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

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: Cancer Care Recipient
• Intervention / Treatment: Other: Quality of Life Questionairre and Education

• Study Type: Observational
• Enrollment (Actual): 26

Contacts and Locations

Study Locations

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

Participation Criteria

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

How is the study designed?

Number of groups / cohorts

1

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	6 months

Collaborators and Investigators

• Sponsor: Mayo Clinic

Study record dates

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