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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02501785
Other study ID # 15-145
Secondary ID
Status Completed
Phase
First received
Last updated
Start date June 2015
Est. completion date August 2018

Study information

Verified date August 2018
Source Memorial Sloan Kettering Cancer Center
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Completed
Enrollment 47
Est. completion date August 2018
Est. primary completion date August 2018
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Caregiver Reaction Assessment (CRA)

The Caregiver Quality of Life - Cancer (CQOLC)


Locations

Country Name City State
United States Memorial Sloan Kettering Cancer Center New York New York

Sponsors (1)

Lead Sponsor Collaborator
Memorial Sloan Kettering Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Caregiver Reaction Assessment (CRA) score 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
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