Lung Cancer Information Study (LCIS-R01)

NCT01924416 | Completed DMC

• 2 other identifiers: 16005R01CA157409-01A1
• Study Type: interventional
• Target: 196
• Locations: 1 country
• Sites: 1

Brief Summary

The primary specific aim is to test the hypothesis that use of a decision aid to enhance informed, shared decision making coupled with quality of life assessment in patients with advanced lung cancer receiving first-, second-, or third-line therapy will lead to a reduction in two major contributors of cost (number of chemotherapy cycles; number of advanced imaging studies) compared with the control arm.

Conditions

Non-Small-Cell Lung Cancer

Outcome Measures

Primary Outcomes (1)

• A reduction in two major contributors of cost: Number of chemotherapy cycles, and number of advanced imaging studies

  Number of chemotherapy cycles administered and number of advanced imaging studies (CT, MRI, PET) related to treatment decisions

  9 weeks

Secondary Outcomes (4)

• QL-PRO assessment

  Every three weeks for 3 cycles, an expected average of 9 weeks

• Decisional conflict

  Pre-post each of three decisions during chemotherapy treament, an expected average of 10 months

• Decisional regret

  Post each of three decisions during chemotherapy treatment, an expected average of 10 months

• Overall decisional regret

  1-2 weeks followup at end of chemotherapy treatment, an expected average of 10 months

Study Arms (2)

Enhanced Care

EXPERIMENTAL

Enhanced Care: Decision aid; QL-PRO immediate summary results; chemotherapy cycles and imaging studies as needed

Behavioral: Enhanced Care (intervention group and comparison group)

Usual Care

ACTIVE COMPARATOR

Usual Care: Routine chemotherapy cycles and imaging studies

Behavioral: Usual care (routine chemotherapy cycles and imaging studies)

Interventions

Enhanced Care (intervention group and comparison group) BEHAVIORAL

Decision aid coupled with immediate QL-PRO results

Enhanced Care

Usual care (routine chemotherapy cycles and imaging studies) BEHAVIORAL

Usual care does not receive intervention

Usual Care

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Pathologically or cytologically determined non-small cell lung cancer (NSCLC)
• Receiving either first-line, second-line, or third-line chemotherapy for advanced NSCLC. Any chemotherapy will be acceptable
• Stage IIIB or IV
• Performance status of KPS 60-100% or ECOG 0-2
• Hematologic and metabolic parameters suitable for chemotherapy
• Patients previously treated with adjuvant therapy who now have recurrent NSCLC, will be included as receiving first line therapy
• Patients with brain metastasis are eligible provided: they are at least 1 week from completion of surgery or RT for brain metastasis, have stable and adequate neurological status to proceed with chemotherapy, and meet all other eligibility criteria
• Patients with prior cancer diagnoses (with or without prior chemotherapy), are eligible provided the previous malignancy is well controlled
• Ages greater than 18 with NSCLC
• Life expectancy greater than three months
• Able to understand English or Spanish, but is not required to be literate

You may not qualify if:

• Patients treated with molecular targeted therapy as their sole treatment
• Patients with documented severe psychiatric diagnoses from the medical record, which may prevent full study participation
• Patients receiving protocol chemotherapy that mandates either the number of cycles of treatment to be received or a fixed schedule of imaging studies
• Patients receiving concomitant chemotherapy and radiation therapy are not eligible for this protocol
• Patients who are prisoners
• Patients who are pregnant (self reporting by patient)
• Patients who are cognitively impaired
• Ages greater than 18
• Able to understand English or Spanish, but is not required to be literate
• Prisoners
• Patients who are cognitively impaired

Sponsors & Collaborators

• University of Virginia: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

University of Virginia

Charlottesville, Virginia, 22908, United States

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Condition Hierarchy (Ancestors)

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

Study Officials

• Patricia J Hollen, PhD

  University of Virginia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, School of Nursing

Study Record Dates

• First Submitted: August 9, 2013
• First Posted: August 16, 2013
• Study Start: September 1, 2012
• Primary Completion: February 1, 2017
• Study Completion: February 1, 2017
• Last Updated: February 19, 2018

Record last verified: 2018-02

Locations

US (1)