Phase I/II Cancer Caregiver Interventions to Improve Quality of Life and Prevent Burnout

June 28, 2018 updated by: Mayo Clinic
This study defines cancer caregivers as unpaid individuals who provide physical, practical, and/or emotional care and support to the cancer patient in the home setting. They may participate in this study if care recipients and the caregiver are both adults (18 years or older), with the patient having been diagnosed with cancer.The 8 intervention sessions will target the five domains of Quality Of Life (emotional, physical, social, cognitive, and spiritual well-being), be provided in group settings, and be delivered in two 45-minute sessions each week over a 4-week period.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

26

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
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Mayo Clinic

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

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Caregivers will be recruited through the Mayo Clinic inpatient and outpatient services, including but not limited to referrals from staff of the Divisions of Medical Oncology, Hematology, and Radiation Oncology and other clinics in the outpatient setting, and Divisions of HospitalMedicine, Hospice and Palliative Medicine, and other inpatient services in the hospital setting. This population was chosen as they are likely to experience caregiver-related distress for which the intervention will be beneficial.

Description

Inclusion Criteria:

  • Ability to provide written informed consent.
  • Ability to speak, read, write and understand English language
  • Has cancer caregiver status defined as an unpaid individual who provides physical, practical, and/or emotional care and support to a cancer care recipient in the home or other healthcare setting.

  • Has a care recipient:

    • ≥ 18 years of age who
    • has a malignancy (either solid tumor or hematologic) diagnosis.
    • who has signed a research authorization form
    • who is undergoing or in the last 6 months has undergone cancer treatment
  • Ability to use and access to a computer, tablet or other device with internet access and video capabilities

Exclusion Criteria:

  • Diagnosis within the past 12 months of active substance abuse (alcohol or drugs)
  • Diagnosis within the past 12 months of active mental health condition that has required psychiatric hospitalization
  • Diagnosis within the past 12 months of suicidal thoughts or attempt
  • Care recipient is currently participating in another psychosocial clinical trial

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
Experimental arm
Other: Quality of Life Questionairre and Education

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
calculate the average number of caregivers participating in each offered web-based session
Time Frame: 6 months
6 months

Collaborators and Investigators

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

Sponsor

Mayo Clinic

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)

September 9, 2013

Primary Completion (Actual)

May 5, 2015

Study Completion (Actual)

June 27, 2018

Study Registration Dates

First Submitted

June 6, 2014

First Submitted That Met QC Criteria

June 16, 2014

First Posted (Estimate)

June 18, 2014

Study Record Updates

Last Update Posted (Actual)

June 29, 2018

Last Update Submitted That Met QC Criteria

June 28, 2018

Last Verified

June 1, 2018

More Information

Terms related to this study

Other Study ID Numbers

  • MC1295

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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