A Study Comparing Two Types of Supportive Interventions for Caregivers of Patients With Cancer (NCT04802720)
A Randomized Controlled Trial of Emotion Regulation Therapy for Cancer Caregivers: A Mechanism-Targeted Approach to Addressing Caregiver Distress
🩺 Plain-English Summary (8th-Grade Level)
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).
Who can join: Review the eligibility criteria below.
Location: University of California, Irvine (Data and Specimen Analysis Only) — Irvine, California
Age range: 18 Years
🧪 Interventions in This Study
- Cognitive Behavioral Therapy for Cancer Caregivers (CBT-C) (OTHER)
- Emotion Regulation Therapy for Cancer Caregivers (ERT-C) (OTHER)
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (5 Sites)
- University of California, Irvine (Data and Specimen Analysis Only) — Irvine, California
- Massachusetts General Hospital — Boston, Massachusetts
- Mount Sinai Hospital (Data Analysis Only) — New York, New York
- Columbia University (Data and Specimen Analysis Only) — New York, New York
- Memorial Sloan Kettering Cancer Center — New York, New York
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
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💡 How to Participate
- Check the checklist above to see if you may qualify.
- Review the official NIH record below to find the coordinating site.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.