NCT00967083

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
53

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Aug 2009

Longer than P75 for all trials

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2009

Completed
25 days until next milestone

First Submitted

Initial submission to the registry

August 26, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 27, 2009

Completed
5.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2014

Completed
Last Updated

December 11, 2014

Status Verified

December 1, 2014

Enrollment Period

5.3 years

First QC Date

August 26, 2009

Last Update Submit

December 10, 2014

Conditions

Keywords

Quality of LifeQuestionnairesInterviewsfamily memberscare givers09-104

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (3)

  • To assess psychosocial and practical barriers to psychosocial support service use among primary family caregivers of lung cancer patients

    13 to 16 weeks

  • To assess family caregivers' preferences (preferred topics, modality, provider, timing) regarding psychosocial support interventions.

    13 to 16 weeks

  • To gather descriptive information regarding participant flow for planning future intervention studies.

    13 to 16 weeks

Study Arms (1)

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

Interventions

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.

family caregivers of lung cancer patients

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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).

You may qualify if:

  • 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).

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Queens Cancer Center of Queens Hospital

Jamaica, New York, 11432, United States

Location

Memorial Sloan Kettering Cancer Center

New York, New York, 10065, United States

Location

Related Links

MeSH Terms

Conditions

Lung Neoplasms

Interventions

Surveys and QuestionnairesInterviews as Topic

Condition Hierarchy (Ancestors)

Respiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Officials

  • Jamie Ostroff, PhD

    Memorial Sloan Kettering Cancer Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 26, 2009

First Posted

August 27, 2009

Study Start

August 1, 2009

Primary Completion

December 1, 2014

Study Completion

December 1, 2014

Last Updated

December 11, 2014

Record last verified: 2014-12

Locations