Emotion Regulation Therapy to Address Distress Among Caregivers

Study Overview
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Brief Summary
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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.

Official Title
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Emotion Regulation Therapy to Address Distress Among Caregivers

Conditions
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Care Givers

Intervention / Treatment
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* Behavioral: Psychosocial Instruments
* Behavioral: Emotion Regulation Therapy for Cancer Caregivers (ERT-C)


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Caregivers<br>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). | Behavioral: Psychosocial Instruments<br> <br> Behavioral: Emotion Regulation Therapy for Cancer Caregivers (ERT-C)<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| number of patients completing at least 6 out of the 8-sessions | feedback from participants by qualitative research methods | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Emotion Regulation Therapy, Distress Among Caregivers, 15-219