Acceptability and Effectiveness of a Novel Internet -Based Decision-Support Aid Based on the NCCN Non-Small Cell Lung Cancer Patient Guidelines
Phase: NA
Conditions: Non-small Cell Lung Cancer
Sponsor: University of California, San Francisco

Acceptability and Effectiveness of a Novel Internet -Based 
Decision-Support Aid Based on the NCCN Non-Small Cell 
Lung Cancer Patient Guidelines
Protocol Number: CC #14655
Version Number: 1.6
Version Date: 03-15-2016
IND Number: N/A
Principal Investigator (Sponsor-Investigator)
Dr. Sue S. Yom, M.D., Ph.D. 
University of California, San Francisco
E-mail: 
Co-Principal Investigator
Matthew Gubens, M.D.
Co-Investigators 
Thierry Jahan, M.D. 
David Jablons, M.D.
Alexander Gottschalk, M.D.
Collin Blakely, M.D. 
Pierre Theodore, M.D. 
Errol Bush, M.D.
Victoria Wang M.D.
Statistician
Vivian Weinberg, Ph.D.
Clinical Research Coordinator
Taylor Dunbar, B.A. University of 
California San Francisco
Revision History
Version 1.0
02-25-2014
Version 1.5
09-16-2015
Version 1.1
Version 1.2
Version 1.3
Version 1.4
05-04-2014
02-26-2015
04-30-2015
07-10-2015
Version 1.6
03-15-2016
Proprietary and Confidential
The information in this document is considered privileged and confidential, and may not be disclosed to others except 
to the extent necessary to obtain Institutional Review Board approval and informed consent, or as required by 
Federal and State laws.  Persons to whom this information is disclosed should be informed that this information is 
NCT03982459

privileged and confidential and that it should not be further disclosed.

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Protocol Signature Page
Protocol No.: 1.6
Version Date: 03-15-2016
1.  I agree to follow this protocol version as approved by the UCSF Protocol Review Committee
(PRC), and Committee on Human Research (CHR.
2.  I will conduct the study in accordance with applicable CHR requirements, Federal 
regulations, and state and local laws to maintain the protection of the rights and welfare of 
study participants.
3.  I certify that I, and the study staff, have received the requisite training to conduct this 
research protocol.
4.  I agree to maintain adequate and accurate records in accordance with CHR policies, 
Federal, state and local laws and regulations.
UCSF Principal Investigator / Study Chair
Printed Name
Signature
Date

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Abstract
Title
Acceptability and Effectiveness of a Novel Internet Based Decision 
Support Aid Based on the NCCN Non Small Cell Lung Cancer Patient 
Guidelines
Patient population
Newly diagnosed patients with NSCLC who have not yet started on any 
therapy
Rationale for Study
To improve the length and quality-of-life outcomes for people with non- 
small cell lung cancer (NSCLC) by enlisting and engaging patients in the 
dissemination of the NCCN guidelines. This is a two-year software 
development and implementation project to develop and field-test a 
decision aid based on the NCCN patient guidelines for NSCLC. The 
study goal is to improve the treatment decision-support process and 
experience for NSCLC patients in an academic medical center.
Primary Objective
The primary study outcomes will emerge from measurement of changes 
in overall practice patterns after implementation of the decision aid. Pre- 
and post-intervention data will be used to determine the level of 
difference before and after implementation of the decision aid into the 
thoracic oncology clinics. Six specific practice patterns will be queried in 
a binary (yes/no) manner:
1.  All stages: smoking cessation discussion reinforced with a 
specific follow up plan and/or medication/patch/psychotherapy or 
counseling;
2.  stage IB, IIA, IIB receiving surgery: adjuvant chemotherapy given 
after surgery;
3.  stage III receiving surgery: pathologic staging of mediastinal
nodal disease prior to initiation of therapies;
4.  stage III not receiving surgery: pathologic staging of mediastinal 
nodal disease prior to initiation of therapies
5.  stage III patients not receiving surgery: if concurrent
chemotherapy and radiation are given upfront;
6.   stage IV: molecular testing for EGFR and ALK mutations prior to 
initiation of systemic therapy.

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Secondary
Objectives
Secondary objectives are to:
1.  Determine agreement between patient and physician post- 
consultation reports of treatments discussed and recommended, 
prognosis, and expected tolerance.
2.  Determine correlations between overall and lung cancer-specific 
quality of life and decision-support preferences.
3.  Determine correlations between overall and lung cancer-specific
quality of life and decisional conflict.
4.  Determine correlations between overall and lung cancer-specific 
quality of life and satisfaction with decision.
5.  Determine correlations between decision-support preferences
and decisional conflict and satisfaction with decision.
6.   Determine correlations between decisional conflict and 
satisfaction with decision.
Study Design
This study involves the evaluation of the decision support tool Patients 
with Power, previously used with breast cancer patients, in the non- 
small cell lung cancer patient population.
1. Characterize physician and patient populations and treatment 
decisions in the UCSF thoracic oncology practices.
2. Establish the acceptability, feasibility, and effectiveness of a novel 
decision aid for decisions made about treatment for NSCLC.
3. Conduct an evaluation of changes in NCCN-guided practice patterns 
before and after implementation of the decision aid, with respect to 6 
clinical scenarios:

All patients: if smoking cessation intervention is provided at initial 
visit;

Stage IB-IIB patients receiving surgery: if adjuvant chemotherapy 
is given after surgery;

Stage III patients receiving surgery: if pathologic staging of 
mediastinal nodal disease is done prior to initiation of therapies;

Stage III patients not receiving surgery: if pathologic staging of 
mediastinal nodal disease is done prior to initiation of therapies;

Stage III patients not receiving surgery: if concurrent 
chemoradiation is given upfront;

Stage IV patients: if molecular testing is done prior to initiation of 
systemic therapy.
4. Collect data to facilitate the design of future larger-scale evaluations, 
including assessments of physician-patient agreement and patients’ 
levels of decisional conflict and satisfaction with decisions made as well 
as potential correlations to patient-reported quality to life.

