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A Problem-Solving Intervention for Family Caregivers in Palliative Oncology

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date  ICMJE April 17, 2015
First Posted Date  ICMJE April 28, 2015
Last Update Posted Date July 26, 2017
Actual Study Start Date  ICMJE April 2015
Actual Primary Completion Date April 29, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 27, 2015)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 27, 2015)
  • 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.
  • 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).
  • 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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: April 27, 2015)
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).
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE A Problem-Solving Intervention for Family Caregivers in Palliative Oncology
Official Title  ICMJE A Problem-Solving Intervention for Family Caregivers in Palliative Oncology
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Condition  ICMJE
  • Palliative Care
  • Caregivers
  • Medical Oncology
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • 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.
    Intervention: Other: Unenhanced Monitoring
  • 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.
    Interventions:
    • Behavioral: Problem-Solving Intervention
    • Other: Unenhanced Monitoring
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 24, 2017)
83
Original Estimated Enrollment  ICMJE
 (submitted: April 27, 2015)
82
Actual Study Completion Date  ICMJE May 24, 2017
Actual Primary Completion Date April 29, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02427490
Other Study ID Numbers  ICMJE 2002215
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Karla Washington, University of Missouri-Columbia
Study Sponsor  ICMJE University of Missouri-Columbia
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Karla Washington, PhD University of Missouri-Columbia
PRS Account University of Missouri-Columbia
Verification Date July 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP