A Web-based Multimedia Intervention for Head and Neck Cancer Patients
Phase: NA
Conditions: Cancer of the Head and Neck
Sponsor: Fox Chase Cancer Center

IRB: 11-822 
FCCC IRB Reviewed: 05/16/2014 
 
 
 
 
 
 
Submission to the Research Review Committee at Fox Chase Cancer Center 
 
 
A Web-based Multimedia Intervention for Head and Neck Cancer Patients 
 
 
Carolyn Y. Fang, PhD, Principal Investigator 
Thomas Galloway, MD, Co-Investigator 
John A. Ridge MD, PhD, Co-Investigator 
Marcin Chwistek, MD, Co-Investigator 
Janice G. Bühler, MS, PT, OCS, CLT-LANA, Co-Investigator 
Barbara Ebersole, MA, CCC-SLP, Co-Investigator 
Eric Ross, PhD, Biostatistician 
Fox Chase Cancer Center 
 
 
 
 
 
Supported by NCI R41CA144100 
 
 
 
 
 
 
 
Original version:  March 21, 2011 
Approved:  
 
April 19, 2011 
Amendment #1: 
November 16, 2012 
Amendment #2:    May 02, 2013 
Amendment #3:  April 16, 2014 
Amendment #4: 
April 3, 2015  
 
 
 
 
 

1 
TABLE OF CONTENTS 
 
1.0 Schema......................................................................................................… 
2 
 
2.0 Introduction 
 
2.1.  Background..........................................................................................  
3  
 
2.2.  Rationale.............................................................................…………... 
5 
 
3.0 Objectives..................................................................................................... 
5 
 
4.0 Selection of Participants............................................................................... 
6 
 
5.0 Registration Procedures…….......................................................................  
7 
 
6.0 Study Design..............................................................................................  
8 
 
7.0 Measurement of Effect.................................................................................  
9 
 
8.0 Study Parameters......................................................................................... 
10 
 
9.0 Pharmacokinetic Studies……....................................................................... 
10 
 
10.0 Off Study Criteria……………………………………………………………...  
10 
 
11.0 Drug Formulation and Procurement Information……………………………. 
10 
 
12.0 Statistical Considerations........................................................................... 
10 
 
13.0 Adverse Event Reporting...........................................................................  
11  
 
14.0 Pathology Review……………………………………………………………..  
12 
 
15.0 Records to be Kept....................................................................................  
12 
 
16.0 Patient Informed Consent……………………………………………………..  
12  
 
17.0 References................................................................................................. 
13 
 
18.0 Multicenter Trials………………………………………………………….…....  
17  
 
19.0 Appendices 
 
 
Appendix A – Usability Testing Measures (Aim 1) 
 
 
Appendix B – Patient Assessments (Aims 2 and 3) 
 
 
Appendix C – Healthcare Professional Assessments (Aim 2) 
 
 
Appendix D – Informed Consent Documents  
 

2 
1.0 SCHEMA 
 
In 2010, cancers of the oral cavity, pharynx, and larynx (which comprise head and neck squamous cell 
carcinoma [HNSCC]) were estimated to account for 49,260 new cancer cases in the United States[1]. In 
addition, approximately $3.2 billion[2] is spent in the U.S. each year on treatment of HNSCCs. Treatment 
for HNSCC includes surgery or radiation therapy and can lead to considerable functional impairment, 
potential disfigurement, and emotional distress. As a consequence, HNSCC patients experience significant 
decrements in quality of life (QOL), poorer interpersonal relations, and increased social isolation[3]. Studies 
suggest that psychoeducational interventions can improve quality of life, reduce psychological distress, and 
enhance coping with cancer in various cancer populations[4-5]. However, few such programs have been 
developed for HNSCC patients. This empirical gap is surprising given that studies have noted that HNSCC 
patients have considerable informational needs that are not being adequately addressed[6]. In addition, 
due to the potential effects of cancer and cancer treatment on facial appearance and speaking ability, 
psychosocial interventions that are delivered in-person may be less appealing to some HNSCC patients 
who are reluctant or unwilling to engage in social interactions due to social anxiety or feeling stigmatized[7-
9]. In addition, patients often find themselves having to manage extensive treatment and rehabilitation 
appointments, and therefore, they have little additional time to participate in or take advantage of any 
available psychosocial services. Indeed, previous studies have reported low attendance to be a common 
barrier to delivering interventions for HNSCC patients[10-11], and patients have also reported psychosocial 
services to be inaccessible to them[12]. Thus, the development of a widely accessible program that 
provides didactic information on treatment-related side effects, as well as cognitive and behavioral 
strategies to enhance psychosocial adjustment and QOL following treatment, would address this gap.  In 
consideration of these factors, web-based interventions represent one option for delivering key information 
to this population in an efficacious, practical and acceptable format. If effective, this medium also has high 
dissemination potential.  
 
