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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02501785
Recruitment Status : Completed
First Posted : July 17, 2015
Last Update Posted : August 14, 2018
Sponsor:
Information provided by (Responsible Party):
Memorial Sloan Kettering Cancer Center

Brief 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.

Condition or disease Intervention/treatment
Caregiver Burden Behavioral: Caregiver Reaction Assessment (CRA) Behavioral: The Caregiver Quality of Life - Cancer (CQOLC)

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Study Type : Observational
Actual Enrollment : 47 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Caregiver Burden Within the Ambulatory Extended Recovery (AXR) Patient Population
Actual Study Start Date : June 2015
Actual Primary Completion Date : August 2018
Actual Study Completion Date : August 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Caregivers

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)



Primary Outcome Measures :
  1. 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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02501785


Locations
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United States, New York
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10065
Sponsors and Collaborators
Memorial Sloan Kettering Cancer Center
Investigators
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Principal Investigator: Mindy Sovel, MPH Memorial Sloan Kettering Cancer Center
Additional Information:
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Responsible Party: Memorial Sloan Kettering Cancer Center
ClinicalTrials.gov Identifier: NCT02501785    
Other Study ID Numbers: 15-145
First Posted: July 17, 2015    Key Record Dates
Last Update Posted: August 14, 2018
Last Verified: August 2018
Keywords provided by Memorial Sloan Kettering Cancer Center:
Quality of Life
Patient care givers
15-145
Ambulatory Extended Recovery