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

Caregiver Clinical Trial

— COMFORT  

Official title:

The COMFORT Caregiver Intervention (CCI)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02603367
• Other study ID #: 15359
• Secondary ID: NCI-2015-0185815
• Status: Completed
• Phase: N/A
• First received: November 10, 2015
• Last updated: August 11, 2017
• Start date: November 24, 2015
• Est. completion date: August 10, 2017

Study information

• Verified date: August 2017
• Source: City of Hope Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: August 10, 2017
• Est. primary completion date: August 10, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Caregiver

Intervention

Other:
• Communication Intervention
Undergo communication coaching
• Educational Intervention
Receive COMFORT communication curriculum
• Psychosocial Support for Caregiver
Undergo communication coaching
• Questionnaire Administration
Complete questionnaires

Locations

Country	Name	City	State
United States	City of Hope Medical Center	Duarte	California

Sponsors (2)

Lead Sponsor	Collaborator
City of Hope Medical Center	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Attrition rate	An electronic recruitment database will be created to document accrual, attrition, and retention rates.	Up to 18 months
Primary	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.	Baseline to 1 month post-intervention
Primary	Recruitment rate	An electronic recruitment database will be created to document accrual, attrition, and retention rates.	Up to 18 months
Primary	Retention rate	An electronic recruitment database will be created to document accrual, attrition, and retention rates.	Up to 18 months
Primary	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.	Up to 18 months
Secondary	Change in caregiver communication confidence, measured using the Caregiver Communication Survey	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.	Baseline to 1 month post-intervention