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

Study Overview
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Brief Summary
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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
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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.

Official Title
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The COMFORT Caregiver Intervention (CCI)

Conditions
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Caregiver

Intervention / Treatment
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* Other: Communication Intervention
* Other: Educational Intervention
* Other: Psychosocial Support for Caregiver
* Other: Questionnaire Administration


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Supportive care (COMFORT communication intervention)<br>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: Communication Intervention<br>* Undergo communication coaching<br>Other: Educational Intervention<br>* Receive COMFORT communication curriculum<br>* Other names: Intervention, Educational;Other: Psychosocial Support for Caregiver<br>* Undergo communication coaching<br>Other: Questionnaire Administration<br>* Complete questionnaires<br>|

What is the study measuring?
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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 |