Emotion Regulation and Cancer Caregiving

November 2, 2023 updated by: Stanford University
The purpose of the study is to determine how the behaviors of cancer caregivers can impact patients.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

968

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Stanford, California, United States, 94305
        • Stanford University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

N/A

Sampling Method

Non-Probability Sample

Study Population

Nonrecurrent breast cancer patients and their caregivers (unpaid person who is close to the patient and provides emotional, medical and/or financial support).

Description

Inclusion Criteria:

All participants must:

  • Be 21 years or older
  • Have access to a computer with internet access

Patients must:

  • Be women
  • Have a diagnosis of breast cancer (non-recurrent)

Caregivers must be:

-The patient's caregiver (providing support to the patient)

Exclusion Criteria:

Participants must not be:

-Younger than 21 years

Patients must not:

  • Be men
  • Have a diagnosis other than breast cancer (non-recurrent)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Control Caregivers
Control participants will write about their daily and future tasks three times.
Behavioral: Expressive Writing
Caregivers complete three 20-min writing sessions in which they write about an assigned topic - emotional or non-emotional.
Expressive Writing Caregivers
Experimental participants will write about their thoughts and feelings about an emotionally difficult event three times.
Behavioral: Expressive Writing
Caregivers complete three 20-min writing sessions in which they write about an assigned topic - emotional or non-emotional.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Emotion Regulation Questionnaire
Time Frame: Baseline through 3 months post-intervention
Emotion regulation refers to the ways people influence which emotions they have, and how they experience and express these emotions. Participants will rate their habitual pursuit of pro-hedonic, contra-hedonic, pro-social, and impression management goals using the ERGS. The items will be rated on the same 7-point scale (1 = never; 7 = always).
Baseline through 3 months post-intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Stanford University

Collaborators

U.S. National Science Foundation

Investigators

  • Principal Investigator: Lameese Eldesouky, PhD, Stanford University
  • Study Director: James Gross, PhD, Stanford University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 16, 2019

Primary Completion (Actual)

July 15, 2019

Study Completion (Actual)

July 15, 2019

Study Registration Dates

First Submitted

January 17, 2019

First Submitted That Met QC Criteria

November 2, 2023

First Posted (Actual)

November 8, 2023

Study Record Updates

Last Update Posted (Actual)

November 8, 2023

Last Update Submitted That Met QC Criteria

November 2, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

  • IRB-47800

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

If data is shared it will only be shared upon request and will be de-identified.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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