Emotion Regulation Therapy to Address Distress Among Caregivers

NCT02697357 | Completed

• 1 other identifier: 15-219
• Study Type: observational
• Target: 32
• Locations: 1 country
• Sites: 1

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.

Conditions

Care Givers

Keywords

Emotion Regulation Therapy; Distress Among Caregivers; 15-219

Outcome Measures

Primary Outcomes (1)

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

  feedback from participants by qualitative research methods

  1 year

Study Arms (1)

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).

Behavioral: Psychosocial Instruments; Behavioral: Emotion Regulation Therapy for Cancer Caregivers (ERT-C)

Interventions

Psychosocial Instruments BEHAVIORAL

Caregivers

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

Caregivers

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Memorial Sloan Kettering Cancer Center: lead
• Hunter College of City University of New York: collaborator
• Weill Medical College of Cornell University: collaborator

Study Sites (1)

Memorial Sloan Kettering Cancer Center

New York, New York, 10065, United States

Location

Related Links

• Memorial Sloan Kettering Cancer Center

Biospecimen

Retention: SAMPLES WITHOUT DNA

optional blood sample and a saliva sample

Study Officials

• Allison Applebaum, PhD

  Memorial Sloan Kettering Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 24, 2016
• First Posted: March 3, 2016
• Study Start: October 1, 2015
• Primary Completion: July 9, 2020
• Study Completion: July 9, 2020
• Last Updated: July 13, 2020

Record last verified: 2020-07

Locations

US (1)