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Communication Training for Caregivers In Advanced Care Planning

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04171895
Recruitment Status : Recruiting
First Posted : November 21, 2019
Last Update Posted : April 15, 2022
Sponsor:
Information provided by (Responsible Party):
Memorial Sloan Kettering Cancer Center

Brief 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.

Condition or disease Intervention/treatment
Primary Malignant Brain Tumors Advanced Care Planning Other: Questionnaires Other: Communication training Part 1 (no longer recruiting) Other: Enhanced usual care Other: Communication training Part II

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Study Type : Observational
Estimated Enrollment : 45 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Communication Training for Caregivers to Promote Advanced Care Planning
Actual Study Start Date : November 19, 2019
Estimated Primary Completion Date : October 2023
Estimated Study Completion Date : November 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Caregivers

Group/Cohort Intervention/treatment
Enhanced Usual Care (EUC) Other: Questionnaires
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.

Other: Enhanced usual care
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 Other: Questionnaires
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.

Other: 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 Part II
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.




Primary Outcome Measures :
  1. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Sampling Method:   Non-Probability Sample
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.
Criteria

Inclusion Criteria:

Part !:

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

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

Exclusion Criteria:

  • None

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04171895


Contacts
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Contact: Allison Applebaum, PhD 646-888-0034 applebaa@mskcc.org
Contact: William Breitbart, MD 646-888-0020

Locations
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United States, New York
Memorial Sloan Kettering Cancer Center Recruiting
New York, New York, United States, 10065
Contact: Allison Applebaum, PhD    646-888-0034      
Sponsors and Collaborators
Memorial Sloan Kettering Cancer Center
Investigators
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Principal Investigator: Allison Applebaum, PhD Memorial Sloan Kettering Cancer Center
Additional Information:
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Responsible Party: Memorial Sloan Kettering Cancer Center
ClinicalTrials.gov Identifier: NCT04171895    
Other Study ID Numbers: 19-398
First Posted: November 21, 2019    Key Record Dates
Last Update Posted: April 15, 2022
Last Verified: April 2022

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Memorial Sloan Kettering Cancer Center:
Communication training
19-398
Additional relevant MeSH terms:
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Brain Neoplasms
Central Nervous System Neoplasms
Nervous System Neoplasms
Neoplasms by Site
Neoplasms
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases