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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT04171895
Other study ID # 19-398
Secondary ID
Status Active, not recruiting
Phase
First received
Last updated
Start date November 19, 2019
Est. completion date November 2024

Study information

Verified date May 2024
Source Memorial Sloan Kettering Cancer Center
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical 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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 49
Est. completion date November 2024
Est. primary completion date October 2024
Accepts healthy volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: 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 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

Study Design


Intervention

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.
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.
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 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.

Locations

Country Name City State
United States Memorial Sloan Kettering Cancer Center New York New York

Sponsors (1)

Lead Sponsor Collaborator
Memorial Sloan Kettering Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary preliminary efficacy Feasibility criteria will be met if the target number of participants (n=10) complete a training session within the planned timeframe. 1 year
See also
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