 
Thus, the overall goal of the proposed project is to develop and examine the acceptability of a 
theory-guided, web-based multimedia intervention program for HNSCC patients who have recently 
completed radiation therapy. Our long-term goal is to evaluate the effects of such an intervention on 
QOL among HNSCC patients. As a first step, we propose to create appropriate content, including 
informational text, brief video scripts, and animated graphics. Next, we will develop a test website that 
includes prototypes for four components of the proposed web-based program.  The specific aims of the 
proposed project are to:    
 
Aim 1:  Develop a prototype web-based multimedia program that includes four components (or 
topic areas), including: 1) Head and Neck Cancer and its Treatment; 2) Changes in Swallowing and 
Oral Care; 3) Changes in Speech; and 4) Coping with Cancer.  During the first 7 months, we will create 
the content and develop a prototype web-based program that presents both didactic information and 
cognitive and behavioral strategies for coping with treatment of HNSCC. Usability testing will be conducted 
with 5 HNSCC patients.  Revisions based on patient feedback will be incorporated.   
 
Aim 2: Evaluate acceptability and satisfaction with the prototype web-based program in a sample of 
up to 75 HNSCC patients and 5 expert professionals. The web-based program developed in Aim 1 will 
be evaluated by up to 75 patients who are currently undergoing or have recently completed radiation 
therapy and 5 healthcare professionals who work with HNSCC patients. Satisfaction and acceptability will 
be demonstrated if mean ratings meet specified criteria (see Section 12.2.b. Indicators of Success). 
 
Exploratory Aim 3:  Obtain preliminary data on potential program impact in a sample of up to 75 
HNSCC patients.  Measures of psychosocial functioning and self-efficacy will be assessed at pre- and 
post-program assessment, in order to obtain preliminary data on potential intervention impact.  These data 
will be used to calculate potential effect sizes and support a future large-scale, randomized trial to evaluate 
the effectiveness of the web-based program in enhancing QOL among HNSCC patients.  

3 
2.0 INTRODUCTION 
 
2.1. 
Background 
 
2.1.a. Quality of Life Following Treatment. Despite advances in diagnostic tools and treatment modalities, 
treatment for HNSCC often confers considerable functional impairment. Consequently, HNSCC patients 
must cope not only with the diagnosis of cancer, but also with the physical sequelae of treatment. 
Treatment can result in: changes in swallowing, speech, and social functioning; dry mouth; need for 
nutritional supplements; pain; difficulties in social eating; and impaired sexual functioning[14].  Routine 
daily activities can become extremely challenging as patients may experience speech difficulties or 
impaired eating ability (e.g., difficulty swallowing, problems with drooling and chewing food)[15-17]. Many 
patients report both physical and psychosocial complaints even after successful therapy[18], and long-term 
deficits in QOL have been reported up to 10 years post-treatment[19].  
 
Given the broad-ranging effects of treatment, it is surprising that 73% of HNSCC patients reported 
receiving little or no information during or following the treatment period[20]. A perceived lack of information 
has been associated with posttreatment uncertainty, anxiety and depression[21]. In contrast, HNSCC 
patients who received more information about the disease and the treatment experience reported fewer 
psychosocial problems[21]. Because the perception of having obtained adequate information is an 
important predictor of positive rehabilitation outcomes in the 2- to 6-year posttreatment period[20], there is 
a clear need for HNSCC patients to be able to obtain information about their disease and post-discharge 
care[22] in an accessible format. 
 
