Emotion Regulation Therapy to Address Distress Among Care... | NCT02697357

Studies
Emotion Regulation Therapy to Address Distress Among Caregivers

NCT02697357

Sponsor

Memorial Sloan Kettering Cancer Center

Status

Completed

Last Update Posted

Jul 13, 2020Actual

Enrollment

32Actual

Phase

Not provided

Conditions

Care Givers

Interventions

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

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2020

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 2015Actual

Primary Completion Date

Jul 9, 2020Actual

Completion Date

Jul 9, 2020Actual

First Submitted Date

Feb 24, 2016

First Submission Date that Met QC Criteria

Feb 26, 2016

First Posted Date

Mar 3, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 10, 2020

Last Update Posted Date

Jul 13, 2020Actual

Name	Class
Hunter College of City University of New York	OTHER
Weill Medical College of Cornell University	OTHER

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

32Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Psychosocial Instruments	Behavioral		Caregivers
Emotion Regulation Therapy for Cancer Caregivers (ERT-C)

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

Eligibility Module

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.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

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.

Sampling Method

Non-Probability Sample