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Completed

NCT Number: NCT02697357

Emotion Regulation Therapy to Address Distress Among Caregivers

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.

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Key information

Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Memorial Sloan Kettering Cancer Center

New York, 10065, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Psychosocial Instruments

Behavioral

Emotion Regulation Therapy for Cancer Caregivers (ERT-C)

Behavioral

Primary outcomes

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

    Time frame: 1 year

    feedback from participants by qualitative research methods

Sponsors and collaborators

Lead sponsor

Memorial Sloan Kettering Cancer Center

Other

Collaborators

  • Hunter College of City University of New York
  • Weill Medical College of Cornell University

Registry information

Important dates

Study start
2015
Primary completion
2020
Study completion
2020
First posted
Mar 3, 2016
Registry last updated
Jul 13, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.