Support Needs and Preferences of Family Caregivers of Lung Cancer Patients

Lung Cancer Clinical Trial

Official title:

Support Needs and Preferences of Family Caregivers of Lung Cancer Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00967083
• Other study ID #: 09-104
• Status: Completed
• Phase: N/A
• First received: August 26, 2009
• Last updated: December 10, 2014
• Start date: August 2009
• Est. completion date: December 2014

Study information

• Verified date: December 2014
• Source: Memorial Sloan Kettering Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 53
• Est. completion date: December 2014
• Est. primary completion date: December 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Lung Cancer
• Lung Neoplasms

Intervention

Behavioral:
• Questionnaires/Interviews
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.

Locations

Country	Name	City	State
United States	Queens Cancer Center of Queens Hospital	Jamaica	New York
United States	Memorial Sloan Kettering Cancer Center	New York	New York

Sponsors (5)

Lead Sponsor	Collaborator
Memorial Sloan Kettering Cancer Center	Indiana University, Michigan State University, National Cancer Institute (NCI), Queens Cancer Center of Queens Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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		13 to 16 weeks	No
Secondary	To assess psychosocial and practical barriers to psychosocial support service use among primary family caregivers of lung cancer patients		13 to 16 weeks	No
Secondary	To assess family caregivers' preferences (preferred topics, modality, provider, timing) regarding psychosocial support interventions.		13 to 16 weeks	No
Secondary	To gather descriptive information regarding participant flow for planning future intervention studies.		13 to 16 weeks	No

External Links

•   Memorial Sloan-Kettering Cancer Center