Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01924416
Other study ID # 16005
Secondary ID R01CA157409-01A1
Status Completed
Phase N/A
First received August 9, 2013
Last updated February 15, 2018
Start date September 2012
Est. completion date February 2017

Study information

Verified date February 2018
Source University of Virginia
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Description:

Appropriate utilization of treatment with systemic therapy remains problematic in advanced lung cancer. A major issue continues to be over-treatment. Contributors to this include barriers in communication concerning patients' wishes and goals, lack of formal monitoring of symptoms using validated health-related quality of life (QL) and patient reported outcomes (PROs) assessment, and over-dependence on imaging studies as the major and often sole assessment tool. All of these factors make quality decision making more difficult and can lead to decisional conflict and patient and family regret with treatment. The primary specific aim is to test the hypothesis that use of a decision aid to enhance informed, shared decision making coupled with QL assessment with immediate results 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 administered and the number of advanced imaging studies [CT, MRI, PET] related to treatment decisions) compared with the control arm. Secondary aims are: 1) To test the hypothesis that patients with advanced lung cancer who receive an intervention decision aid coupled with immediate QL-PRO results) will have reduced decisional conflict, and reduced decisional regret related to the decision-making process, than those who do not; and 2) to explore the hypothesis that patients with advanced lung cancer who have greater agreement with their chosen supporter (less difference in perception of QL-PROs between the patient and the supporter) will have fewer chemotherapy cycles, than those who do not have close agreement. This phase III, two-arm, prospective, randomized clinical trial (RCT) will test the use of a decision aid ("DecisionKEYS") for patients with advanced lung cancer and coupled with the validated, Electronic Lung Cancer Symptom Scale ("eLCSS-QL") to provide immediate QL-PRO results over the treatment period. A repeated measures design will obtain QL assessment at baseline, every 3 weeks while chemotherapy is given, and at the completion of chemotherapy. This study will use a pretest/ posttest design covering timing for each of three consequential decisions of cancer chemotherapy: Decision 1 ("Starting Chemotherapy"), Decision 2 ("Changing Chemotherapy"), and Decision 3 ("Stopping Anti-Cancer Treatment"). There will be three entry points: patients can be entered into the trial either at their initial chemotherapy, or at the time of starting 1st-, 2nd- or 3rd-line chemotherapy. A stratified block randomization design will be used in which strata are determined by two variables: line of therapy and presenting quality of life. This RCT will be conducted in the outpatient setting at three cancer centers in three states. The sample will include 196 patients with advanced non-small cell lung cancer and their chosen supporter (if available). The sampling plan will include serially screening the clinic appointment roster in the clinics. QL-PRO assessment, decisional conflict, and decisional regret will be used to evaluate response to the decision aid. A specific protocol will be followed by the physician and study nurse at each visit. Descriptive statistics, subgroup analyses (t-test), and Generalized Linear Model (GLM) method will be used for analyses.


Recruitment information / eligibility

Status Completed
Enrollment 196
Est. completion date February 2017
Est. primary completion date February 2017
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility A. Inclusion criteria for lung cancer subject:

1. Pathologically or cytologically determined non-small cell lung cancer (NSCLC)

2. Receiving either first-line, second-line, or third-line chemotherapy for advanced NSCLC. Any chemotherapy will be acceptable

3. Stage IIIB or IV

4. Performance status of KPS 60-100% or ECOG 0-2

5. Hematologic and metabolic parameters suitable for chemotherapy

6. Patients previously treated with adjuvant therapy who now have recurrent NSCLC, will be included as receiving first line therapy

7. 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

8. Patients with prior cancer diagnoses (with or without prior chemotherapy), are eligible provided the previous malignancy is well controlled

9. Ages greater than 18 with NSCLC

10. Life expectancy greater than three months

11. Able to understand English or Spanish, but is not required to be literate

B. Exclusion criteria for lung cancer subject:

1. Patients treated with molecular targeted therapy as their sole treatment

2. Patients with documented severe psychiatric diagnoses from the medical record, which may prevent full study participation

3. Patients receiving protocol chemotherapy that mandates either the number of cycles of treatment to be received or a fixed schedule of imaging studies

4. Patients receiving concomitant chemotherapy and radiation therapy are not eligible for this protocol

5. Patients who are prisoners

6. Patients who are pregnant (self reporting by patient)

7. Patients who are cognitively impaired

C. Inclusion criteria for supporter:

1. Ages greater than 18

2. Able to understand English or Spanish, but is not required to be literate

D. Exclusion criteria for supporter:

1. Prisoners

2. Patients who are cognitively impaired

Study Design


Intervention

Behavioral:
Enhanced Care (intervention group and comparison group)
Decision aid coupled with immediate QL-PRO results
Usual care (routine chemotherapy cycles and imaging studies)
Usual care does not receive intervention

