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

The COMFORT Caregiver Intervention (CCI)

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 Overview

• Status: Completed
• Conditions: Caregiver
• Intervention / Treatment: Other: Questionnaire Administration; Other: Communication Intervention; Other: Educational Intervention; Other: Psychosocial Support for Caregiver

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.

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Duarte, California, United States, 91010
      • City of Hope Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: 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.

Other: Questionnaire Administration; Complete questionnaires; Other: Communication Intervention; Undergo communication coaching; Other: Educational Intervention; Receive COMFORT communication curriculum; Other Names: Education for Intervention; Intervention, Educational; Other: Psychosocial Support for Caregiver; Undergo communication coaching

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Attrition rate	An electronic recruitment database will be created to document accrual, attrition, and retention rates.	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.	Baseline to 1 month post-intervention
Recruitment rate	An electronic recruitment database will be created to document accrual, attrition, and retention rates.	Up to 18 months
Retention rate	An electronic recruitment database will be created to document accrual, attrition, and retention rates.	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.	Up to 18 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: City of Hope Medical Center
• Collaborators: National Cancer Institute (NCI)
• Investigators: Principal Investigator: Elaine Wittenberg, PhD, City of Hope Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): November 24, 2015
• Primary Completion (Actual): August 10, 2017
• Study Completion (Actual): August 10, 2017

Study Registration Dates

• First Submitted: November 10, 2015
• First Submitted That Met QC Criteria: November 10, 2015
• First Posted (Estimate): November 11, 2015

Study Record Updates

• Last Update Posted (Actual): August 15, 2017
• Last Update Submitted That Met QC Criteria: August 11, 2017
• Last Verified: August 1, 2017

More Information

Terms related to this study

• Other Study ID Numbers: 15359 (Other Identifier: City of Hope Medical Center); NCI-2015-01858 (Registry Identifier: CTRP (Clinical Trial Reporting Program))