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

NCT00823667 | Completed

• 5 other identifiers: 08034P01CA136396P30CA033572CHNMC-08034CDR0000631255
• Study Type: interventional
• Target: 198
• Locations: 1 country
• Sites: 1

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

Conditions

Lung Cancer

Keywords

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

Outcome Measures

Primary Outcomes (5)

• Overall quality of life and psychological distress

  1 year after study enrollment

• Symptom control

  1 year 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

  1 year after study enrollment

• Resource use as measured by chart audits

  1 year 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 12

  Week 12 after study enrollment

Study Arms (2)

Phase 1 Usual care

ACTIVE COMPARATOR

Other: medical chart review; Other: questionnaire administration; Procedure: end-of-life treatment/management; Procedure: psychosocial assessment and care; Procedure: quality-of-life assessment

Phase 2 Intervention

ACTIVE COMPARATOR

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

Interventions

educational intervention OTHER

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

Phase 2 Intervention

medical chart review OTHER

Occurs at 1 year post study enrollment

Phase 1 Usual care; Phase 2 Intervention

questionnaire administration OTHER

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

Phase 1 Usual care; Phase 2 Intervention

end-of-life treatment/management PROCEDURE

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

Phase 1 Usual care; Phase 2 Intervention

psychosocial assessment and care PROCEDURE

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

Phase 1 Usual care; Phase 2 Intervention

quality-of-life assessment PROCEDURE

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

Phase 1 Usual care; Phase 2 Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• City of Hope Medical Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

City of Hope Comprehensive Cancer Center

Duarte, California, 91010-3000, United States

Location

Related Publications (1)

• Kim JY, Sun V, Raz DJ, Williams AC, Fujinami R, Reckamp K, Koczywas M, Cristea M, Hurria A, Ferrell B. The impact of lung cancer surgery on quality of life trajectories in patients and family caregivers. Lung Cancer. 2016 Nov;101:35-39. doi: 10.1016/j.lungcan.2016.08.011. Epub 2016 Aug 30.

  PMID: 27794406 DERIVED

MeSH Terms

Conditions

Lung Neoplasms; Carcinoma, Non-Small-Cell Lung

Interventions

Early Intervention, Educational; Therapeutics; Psychiatric Rehabilitation

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Carcinoma, Bronchogenic; Bronchial Neoplasms

Intervention Hierarchy (Ancestors)

Child Health Services; Community Health Services; Health Services; Health Care Facilities Workforce and Services; Preventive Health Services; Rehabilitation

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 14, 2009
• First Posted: January 15, 2009
• Study Start: September 1, 2009
• Primary Completion: September 1, 2014
• Study Completion: September 1, 2014
• Last Updated: September 19, 2014

Record last verified: 2014-09

Locations

US (1)