary outcome
preliminary efficacy
Time frame: 1 year
Feasibility criteria will be met if the target number of participants (n=10) complete a training session within the planned timeframe.
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 26 Aug 2024.
- Memorial Sloan Kettering 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.
Allison Applebaum, PhD principal investigator
Memorial Sloan Kettering Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Primary Malignant Brain Tumors and Advanced Care Planning, run by Memorial Sloan Kettering 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 15 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 26 Aug 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 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?
preliminary efficacy (time frame: 1 year). 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 26 Aug 2024.