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Completed

NCT Number: NCT02427490

A Problem-Solving Intervention for Family Caregivers in Palliative Oncology

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.

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Key information

Conditions

Palliative Care Caregivers Medical Oncology

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Missouri Ambulatory Palliative Care Clinic

Columbia, Missouri, 65212, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Other names: Problem-Solving Intervention for Family Caregivers

Unenhanced Monitoring

Other

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

Other names: Unenhanced Monitoring of Behavioral Health Outcomes

Primary outcomes

  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 outcomes

  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 outcomes

  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).

Sponsors and collaborators

Lead sponsor

University of Missouri-Columbia

Other

Registry information

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Apr 28, 2015
Registry last updated
Oct 26, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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