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Clinical Trials/NCT02427490
NCT02427490
Completed
Not Applicable

A Problem-Solving Intervention for Family Caregivers in Palliative Oncology

University of Missouri-Columbia1 site in 1 country83 target enrollmentApril 2015

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Palliative Care
Sponsor
University of Missouri-Columbia
Enrollment
83
Locations
1
Primary Endpoint
Change in anxiety (as measured by the Generalized Anxiety Disorder Form - 7)
Status
Completed
Last Updated
4 years ago

Overview

Brief Summary

In congruence with the National Cancer Institute's commitment to supporting families of individuals with cancer across the full disease trajectory, the investigators seek to examine the feasibility of a technologically-mediated problem-solving intervention designed to improve the quality of life and decrease the psychological distress of family caregivers of cancer patients receiving outpatient palliative care. Investigators involved in this mixed methods pilot study will collect and analyze both quantitative and qualitative data, which will subsequently inform a large-scale randomized clinical trial of the problem-solving intervention.

Detailed Description

Palliative oncology providers are ideally situated to improve the cancer journey for the millions of family members and friends who are vital to the care of seriously ill patients. In recent decades, the primary setting for cancer care has shifted from the hospital inpatient unit to the outpatient clinic, leaving family caregivers responsible for providing the majority of patient care in the home, often with little support or preparation. The numerous stressors associated with family caregiving often give rise to caregiver anxiety, depression, fatigue, neglect of self-care and, for particularly strained caregivers, psychological symptoms that mirror those experienced by trauma survivors. In congruence with the National Cancer Institute's commitment to supporting families of individuals with cancer across the full disease trajectory, the investigators seek to examine the feasibility of a technologically-mediated problem-solving intervention designed to improve the quality of life and decrease the psychological distress of family caregivers of cancer patients receiving outpatient palliative care. Specifically, the investigators aim to 1) examine the feasibility of the intervention relative to recruitment, randomization, retention, and fidelity to core intervention components; 2) investigate the impact of the intervention on family caregiver anxiety, depression, and quality of life; and 3) explore the benefits and challenges associated with the intervention from the perspective of participants. To accomplish these aims, investigators will recruit and randomly assign 82 family caregivers of cancer patients receiving outpatient palliative care into two groups (usual care and intervention) and collect quantitative and qualitative data, which will be analyzed to inform a future large-scale randomized clinical trial of the problem-solving intervention.

Registry
clinicaltrials.gov
Start Date
April 2015
End Date
May 24, 2017
Last Updated
4 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Karla Washington

Principal Investigator

University of Missouri-Columbia

Eligibility Criteria

Inclusion Criteria

  • 18 years of age or older,
  • access to an Internet-connected device that will support videoconferencing software

Exclusion Criteria

  • Younger than 18 years of age,
  • lack of access to an Internet-connected device that will support videoconferencing software

Outcomes

Primary Outcomes

Change in anxiety (as measured by the Generalized Anxiety Disorder Form - 7)

Time Frame: Upon study enrollment, two weeks, four weeks, eight weeks

Family caregivers indicate the frequency with which they experience seven different symptoms of anxiety (7 items); higher scores reflect higher anxiety severity.

Secondary Outcomes

  • Change in quality of life (as measured by the Caregiver Quality of Life Index - Revised)(Upon study enrollment, two weeks, four weeks, eight weeks)
  • Change in depression (as measured by the Patient Health Questionnaire - 9)(Upon study enrollment, two weeks, four weeks, eight weeks)
  • Change in problem-solving approach (as measured by the Problem-Solving Inventory)(Upon study enrollment, two weeks, four weeks, eight weeks)

Study Sites (1)

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