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ACTIVE NOT RECRUITING
NCT04802720
NA

A Study Comparing Two Types of Supportive Interventions for Caregivers of Patients With Cancer

Sponsor: Memorial Sloan Kettering Cancer Center

View on ClinicalTrials.gov

Summary

The purpose of this study is to compare two types of therapy for caregivers of cancer patients: Emotion Regulation Therapy for Cancer Caregivers (ERT-C) and Cognitive Behavioral Therapy (CBT-C). The researchers want to see if ERT-C is better than, the same as, or worse than traditional CBT-C at improving caregiver distress. The researchers will look at how the two types of therapy affect caregivers' anxiety, depression, and quality of life. The researchers will also see how ERT-C and CBT-C affect hormone and stress levels in caregivers' saliva samples. In addition, this trial will enroll cancer patients in this study to see how their caregivers' participation in ERT-C or CBT may affect the patients' quality of life, stress, and use of healthcare services. Participants who become bereaved while on study will be given the option to withdraw or remain on study. Assessments for bereaved caregivers will not include the Caregiver Quality of Life Index-Cancer (CQOLC) or the Caregiver Reaction Assessment (CRA).

Official title: A Randomized Controlled Trial of Emotion Regulation Therapy for Cancer Caregivers: A Mechanism-Targeted Approach to Addressing Caregiver Distress

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

348

Start Date

2021-02-26

Completion Date

2026-01-08

Last Updated

2025-07-28

Healthy Volunteers

Yes

Interventions

OTHER

Cognitive Behavioral Therapy for Cancer Caregivers (CBT-C)

The sessions are outlined as follow: 1. psychoeducation, goal-setting, and describing the rationale for CBT (Session 1); 2. coping effectiveness training (Session 2); 3. identifying unhelpful cognitions and dysfunctional beliefs (Session 3); 4. challenging and restructuring unhelpful cognitions (Session 4); 5. behavioral activation within the limitations of the caregiving context (Session 5); 6. problem-solving (Session 6); 7. communication strategies and assertiveness training (Session 7); 8. consolidating gains, maintenance, and relapse prevention (Session 8).

OTHER

Emotion Regulation Therapy for Cancer Caregivers (ERT-C)

The sessions are outlined as follow: 1. psychoeducation and motivation/dysregulation cue detection within caregiving contexts (Session 1); 2. attention regulation skills training (Sessions 1-2); 3. training in metacognitive skills (Sessions 3-4); 4. exposure to proactive living in the face of risk and loss while applying skills (Sessions 5-7); 5. consolidating gains, taking larger proactive steps, and relapse prevention (Session 8).

Locations (5)

University of California, Irvine (Data and Specimen Analysis Only)

Irvine, California, United States

Massachusetts General Hospital

Boston, Massachusetts, United States

Mount Sinai Hospital (Data Analysis Only)

New York, New York, United States

Columbia University (Data and Specimen Analysis Only)

New York, New York, United States

Memorial Sloan Kettering Cancer Center

New York, New York, United States