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Number of patients
250
Duration of
Intervention
The patients will have access to the decision support tool indefinitely 
(lifetime) but collection of all study metrics will end at 12 months after 
the period of their first 2 initial consultations for NSCLC.
Duration of Follow 
up
Questionnaires will be completed at the time of initial consultation, with 
no planned follow up; PwP website-based metrics will be followed in 
aggregate for a maximum of 1 year.
Duration of study
Twenty four months:
Month 1-8: (1) Analyze existing practice patterns focused on 6 decision 
nodes derived from the NCCN decision tree for NSCLC.  The study of 
practice patterns will be based on primarily on review of medical records 
by a trained research coordinator under Dr. Yom’s direction. (2) 
Programming of NSCLC decision aid under Dr. Yom’s direction, 
conducted with technical assistance as needed from PwP. The results 
will be reviewed by co-investigators for accuracy and ease of use.
Month 8-20: Conduct prospective trial of the decision aid, collecting data 
directly from patients over the course of their initial 2 consultations.
Month 20-24: Completion of data collection and data analysis activities.
Study Intervention
The interactive PwP interface allows structured exploration of choices, 
sequencing, and timing of therapies. The aid thus enables the patient to 
discuss proposed treatments with the oncologist (rather than assuming 
passive acceptance). Furthermore, the decision aid allows evolving 
display of the treatment choices and timeline/calendar in a graphical, 
simplified format during the discussion (rather than assuming absorption 
and recall of details of a verbal communication). We will collect pilot data 
related to the collaborative, patient-oriented approach facilitated by this 
decision aid.
Study Assessments
A total of five patient-reported instruments will be used to score overall 
and lung cancer-specific quality of life, decision-support preferences, 
decisional conflict, and satisfaction with decision:
1.  Decision Support Preference Questionnaire (DMPQ)
2.  FACT-L
3.  FACT/NCCN-Lung Symptom Index (NCCN-FACT FLSI-17)
4.  Decisional Conflict Scale (DCS)
5.  Post-Consultation Questionnaire
6.  Satisfaction with Health Care Decision (SWD)

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Unique Aspects of 
this Study
The decision aid in this study will be developed in collaboration with a 
technology startup, Patients with Power (PwP). PwP has developed an 
innovative web-based software that displays patient-friendly content 
adapted from the NCCN guidelines. The interactive web interface allows 
physicians or patients to input an individual patient’s characteristics and 
then, drawing from the NCCN-guidelines-based decision trees, to design 
a patient-specific decision tree accompanied by a timeline tying 
anticipated procedures to specific dates. At present, PwP has developed 
a proof of concept only for breast cancer, but PwP has shared
proprietary data with the Principal Investigator establishing the feasibility 
of customizing the interface for NSCLC-related content.

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List of Abbreviations
AE
Adverse event
CHR
Committee on Human Research (UCSF IRB)
CRC
Clinical Research Coordinator
CTMS
Clinical Trial Management System
FDA
Food and Drug Administration
GCP
Good Clinical Practice
HDFCCC
Helen Diller Family Comprehensive Cancer Center
ICH
International Conference on Harmonization
IRB
Institutional Review Board
NCI
National Cancer Institute
PRC
Protocol Review Committee (UCSF)

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Table of Contents
Protocol Signature Page ................................................................................................. 2
Abstract
3
List of Abbreviations ........................................................................................................ 7
1
1.1
Introduction............................................................................................. 10
Background on Intervention.................................................................... 10
1.2
Patients with Power – An Innovative Decision Aid to Visualize NCCCN
Guidelines .............................................................................................. 10
1.2.1
Patients’ Reactions to PwP Proof of Concept ..................................... 11
2
1.3
Rationale for the Proposed Study........................................................... 12
Objectives of the Study........................................................................... 13
2.1
Primary ................................................................................................... 13
2.2
Secondary .............................................................................................. 13
2.3
Endpoints ............................................................................................... 14
2.3.1
Primary Endpoints............................................................................... 14
3
2.3.2
Secondary Endpoints .......................................................................... 14
Study Design .......................................................................................... 14
3.1
Number of Subjects ................................................................................ 14
3.2
Eligibility Criteria ..................................................................................... 14
3.2.1
Inclusion Criteria ................................................................................. 14
3.2.2
Exclusion Criteria ................................................................................ 15
3.3
Duration of Intervention .......................................................................... 15
3.4
Duration of Follow Up ............................................................................. 15
3.5
Study Timeline........................................................................................ 15
4
3.5.1
Study Completion................................................................................ 16
Study Procedures and Observations ...................................................... 16
4.1
Schedule of Procedures and Observations ............................................ 16
4.1.1
Pre-consultation Assessments ............................................................ 16
4.1.2
Patients with Power Training............................................................... 16
5
4.1.3
Post-consultation Assessments .......................................................... 16
Reporting and Documentation of Results ............................................... 17
6
5.1
Evaluation of PwP .................................................................................. 17
Statistical Considerations and Evaluation of Results .............................. 19
6.1
Study Endpoints ..................................................................................... 19
6.1.1
Study Design....................................................................................... 19
6.2
Determination of Sample Size and Accrual Rate.................................... 20
6.2.1
Sample Size and Power Estimate ....................................................... 20
6.2.2
Accrual estimates................................................................................ 21
6.3
Analyses Plans ....................................................................................... 21
6.3.1
Primary Analysis (or Analysis of Primary Endpoints) .......................... 21
6.3.2
Secondary Analysis (or Analysis of Secondary Endpoints) ................. 21

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7
7.1
Study Management ................................................................................ 21
Pre-study Documentation ....................................................................... 21
7.2
Institutional Review Board Approval ....................................................... 22
7.3
Informed Consent ................................................................................... 22
7.4
Changes in the Protocol ......................................................................... 22
7.5
Data Storage and Confidentiality ............................................................ 22
8
7.6
Record Keeping and Record Retention .................................................. 23
Protection of Human Subjects ................................................................ 23
8.1
Protection from Unnecessary Harm........................................................ 23
8.2
Protection of Privacy............................................................................... 24
References
25
Appendix 1
Questionnaires ....................................................................................... 27

