Ignite Creation Date:
2024-05-06 @ 3:56 PM
Last Modification Date:
2025-12-16 @ 9:14 PM
Study NCT ID:
NCT04802720
Status:
None
Last Update Posted:
2025-07-28 00:00:00
First Post:
2021-03-01 00:00:00
Brief Title:
A Study Comparing Two Types of Supportive Interventions for Caregivers of Patients With Cancer
Sponsor:
Memorial Sloan Kettering Cancer Center
Organization:
Memorial Sloan Kettering Cancer Center
Study Overview
Official Title:
A Randomized Controlled Trial of Emotion Regulation Therapy for Cancer Caregivers: A Mechanism-Targeted Approach to Addressing Caregiver Distress
Status:
None
Status Verified Date:
2025-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
CBT-C and ERT-C are each 8-session, individual, caregivers-directed interventions delivered by a trained study therapist listed on the face page and facilitated by a manualized workbook with between-session practice exercises. To accommodate caregivers and reduce compliance issues with attendance of sessions, the 8 sessions are to be completed within 8 to 16 weeks from initiation of the first session. Each session is 60 minutes in length and will be audio and video recorded for MSK participants; sessions will only be audio recorded for MGH participants. Specific modules and intervention components are described below. To accommodate as many caregivers as possible and in response to the restrictions placed on caregivers currently in the context of the COVID-19 pandemic, sessions will be offered via telepsychiatry (using WebEx , Zoom, Teams).
Training case participants will be identified and consented onto the study for training purposes only. Participants who are consented as training cases will not be randomized and will not complete any assessments. Data collected on training cases will be used for training and supervision purposes on this study only. These records will not be shown outside of the study supervisors, therapist in training, and staff.
Training case participants will be identified and consented onto the study for training purposes only. Participants who are consented as training cases will not be randomized and will not complete any assessments. Data collected on training cases will be used for training and supervision purposes on this study only. These records will not be shown outside of the study supervisors, therapist in training, and staff.
Detailed Description:
CBT-C and ERT-C are each 8-session individual caregivers-directed interventions delivered by a trained study therapist listed on the face page and facilitated by a manualized workbook with between-session practice exercises To accommodate caregivers and reduce compliance issues with attendance of sessions the 8 sessions are to be completed within 8 to 16 weeks from initiation of the first session Each session is 60 minutes in length and will be audio and video recorded for MSK participants sessions will only be audio recorded for MGH participants Specific modules and intervention components are described below To accommodate as many caregivers as possible and in response to the restrictions placed on caregivers currently in the context of the COVID-19 pandemic sessions will be offered via telepsychiatry using WebEx Zoom Teams
Training case participants will be identified and consented onto the study for training purposes only Participants who are consented as training cases will not be randomized and will not complete any assessments Data collected on training cases will be used for training and supervision purposes on this study only These records will not be shown outside of the study supervisors therapist in training and staff
Training case participants will be identified and consented onto the study for training purposes only Participants who are consented as training cases will not be randomized and will not complete any assessments Data collected on training cases will be used for training and supervision purposes on this study only These records will not be shown outside of the study supervisors therapist in training and staff
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None