Caregiver Burden Within the Ambulatory Extended Recovery (AXR) Patient Population

August 13, 2018 updated by: Memorial Sloan Kettering Cancer Center
The purpose of this study is to understand the level of caregiver burden related to caring for a patient who goes home within the first 24 hours following surgery. As the caregiver they are providing care to a family member, friend, or neighbor. Even when not formally trained, the care they provide is important to the patient's recovery. Providing care in this manner can be stressful. This study will help us understand what aspects of the patient's recovery are most difficult for the caregiver.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

47

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
    • New York
      • New York, New York, United States, 10065
        • Memorial Sloan Kettering Cancer Center

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients and caregivers will be recruited prior to the patient's scheduled surgery during a clinic visit within the four target services. (Breast, Gynecology, Head and Neck, and Urology

Description

Inclusion Criteria:

  • Caregiver/patient pairs undergoing surgery for an indication tracked within the Breast, Gynecology, Head and Neck, and Urology AXR program
  • English speaking
  • Patients willing to provide demographic, surgical, and outcome information
  • Caregivers willing to provide demographic, socioeconomic, and caregiver experience information
  • Caregivers willing to complete the caregiver burden measurement scales

Exclusion Criteria:

  • Patients undergoing surgery within the AXR pathway that do not have a caregiver
  • Non-English speaking patients or caregivers
  • Patients unwilling to provide demographic and surgical information
  • Caregivers unwilling to provide demographic, socioeconomic, or caregiver experience information or unwilling to complete the caregiver burden measurement scales

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

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
patient and caregivers
This is a prospective cohort study. Four questionnaires will be used to collect data from caregivers: demographic and socioeconomic data will be collected from the caregiver before the patient's surgery, and caregiver burden information will be collected 15 (+/- 3) days after surgery.
Behavioral: Caregiver Reaction Assessment (CRA)
Behavioral: The Caregiver Quality of Life - Cancer (CQOLC)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Caregiver Reaction Assessment (CRA) score
Time Frame: 1 year
in the AXR patient population. Burden will be defined as both a total CRA score and sub scores and will be summarized using descriptive statistics. CRA total score of 72 and subscale scores of 3 or greater will be used to indicate high levels of caregiver
1 year

Collaborators and Investigators

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

Sponsor

Memorial Sloan Kettering Cancer Center

Investigators

  • Principal Investigator: Mindy Sovel, MPH, Memorial Sloan Kettering Cancer Center

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.

Helpful Links

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)

June 1, 2015

Primary Completion (Actual)

August 1, 2018

Study Completion (Actual)

August 1, 2018

Study Registration Dates

First Submitted

July 9, 2015

First Submitted That Met QC Criteria

July 15, 2015

First Posted (Estimate)

July 17, 2015

Study Record Updates

Last Update Posted (Actual)

August 14, 2018

Last Update Submitted That Met QC Criteria

August 13, 2018

Last Verified

August 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 15-145

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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