Expired Study
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Duarte, California 91010


Purpose:

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.


Study summary:

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.


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


NCT ID:

NCT02603367


Primary Contact:

Principal Investigator
Elaine Wittenberg, PhD
City of Hope Medical Center


Backup Contact:

N/A


Location Contact:

Duarte, California 91010
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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