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National Comprehensive Cancer Network (NCCN) Decision Support Tool for Patients With NSCLC

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ClinicalTrials.gov Identifier: NCT03982459
Recruitment Status : Completed
First Posted : June 11, 2019
Last Update Posted : June 11, 2019
Sponsor:
Collaborator:
National Comprehensive Cancer Network
Information provided by (Responsible Party):
Sue Yom, University of California, San Francisco

Brief Summary:
This study involves the evaluation of a decision support tool, based on the patient version of the NCCN guidelines, for the non-small cell lung cancer patient population.

Condition or disease Intervention/treatment Phase
Non-small Cell Lung Cancer Behavioral: decision support tool Not Applicable

Detailed Description:
This study involves the evaluation of a decision support tool, based on the patient version of the NCCN guidelines, for the non-small cell lung cancer patient population. The decision support tool is offered by a trained coordinator to the patient and then utilized during an initial consultation. Patients complete forms before and after the visit indicating their level of decisional conflict, satisfaction, and satisfaction with decision. Pre-determined indices of quality of care were also collected by the study team.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 76 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Acceptability and Effectiveness of a Novel Internet -Based Decision-Support Aid Based on the NCCN Non-Small Cell Lung Cancer Patient Guidelines
Actual Study Start Date : February 1, 2015
Actual Primary Completion Date : September 1, 2017
Actual Study Completion Date : September 1, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer

Arm Intervention/treatment
Experimental: Decision support tool
Patients in this single-arm study all receive training in use of a decision support tool by a trained coordinator.
Behavioral: decision support tool
computerized online decision support tool




Primary Outcome Measures :
  1. Quality of Care [ Time Frame: 1 Day ]
    Change in percentage of patients receiving care according to 6 selected NCCN recommendations


Secondary Outcome Measures :
  1. Change in Decisional Conflict [ Time Frame: 1 Day ]
    Change in level of decisional conflict will be assessed by the Decisional Conflict Scale (DCS). Assessment will be completed before and after consultation. The DCS is a scale designed to measure patients' uncertainty in making health-related decisions, factors contributing to uncertainty, and patients' perceived effective decision-support. The DCS has 16 items and uses a five-point Likert scale for each item. The total score ranging from 0-64 is divided by 16 and then multiplied by 25 to calculate a final total score with 0 indicating low conflict and 100 indicating high conflict.

  2. Satisfaction with Health Care Decision [ Time Frame: 1 Day ]
    Satisfaction will be assessed using the Patient Satisfaction with Health Care Decision (SWD) six-item scale. The SWD will be completed once after the consultation. The range of scoring on this instrument is 0-30, with 30 indicating the highest satisfaction with decision.

  3. Characterize Decisional Support Preference [ Time Frame: 1 Day ]
    Patients' preferred style of decision making with their physician will be assessed using the Decision Making Preference Questionnaire (DMPQ). The DMPQ will be completed once before the consultation. The DMPQ consists of a single question with five choices, ranging from a preference to have the doctor make all of the decisions (passive) to the patient making all of the decisions themselves about their treatment (active) or the intermediate state of shared decision making. There are choices from 1-5 with 5 indicating the most active decision making preference.

  4. Quality of Life by the Functional Assessment of Cancer Therapy-Lung (FACT-L) Questionnaire [ Time Frame: 1 Day ]
    Quality of life will be assessed using the FACT-L quality of life instrument, a 44-item self-report questionnaire that uses a five-point Likert scale. The FACT-L will be completed once before the consultation. The FACT-L is graded on a scale from 0-84 with a lung cancer subscale that ranges from 0-24 with the higher scores indicating better quality of life.

  5. Lung Cancer Symptom Evaluation Score by the National Comprehensive Cancer Network-Functional Assessment of Cancer Therapy Lung Symptom Index (NFLSI-17) [ Time Frame: 1 Day ]
    Patients' symptoms will be evaluated using the National Comprehensive Cancer Network- Functional Assessment of Cancer Therapy Lung Symptom Index (NFLSI-17), a 17-item patient-reported questionnaire that uses a five-point Likert scale and is scored from 0-68. It includes three subscales: Disease-Related Subscale, Treatment Side Effects, and Functional Well-Being. The NFLSI-17 will be completed once before the consultation.

  6. Post Consultation Agreement Between Patient and Physician [ Time Frame: 1 Day ]
    By using a post-consultation questionnaire, we will determine the level of agreement between patient and physician with respect to treatments discussed and recommended, prognosis, and expected tolerance.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Over age of 18
  • Able to provide informed consent
  • Able to use a web-based interface
  • Histologically proven or clinically apparent diagnosis of non-small cell lung cancer
  • Newly diagnosed, with new primary occurrence of NSCLC, or diagnosed with a new recurrence or new progression of existing disease, and not yet treated for the new problem
  • Being seen in consultation at thoracic oncology clinics

Exclusion Criteria:

  • Unable to fill out questionnaires
  • Already treated for the current diagnosis of a new primary occurrence of NSCLC, or already treated for the new recurrence or new progression of existing disease

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03982459


Locations
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United States, California
University of California, San Francisco
San Francisco, California, United States, 94143
Sponsors and Collaborators
University of California, San Francisco
National Comprehensive Cancer Network
Investigators
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Principal Investigator: Sue Yom, MD, PhD University of California, San Francisco

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Responsible Party: Sue Yom, Professor, University of California, San Francisco
ClinicalTrials.gov Identifier: NCT03982459     History of Changes
Other Study ID Numbers: 14655
First Posted: June 11, 2019    Key Record Dates
Last Update Posted: June 11, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Data will be shared on request.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Time Frame: available now
Access Criteria: request to Principal Investigator

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms