Support Needs and Preferences of Family Caregivers of Lung Cancer Patients
December 10, 2014 updated by: Memorial Sloan Kettering Cancer Center
This study is being done to learn what the needs are in relation to the family members.
Some family members seek counseling; others do not.
The institution wants to try to understand why and wants to see if they can improve our support services for family members.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Actual)
53
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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New York
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Jamaica, New York, United States, 11432
- Queens Cancer Center of Queens Hospital
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New York, New York, United States, 10065
- Memorial Sloan Kettering Cancer Center
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Patients whose family caregivers may be eligible for this study will be identified by a member of the patient's treatment team, the protocol investigator, or research team at Memorial Sloan-Kettering Cancer Center (MSKCC) or Queens Cancer Center (QCC).
Description
Inclusion Criteria:
- Primary family caregiver identified by a patient who is approximately within 4 to 6 weeks of a new visit to a thoracic clinic and receiving cancer care at Memorial Sloan-Kettering Cancer Center or Queens Cancer Center
- Caregiver is at least 18 years of age.
- Caregiver has adequate English fluency for completion of data collection. The surveys were designed and validated in English and are not currently available in other languages. Translation of questionnaires into other languages would require reestablishing the reliability and validity of these measures. Therefore, participants must be able to communicate in English to complete the surveys.
- Clinically meaningful distress defined as a score of 8 or greater on the Anxiety or Depression subscale of the HADS (see Bjelland et al., 2002; Zigmond & Snaith, 1983).
Exclusion Criteria:
- Patients or caregivers exhibiting significant psychiatric or cognitive impairment (dementia/delirium, retardation, active psychosis) that in the judgment of the investigators would preclude providing informed consent and study participation
- Patient has lung cancer recurrence
- Currently participating in a psychosocial intervention trial
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
family caregivers of lung cancer patients
In this 2-year pilot study, we plan to screen family caregivers of lung cancer patients within 4 to 6 weeks after the a new visit to the thoracic clinic.
We will screen spouses, adult children, and other family members using the HAD-18 to determine their level of anxiety and depressive symptoms at enrollment.
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Baseline assessment of distressed caregivers within 4-6 weeks a new visit to the thoracic clinic.
Three-month follow-up assessment of caregivers.
Qualitative phone interviews with a subsample of 30 caregivers within 3 weeks of follow-up.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Assess psychosocial info & practical needs of prim family caregivers of lung cancer pts.Mental health (anxiety & depression)& behavioral health needs(smoking cessation,alcohol abuse)will be assessed b/c these 2 types of needs are strongly correlate
Time Frame: 13 to 16 weeks
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13 to 16 weeks
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
To assess psychosocial and practical barriers to psychosocial support service use among primary family caregivers of lung cancer patients
Time Frame: 13 to 16 weeks
|
13 to 16 weeks
|
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To assess family caregivers' preferences (preferred topics, modality, provider, timing) regarding psychosocial support interventions.
Time Frame: 13 to 16 weeks
|
13 to 16 weeks
|
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To gather descriptive information regarding participant flow for planning future intervention studies.
Time Frame: 13 to 16 weeks
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13 to 16 weeks
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
August 1, 2009
Primary Completion (Actual)
December 1, 2014
Study Completion (Actual)
December 1, 2014
Study Registration Dates
First Submitted
August 26, 2009
First Submitted That Met QC Criteria
August 26, 2009
First Posted (Estimate)
August 27, 2009
Study Record Updates
Last Update Posted (Estimate)
December 11, 2014
Last Update Submitted That Met QC Criteria
December 10, 2014
Last Verified
December 1, 2014
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 09-104
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.