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1        Introduction
1.1     Background on Intervention
Many physicians are reluctant to disclose specific details to cancer patients, such as 
risks of treatment, prognosis and treatment alternatives.1-4  
Communication is 
complicated by the stigma and fear associated with cancer,5 the complexity of the 
information,  and  uncertainty  about  the  course  of  the  disease  and  benefits  of 
treatment.6,7 Discussions of treatment options are detailed and prolonged, leading to 
information loss and misunderstandings. However, the literature shows that providing 
detailed information to patients has not been associated with adverse psychological 
sequelae and, in some studies, it has contributed to decreased anxiety and increased 
treatment adherence.
Most educational interventions for cancer patients aim to help manage side effects, 
decrease anxiety, and increase compliance.8-13 Recently, decision aids have been 
developed, to help patients go beyond traditional educational interventions by engaging 
them more directly in the decision process.14 Major types of decision aids are interactive 
videos, personalized audiotapes, or booklets. In its systematic review, the Cochrane 
Collaboration found that these interventions improved knowledge and encouraged more 
appropriate use of surgical interventions.15
A few studies have explored decision aids used jointly and interactively by physicians 
and patients during a consultation. Whelan et al. found that a Decision Board 
intervention for breast cancer patients was associated with increased knowledge and 
use of breast-conserving surgery.16-18 Siminoff et al. tested Adjuvant Online with early- 
stage  breast  cancer  patients  and  found  that  the  intervention  group  was  more
knowledgeable and less likely to choose adjuvant therapy featuring very marginal 
benefit.19-21
This study will test an innovative, interactive decision aid designed to facilitate patient 
and oncologist decision-support as a team. Improved patient-physician communication 
is likely to yield benefits in knowledge, decision certainty, and satisfaction.
1.2
Patients with Power – An Innovative Decision Aid to Visualize NCCCN 
Guidelines
The decision aid in this study will be developed in collaboration with a technology 
startup, Patients with Power (PwP). PwP has developed an innovative web-based 
software that displays content excerpted from the NCCN patient guidelines. The 
interactive web interface allows physicians or patients to input an individual patient’s 
characteristics and then, drawing from the NCCN-guidelines-based decision trees, to 
design a patient-specific decision tree accompanied by a timeline tying anticipated 
procedures to specific dates. At present, PwP has developed a proof of concept only for 
breast cancer, but PwP has shared proprietary data with the Principal Investigator 
establishing the feasibility of customizing the interface for NSCLC-related content.

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The interactive PwP interface allows structured exploration of choices, sequencing, and 
timing of therapies. The aid thus enables the patient to discuss proposed treatments 
with the oncologist (rather than assuming passive acceptance). Furthermore, the 
decision aid allows evolving display of the treatment choices and timeline/calendar in a 
graphical, simplified format during the discussion (rather than assuming absorption and 
recall of details of a verbal communication). We will collect pilot data related to the 
collaborative, patient-oriented approach facilitated by this decision aid.
1.2.1  Patients’ Reactions to PwP Proof of Concept
The PwP prototype decision aid has met with very positive responses in the breast 
cancer community:
From a newly diagnosed patient: “[I[t is amazing. It seems that my surgeon is 
following the right course. She has not talked about chemotherapy yet since the 
surgery comes first and then pathology…. My surgeon is also interested in 
learning more about this software.”
From a 2-year survivor: “[K]nowing the NCCN guidelines as compared to what 
doctors are recommending is really valuable.”
From a 6-year survivor: “I love the concept and the sleek, clean, bright design…. 
With your drop down lists, it was a snap to pick the correct answers. Your site 
has the potential to be a great source of information for hungry patients. I would 
have loved to have had something like it when I went through treatment.”
From a friend of a patient: “She and I went on[line] together. She is not tech 
savvy so I wasn't sure how she would react. I am a geek so it makes perfect 
sense to me. She really liked it and was able to navigate around with ease…. We 
especially liked the fact that information was available at decision points where 
choices would need to be made. That makes the journey a whole lot less 
confusing.”
From a cancer survivor and activist: “If this existed when I'd been diagnosed, it
would've been the compass to help guide and map out my journey.”
Startup technology companies often launch prototypes in high-profile diseases such as 
breast cancer. This project will extend the innovation to a more marginalized and 
underserved population in NSCLC. While extending the concept to NSCLC, our project 
will preserve the core features of the decision aid, including the graphical visualization 
of the guidelines, the ease of navigation in the user interface, the personalization 
enabled by the drop-down boxes, and the ability to create, modify, and review multiple 
scenarios (see Figure 1).

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Figure 1. Screenshot of Patients with Power decision aid, designed currently for 
patients with breast cancer.
1.3     Rationale for the Proposed Study
This is a two-year career development project to develop and field-test a decision aid 
based on the NCCN patient guidelines for NSCLC. The study goal is to improve the 
treatment decision-support process in NSCLC patients in an academic medical center. 
If successful, this decision aid will be disseminated more broadly to community settings.
This study will consist of a development phase followed by an evaluation phase. After 
initial prototyping, refinement, coding, and implementation of the intervention, a study 
will  be  implemented  using  a  pre/post  design  to  estimate  the  effect  size  of  the 
intervention with respect to disseminating NCCN-guided treatment choices (primary 
outcome) and to generate preliminary data about secondary outcomes.
Specifically, this project will:
1. Characterize physician and patient populations and treatment decisions in the UCSF
thoracic oncology practices.
2. Establish the acceptability, feasibility, and effectiveness of a novel decision aid for 
decisions made about treatment for NSCLC.

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3. Conduct an evaluation of changes in NCCN-guided practice patterns before and after 
implementation of the decision aid, with respect to 6 clinical scenarios:
1.  All patients: if smoking cessation intervention is provided at initial visit;
2.  Stage IB-IIB patients receiving surgery: if adjuvant chemotherapy is given 
after surgery;
3.  Stage III patients receiving surgery: if pathologic staging of mediastinal nodal 
disease is done prior to initiation of therapies;
4.  Stage III patients not receiving surgery: if pathologic staging of mediastinal 
nodal disease is done prior to initiation of therapies
5.  Stage III patients not receiving surgery: if concurrent chemoradiation is given 
upfront;
6.  Stage IV patients: if molecular testing is done prior to initiation of systemic 
therapy.
4. Collect data to facilitate the design of future larger-scale evaluations, including 
assessments of physician-patient agreement and patients’ levels of decisional conflict 
and satisfaction with decisions made.
2        Objectives of the Study
2.1     Primary
The primary study outcomes will emerge from measurement of changes in overall 
practice patterns after implementation of the decision aid. Pre- and post-intervention 
data will be used to determine the level of difference before and after implementation of 
the decision aid into the thoracic oncology clinics. Six specific practice patterns will be 
queried in a binary (yes/no) manner:
1.  All stages: smoking cessation discussion reinforced with a specific followup plan 
and/or medication/patch/psychotherapy or counseling;
2.  Stage IB, IIA, IIB receiving surgery: adjuvant chemotherapy given after surgery;
3.  Stage III receiving surgery: pathologic staging of mediastinal nodal disease prior 
to initiation of therapies;
4.  Stage III not receiving surgery: pathologic staging of mediastinal nodal disease 
prior to initiation of therapies
5.  Stage III patients not receiving surgery: if concurrent chemoradiation is given 
upfront
6.  Stage IV: molecular testing for EGFR and ALK mutations prior to initiation of 
systemic therapy.
2.2     Secondary
Secondary objectives are to:
1.  Determine agreement between patient and physician post-consultation reports of 
treatments discussed and recommended, prognosis, and expected tolerance.

