CaregiverCOMFORTNCT02603367
COMFORT Caregiver Intervention in Improving Communication and Reducing Distress in Caregivers of Patients With Lung Cancer
A study testing Communication Intervention, Educational Intervention and Psychosocial Support for Caregiver in people with Caregiver, run by City of Hope Medical Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Caregiver
- What is being tested?
- Communication Intervention, Educational Intervention and Psychosocial Support for Caregiver
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Nov 2015to 10 Aug 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
City of Hope Medical Center
Duarte, California, 91010
About this study
Official title: 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.
Read the detailed description
PRIMARY OBJECTIVES:
- 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.
- Conditions
- Caregiver
- Being tested
- Communication Intervention, Educational Intervention, Psychosocial Support for Caregiver, Questionnaire Administration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Communication InterventionOther
Undergo communication coaching
Educational InterventionOther
Also called Education for Intervention, Intervention, Educational
Receive COMFORT communication curriculum
Psychosocial Support for CaregiverOther
Undergo communication coaching
Questionnaire AdministrationOther
Complete questionnaires
| Study group | Role | What they receive |
|---|---|---|
| Supportive care (COMFORT communication intervention) | Experimental | 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. Receives: Other: Communication Intervention; Other: Educational Intervention; Other: Psychosocial Support for Caregiver; Other: Questionnaire Administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Attrition rate
An electronic recruitment database will be created to document accrual, attrition, and retention rates.
Measured: 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.
Measured: Baseline to 1 month post-intervention
Recruitment rate
An electronic recruitment database will be created to document accrual, attrition, and retention rates.
Measured: Up to 18 months
Retention rate
An electronic recruitment database will be created to document accrual, attrition, and retention rates.
Measured: 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.
Measured: Up to 18 months
Secondary outcomes (1)
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.
Measured: Baseline to 1 month post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Nov 2015 (estimated)
- Study start24 Nov 2015
- Primary completion10 Aug 2017
- Study completion10 Aug 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CaregiverStudies of the same condition, open and under way.
- More trials run by City of Hope Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- City of Hope Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Elaine Wittenberg, PhD, Principal investigator, City of Hope Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02603367
- Sponsor's protocol ID
- 15359
- Other IDs
- NCI-2015-01858, 15359
- Acronym
- COMFORT
- Status last verified
- Aug 2017
- First submitted
- 10 Nov 2015
- Last updated
- 15 Aug 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The COMFORT Caregiver Intervention (CCI)
- ClinicalTrials.gov ID
- NCT02603367
- Acronym / sponsor ID
- COMFORT / 15359
- Conditions
- Caregiver
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- City of Hope Medical CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 24 Nov 2015 (actual)
- Primary completion
- 10 Aug 2017 (actual)
- Study completion
- 10 Aug 2017 (actual)
- First posted
- 11 Nov 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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 design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Supportive care (COMFORT communication intervention) | Experimental | Other: Communication Intervention, Other: Educational Intervention, Other: Psychosocial Support for Caregiver, Other: Questionnaire AdministrationParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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:
- All subjects must have the ability to understand and the willingness to participate in the informed consent process
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Communication InterventionUndergo communication coaching | Other | Supportive care (COMFORT communication intervention) |
| Educational InterventionAlso: Education for Intervention, Intervention, EducationalReceive COMFORT communication curriculum | Other | Supportive care (COMFORT communication intervention) |
| Psychosocial Support for CaregiverUndergo communication coaching | Other | Supportive care (COMFORT communication intervention) |
| Questionnaire AdministrationComplete questionnaires | Other | Supportive care (COMFORT communication intervention) |
Primary outcome
Attrition rate
Time frame: Up to 18 months
An electronic recruitment database will be created to document accrual, attrition, and retention rates.
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.
Recruitment rate
Time frame: Up to 18 months
An electronic recruitment database will be created to document accrual, attrition, and retention rates.
Retention rate
Time frame: Up to 18 months
An electronic recruitment database will be created to document accrual, attrition, and retention rates.
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.
1 secondary outcome
Change in caregiver communication confidence, measured using the Caregiver Communication Survey
Time frame: Baseline to 1 month post-intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Aug 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Elaine Wittenberg, PhD principal investigator
City of Hope Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Communication Intervention, Educational Intervention and Psychosocial Support for Caregiver in people with Caregiver, run by City of Hope Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Attrition rate (time frame: Up to 18 months). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Aug 2017.