MedDataX Logo

A Problem-Solving Intervention for Family Caregivers in Palliative Oncology

NCT ID: NCT02427490

Last Updated: 2021-10-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

83 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-04-30

Study Completion Date

2017-05-24

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Palliative Care Caregivers Medical Oncology

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Group Type ACTIVE_COMPARATOR

Unenhanced Monitoring

Intervention Type OTHER

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

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.

Group Type EXPERIMENTAL

Problem-Solving Intervention

Intervention Type 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.

Unenhanced Monitoring

Intervention Type OTHER

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type BEHAVIORAL

Unenhanced Monitoring

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

Intervention Type OTHER

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Problem-Solving Intervention for Family Caregivers Unenhanced Monitoring of Behavioral Health Outcomes

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

University of Missouri-Columbia

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Karla Washington

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Karla Washington, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Missouri-Columbia

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

University of Missouri Ambulatory Palliative Care Clinic

Columbia, Missouri, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type DERIVED
PMID: 37190779 (View on PubMed)

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.

Reference Type DERIVED
PMID: 33605647 (View on PubMed)

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.

Reference Type DERIVED
PMID: 31204604 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2002215

Identifier Type: -

Identifier Source: org_study_id