Clinical trial NCT02603367: COMFORT Caregiver Intervention in Improving Communication and Reducing Distress in Caregivers of Patients With Lung Cancer
Official title: The COMFORT Caregiver Intervention (CCI)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Caregiver
Lead sponsor: City of Hope Medical Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2015-11-11
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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.

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.

Eligibility 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

Primary outcomes:
measure: Attrition rate
timeFrame: Up to 18 months
measure: Change in caregiver psychological distress, measured using the Distress Thermometer
timeFrame: Baseline to 1 month post-intervention
measure: Recruitment rate
timeFrame: Up to 18 months
measure: Retention rate
timeFrame: Up to 18 months
measure: Themes derived from qualitative content analysis
timeFrame: Up to 18 months
Secondary outcomes:
measure: Change in caregiver communication confidence, measured using the Caregiver Communication Survey
timeFrame: Baseline to 1 month post-intervention
Other outcomes:
Locations:
city: Duarte
country: United States
facility: City of Hope Medical Center
state: California
Study officials:
affiliation: City of Hope Medical Center
name: Elaine Wittenberg, PhD
role: PRINCIPAL_INVESTIGATOR
References: