COMFORT Caregiver Intervention in Improving Communication and Reducing Distress in Caregivers of Patients With Lung Cancer
COMFORT
The COMFORT Caregiver Intervention (CCI)
2 other identifiers
interventional
50
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Nov 2015
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 10, 2015
CompletedFirst Posted
Study publicly available on registry
November 11, 2015
CompletedStudy Start
First participant enrolled
November 24, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 10, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
August 10, 2017
CompletedAugust 15, 2017
August 1, 2017
1.7 years
November 10, 2015
August 11, 2017
Conditions
Outcome Measures
Primary Outcomes (5)
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 Outcomes (1)
Change in caregiver communication confidence, measured using the Caregiver Communication Survey
Baseline to 1 month post-intervention
Study Arms (1)
Supportive care (COMFORT communication intervention)
EXPERIMENTALParticipants 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.
Interventions
Undergo communication coaching
Receive COMFORT communication curriculum
Undergo communication coaching
Complete questionnaires
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- City of Hope Medical Centerlead
- National Cancer Institute (NCI)collaborator
Study Sites (1)
City of Hope Medical Center
Duarte, California, 91010, United States
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Elaine Wittenberg, PhD
City of Hope Medical Center
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 10, 2015
First Posted
November 11, 2015
Study Start
November 24, 2015
Primary Completion
August 10, 2017
Study Completion
August 10, 2017
Last Updated
August 15, 2017
Record last verified: 2017-08