A Study Comparing Two Types of Supportive Interventions for Caregivers of Patients With Cancer
Running, not enrolling · Not applicable
Conditions studied: Cancer Patients, Family Caregivers
In brief
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).
Key facts
- Study ID
- NCT04802720
- Run by
- Memorial Sloan Kettering Cancer Center
- People needed
- 348
- Starts
- 2021-02-26
- Expected to finish
- 2027-01-08
- Last updated by the study team
- 2026-06-10
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- Caregivers:
- As per self-report, age 18 years or older.
- As per self-report, are a caregiver to an MSK or MGH patient with any site/stage of cancer who has received any type of treatment (e.g. curative, palliative) in the past 12 months.
- Experience distress as evidenced by a score of 4 or greater on the Distress Thermometer (DT) and answer "Yes" to at least one of the follow-up questions (i.e. reporting that their distress is related to their caregiving experience, or their distress started or is related to caregiving or has gotten worse since the patient was diagnosed or began treatment. (N/A for training case participants)
- English fluent: Self-report by subject identifying English as the preferred language for healthcare, and self-reported degree of fluency as speaking English "Very well."
- As per self-report, residing in New York or New Jersey (for MSK participants), or Massachusetts (for MGH participants), or have the ability to complete sessions while complying with current telehealth regulations.
- Patients:
- Age 18 years or older as per EMR.
- Patient of an eligible caregiver per self-report or the EMR.
- English speaking as per the EMR or self report by subject identifying English as the preferred language for healthcare, and self-reported degree of fluency as speaking English "Very well.".
You may not qualify if…
- Caregivers:
- As per self-report, presence of disorder that compromises comprehension of assessments or informed consent information (e.g., dementia).
- As per the judgement of the consenting professional, clinical, PI, and/or as per the medical record, severe psychopathology or cognitive impairment which is likely to interfere with the participation or completion of the protocol or their ability to provide meaningful information
- As per self-report, currently engaged in regular individual psychotherapeutic support (that the participant is unable or unwilling to put on hold for the course of treatment).
- As per self-report, a lifetime history of bipolar disorder, schizophrenia, or schizoaffective disorder.
- As per self-report, has medical condition or medication use known to confound measures of systemic inflammation (e.g., autoimmune disorder, inflammatory disease; uncontrolled thyroid disease; active infection; myocardial infarction or stroke in the last 6 months; Type I diabetes; acute hepatitis; recent vaccination for viral disease). (N/A for training case participants)
- As per self-report, is a regular smoker, defined as having more than 2 cigarettes per day on most days. (N/A for training case participants)
- As per self-report, providing care for a patient who has a caregiver is currently or formerly enrolled in this study ('formerly enrolled' is N/A for training case participants).
- As per self-report, currently enrolled in another study focused on supportive care for caregivers (MGH participants only).
- Patients:
- Presence of disorder that compromises comprehension of assessments or informed consent information (e.g., dementia) as per EMR or clinician judgment.
- As per the judgement of the consenting professional, clinical, PI, and/or as per the medical record, severe psychopathology or cognitive impairment which is likely to interfere with the participation or completion of the protocol or their ability to provide meaningful information
Where it is running
- 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
Full record on ClinicalTrials.gov
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