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Completed

NCT Number: NCT02603367

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

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.

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Key information

Conditions

Caregiver

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

City of Hope Medical Center

Duarte, California, 91010, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Communication intervention

Other

Undergo communication coaching

Educational Intervention

Other

Receive COMFORT communication curriculum

Other names: Education for Intervention, Intervention, Educational

Psychosocial Support for Caregiver

Other

Undergo communication coaching

Questionnaire Administration

Other

Complete questionnaires

Primary outcomes

  1. Attrition rate

    Time frame: Up to 18 months

    An electronic recruitment database will be created to document accrual, attrition, and retention rates.

  2. Change in caregiver psychological distress, measured using the Distress Thermometer

    Time frame: Baseline to 1 month post-intervention

    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.

  3. Recruitment rate

    Time frame: Up to 18 months

    An electronic recruitment database will be created to document accrual, attrition, and retention rates.

  4. Retention rate

    Time frame: Up to 18 months

    An electronic recruitment database will be created to document accrual, attrition, and retention rates.

  5. Themes derived from qualitative content analysis

    Time frame: Up to 18 months

    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.

Secondary outcomes

  1. Change in caregiver communication confidence, measured using the Caregiver Communication Survey

    Time frame: Baseline to 1 month post-intervention

    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.

Sponsors and collaborators

Lead sponsor

City of Hope Medical Center

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study title

The COMFORT Caregiver Intervention (CCI)

Acronym: COMFORT

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Nov 11, 2015
Registry last updated
Aug 15, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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