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| Name | Class |
|---|---|
| University of Aarhus | OTHER |
| Columbia University | OTHER |
| University of California | OTHER |
| University of Michigan |
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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).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ERT-C: Emotion Regulation Therapy for Cancer Caregivers | Experimental | Emotion 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. |
|
| CBT-C: Cognitive Behavioral Therapy for Cancer Caregivers | Experimental | Cognitive 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. |
|
| Training case group | Experimental | Will be assigned to receive ERT-C only and will not complete questionnaires. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cognitive Behavioral Therapy for Cancer Caregivers (CBT-C) | Other | The sessions are outlined as follow:
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | up to 6 months |
| 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 | up to 6 months |
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Inclusion Criteria:
Caregivers:
Patients:
Exclusion Criteria:
Caregivers:
Patients:
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| Name | Affiliation | Role |
|---|---|---|
| Rebecca Saracino, PhD | Memorial Sloan Kettering Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California, Irvine (Data and Specimen Analysis Only) | Irvine | California | 92697 | United States | ||
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| Label | URL |
|---|---|
| Memorial Sloan Kettering Cancer Center | View source |
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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.
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| ID | Title | Description |
|---|---|---|
| FG000 | ERT-C: Emotion Regulation Therapy for Cancer Caregivers | Emotion 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. Emotion Regulation Therapy for Cancer Caregivers (ERT-C): The sessions are outlined as follow:
|
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Sep 23, 2024 |
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| OTHER |
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.
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| Emotion Regulation Therapy for Cancer Caregivers (ERT-C) | Other | The sessions are outlined as follow:
|
|
| Massachusetts General Hospital |
| Boston |
| Massachusetts |
| 02114 |
| United States |
| Mount Sinai Hospital (Data Analysis Only) | New York | New York | 10029 | United States |
| Columbia University (Data and Specimen Analysis Only) | New York | New York | 10032 | United States |
| Memorial Sloan Kettering Cancer Center | New York | New York | 10065 | United States |
| FG001 | CBT-C: Cognitive Behavioral Therapy for Cancer Caregivers | Cognitive 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. Cognitive Behavioral Therapy for Cancer Caregivers (CBT-C): The sessions are outlined as follow:
|
| FG002 | Training Case Group | Will be assigned to receive ERT-C only and will not complete questionnaires. Emotion Regulation Therapy for Cancer Caregivers (ERT-C): The sessions are outlined as follow:
|
| FG003 | Patient Group | Patient participants will complete baseline assessments and at 3-months following caregiver completion of ERT-C or CBT-C |
| COMPLETED |
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| NOT COMPLETED |
|
|
No participants accrued to the Training case group
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| ID | Title | Description |
|---|---|---|
| BG000 | ERT-C: Emotion Regulation Therapy for Cancer Caregivers | Emotion 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. Emotion Regulation Therapy for Cancer Caregivers (ERT-C): The sessions are outlined as follow:
|
| BG001 | CBT-C: Cognitive Behavioral Therapy for Cancer Caregivers | Cognitive 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. Cognitive Behavioral Therapy for Cancer Caregivers (CBT-C): The sessions are outlined as follow:
|
| BG002 | Training Case Group | Will be assigned to receive ERT-C only and will not complete questionnaires. Emotion Regulation Therapy for Cancer Caregivers (ERT-C): The sessions are outlined as follow:
|
| BG003 | Patient Group | Patient participants will complete baseline assessments and at 3-months following caregiver completion of ERT-C or CBT-C |
| BG004 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Full Range | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Region of Enrollment | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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 | no participants accrued to Training case group. Patient group not assessed at 6 months | Posted | Mean | Standard Error | score on a scale | up to 6 months |
|
|
| ||||||||||||||||||||||||||||||||||
| Primary | 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 | no participants accrued to Training case group. Patient group not assessed at 6 months | Posted | Mean | Standard Error | score on a scale | up to 6 months |
|
Up to 6 months
No participants accrued to Training case group
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | ERT-C: Emotion Regulation Therapy for Cancer Caregivers | Emotion 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. Emotion Regulation Therapy for Cancer Caregivers (ERT-C): The sessions are outlined as follow:
| 0 | 124 | 0 | 124 | 0 | 124 |
| EG001 | CBT-C: Cognitive Behavioral Therapy for Cancer Caregivers | Cognitive 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. Cognitive Behavioral Therapy for Cancer Caregivers (CBT-C): The sessions are outlined as follow:
| 0 | 120 | 0 | 120 | 0 | 120 |
| EG002 | Training Case Group | Will be assigned to receive ERT-C only and will not complete questionnaires. Emotion Regulation Therapy for Cancer Caregivers (ERT-C): The sessions are outlined as follow:
| 0 | 0 | 0 | 0 | 0 | 0 |
| EG003 | Patient Group | Patient participants will complete baseline assessments and at 3-months following caregiver completion of ERT-C or CBT-C | 13 | 95 | 0 | 95 | 0 | 95 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Rebecca Saracino PhD | Memorial Sloan Kettering Cancer Center | 646-888-0263 | jamesr@mskcc.org |
| Feb 16, 2026 |
| Prot_SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Sep 23, 2024 | Apr 14, 2025 | ICF_000.pdf |
| ID | Term |
|---|---|
| D015928 | Cognitive Behavioral Therapy |
| ID | Term |
|---|---|
| D001521 | Behavior Therapy |
| D011613 | Psychotherapy |
| D004191 | Behavioral Disciplines and Activities |
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| Male |
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| Not Hispanic or Latino |
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| Unknown or Not Reported |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
|
| Unknown or Not Reported |
|
Cognitive 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. Cognitive Behavioral Therapy for Cancer Caregivers (CBT-C): The sessions are outlined as follow:
|
| OG002 | Training Case Group | Will be assigned to receive ERT-C only and will not complete questionnaires. Emotion Regulation Therapy for Cancer Caregivers (ERT-C): The sessions are outlined as follow:
|
| OG003 | Patient Group | Patient participants will complete baseline assessments and at 3-months following caregiver completion of ERT-C or CBT-C |
|
|