2.1.b. Interventions can Lead to Enhanced Quality of Life.  Psychosocial interventions can significantly 
enhance psychosocial functioning in cancer patient populations[4-5]. Although many programs have been 
developed for cancer patients (notably, breast cancer patients[23-24]), few have been developed for 
HNSCC patients. The few interventions tested have generally yielded beneficial effects among HNSCC 
patients[25-26], particularly when they are provided immediately following treatment. However, barriers to 
participation have also been noted. Specifically, requiring HNSCC patients to attend in-person sessions is 
a major barrier to participation, and compliance with interventions that entail multiple in-person interactions 
is difficult to achieve[27]. Hence, web-based programs, which do not require an in-person session, may 
greatly reduce or eliminate such barriers.  Greater confidence in the effectiveness of a web-based program 
is also derived from a study that compared different approaches for delivering a coping strategies 
intervention for HNSCC patients (in-person with a therapist vs. a self-contained workbook with no therapist 
sessions)[28].  In both formats, the intervention was comprised of a workbook that covered various topics 
on coping skills, effective use of social support, problem-solving techniques, goal setting, and relaxation 
training[29]. Overall, all patients receiving the intervention program (regardless of format) reported 
improved QOL compared to control group patients receiving usual care[28, 30]. Further, the home format 
was as effective in enhancing QOL as the therapist-delivered format, thereby suggesting that such 
programs can be appropriately adapted for web-based delivery. In sum, a web-based program would be 
responsive to patient preferences for the receipt of materials and interventions that can be viewed at home, 
as well as reduce barriers to participation in such programs. In turn, such programs may yield positive 
effects on QOL and psychological adjustment among HNSCC patients[26, 30-31].   
 
 
Rationale for a web-based intervention. Web-based psychoeducational interventions are increasingly 
common[32-36], but not within the HNSCCC context.  A web-based approach for this underserved 
population has several practical advantages: First, empirical evidence (and our pilot data, see Section 
2.1.d.) suggests that patients prefer to receive materials that they can view at home[30]. There is often 
insufficient time for patients to absorb critical information during medical appointments[13] and it is difficult 
to retain such information under stress. Second, for patients who are reluctant to engage in social 
interactions following treatment[7-9], web-based content offers an interim approach for providing strategies 
to facilitate re-entry into social interactions when ready. Learning about and practicing strategies within 

4 
one’s home and watching videos of how other HNSCC survivors have overcome concerns related to social 
engagement may increase confidence in re-initiating social interactions. Third, the Internet offers a 
functional advantage over print materials, particularly through the transmission of video. Videotaped 
vignettes can increase knowledge about cancer and treatments[37-38] and video modeling can improve 
patient self-care practices[39].  Web-based programs have yielded benefits ranging from decreases in pain 
to improved QOL[40-41]. Fourth, a web-based approach has high dissemination potential to the larger 
population of HNSCC patients.  Over 73% of the US population reports Internet use[42]. Among home 
Internet users, almost 80% have high-speed Internet access allowing users to watch or download video 
online[43]. In sum, given the trend of increasing Internet use, it has become an essential tool for 
disseminating important health information[44-46].   
 
2.1.c. A Theoretical Framework to Guide Intervention Development. Social Cognitive Theory (SCT)[60-64] 
has been widely used to guide health promotion interventions, and it proposes that behaviors are learned 
through information provision and vicarious process. Guided by SCT, interventions can teach skills through 
demonstration and physical rehearsal (e.g., exercises to increase active range of motion; oral care), which 
results in positive self-efficacy and outcome expectancies. A recent SCT-based intervention demonstrated 
that behavioral modeling was effective in promoting physical rehabilitation and reducing functional 
limitations in the injury recovery setting[65]. Patients who received the modeling intervention reported 
greater self-efficacy as well as greater objective functional outcome scores compared to controls[65]. Thus, 
the proposed program will attend to self-efficacy expectations of patients by providing them with various 
exercises to enhance coping and improve functional abilities (e.g., demonstrating exercise movements, 
teaching coping skills, modeling strategies for improving communication, providing tips for enlisting support 
from family and/or friends) and will include personal experiences of other survivors.  
 
