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Completed

NCT Number: NCT00823732

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

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.

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Key information

Conditions

Lung Cancer Bronchial Neoplasms Carcinoma, Bronchogenic Carcinoma, Non-Small-Cell Lung Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

City of Hope Comprehensive Cancer Center

Duarte, California, 91010-3000, United States

About this study

OBJECTIVES:

  • To compare the effects of palliative care intervention (PCI) vs standard care on overall quality of life and psychological distress in patients with unresectable stage IIIB or IV non-small cell lung cancer.
  • To compare symptom control in these patients.
  • To compare 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, 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 are assigned to 1 of 2 groups.

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

Group II (palliative care intervention): Patients receive an individualized interdisciplinary palliative care intervention comprising 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Educational Intervention

Other

Undergo individualized interdisciplinary palliative care intervention

medical chart review

Other

Ancillary studies

Questionnaire Administration

Other

Ancillary studies

end-of-life treatment/management

Procedure

Undergo end-of-life treatment/management

psychosocial assessment and care

Procedure

Undergo psychosocial assessment and care

quality-of-life assessment

Procedure

Ancillary studies

management of therapy complications

Procedure

Undergo management of therapy complications

Other names: complications of therapy, management of

assessment of therapy complications

Procedure

Undergo assessment of therapy complications

Primary outcomes

  1. Overall quality of life and psychological distress

    Time frame: 6 months after study enrollment

  2. Symptom control

    Time frame: 6 months after study enrollment

  3. 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: 6 months after study enrollment

  4. Resource use as measured by chart audits

    Time frame: 6 months after study enrollment

  5. 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

    Time frame: Week 24 after study enrollment

Sponsors and collaborators

Lead sponsor

City of Hope Medical Center

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study title

Palliative Care for Quality of Life and Symptom Concerns in Late Stage Lung Cancer

Important dates

Study start
2008
Primary completion
2014
Study completion
2014
First posted
Jan 16, 2009
Registry last updated
Nov 6, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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