COMFORT Caregiver Intervention in Improving Communication and Reducing Distress in Caregivers of Patients With Lung Cancer

NCT ID: NCT02603367

Last Updated: 2017-08-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-11-24
• Study Completion Date: 2017-08-10

Brief Summary

This pilot clinical trial studies the COMFORT (C-Communication, O-Orientation and opportunity, M-Mindful presence, F-Family, O-Openings, R-Relating, and T-Team) caregiver intervention in improving communication and reducing distress in caregivers of patients with lung cancer. Caregivers of patients with cancer may experience stress and anxiety due to difficulty communicating with family, friends, and healthcare providers, or feeling unable to communicate openly. A communication intervention that improves the caregiver's ability to communicate with patients and healthcare providers may help reduce caregivers' psychological distress and improve the health outcomes of patients.

Detailed Description

PRIMARY OBJECTIVES:

I. To assess the feasibility of the COMFORT Caregiver Intervention (CCI) for family caregivers.

II. To explore common family caregiver communication concerns in oncology and their impact.

III. Estimate the effects of the CCI on family caregivers' psychological distress (primary outcome) and caregiver confidence with communication (secondary outcome).

OUTLINE:

Participants receive the printed communication tool "A Communication Guide for Caregivers," a guide developed from the COMFORT communication curriculum, a national training program for palliative care communication. After a 1 week period to review the material, participants undergo communication coaching with a research nurse by phone over approximately 1 hour.

After completion of the study, caregivers are followed up at 1 month to complete questionnaires and rate their satisfaction with the intervention.

Conditions

Caregiver

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Supportive care (COMFORT communication intervention)

Participants receive the printed communication tool "A Communication Guide for Caregivers," a guide developed from the COMFORT communication curriculum, a national training program for palliative care communication. After a 1 week period to review the material, participants undergo communication coaching with a research nurse by phone over approximately 1 hour.

Group Type: EXPERIMENTAL

Communication Intervention

Intervention Type: OTHER

Undergo communication coaching

Educational Intervention

Intervention Type: OTHER

Receive COMFORT communication curriculum

Psychosocial Support for Caregiver

Intervention Type: OTHER

Undergo communication coaching

Questionnaire Administration

Intervention Type: OTHER

Complete questionnaires

Interventions

Communication Intervention

Undergo communication coaching

Intervention Type: OTHER

Educational Intervention

Receive COMFORT communication curriculum

Intervention Type: OTHER

Psychosocial Support for Caregiver

Undergo communication coaching

Intervention Type: OTHER

Questionnaire Administration

Complete questionnaires

Intervention Type: OTHER

Other Intervention Names

Education for Intervention; Intervention, Educational

Eligibility Criteria

Inclusion Criteria

• Family caregivers will need to be the primary family caregiver as identified by the lung cancer patient (ten caregivers from each of the following cancer care continuum points will be recruited)
• English-speaking
• Cancer care continuum points are defined as follows:

• Diagnosis: A lung cancer patient who has received diagnosis within the last 45 days but has not yet started treatment
• Treatment: A lung cancer patients who has started initial treatment (chemotherapy, radiation, surgery) for diagnosis within the last 30 days, is actively receiving treatment, and has a prognosis of more than one year
• Survivorship: A lung cancer patient who has completed treatment and who is clinically disease free at the time of caregiver enrollment to study
• End of Life: A lung cancer patient who is estimated to have 6 months or less to live
• All subjects must have the ability to understand and the willingness to participate in the informed consent process

Exclusion Criteria

• Research participants who do not speak or read English
• Subjects, who in the opinion of the investigator, may not be able to comply with the safety monitoring requirements of the study

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

City of Hope Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Elaine Wittenberg, PhD

Role: PRINCIPAL_INVESTIGATOR

City of Hope Medical Center

Locations

City of Hope Medical Center

Duarte, California, United States

Countries

United States

Other Identifiers

NCI-2015-01858

Identifier Type: REGISTRY

Identifier Source: secondary_id

15359

Identifier Type: OTHER

Identifier Source: secondary_id

15359

Identifier Type: -

Identifier Source: org_study_id