Emotion Regulation Therapy to Address Distress Among Caregivers

Care Givers Clinical Trial

Official title:

Emotion Regulation Therapy to Address Distress Among Caregivers

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02697357
• Other study ID #: 15-219
• Status: Completed
• Start date: October 2015
• Est. completion date: July 9, 2020

Study information

• Verified date: July 2020
• Source: Memorial Sloan Kettering Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: July 9, 2020
• Est. primary completion date: July 9, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Care Givers

Intervention

Behavioral:
• Psychosocial Instruments

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

Locations

Country	Name	City	State
United States	Memorial Sloan Kettering Cancer Center	New York	New York

Sponsors (3)

Lead Sponsor	Collaborator
Memorial Sloan Kettering Cancer Center	Hunter College of City University of New York, Weill Medical College of Cornell University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	number of patients completing at least 6 out of the 8-sessions	feedback from participants by qualitative research methods	1 year

External Links

•   Memorial Sloan Kettering Cancer Center