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

City of Hope Medical Center50 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

SUPPORTIVE_CARE

Masking

NONE

Enrollment

Conditions

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Attrition rate

An electronic recruitment database will be created to document accrual, attrition, and retention rates.

Time frame: Up to 18 months

Change in caregiver psychological distress, measured using the Distress Thermometer

Data will be summarized using descriptive statistics, including means for normally distributed continuous data, medians for non-normally distributed continuous data or proportions for categorical data. The established instruments will be scored according to standard instructions, and appropriate descriptive statistics will be computed. Outcomes will be compared pre- and post-intervention without full effectiveness analysis, as this is a pilot study.

Time frame: Baseline to 1 month post-intervention

Recruitment rate

An electronic recruitment database will be created to document accrual, attrition, and retention rates.

Time frame: Up to 18 months

Retention rate

An electronic recruitment database will be created to document accrual, attrition, and retention rates.

Time frame: Up to 18 months

Themes derived from qualitative content analysis

Qualitative review of recruitment procedures and evaluation of research nurse feedback about intervention calls will be conducted. Content analysis will be conducted on the transcribed qualitative data. A qualitative summary of themes derived from study documents will be used. The intervention will be refined based on study results, and improvements made for it to be suited to a larger randomized, controlled trial.

Time frame: Up to 18 months

Secondary Outcomes

Change in caregiver communication confidence, measured using the Caregiver Communication Survey

Time frame: Baseline to 1 month post-intervention

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

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes