Effects of Palliative Care on Quality of Life and Symptom Control in Patients With Stage I, Stage II, or Stage IIIA Non-Small Cell Lung Cancer That Can Be Removed by Surgery - Full Text View

Purpose

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 I, stage II, or stage IIIA non-small cell lung cancer that can be removed by surgery.

Condition	Intervention
Lung Cancer	Other: educational intervention Other: medical chart review Other: questionnaire administration Procedure: end-of-life treatment/management Procedure: psychosocial assessment and care Procedure: quality-of-life assessment

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Supportive Care
Official Title:	Palliative Care for Quality of Life and Symptom Concerns in Early Stage Lung Cancer

Resource links provided by NLM:

MedlinePlus related topics: Anxiety Cancer Lung Cancer Palliative Care

U.S. FDA Resources

Further study details as provided by City of Hope Medical Center:

Primary Outcome Measures:

Overall quality of life and psychological distress [ Time Frame: 1 year after study enrollment ] [ Designated as safety issue: No ]
Symptom control [ Time Frame: 1 year after study enrollment ] [ Designated as safety issue: No ]
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 [ Time Frame: 1 year after study enrollment ] [ Designated as safety issue: No ]
Resource use as measured by chart audits [ Time Frame: 1 year after study enrollment ] [ Designated as safety issue: No ]
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 12 [ Time Frame: Week 12 after study enrollment ] [ Designated as safety issue: No ]

Estimated Enrollment:	207
Study Start Date:	October 2008
Estimated Primary Completion Date:	November 2013 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: Phase 1 Usual care	Other: medical chart review Occurs at 1 year post study enrollment Other: questionnaire administration Occurs at baseline, 6 weeks, 12 weeks, 24 weeks, 36 weeks and 52 weeks post study enrollment Procedure: end-of-life treatment/management Occurs at baseline, 6 weeks, 12 weeks, 24 weeks, 36 weeks and 52 weeks post study enrollment Procedure: psychosocial assessment and care Occurs at baseline, 6 weeks, 12 weeks, 24 weeks, 36 weeks and 52 weeks post study enrollment Procedure: quality-of-life assessment Occurs at baseline, 6 weeks, 12 weeks, 24 weeks, 36 weeks and 52 weeks post study enrollment
Active Comparator: Phase 2 Intervention	Other: educational intervention Palliative care intervention at weeks 3,4,5 and 6 post study enrollment Other: medical chart review Occurs at 1 year post study enrollment Other: questionnaire administration Occurs at baseline, 6 weeks, 12 weeks, 24 weeks, 36 weeks and 52 weeks post study enrollment Procedure: end-of-life treatment/management Occurs at baseline, 6 weeks, 12 weeks, 24 weeks, 36 weeks and 52 weeks post study enrollment Procedure: psychosocial assessment and care Occurs at baseline, 6 weeks, 12 weeks, 24 weeks, 36 weeks and 52 weeks post study enrollment Procedure: quality-of-life assessment Occurs at baseline, 6 weeks, 12 weeks, 24 weeks, 36 weeks and 52 weeks post study enrollment

Arms

Assigned Interventions

Active Comparator: Phase 1 Usual care

Other: medical chart review

Occurs at 1 year post study enrollment

Other: questionnaire administration

Occurs at baseline, 6 weeks, 12 weeks, 24 weeks, 36 weeks and 52 weeks post study enrollment

Procedure: end-of-life treatment/management

Occurs at baseline, 6 weeks, 12 weeks, 24 weeks, 36 weeks and 52 weeks post study enrollment

Procedure: psychosocial assessment and care

Occurs at baseline, 6 weeks, 12 weeks, 24 weeks, 36 weeks and 52 weeks post study enrollment

Procedure: quality-of-life assessment

Occurs at baseline, 6 weeks, 12 weeks, 24 weeks, 36 weeks and 52 weeks post study enrollment

