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Cancer PatientsNCT04802720

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

A study testing Cognitive Behavioral Therapy for Cancer Caregivers (CBT-C) and Emotion Regulation Therapy for Cancer Caregivers (ERT-C) in people with Cancer Patients and Family Caregivers, run by Memorial Sloan Kettering Cancer Center at 5 sites in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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). Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Cancer Patients, Family Caregivers
What is being tested?
Cognitive Behavioral Therapy for Cancer Caregivers (CBT-C) and Emotion Regulation Therapy for Cancer Caregivers (ERT-C)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
348 participants
Where
5 sitesUnited States
Study dates
26 Feb 2021to 8 Jan 2027
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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.
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  • 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.".

Who cannot join

  • 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)
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  • 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

Trial locations and contacts

5 sites in 1 country.

5 sites in 1 country

United States5 sites

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114

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

    Irvine, California, 92697

  • Mount Sinai Hospital (Data Analysis Only)

    New York, New York, 10029

  • Columbia University (Data and Specimen Analysis Only)

    New York, New York, 10032

  • Memorial Sloan Kettering Cancer Center

    New York, New York, 10065

Other trials in United States

About this study

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

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).

Read the 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.

Being tested
Cognitive Behavioral Therapy for Cancer Caregivers (CBT-C), Emotion Regulation Therapy for Cancer Caregivers (ERT-C)
Keywords
Emotion Regulation Therapy, Addressing Caregiver Distress, Supportive Interventions, 20-407, Training participants

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Cognitive Behavioral Therapy for Cancer Caregivers (CBT-C)Other

    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).

  • Emotion Regulation Therapy for Cancer Caregivers (ERT-C)Other

    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).
Study groups in NCT04802720
Study groupRoleWhat they receive
ERT-C: Emotion Regulation Therapy for Cancer CaregiversExperimentalEmotion Regulation Therapy for Cancer Caregivers (ERT-C) is an 8-session intervention that builds upon the foundations of CBT-C and addresses earlier motivational processing components of the caregivers context while targeting earlier and later components of internal distress and resultant maladaptive behavioral coping.
Receives: Other: Emotion Regulation Therapy for Cancer Caregivers (ERT-C)
CBT-C: Cognitive Behavioral Therapy for Cancer CaregiversExperimentalCognitive Behavioral Therapy (CBT-C) is an evidence-based psychotherapeutic approach that is grounded in the cognitive model that purports that a person's emotional, behavioral, and physiological reactions to a situation is based on their appraisal of that situation. The focus of therapy is on changing cognitions and beliefs about a situation and altering automatic behavioral responses evoked by that perception. CBT-C aims to improve emotion regulation by challenging and changing unhelpful cognitions and behaviors and improving personal coping strategies.
Receives: Other: Cognitive Behavioral Therapy for Cancer Caregivers (CBT-C)
Training case groupExperimentalWill be assigned to receive ERT-C only and will not complete questionnaires.
Receives: Other: Emotion Regulation Therapy for Cancer Caregivers (ERT-C)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Changes in Anxiety Symptoms

    as assessed via the HADS Developed by Zigmond and Snaith in 1983, the HADS produces two scales, one for anxiety (HADS-A) and one for depression (HADS-D), differentiating the two states. Items of the overall severity of anxiety and depression are rated on a five-point (0-4) severity scales (ranging from 0 = no not at all, to 4 = yes definitely), for a total score ranging from 0-21 for each subscale. A higher score indicates higher distress

    Measured: up to 6 months

  2. Changes in Depressive Symptoms

    as assessed via the HADS Developed by Zigmond and Snaith in 1983, the HADS produces two scales, one for anxiety (HADS-A) and one for depression (HADS-D), differentiating the two states. Items of the overall severity of anxiety and depression are rated on a five-point (0-4) severity scales (ranging from 0 = no not at all, to 4 = yes definitely), for a total score ranging from 0-21 for each subscale. A higher score indicates higher distress

    Measured: up to 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Mar 2021
  2. Study start26 Feb 2021
  3. Primary completion24 Feb 2025
  4. Study completion8 Jan 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Model description
This study will utilize a randomized, controlled, repeated measures design to investigate the efficacy of Emotion Regulation Therapy for Cancer Caregivers (ERT-C) vs. Cognitive Behavioral Therapy for Cancer Caregivers.
Masking
None (open label)
Enrolment
348 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04802720
Sponsor's protocol ID
20-407
Status last verified
May 2026
First submitted
1 Mar 2021
Last updated
10 Jun 2026
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.

Publications

  • Applebaum AJ, Jacobs JM, Fresco DM, Hoyt MA, Schofield E, Loschiavo MJ, O'Toole MS, Dunderdale LE, Mennin DS. Randomized controlled trial of emotion regulation therapy versus cognitive behavioral therapy to address distress in cancer caregivers. Ann Behav Med. 2026 Jan 7;60(1):kaag021. doi: 10.1093/abm/kaag021.

    PubMed 42847373

Questions about this trial

What is this clinical trial studying?

A study testing Cognitive Behavioral Therapy for Cancer Caregivers (CBT-C) and Emotion Regulation Therapy for Cancer Caregivers (ERT-C) in people with Cancer Patients and Family Caregivers, run by Memorial Sloan Kettering Cancer Center at 5 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 10 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 10 Jun 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Changes in Anxiety Symptoms (time frame: up to 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04802720, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jun 2026.

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