- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02427490
A Problem-Solving Intervention for Family Caregivers in Palliative Oncology
October 24, 2021 updated by: Karla Washington, University of Missouri-Columbia
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
83
Phase
- Not Applicable
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
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Missouri
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Columbia, Missouri, United States, 65212
- University of Missouri Ambulatory Palliative Care Clinic
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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
Description
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
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
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Unenhanced Monitoring
Family caregivers of cancer patients receiving outpatient palliative care will complete standardized questionnaires at the time of study enrollment and two, four, and eight weeks after study enrollment.
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Study participant completes standardized questionnaires upon study enrollment and at two, four, and eight weeks after study enrollment.
Other Names:
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Experimental: Problem-Solving Intervention
Family caregivers of cancer patients receiving outpatient palliative care will use videoconferencing tools to participate in three problem-solving sessions with a member of the research team.
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Study participant completes standardized questionnaires upon study enrollment and at two, four, and eight weeks after study enrollment.
Other Names:
The problem-solving approach that will be taught in the problem-solving intervention is based on the ADAPT model, which encourages participants to follow five steps when solving problems: focus on adopting a positive attitude to problem-solving, define the problem and set goals, generate a list of alternative solutions to the problem, predict consequences of the alternative solutions, and try implementing the most promising solution from among the list of alternatives.
The problem-solving intervention will be delivered by a trained interventionist in three structured sessions using videoconferencing tools.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in anxiety (as measured by the Generalized Anxiety Disorder Form - 7)
Time Frame: Upon study enrollment, two weeks, four weeks, eight weeks
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Family caregivers indicate the frequency with which they experience seven different symptoms of anxiety (7 items); higher scores reflect higher anxiety severity.
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Upon study enrollment, two weeks, four weeks, eight weeks
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in depression (as measured by the Patient Health Questionnaire - 9)
Time Frame: Upon study enrollment, two weeks, four weeks, eight weeks
|
Family caregivers indicate the frequency with which they experience nine different symptoms of depression (9 items); higher scores reflect higher depression severity.
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Upon study enrollment, two weeks, four weeks, eight weeks
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Change in problem-solving approach (as measured by the Problem-Solving Inventory)
Time Frame: Upon study enrollment, two weeks, four weeks, eight weeks
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Family caregivers indicate the extent to which different statements describing approaches to problem-solving apply to them (25 items).
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Upon study enrollment, two weeks, four weeks, eight weeks
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Change in quality of life (as measured by the Caregiver Quality of Life Index - Revised)
Time Frame: Upon study enrollment, two weeks, four weeks, eight weeks
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Family caregivers complete four items rating their physical, emotional, social, and financial quality of life on a scale of 0-10.
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Upon study enrollment, two weeks, four weeks, eight weeks
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in caregiving problems and intensity
Time Frame: Upon study enrollment, two weeks, four weeks, eight weeks
|
Family caregivers select three problems and rate their corresponding distress using a scale of 0-3 where 0 = problem is not at all distressful and 3 = problem is very distressful (3 items).
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Upon study enrollment, two weeks, four weeks, eight weeks
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Karla Washington, PhD, University of Missouri-Columbia
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Washington KT, Benson JJ, Chakurian DE, Popejoy LL, Demiris G, Rolbiecki AJ, Oliver DP. Comfort Needs of Cancer Family Caregivers in Outpatient Palliative Care. J Hosp Palliat Nurs. 2021 Jun 1;23(3):221-228. doi: 10.1097/NJH.0000000000000744.
- Washington KT, Craig KW, Parker Oliver D, Ruggeri JS, Brunk SR, Goldstein AK, Demiris G. Family caregivers' perspectives on communication with cancer care providers. J Psychosoc Oncol. 2019 Nov-Dec;37(6):777-790. doi: 10.1080/07347332.2019.1624674. Epub 2019 Jun 16.
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)
April 1, 2015
Primary Completion (Actual)
April 29, 2017
Study Completion (Actual)
May 24, 2017
Study Registration Dates
First Submitted
April 17, 2015
First Submitted That Met QC Criteria
April 27, 2015
First Posted (Estimate)
April 28, 2015
Study Record Updates
Last Update Posted (Actual)
October 26, 2021
Last Update Submitted That Met QC Criteria
October 24, 2021
Last Verified
October 1, 2021
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2002215
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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