Emotion Regulation and Cancer Caregiving

Sponsor

Stanford University (Other)

Overall Status

Completed

CT.gov ID

NCT06123416

Collaborator

U.S. National Science Foundation (U.S. Fed)

Enrollment

Location

5.9

Actual Duration (Months)

5.1

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of the study is to determine how the behaviors of cancer caregivers can impact patients.

Condition or Disease	Intervention/Treatment	Phase
Breast Cancer Cancer Healthy Emotions	Behavioral: Expressive Writing

Study Design

Study Type:

Observational [Patient Registry]

Actual Enrollment :

30 participants

Observational Model:

Cohort

Time Perspective:

Cross-Sectional

Official Title:

Emotion Regulation and Cancer Caregiving

Actual Study Start Date :

Jan 16, 2019

Actual Primary Completion Date :

Jul 15, 2019

Actual Study Completion Date :

Jul 15, 2019

Arms and Interventions

Arm	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.

Arm

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.

Outcome Measures

Primary Outcome Measures

Emotion Regulation Questionnaire [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).

Eligibility Criteria

Criteria

Ages Eligible for Study:

21 Years and Older

Sexes Eligible for Study:

All

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)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Stanford University	Stanford	California	United States	94305

Sponsors and Collaborators

Stanford University
U.S. National Science Foundation

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:

Stanford University

ClinicalTrials.gov Identifier:

NCT06123416

Other Study ID Numbers:

IRB-47800

First Posted:

Nov 8, 2023

Last Update Posted:

Nov 13, 2023

Last Verified:

Nov 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Study Results

No Results Posted as of Nov 13, 2023