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Clinical Trials/NCT02697357
NCT02697357
Completed
N/A

Emotion Regulation Therapy to Address Distress Among Caregivers

Memorial Sloan Kettering Cancer Center1 site in 1 country32 target enrollmentOctober 2015
ConditionsCare Givers

Overview

Phase
N/A
Intervention
Not specified
Conditions
Care Givers
Sponsor
Memorial Sloan Kettering Cancer Center
Enrollment
32
Locations
1
Primary Endpoint
number of patients completing at least 6 out of the 8-sessions
Status
Completed
Last Updated
5 years ago

Overview

Brief 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.

Registry
clinicaltrials.gov
Start Date
October 2015
End Date
July 9, 2020
Last Updated
5 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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.

Outcomes

Primary Outcomes

number of patients completing at least 6 out of the 8-sessions

Time Frame: 1 year

feedback from participants by qualitative research methods

Study Sites (1)

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