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

NCT02166866 | Completed

• 1 other identifier: MC1295
• Study Type: observational
• Target: 26
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Cancer Care Recipient

Outcome Measures

Primary Outcomes (1)

• calculate the average number of caregivers participating in each offered web-based session

  6 months

Study Arms (1)

Experimental arm

Other: Quality of Life Questionairre and Education

Interventions

Quality of Life Questionairre and Education OTHER

Experimental arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

Related Publications (1)

• Lapid MI, Atherton PJ, Kung S, Clark MM, Sloan JA, Whitford KJ, Hubbard JM, Gentry MT, Miller JJ, Rummans TA. A feasibility study of virtual group therapy to improve quality of life of cancer caregivers. J Psychosoc Oncol. 2022;40(6):854-867. doi: 10.1080/07347332.2021.2000550. Epub 2021 Nov 29.

  PMID: 34842060 DERIVED

MeSH Terms

Interventions

Educational Status

Intervention Hierarchy (Ancestors)

Socioeconomic Factors; Population Characteristics

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 6, 2014
• First Posted: June 18, 2014
• Study Start: September 9, 2013
• Primary Completion: May 5, 2015
• Study Completion: June 27, 2018
• Last Updated: June 29, 2018

Record last verified: 2018-06

Locations

US (1)