- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02697357
Emotion Regulation Therapy to Address Distress Among Caregivers
July 10, 2020 updated by: Memorial Sloan Kettering Cancer Center
The aim of this study is to adapt and pilot test a type of therapy called Emotion Regulation Therapy (ERT-C) for informal caregivers of patients with cancer.
Informal caregivers include partners, family members, children, parents, and friends providing informal care to a patient.
Providing care to someone with cancer can be difficult.
The purpose of this intervention is to improve coping and physical well-being among caregivers, which in turn will allow them to provide better care for their loved ones.
Investigators would also like to learn about biological factors like stress that may affect one's emotional and physical well-being.
This study will allow to better understand caregivers needs, and further develop a program to provide services to caregivers within MSKCC community and nationwide.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Actual)
32
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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New York
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New York, New York, United States, 10065
- Memorial Sloan Kettering Cancer Center
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Participants will be recruited from outpatient clinics in various departments at MSKCC, including the Department of Psychiatry & Behavioral Sciences, Social Work, Neurology, Integrative Medicine and Bone Marrow Transplant services.
Description
Inclusion Criteria:
- As per self-report, age 18 or over
- As per self-report, a current caregiver to a patient with any site or stage of cancer
- score of ≥ 4 on the Distress Thermometer (DT) and indication that this distress is related in some way to the caregiving role. Potential participants will be asked whether or not their distress is in any way related to their caregiving experience. Individuals who answer "no" will be asked whether or not their distress started or has gotten worse since the patient began treatment or was diagnosed.
- Either a score of ≥ 15 on the Brief Penn State Worry Questionnaire OR a score > 12 on the Brooding Subscale of the Rumination Response Scale
- In the judgment of the investigators and/or consenting professional, able to read and comprehend English
- In the judgment of the consenting professional cognitively able to provide informed consent
Exclusion Criteria:
- As per self-report, a lifetime history of bipolar disorder, schizophrenia, or schizoaffective disorder
- In the judgment of the consenting professional is unable to provide informed consent and complete study sessions and assessment.
- If participating in optional biospecimen collection;as per self-report, has medical conditions that affect the immune system and would confound immune evaluation (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)
- As per self-report, is a regular smoker (daily use)
- As per self-report, is a heavy drinker (regularly having more than 14 alcoholic beverages per week for men, 7 for women)
- As per self- report, engaging in night shift work
- As per self- report, currently engaged in ongoing psychotherapy.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Caregivers
This study is a pilot, single-arm intervention of Emotion Regulation Therapy for Cancer Caregivers (ERT-C).
We plan to recruit a pilot sample 32 consented (24 evaluable) caregivers of patients diagnosed with cancer and measure their distress, anxiety, and other psychological outcomes at baseline.
Caregivers will be consented into an 8-session ERT-C therapy (approximately 12 - 16 weeks).
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
number of patients completing at least 6 out of the 8-sessions
Time Frame: 1 year
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feedback from participants by qualitative research methods
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1 year
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
October 1, 2015
Primary Completion (Actual)
July 9, 2020
Study Completion (Actual)
July 9, 2020
Study Registration Dates
First Submitted
February 24, 2016
First Submitted That Met QC Criteria
February 26, 2016
First Posted (Estimate)
March 3, 2016
Study Record Updates
Last Update Posted (Actual)
July 13, 2020
Last Update Submitted That Met QC Criteria
July 10, 2020
Last Verified
July 1, 2020
More Information
Terms related to this study
Other Study ID Numbers
- 15-219
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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