Active Comparator: Phase 2 Intervention

Other: educational intervention

Palliative care intervention at weeks 3,4,5 and 6 post study enrollment

Other: medical chart review

Occurs at 1 year post study enrollment

Other: questionnaire administration

Occurs at baseline, 6 weeks, 12 weeks, 24 weeks, 36 weeks and 52 weeks post study enrollment

Procedure: end-of-life treatment/management

Occurs at baseline, 6 weeks, 12 weeks, 24 weeks, 36 weeks and 52 weeks post study enrollment

Procedure: psychosocial assessment and care

Occurs at baseline, 6 weeks, 12 weeks, 24 weeks, 36 weeks and 52 weeks post study enrollment

Procedure: quality-of-life assessment

Occurs at baseline, 6 weeks, 12 weeks, 24 weeks, 36 weeks and 52 weeks post study enrollment

Detailed Description:

OBJECTIVES:

To compare the effects of palliative care intervention (PCI) vs standard care on overall quality of life and psychological distress in patients with resectable stage I-IIIA non-small cell lung cancer.
To compare symptom control in these patients.
To compare geriatric assessment outcomes, as measured by OARS (Older Americans Resources and Services) Instrumental Activities of Daily Living, MOS Activities of Daily Living, MOS (Medical Outcomes Study)Social Activities Limitation Scale, Hospital Anxiety and Depression Scale scores, and Karnofsky performance scale, in these patients.
To compare the effects of the PCI vs standard care on resource use.
To identify subgroups of patients who benefit most from the PCI in relation to sociodemographic characteristics, treatment factors, and geriatric assessment predictors at week 12.

OUTLINE: Patients assigned to 1 of 2 groups.

Group I (standard care): Patients receive standard care. Patients complete questionnaires at baseline and at 6, 12, 24, 36, and 52 weeks to evaluate quality of life (QOL), symptoms, psychological distress, and geriatric assessments. A medical chart review is performed at 52 weeks to assess the progression of treatment, episodes of care, and re-admissions.
Group II (palliative care intervention): Patients receive an individualized interdisciplinary palliative care intervention combining patient-centered teaching principles and concepts that are learner-centered (builds on the strengths, interests, and needs of the learner), knowledge-centered (teacher is proficient in the content being taught), assessment-centered (learners are given an opportunity to test their understanding and receive feedback), and community-centered (opportunities are available for continued learning and support). Patients undergo 4 teaching sessions (based on the patient-centered teaching principles and concepts) that focus on physical, psychological, social, and spiritual well-being, respectively, once a week in weeks 3-6. Patients then receive 4 follow-up phone calls in weeks 9-21 to clarify questions or review concerns from the teaching sessions and to coordinate follow-up resources as needed. Patients also complete questionnaires as in group I.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Diagnosis of stage I-IIIA resectable NSCLC - Undergoing either lobectomy, pneumonectomy, segmentectomy, or wedge resection
Living within a 50 mile radius of the City of Hope
No previous cancer within the past 5 years

Exclusion Criteria:

Diagnosis of stage II-III NSCLC that are not resectable based on clinical and individual characteristics (co-morbidities, extent of disease, bulky mediastinal lymph nodes [N2], etc.)
NSCLC patients receiving radiofrequency ablation

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00823667

Locations

United States, California
City of Hope Comprehensive Cancer Center
Duarte, California, United States, 91010-3000

Sponsors and Collaborators

City of Hope Medical Center

National Cancer Institute (NCI)

Investigators

Principal Investigator:

Betty Ferrell, PhD

Beckman Research Institute

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	City of Hope Medical Center
ClinicalTrials.gov Identifier:	NCT00823667 History of Changes
Other Study ID Numbers:	08034, P01CA136396, P30CA033572, CHNMC-08034, CDR0000631255
Study First Received:	January 14, 2009
Last Updated:	December 31, 2012
Health Authority:	United States: Institutional Review Board

Keywords provided by City of Hope Medical Center:

stage I non-small cell lung cancer
stage II non-small cell lung cancer
stage IIIA non-small cell lung cancer

Additional relevant MeSH terms:

Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Carcinoma, Bronchogenic
Bronchial Neoplasms
Respiratory Tract Neoplasms

Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on May 23, 2013