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

This study is enrolling participants by invitation only.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
City of Hope Medical Center
ClinicalTrials.gov Identifier:
NCT00823667
First received: January 14, 2009
Last updated: January 6, 2014
Last verified: January 2014

January 14, 2009
January 6, 2014
October 2008
November 2014   (final data collection date for primary outcome measure)
  • 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 ]
  • Overall quality of life and psychological distress [ Designated as safety issue: No ]
  • Symptom control [ 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 [ Designated as safety issue: No ]
  • Resource use as measured by chart audits [ 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 [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00823667 on ClinicalTrials.gov Archive Site
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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
Palliative Care for Quality of Life and Symptom Concerns in Early Stage Lung Cancer

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.

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.
Interventional
Not Provided
Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Lung Cancer
  • 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
  • Active Comparator: Phase 1 Usual care
    Interventions:
    • Other: medical chart review
    • Other: questionnaire administration
    • Procedure: end-of-life treatment/management
    • Procedure: psychosocial assessment and care
    • Procedure: quality-of-life assessment
  • Active Comparator: Phase 2 Intervention
    Interventions:
    • 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Enrolling by invitation
207
Not Provided
November 2014   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00823667
08034, P01CA136396, P30CA033572, CHNMC-08034, CDR0000631255
No
City of Hope Medical Center
City of Hope Medical Center
National Cancer Institute (NCI)
Principal Investigator: Betty Ferrell, PhD Beckman Research Institute
City of Hope Medical Center
January 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP