Support Needs and Preferences of Family Caregivers of Lung Cancer Patients

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
Queens Cancer Center of Queens Hospital
Michigan State University
Indiana University
Information provided by (Responsible Party):
Memorial Sloan-Kettering Cancer Center
ClinicalTrials.gov Identifier:
NCT00967083
First received: August 26, 2009
Last updated: December 3, 2013
Last verified: December 2013
  Purpose

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.


Condition Intervention
Lung Cancer
Behavioral: Questionnaires/Interviews

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Support Needs and Preferences of Family Caregivers of Lung Cancer Patients

Resource links provided by NLM:


Further study details as provided by Memorial Sloan-Kettering Cancer Center:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
  • To assess family caregivers' preferences (preferred topics, modality, provider, timing) regarding psychosocial support interventions. [ Time Frame: 13 to 16 weeks ] [ Designated as safety issue: No ]
  • To gather descriptive information regarding participant flow for planning future intervention studies. [ Time Frame: 13 to 16 weeks ] [ Designated as safety issue: No ]

Enrollment: 53
Study Start Date: August 2009
Estimated Study Completion Date: August 2014
Estimated Primary Completion Date: August 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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.
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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).

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00967083

Locations
United States, New York
Queens Cancer Center of Queens Hospital
Jamaica, New York, United States, 11432
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10065
Sponsors and Collaborators
Memorial Sloan-Kettering Cancer Center
Queens Cancer Center of Queens Hospital
Michigan State University
Indiana University
Investigators
Principal Investigator: Jamie Ostroff, PhD Memorial Sloan-Kettering Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: Memorial Sloan-Kettering Cancer Center
ClinicalTrials.gov Identifier: NCT00967083     History of Changes
Other Study ID Numbers: 09-104
Study First Received: August 26, 2009
Last Updated: December 3, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Memorial Sloan-Kettering Cancer Center:
Quality of Life
Questionnaires
Interviews
family members
care givers
09-104

Additional relevant MeSH terms:
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on September 18, 2014