Locations

Country Name City State
United States University of Virginia Charlottesville Virginia

Sponsors (2)

Lead Sponsor Collaborator
University of Virginia National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 QL-PRO assessment Change in QL-PRO assessment at each new cycle to help in informed, shared decision making Every three weeks for 3 cycles, an expected average of 9 weeks
Secondary Decisional conflict Change in decisional conflict for three treatment decisions:
Decision 1 (Starting Chemotherapy); Decision 2 (Changing Chemotherapy); Decision 3 (Stopping Anti-Cancer Treatment)
Pre-post each of three decisions during chemotherapy treament, an expected average of 10 months
Secondary Decisional regret Degree of decisional regret after each of three treatment decisions:
Decision 1 (Starting Chemotherapy); Decision 2 (Changing Chemotherapy); Decision 3 (Stopping Anti-Cancer Treatment)
Post each of three decisions during chemotherapy treatment, an expected average of 10 months
Secondary Overall decisional regret Degree of decisional regret after completion of treatment (1-2 weeks followup telephone contact) 1-2 weeks followup at end of chemotherapy treatment, an expected average of 10 months
See also
  Status Clinical Trial Phase
Terminated NCT02495233 - A Study of ASP2215 in Combination With Erlotinib in Subjects With Epidermal Growth Factor Receptor (EGFR) Activating Mutation-Positive (EGFRm+) Advanced Non-Small-Cell Lung Cancer (NSCLC) Who Have Acquired Resistance to an EGFR Tyrosine Kinase Inhibitor (TKI) Phase 1/Phase 2
Withdrawn NCT02672358 - Study of Efficacy and Safety of Dabrafenib and Trametinib Combination Therapy in Japanese Patients With BRAF V600E Stage IV NSCLC Phase 2
Recruiting NCT05815472 - Advanced Patient Monitoring and A.I. Supported Outcomes Assessment in Lung Cancer Using Internet of Things Technologies (A.I. - APALITT) N/A
Not yet recruiting NCT05900219 - Efficacy and Safety of HL-085 Combined With Vemurafenib in BRAF V600E Patients With Non-small Cell Lung Cancer: a Phase II Clinical Study Phase 2
Not yet recruiting NCT04560244 - A Trial of SHR1701 Combined With Radiotherapy for Metastatic Non-small Cell Lung Cancer Failure After First-line Treatment Phase 2
Not yet recruiting NCT02907606 - Urinary Circulating Tumor DNA Detection in Non-small Cell Lung Cancer: a Prospective Study N/A
Completed NCT01136083 - Effect of Exercise Training on Angiogenesis and Cachexia in Lung Cancer Patients N/A
Completed NCT00831454 - Identification of EGFR-TKIs Sensitivity or Resistance Markers in NSCLC May Help in Optimal Patient Selection N/A
Completed NCT00363766 - Study of LY573636-Sodium in Patients With Metastatic Non-Small Cell Lung Cancer Phase 2
Completed NCT00913705 - Neoadjuvant or Adjuvant Chemotherapy in Patients With Operable Non-small-cell Lung Cancer Phase 3
Completed NCT01383135 - Biodistribution and Safety of the PET Probes [18F]FPRGD2 and [18F]FPPRGD2 Early Phase 1
Completed NCT01124864 - A Study of AUY922 in Non-small-cell Lung Cancer Patients Who Have Received Previous Two Lines of Chemotherapy. Phase 2
Completed NCT00049998 - Oral Topotecan Versus Intravenous Docetaxel In Pretreated, Advanced Non-Small Cell Lung Cancer Phase 3
Terminated NCT05061537 - Study of PF-07263689 in Participants With Selected Advanced Solid Tumors Phase 1
Completed NCT03320044 - Early Diagnosis of Small Pulmonary Nodules by Multi-omics Sequencing
Recruiting NCT04895930 - Furmonertinib Combined With Anlotinib as the First-line Treatment in Patients With EGFR Mutation-positive NSCLC Phase 2
Recruiting NCT03267654 - Gefitinib With Chemotherapy or Anti-angiogenesis in NSCLC Patients With Bim Deletion or Low EGFR Mutation Abundance Phase 2
Recruiting NCT04401059 - Synergistic Effect of Elemene Plus TKIs Compared With TKIs in EGFR-mutated Advanced NSCLC:Prospective Study Phase 4
Not yet recruiting NCT02938546 - 18F-FDG Metabolism Imaging Monitoring Non-small Cell Lung Cancer Curative Effect of Chemotherapy Multicenter Clinical Study Phase 3
Not yet recruiting NCT02930954 - Gefitinib Combined With Chemotherapy or Antiangiogensis in Patients With Bim Deletion or Low EGFR Mutation Abundance Phase 2