A Problem-Solving Intervention for Family Caregivers in Palliative Oncology

NCT02427490 | Completed

• 1 other identifier: 2002215
• Study Type: interventional
• Target: 83
• Locations: 1 country
• Sites: 1

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.

Conditions

Palliative Care; Caregivers; Medical Oncology

Keywords

Palliative Care; Caregivers; Medical Oncology

Outcome Measures

Primary Outcomes (1)

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

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

  Upon study enrollment, two weeks, four weeks, eight weeks

Secondary Outcomes (3)

• 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

• Change in quality of life (as measured by the Caregiver Quality of Life Index - Revised)

  Upon study enrollment, two weeks, four weeks, eight weeks

Other Outcomes (1)

• Change in caregiving problems and intensity

  Upon study enrollment, two weeks, four weeks, eight weeks

Study Arms (2)

Unenhanced Monitoring

ACTIVE COMPARATOR

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

Problem-Solving Intervention

EXPERIMENTAL

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; Other: Unenhanced Monitoring

Interventions

Problem-Solving Intervention BEHAVIORAL

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.

Also known as: Problem-Solving Intervention for Family Caregivers

Problem-Solving Intervention

Unenhanced Monitoring OTHER

Study participant completes standardized questionnaires upon study enrollment and at two, four, and eight weeks after study enrollment.

Also known as: Unenhanced Monitoring of Behavioral Health Outcomes

Problem-Solving Intervention; Unenhanced Monitoring

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University of Missouri-Columbia: lead

Study Sites (1)

University of Missouri Ambulatory Palliative Care Clinic

Columbia, Missouri, 65212, United States

Location

Related Publications (3)

• Benson JJ, Washington KT, Landon OJ, Chakurian DE, Demiris G, Parker Oliver D. When Family Life Contributes to Cancer Caregiver Burden in Palliative Care. J Fam Nurs. 2023 Aug;29(3):275-287. doi: 10.1177/10748407231167545. Epub 2023 May 16.

  PMID: 37190779 DERIVED

• 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.

  PMID: 33605647 DERIVED

• 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.

  PMID: 31204604 DERIVED

MeSH Terms

Interventions

Caregivers

Intervention Hierarchy (Ancestors)

Health Personnel; Health Care Facilities Workforce and Services

Study Officials

• Karla Washington, PhD

  University of Missouri-Columbia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 17, 2015
• First Posted: April 28, 2015
• Study Start: April 1, 2015
• Primary Completion: April 29, 2017
• Study Completion: May 24, 2017
• Last Updated: October 26, 2021

Record last verified: 2021-10

Locations

US (1)