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

18 Years
Open (Enrolling by invite only)
Lung Cancer

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Trial Information

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


- 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

- 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.

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

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Outcome Measure:

Overall quality of life and psychological distress

Outcome Time Frame:

1 year after study enrollment

Safety Issue:


Principal Investigator

Betty Ferrell, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Beckman Research Institute


United States: Institutional Review Board

Study ID:




Start Date:

October 2008

Completion Date:

Related Keywords:

  • Lung Cancer
  • stage I non-small cell lung cancer
  • stage II non-small cell lung cancer
  • stage IIIA non-small cell lung cancer
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms



City of Hope Comprehensive Cancer CenterDuarte, California  91010