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2.  Determine correlations between overall and lung cancer-specific quality of life 
and decision-support preferences.
3.  Determine correlations between overall and lung cancer-specific quality of life 
and decisional conflict.
4.  Determine correlations between overall and lung cancer-specific quality of life 
and satisfaction with decision.
5.  Determine  correlations  between  decision-support  preferences  and  decisional 
conflict and satisfaction with decision.
6.  Determine correlations between decisional conflict and satisfaction with decision.
2.3     Endpoints
2.3.1  Primary Endpoints
The practice pattern survey completed during the first 8 months will provide the baseline 
data that will be compared to results obtained after implementation of the decision aid.
2.3.2  Secondary Endpoints
A total of five patient-reported instruments will be used to score overall and lung cancer- 
specific quality of life, decision-support preferences, decisional conflict, and satisfaction 
with decision:
1.  Decision Support Preference Questionnaire (DMPQ)
2.  FACT-L
3.  ACT/NCCN-Lung Symptom Index (NCCN-FACT FLSI-17)
4.  Decisional Conflict Scale (DCS)
5.  Post-Consultation Questionnaire
6.  Satisfaction with Health Care Decision (SWD).
3        Study Design
3.1     Number of Subjects
The total number of participants to be enrolled is 250.   The expected number of 
participants to be enrolled per quarter is 60-65.
3.2     Eligibility Criteria
The patient must be thoroughly informed about all aspects of the study, including the 
study visit schedule and required evaluations and all regulatory requirements for 
informed consent.  The written informed consent must be obtained from the patient prior 
to enrollment.  The following criteria apply to all patients enrolled onto the study unless 
otherwise specified.
3.2.1  Inclusion Criteria
1.  Over age of 18

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2.  Able to provide informed consent
3.  Able to use a web-based interface
4.  Histologically  proven  or  clinically  apparent  diagnosis  of  non-small  cell  lung 
cancer. Eligible NSCLC histological types include:

Adenocarcinoma

Squamous Cell Carcinoma

Large Cell Carcinoma

Adenosquamuos Carcinoma
5.  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.
6.  Being seen in consultation at the UCSF thoracic oncology clinics
3.2.2  Exclusion Criteria
1.  Unable to fill out questionnaires
2.
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.
3.3      Duration of Intervention
The patients will have access to the decision support tool indefinitely (lifetime) but 
collection of all study metrics will end at 12 months after the period of their first 2 initial 
consultations for NSCLC.
3.4     Duration of Follow Up
Questionnaires will be completed at the time of initial consultation, with no planned 
follow up; PwP website-based metrics will be followed in aggregate for a maximum of 1 
year.
3.5     Study Timeline
Month 1-8:
(1) Analyze existing practice patterns focused on 6 decision points derived from the 
NCCN decision tree for NSCLC (see Main Scientific Question). The study of practice 
patterns will be based on direct observation of new patient visits coded by a trained 
research coordinator and review of medical records.
(2) Programming of NSCLC decision aid by a research fellow under my direction, 
conducted with technical assistance as needed from PwP. The results will be reviewed 
by co-investigators for accuracy and ease of use.
Month 8-20: Conduct prospective trial of the decision aid.

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Month 21-27: Completion of data collection and data analysis activities.

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First  Participant  in  (estimated  date  of  first  participant  enrolled):  from  6/1/2014  to
2/23/2015
Last  Participant  in  (estimated  date  of  last  participant  enrolled):  from  5/31/2015  to
8/1/2015
Last Participant Last Visit (estimated date of completion of Therapy for all participants 
enrolled): from 5/31/2015 to 8/1/2015
3.5.1  Study Completion
Completion of data collection and data analysis activities will be completed within 4 
months after the study is closed to accrual.
4
Study Procedures and Observations
4.1
Schedule of Procedures and Observations
4.1.1  Pre-consultation Assessments
The pre-consultation questionnaires will take about 20-30 minutes to complete.
  Decision Support Preference Questionnaire (DMPQ)
  FACT-L
  NCCN-Functional  Assessment  of  Cancer  Therapy  Lung  Symptom  Index-17 
(NFLSI-17).
  Decisional Conflict Scale (DCS): The DCS will be completed before and after
the patient’s PwP training session.
4.1.2  Patients with Power Training
The patient will be trained on the use of the Patients with Power software by the Clinical
Research Coordinator. The training will take approximately 15 minutes.
4.1.3  Post-consultation Assessments
The post-consultation questionnaires, completed by the patient and their oncologist, will 
take about 10-20 minutes to complete.

Decisional Conflict Scale (DCS): The DCS will be also be completed before the
patient’s PwP training session.

Post-Consultation Questionnaire

Satisfaction with Health Care Decision (SWD).

