NCT04802720

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

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

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 348 (actual)
• Sponsor: Memorial Sloan Kettering Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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).

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.

Conditions

• Cancer Patients
• Family Caregivers

Interventions

Type	Name	Description
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).

Timeline

• Start date: 2021-02-26
• Primary completion: 2025-02-14
• Completion: 2026-01-08
• First posted: 2021-03-17
• Last updated: 2025-07-28

Locations

5 sites across 1 country: United States