NCT00823732

Brief Summary

RATIONALE: Palliative care may be more effective than standard care in improving quality of life and symptoms in patients with lung cancer. PURPOSE: This clinical trial is studying the effects of palliative care on quality of life and symptom control in patients with stage IIIB or stage IV non-small cell lung cancer that cannot be removed by surgery.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
280

participants targeted

Target at P75+ for not_applicable lung-cancer

Timeline
Completed

Started Oct 2008

Longer than P75 for not_applicable lung-cancer

Geographic Reach
1 country

1 active site

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

October 1, 2008

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

January 15, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 16, 2009

Completed
5.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2014

Completed
Last Updated

November 6, 2015

Status Verified

November 1, 2015

Enrollment Period

6 years

First QC Date

January 15, 2009

Last Update Submit

November 4, 2015

Conditions

Lung Cancer

Keywords

stage IIIB non-small cell lung cancerstage IV non-small cell lung cancerrecurrent non-small cell lung cancer

Outcome Measures

Primary Outcomes (5)

  • Overall quality of life and psychological distress

    6 months after study enrollment

  • Symptom control

    6 months after study enrollment

  • Geriatric assessment outcomes as measured by OARS Instrumental Activities of Daily Living, MOS Activities of Daily Living, MOS Social Activities Limitation Scale, Hospital Anxiety and Depression Scale scores, and Karnofsky performance scale

    6 months after study enrollment

  • Resource use as measured by chart audits

    6 months after study enrollment

  • Identification of subgroups of patients who benefit most from the palliative care intervention in relation to sociodemographic characteristics, treatment factors, and geriatric assessment predictors at week 24

    Week 24 after study enrollment

Study Arms (2)

Phase 2 Intervention

ACTIVE COMPARATOR

GROUP II (palliative care intervention): Patients receive an individualized interdisciplinary palliative care intervention comprising learner-centered, knowledge-centered, assessment-centered, and community-centered concepts. Patients undergo 4 teaching sessions, focused on physical, psychological, social, and spiritual well-being, once weekly in weeks 3-6. Patients then receive 4 follow-up phone calls in weeks 9, 13, 17, and 21.

Other: educational interventionOther: medical chart reviewOther: questionnaire administrationProcedure: end-of-life treatment/managementProcedure: psychosocial assessment and careProcedure: quality-of-life assessmentProcedure: management of therapy complicationsProcedure: assessment of therapy complications

Phase I Usual Care

NO INTERVENTION

GROUP I (usual care): Patients receive standard care.

Interventions

educational interventionOTHER

Undergo individualized interdisciplinary palliative care intervention

Phase 2 Intervention
medical chart reviewOTHER

Ancillary studies

Phase 2 Intervention
questionnaire administrationOTHER

Ancillary studies

Phase 2 Intervention
end-of-life treatment/managementPROCEDURE

Undergo end-of-life treatment/management

Phase 2 Intervention
psychosocial assessment and carePROCEDURE

Undergo psychosocial assessment and care

Phase 2 Intervention
quality-of-life assessmentPROCEDURE

Ancillary studies

Phase 2 Intervention
management of therapy complicationsPROCEDURE

Undergo management of therapy complications

Also known as: complications of therapy, management of
Phase 2 Intervention
assessment of therapy complicationsPROCEDURE

Undergo assessment of therapy complications

Phase 2 Intervention

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Criteria: * Diagnosis of stage IIIb-IV unresectable NSCLC * Undergoing treatment with chemotherapy, radiation, or combined modalities * Living within a 50 mile radius of the City of Hope * No previous cancer within the past 5 years

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

City of Hope Comprehensive Cancer Center

Duarte, California, 91010-3000, United States

Location

MeSH Terms

Conditions

Lung NeoplasmsCarcinoma, Non-Small-Cell Lung

Interventions

Early Intervention, EducationalTherapeuticsPsychiatric Rehabilitation

Condition Hierarchy (Ancestors)

Respiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract DiseasesCarcinoma, BronchogenicBronchial Neoplasms

Intervention Hierarchy (Ancestors)

Child Health ServicesCommunity Health ServicesHealth ServicesHealth Care Facilities Workforce and ServicesPreventive Health ServicesRehabilitation

Study Officials

  • Betty Ferrell, PhD

    City of Hope Comprehensive Cancer Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 15, 2009

First Posted

January 16, 2009

Study Start

October 1, 2008

Primary Completion

October 1, 2014

Study Completion

October 1, 2014

Last Updated

November 6, 2015

Record last verified: 2015-11

Locations

US(1)