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Procedure
Clinical Visit
Informed consent
X
Decision Support Preference Questionnaire (DMPQ)
X1
FACT-L Questionnaire
X1
FACT/NCCN-Lung Symptom Index (NCCN-FACT FLSI-17) Questionnaire
X1
Decisional Conflict Scale (DCS) Questionnaire
X1,2
PwP Training Session
X
Post-Consultation Questionnaire
X2
Satisfaction with Health Care Decision (SWD) Questionnaire
X2
1pre consultation questionnaire
2post consultation questionnaire
5
Reporting and Documentation of Results
5.1
Evaluation of PwP
1.
Decision  Support  Preference  Questionnaire  (DMPQ):       The  Decision 
Support  Preference  Questionnaire  (DMPQ)  is  a  brief  assessment  of 
patients’ preferred style in decision making with their physician. Patients 
check off the single statement out of five that best describes their preferred 
level of shared decision making responsibility. The Decision Support 
Preference Questionnaire (DMPQ) will be completed once before the 
consultation.
2.
FACT-L:   The FACT-L is a 44-item self-report instrument that measures 
multidimensional quality of life, focused on common concerns of lung cancer 
patients measured on a 5-point Likert scale. It includes domains of Physical 
Well Being, Emotional Well Being, Social Well Being, and Functional Well 
Being. Available in eight languages, it is currently being used in several 
Phase II and III lung cancer clinical trials (Cella DF, Bonomi AE, Lloyd SR, 
Tulsky DS, Kaplan E, Bonomi P. Reliability and validity of the Functional 
Assessment of Cancer Therapy-Lung (FACT-L) quality of life instrument. 
Lung Cancer. 1995 Jun;12(3):199-220). The FACT-L will be completed once 
before the consultation.
3.
NCCN-Functional Assessment of Cancer Therapy Lung Symptom Index-
17 (NFLSI-17): The NCCN-FACT FLSI-17 is a 17-item patient-reported 
questionnaire that indexes the symptoms most highly valued by physicians, 
nurses, and patients with advanced-stage lung cancer.25  It employs a five- 
point Likert scale and is scored from 0-68. It includes three subscales, 
Disease-Related Subscale (DRS), Treatment Side Effects (TSE), and 
Functional Well-Being (FWB). A unique aspect of this instrument is the

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separation of disease-related and treatment-related effects. The NFLSI-17 
will be completed once before the consultation.
4.
Decisional Conflict Scale: The Decisional Conflict Scale (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. The scale is especially designed to help provide information 
about the efficacy of decision aids.22 It has been used in a variety of cancer 
prevention  and  treatment-related  settings.  The  DCS  will  be  completed
before and after the consultation.
5.
Post-Consultation Questionnaire:  The Post-Consultation Questionnaire will 
be completed by the patient and their oncologist once after the consultation. 
It includes the following components:
a. Treatment Recommendations and Decisions: Treatments discussed, 
recommended, and chosen by the patient and their oncologist will be 
recorded. Options may include surgery, radiation therapy, chemotherapy, 
targeted therapy, observation, hospice, no treatment, or unresolved. The 
oncologist and patient will also be asked for an estimation of the tolerance 
of the treatment. This information will be obtained from the patient and 
oncologist immediately after the consultation.
b. Prognosis Estimates: Estimates of prognosis with no treatment and with the 
recommended treatment will be obtained from the patient and oncologist 
immediately after the consultation.
c. Program Evaluation: The patient will be asked to score the extent to 
which this process increased their understanding of their cancer treatment 
options and confidence in their oncologist immediately after the 
consultation.
6.
Satisfaction  with  Health  Care  Decision  (SWD):  Although  the  DCS  will 
provide a general measure of satisfaction with the medical encounter, it 
does not specifically query the patient's satisfaction with the health care 
decision itself. The Patient Satisfaction with Health Care Decision (SWD) is 
a six-item scale with excellent reliability and good discriminate validity. The 
instrument  was  validated  using  a  sample  of  postmenopausal  women
specifically to evaluate the utility of patient decision aids.14 The strength of 
the SWD is that it measures satisfaction with the decision made regardless 
of how good or bad the prognosis or health outcome might be for the
individual patient. The SWD will be completed once after the consultation.

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7.
Acceptability: The PwP website will be monitored for usage during the 
consultation and afterwards. Patients will be given an account to enable 
continuous, unlimited access for the life of the grant. Usage statistics will be 
monitored only in aggregate terms, without reference to specific content 
accessed by individual patients. Repeat visiting to the website will be 
quantified to establish evidence of acceptance on the part of patients. 
Physician acceptance will be judged by rates of participation in using the 
decision aid during the consultation process.
6        Statistical Considerations and Evaluation of Results
6.1     Study Endpoints
Primary Endpoints:  The practice pattern survey completed during the first 8 months will 
provide the baseline data that will be compared to results obtained after implementation 
of the decision aid.
Secondary Endpoints:  A total of five patient-reported instruments will be used to score 
overall and lung cancer-specific quality of life, decision-support preferences, decisional 
conflict, and satisfaction with decision:
Decision Support Preference Questionnaire (DMPQ) 
FACT-L
FACT/NCCN-Lung Symptom Index (NCCN-FACT FLSI-17) 
Decisional Conflict Scale (DCS)
Post-Consultation Questionnaire
Satisfaction with Health Care Decision (SWD).
6.1.1  Study Design
This study involves the evaluation of the decision support tool Patients with Power, 
previously used with breast cancer patients, in the non-small cell lung cancer patient 
population.
1. Characterize physician and patient populations and treatment decisions in the UCSF
thoracic oncology practices.
2. Establish the acceptability, feasibility, and effectiveness of a novel decision aid for 
decisions made about treatment for NSCLC.
3. Conduct an evaluation of changes in NCCN-guided practice patterns before and after 
implementation of the decision aid, with respect to 6 clinical scenarios:

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All patients: if smoking cessation intervention is provided at initial visit;
Stage IB-IIB patients receiving surgery: if adjuvant chemotherapy is given after surgery; 
Stage III patients receiving surgery: if pathologic staging of mediastinal nodal disease is
done prior to initiation of therapies;
Stage  III  patients  not  receiving  surgery:  if  pathologic  staging  of  mediastinal  nodal 
disease is done prior to initiation of therapies;
Stage III patients not receiving surgery: if concurrent chemoradiation is given upfront; 
Stage IV patients: if molecular testing is done prior to initiation of systemic therapy.
4. Collect data to facilitate the design of future larger-scale evaluations, including 
assessments of physician-patient agreement and patients’ levels of decisional conflict 
and satisfaction with decisions made as well as potential correlations to patient-reported 
quality to life.
6.2     Determination of Sample Size and Accrual Rate
6.2.1  Sample Size and Power Estimate
We expect that the clinical volume of 30 patients/month for 12 months will yield a 
potential enrollment pool of 360 patients. Anticipating a 30% decline, dropout, or 
ineligibility rate at the time of potential enrollment, then at least 250 patients should be 
evaluable. The sample size was determined based on the primary outcomes of changes 
in practice patterns. For each disease stage, a test of at least a 25% improvement using 
the decision aid compared with the pre-intervention results in the proportion of patients 
satisfying the stage-specific criterion listed above will be carried out (see Primary 
Endpoint for practice pattern metrics). In addition, the entire study sample will be 
evaluated to test for a change in smoking cessation plans. Patients will be included in 
up to 3 individual analyses. The maximum sample size for any one test is based upon 
assuming a null hypothesis of 50% in the pre-intervention cohort. This estimate for the 
null hypothesis will be modified using the results obtained prior to use of the decision 
aid (Months 1-8). Based upon the one-sample binary exact test with power set at 90% 
and a 2-sided type I error of 0.017 (adjusted for up to 3 tests for all patients), 53 patients 
would be required for each test. The test would reflect the actual accrual by stage with 
the use of the decision aid. With a fixed type I error of 0.017, this means for any 
individual test that the sample size may differ from 53, and the null hypothesis may 
differ from 50% and result in reduced power but will be at least 80%. For example, if 
adjuvant chemotherapy is given after surgery to 40% of stage IB and II patients 
determined from the pre-intervention assessment, then a test to detect a 50% 
improvement to 60% will require 70 patients with 80% power and 88 patients with 91% 
power. Similarly, if 60% of patients satisfy the smoking cessation criterion during the

