New therapy aims to ease the heavy burden on cancer caregivers
NCT ID NCT04802720
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests a new type of talk therapy (Emotion Regulation Therapy) against standard cognitive behavioral therapy for people caring for a loved one with cancer. About 348 caregivers will participate to see which approach better reduces anxiety, depression, and stress. The study also looks at how the caregiver's therapy affects the cancer patient's well-being.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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348 people
The number who actually took part.
- Started
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Feb 2021
- Expected to finish
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Jan 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 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.". Exclusion Criteria: 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
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Genom att skicka in godkänner du våra Användarvillkor
Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Columbia University (Data and Specimen Analysis Only)
New York, New York, 10032, United States
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Massachusetts General Hospital
Boston, Massachusetts, 02114, United States
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Memorial Sloan Kettering Cancer Center
New York, New York, 10065, United States
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Mount Sinai Hospital (Data Analysis Only)
New York, New York, 10029, United States
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University of California, Irvine (Data and Specimen Analysis Only)
Irvine, California, 92697, United States
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Other studies related to the condition(s) this trial covers.
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