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Trial record 17 of 33 for:    "Oncology, Medical"

A Problem-Solving Intervention for Family Caregivers in Palliative Oncology

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ClinicalTrials.gov Identifier: NCT02427490
Recruitment Status : Completed
First Posted : April 28, 2015
Last Update Posted : July 26, 2017
Sponsor:
Information provided by (Responsible Party):
Karla Washington, University of Missouri-Columbia

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.

Condition or disease Intervention/treatment Phase
Palliative Care Caregivers Medical Oncology Behavioral: Problem-Solving Intervention Other: Unenhanced Monitoring Not Applicable

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  (Clinical Trial)
Actual Enrollment : 83 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: A Problem-Solving Intervention for Family Caregivers in Palliative Oncology
Actual Study Start Date : April 2015
Actual Primary Completion Date : April 29, 2017
Actual Study Completion Date : May 24, 2017

Resource links provided by the National Library of Medicine


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.
Other: Unenhanced Monitoring
Study participant completes standardized questionnaires upon study enrollment and at two, four, and eight weeks after study enrollment.
Other Name: Unenhanced Monitoring of Behavioral Health Outcomes

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.
Behavioral: Problem-Solving Intervention
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 Name: Problem-Solving Intervention for Family Caregivers

Other: Unenhanced Monitoring
Study participant completes standardized questionnaires upon study enrollment and at two, four, and eight weeks after study enrollment.
Other Name: Unenhanced Monitoring of Behavioral Health Outcomes




Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. 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.

  2. Change in problem-solving approach (as measured by the Problem-Solving Inventory) [ Time Frame: Upon study enrollment, two weeks, four weeks, eight weeks ]
    Family caregivers indicate the extent to which different statements describing approaches to problem-solving apply to them (25 items).

  3. 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 ]
    Family caregivers complete four items rating their physical, emotional, social, and financial quality of life on a scale of 0-10.


Other Outcome Measures:
  1. 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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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02427490


Locations
United States, Missouri
University of Missouri Ambulatory Palliative Care Clinic
Columbia, Missouri, United States, 65212
Sponsors and Collaborators
University of Missouri-Columbia
Investigators
Principal Investigator: Karla Washington, PhD University of Missouri-Columbia

Responsible Party: Karla Washington, Principal Investigator, University of Missouri-Columbia
ClinicalTrials.gov Identifier: NCT02427490     History of Changes
Other Study ID Numbers: 2002215
First Posted: April 28, 2015    Key Record Dates
Last Update Posted: July 26, 2017
Last Verified: July 2017

Keywords provided by Karla Washington, University of Missouri-Columbia:
Palliative Care
Caregivers
Medical Oncology

Additional relevant MeSH terms:
Neoplasms