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pre-intervention interval, a 50% improvement will require 32 patients with 92% power, 
but a 15% improvement with 90% power requires 135 patients across all disease 
stages. It is therefore not anticipated that the comparisons will require more than the 
expected enrollment of 250 patients.
6.2.2  Accrual estimates
The total number of participants to be enrolled is 250.   The expected number of 
participants to be enrolled per quarter is 60-65
6.3     Analyses Plans
6.3.1  Primary Analysis (or Analysis of Primary Endpoints)
The major focus of the trial analysis will be to determine if there is a statistically 
discernible effect for the decision aid in influencing practice patterns before and after 
implementation of the decision aid. The rates of NCCN adherence by stage will be an 
important  covariate.  The  current  sample  size  now  reflects  the  ability  to  detect  a 
moderate effect size for decision aid interactions with outcomes. More detailed analysis 
to correlate correlations between changes in practice patterns to other variables will be 
carried 
out 
with 
logistic 
regression, 
with 
special 
modifications 
for 
patient 
sociodemographic and clinical characteristics (e.g., nodes, tumor size, histology).
6.3.2  Secondary Analysis (or Analysis of Secondary Endpoints)
In addition to the primary analysis, additional analyses will be carried out to determine 
correlations between sociodemographic and clinical variables, similarity in physician 
and patient post-consultation  reports,  quality of  life  scores,  decision-support 
preferences, decisional conflict, and satisfaction with decision.
All  data  analyses  will  be  conducted  by  first  using  exploratory  data  techniques  to 
examine univariate and bivariate relationships for statistical significance. Multivariate 
models will be constructed using statistical criteria, plausibility of associations, the 
existence of a priori hypotheses, and proposed causal pathways. Chi-square, non- 
parametric and log-linear techniques will be used for categorical or ordinal data, and t- 
tests, where appropriate, for continuous data. Multivariate models will use the observed 
likelihood ratio statistic as a statistical index of model fit. Observed effect sizes and their 
precision (expressed as 95% confidence intervals) will be more important components 
of these analyses than the associated p-values.
7        Study Management
7.1     Pre-study Documentation
This study will be conducted in accordance with the ethical principles that have their 
origin in the Declaration of Helsinki as stated in 21 CFR §312.120(c)(4); consistent with 
GCP and all applicable regulatory requirements.

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Before initiating this trial, the Investigator will have written and dated approval from the 
Institutional Review Board for the protocol, written informed consent form, subject 
recruitment materials, and any other written information to be provided to subjects 
before any protocol related procedures are performed on any subjects.
The Investigator must comply with the applicable regulations in Title 21 of the Code of 
Federal Regulations (21 CFR §50, §54, and §312), GCP/ICH guidelines, and all 
applicable regulatory requirements.   The IRB must comply with the regulations in 21
CFR §56 and applicable regulatory requirements.
7.2     Institutional Review Board Approval
The protocol, the proposed informed consent form, and all forms of participant 
information related to the study (e.g. advertisements used to recruit participants) will be 
reviewed and approved by the UCSF CHR (UCSF Institutional Review Board).  Prior to 
obtaining CHR approval, the protocol must be approved by the Helen Diller Family 
Comprehensive Cancer Center Site Committee and by the Protocol Review Committee 
(PRC).  The initial protocol and all protocol amendments must be approved by the IRB 
prior to implementation.
7.3     Informed Consent
All participants must be provided a consent form describing the study with sufficient 
information for each participant to make an informed decision regarding their 
participation.  Participants must sign the CHR-approved informed consent form prior to 
participation in any study specific procedure.  The participant must receive a copy of the 
signed  and  dated  consent  document.    The  original  signed  copy  of  the  consent 
document must be retained in the medical record or research file.
7.4     Changes in the Protocol
Once the protocol has been approved by the UCSF CHR, any changes to the protocol 
must be documented in the form of an amendment.  The amendment must be signed by 
the Investigator and approved by PRC and the CHR prior to implementation.
If it becomes necessary to alter the protocol to eliminate an immediate hazard to 
patients, an amendment may be implemented prior to CHR approval.   In this 
circumstance, however, the Investigator must then notify the CHR in writing within five 
(5) working days after implementation.  The Study Chair and the UCSF study team will 
be responsible for updating any participating sites.
7.5     Data Storage and Confidentiality
Patient confidentiality will be ensured at all times. Study results will not be released to 
participants. Patient identifiers will not be accessible to associated research scientists or 
clinicians conducting the research unless subsequently approved through the CHR. De- 
identified clinical and laboratory information may be shared with other investigators at 
other institutions. There are currently no plans to contact patients to inform them about

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any finding of the study. Patient identifiers will not be made available to any other 
hospitals, insurers, or agencies. The results of studies emerging from this work may be 
published but individual patients will not be identifiable in these publications.
7.6     Record Keeping and Record Retention
The Principal Investigator is required to maintain adequate records.
The Principal Investigator is required to prepare and maintain adequate and accurate 
case histories that record all observations and other data pertinent to the investigation 
on each individual administered the intervention in the investigation. Case histories 
include the case report forms and supporting data (e.g., signed and dated consent 
forms and medical records, such as progress notes of the physician, the individual's 
hospital chart(s), and the nurses' notes. The case history for each individual shall 
document that informed consent was obtained prior to participation in the study.
Study documentation includes all CRFs, data correction forms or queries, source 
documents, 
Sponsor-Investigator 
correspondence, 
monitoring 
logs/letters, 
and 
regulatory documents (e.g., protocol and amendments, CHR correspondence and 
approval, signed patient consent forms).
Source  documents  include  all  recordings  of  observations  or  notations  of  clinical 
activities and all reports and records necessary for the evaluation and reconstruction of 
the clinical research study.
In accordance with FDA regulations, the investigator shall retain records for a period of
2 years following the date a marketing application is approved for the drug for the 
indication for which it is being investigated; or, if no application is to be filed or if the 
application is not approved for such indication, until 2 years after the investigation is 
discontinued and FDA is notified.
8        Protection of Human Subjects
8.1     Protection from Unnecessary Harm
Each clinical site is responsible for protecting all subjects involved in human 
experimentation. This is accomplished through the CHR mechanism and the process of 
informed consent. The CHR reviews all proposed studies involving human 
experimentation and ensures that the subject’s rights and welfare are protected and that 
the potential benefits and/or the importance of the knowledge to be gained outweigh the 
risks  to  the  individual.  The  CHR  also  reviews  the  informed  consent  document 
associated with each study in order to ensure that the consent document accurately and 
clearly communicates the nature of the research to be done and its associated risks and 
benefits.

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8.2     Protection of Privacy
Patients will be informed of the extent to which their confidential health information 
generated  from  this  study  may  be  used  for  research  purposes.  Following  this 
discussion, they will be asked to sign the HIPAA form and informed consent documents. 
The original signed document will become part of the patient’s medical records, and 
each patient will receive a copy of the signed document. The use and disclosure of 
protected health information will be limited to the individuals described in the informed 
consent document.

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References
1.
Silva MC, Sorrell JM. Enhancing comprehension of information for informed 
consent: a review of empirical research. Irb. Jan-Feb 1988;10(1):1-5.
2.
Fitts WT, Jr., Ravdin IS. What Philadelphia physicians tell patients with cancer. J 
Am Med Assoc. Nov 7 1953;153(10):901-904.
3.
Tuckett D, Williams A. Approaches to the measurement of explanation and 
information-giving in medical consultations: a review of empirical studies. Soc Sci Med.
1984;18(7):571-580.
4.
Wu WC, Pearlman RA. Consent in medical decision making: the role of 
communication. J Gen Intern Med. Jan-Feb 1988;3(1):9-14.
5.
What doctors tell patients with breast cancer about diagnosis and treatment: 
findings from a study in general hospitals. GIVIO (Interdisciplinary Group for Cancer 
Care Evaluation) Italy. Br J Cancer. Aug 1986;54(2):319-326.
6.
Brewin TB. The cancer patient: communication and morale. Br Med J. Dec 24-31
1977;2(6103):1623-1627.
7.
Frei E, 3rd. The National Cancer Chemotherapy Program. Science. Aug 13
1982;217(4560):600-606.
8.
Dodd MJ. Cancer patients' knowledge of chemotherapy: assessment and 
informational interventions. Oncol Nurs Forum. Summer 1982;9(3):39-44.
9.
Cassileth BR, Heiberger RM, March V, Sutton-Smith K. Effect of audiovisual 
cancer programs on patients and families. J Med Educ. Jan 1982;57(1):54-59.
10.
Crosson K. Cancer patient education: what, where, and by whom? Health Educ
Q. Spring 1984;10 Suppl:19-29.
11.
Rimer B, Keintz MK, Glassman B. Cancer patient education: reality and potential.
Prev Med. Nov 1985;14(6):801-818.
12.
Beck S. Impact of a systematic oral care protocol on stomatitis after 
chemotherapy. Cancer Nurs. Jun 1979;2(3):185-199.
13.
Jacobs C, Ross RD, Walker IM, Stockdale FE. Behavior of cancer patients: a 
randomized study of the effects of education and peer support groups. Am J Clin Oncol. 
Jun 1983;6(3):347-353.
14.
Holmes-Rovner M. Evaluation standards for patient decision supports. Med
Decis Making. Jan-Mar 1995;15(1):2-3.

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15.
Stacey D, Bennett CL, Barry MJ, et al. Decision aids for people facing health 
treatment or screening decisions. Cochrane Database Syst Rev. 2011(10):CD001431.
16.
Whelan T, Levine M, Willan A, et al. Effect of a decision aid on knowledge and 
treatment decision making for breast cancer surgery: a randomized trial. Jama. Jul 28
2004;292(4):435-441.
17.
Whelan T, Sawka C, Levine M, et al. Helping patients make informed choices: a 
randomized trial of a decision aid for adjuvant chemotherapy in lymph node-negative 
breast cancer. J Natl Cancer Inst. Apr 16 2003;95(8):581-587.
18.
Whelan TJ, Loprinzi C. Physician/patient decision aids for adjuvant therapy. J 
Clin Oncol. Mar 10 2005;23(8):1627-1630.
19.
Belkora JK, Hutton DW, Moore DH, Siminoff LA. Does use of the adjuvant! model 
influence use of adjuvant therapy through better risk communication? J Natl Compr
Canc Netw. Jul 1 2011;9(7):707-712.
20.
Peele PB, Siminoff LA, Xu Y, Ravdin PM. Decreased use of adjuvant breast 
cancer therapy in a randomized controlled trial of a decision aid with individualized risk 
information. Med Decis Making. May-Jun 2005;25(3):301-307.
21.
Siminoff LA, Gordon NH, Silverman P, Budd T, Ravdin PM. A decision aid to 
assist in adjuvant therapy choices for breast cancer. Psychooncology. Nov
2006;15(11):1001-1013.
22.
O'Connor AM. Validation of a decisional conflict scale. Med Decis Making. Jan- 
Mar 1995;15(1):25-30.
23.
Holmes-Rovner M, Kroll J, Schmitt N, et al. Patient satisfaction with health care 
decisions: the satisfaction with decision scale. Med Decis Making. Jan-Mar
1996;16(1):58-64.
24.
Cella DF, Tulsky DS, Gray G, et al. The Functional Assessment of Cancer
Therapy scale: development and validation of the general measure. J Clin Oncol. Mar
1993;11(3):570-579.
25.
Yount S, Beaumont J, Rosenbloom S, et al. A brief symptom index for advanced 
lung cancer. Clin Lung Cancer. Jan 2012;13(1):14-23.
26.
Cassileth BR, Zupkis RV, Sutton-Smith K, March V. Information and participation 
preferences among cancer patients. Ann Intern Med. Jun 1980;92(6):832-836.
27.
Strull WM, Lo B, Charles G. Do patients want to participate in medical decision 
making? Jama. Dec 7 1984;252(21):2990-2994.

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Appendix 1a Questionnaires - Patient
Decision Making Preference Questionnaire
After they have all the information they need about their illness and possible treatments, some patients prefer 
to leave decisions about their treatment up to their doctor, while others prefer to participate in these 
decisions. Please check the statement that best describes what you believe would be ideal.
□  The doctor should make the decisions using all that’s known about the treatments.
□  The doctor should make the decisions but strongly consider my opinion.
□  The doctor and I should make the decisions together on an equal basis.
□  I should make the decisions, but strongly consider the doctor’s opinion.
□  I should make the decisions using all I know or learn about the treatments.

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Not
A little
Some-
Quite
Very
at all
bit
what
a bit
much
FACT-L (Version 4)
Below is a list of statements that other people with your illness have said are important. Please circle 
or mark one number per line to indicate your response as it applies to the past 7 days.
PHYSICAL WELL-BEING
GP1
I have a lack of energy .......................................................
0
1
2
3
4
GP2
I have nausea ......................................................................
0
1
2
3
4
GP3
Because of my physical condition, I have trouble
meeting the needs of my family .........................................
0
1
2
3
4
GP4
I have pain ..........................................................................
0
1
2
3
4
GP5
I am bothered by side effects of treatment .........................
0
1
2
3
4
GP6
I feel ill ...............................................................................
0
1
2
3
4
GP7
I am forced to spend time in bed ........................................
0
1
2
3
4
SOCIAL/FAMILY WELL-BEING 
Not 
at all
A little 
bit
Some- 
what
Quite 
a bit
Very 
much
GS1
I feel close to my friends ....................................................
0
1
2
3
4
GS2
I get emotional support from my family ............................
0
1
2
3
4
GS3
I get support from my friends.............................................
0
1
2
3
4
GS4
My family has accepted my illness ....................................
0
1
2
3
4
GS5
I am satisfied with family communication about my 
illness..................................................................................
0
1
2
3
4
GS6
I feel close to my partner (or the person who is my main
support) ..............................................................................
0
1
2
3
4
Q1
Regardless of your current level of sexual activity, please 
answer the following question. If you prefer not to answer it, 
please mark this box
and go to the next section.
GS7
I am satisfied with my sex life ............................................
0
1
2
3
4

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FACT-L (Version 4)
Please circle or mark one number per line to indicate your response as it applies to the past 7 
days.
EMOTIONAL WELL-BEING 
Not 
at all
A little 
bit
Some- 
what
Quite 
a bit
Very 
much
GE1
I feel sad ..............................................................................
0
1
2
3
4
GE2
I am satisfied with how I am coping with my illness..........
0
1
2
3
4
GE3
I am losing hope in the fight against my illness ..................
0
1
2
3
4
GE4
I feel nervous .......................................................................
0
1
2
3
4
GE5
I worry about dying .............................................................
0
1
2
3
4
GE6
I worry that my condition will get worse ............................
0
1
2
3
4
FUNCTIONAL WELL-BEING 
Not 
at all
A little 
bit
Some- 
what
Quite 
a bit
Very 
much
GF1
I am able to work (include work at home) ..........................
0
1
2
3
4
GF2
My work (include work at home) is fulfilling .....................
0
1
2
3
4
GF3
I am able to enjoy life..........................................................
0
1
2
3
4
GF4
I have accepted my illness...................................................
0
1
2
3
4
GF5
I am sleeping well ...............................................................
0
1
2
3
4
GF6
I am enjoying the things I usually do for fun ......................
0
1
2
3
4
GF7
I am content with the quality of my life right now..............
0
1
2
3
4

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FACT-L (Version 4)
Please circle or mark one number per line to indicate your response as it applies to the past 7 
days.
ADDITIONAL CONCERNS 
Not at 
all
A little 
bit
Some- 
what
Quite 
a bit
Very 
much
B1
I have been short of breath ..................................................
0
1
2
3
4
C2
I am losing weight ...............................................................
0
1
2
3
4
L1
My thinking is clear ............................................................
0
1
2
3
4
L2
I have been coughing ..........................................................
0
1
2
3
4
B5
I am bothered by hair loss ...................................................
0
1
2
3
4
C6
I have a good appetite .........................................................
0
1
2
3
4
L3
I feel tightness in my chest ..................................................
0
1
2
3
4
L4
Breathing is easy for me......................................................
0
1
2
3
4
Q3
Have you ever smoked?
No  
Yes  
If yes:
L5
I regret my smoking ............................................................
0
1
2
3
4

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Decisional Conflict Scale (DCS)
Strongly
Agree
Agree
Neither
Agree
Nor
Disagree
Disagree
Strongly
Disagree
I know which options are available to me.
□
□
□
□
□
I know the benefits of each option.
□
□
□
□
□
I know the risks and side effects of each option.
□
□
□
□
□
I am clear about which benefits matter most to 
me.
□
□
□
□
□
I am clear about which risks and side effects 
matter most to me.
□
□
□
□
□
I am clear about which is more important to me
(the benefits or the risks and side effects).
□
□
□
□
□
I have enough support from others to make a 
choice.
□
□
□
□
□
I am choosing without pressure from others.
□
□
□
□
□
I have enough advice to make a choice.
□
□
□
□
□
I am clear about the best choice for me.
□
□
□
□
□
I feel sure about what to choose.
□
□
□
□
□
This decision is easy for me to make.
□
□
□
□
□
I feel I have made an informed choice.
□
□
□
□
□
My decision shows what is important to me.
□
□
□
□
□
I expect to stick with my decision.
□
□
□
□
□
I am satisfied with my decision.
□
□
□
□
□
AM O’Connor, Decisional Conflict Scale. ©1993 [updated 2005]. Available from www.ohri.ca/decionaid.