2.1.d. Preliminary Studies. With support from the Keystone Program in Head and Neck Cancer, the 
research team has been conducting work directly relevant to this proposal:  
 
 
i) Psychosocial Functioning and Informational Needs in HNSCC Patients.  The research team 
conducted a pilot study of HNSCC patients (n = 88)[52].  Participants were predominantly male (67.8%) 
with a mean age of 58.9 years (SD = 10.8). Over half (58%) was classified as having early-stage disease. 
Participants reported high levels of cancer-specific distress (M = 18.17, SD = 10.32) as measured by the 
Impact of Events Scale (IES[53]). Patients also reported high levels of general distress (M = 30.61, SD = 
23.26) on the combined subscales of anxiety, depression, and anger from the Profile of Mood States 
(POMS[54]). Our findings are consistent with previous studies demonstrating significant levels of 
psychological distress among HNSCC patients[3, 17, 55] and support the need for developing psychosocial 
intervention programs for this population[13, 50]. Patients were queried about: 1) their levels of interest in 
receiving additional programs; 2) the type of program they desired; and 3) their preferred method for 
receiving such programs. All participants indicated that they would like to receive additional programming, 
particularly focused on treatment side effects. When asked about their preferences and needs, 89.7% of 
patients reported that they preferred to receive additional information they could read or view at home. The 
majority (79.3%) reported that they have a computer at home and 88% reported having Internet access 
(either at home or work). The majority of patients preferred to receive information either during treatment or 
shortly after treatment.  The most requested topics included: 1) Basic information about HNSCC and 
treatment; 2) Information about changes in swallowing and speaking following treatment; 3) Tips and 
strategies to help make eating and speaking easier; 4) Tips for coping with stress and anxiety; 5) How to 
stay healthy after treatment.   
 
 
ii) Psychosocial Interventions for Cancer Patients and At-Risk Populations. The research team 
will work closely with Triad Interactive to develop the proposed web-based intervention. Triad Interactive 
has extensive experience in developing multimedia interventions in the oncology setting.  For example, 
Triad Interactive designed and developed an interactive multimedia intervention (delivered via CD-ROM) to 
enhance knowledge about Microsatellite Instability (MSI) Testing and decision-making about MSI testing. 

5 
The total development time of the CD-ROM, including modifications, was 6 months. Results were uniformly 
positive, with 92.5% of CD-ROM participants reporting that the educational information was presented 
clearly, and 87.6% reported that they learned new information. Although the program was delivered via 
CD-ROM, it was developed using Web-ready technologies including HTML, JavaScript, and Adobe® 
Flash®.  Triad Interactive has also been involved in the graphic and instructional design, production, and 
programming for other NCI-funded studies including an interactive web-based program to facilitate decision 
making about prostate cancer screening (Lombardi Cancer Center); and an interactive computer-based 
program for decision making about BRCA1/2 genetic testing (Mt. Sinai School of Medicine). 
 
 
 
In sum, the preliminary findings suggest the following: 1) HNSCC patients report poor QOL and 
elevated distress, which supports the need for developing accessible intervention programs for this 
population; 2) most HNSCC patients (90%) noted that they would prefer to have informational materials 
that they could view at home, particularly on topics related to: cancer and cancer treatment; changes in 
speech and swallowing following treatment; and coping skills and communication training; and 3) the 
development of the proposed multimedia intervention is feasible to accomplish within the grant funding 
period. Finally, our team offers a diversity of expertise, including expertise in psycho-oncology and 
intervention development (Fang, Longacre), head and neck oncology (with Drs. Ridge, Burtness, and 
Galloway representing surgical, medical, and radiation oncology, respectively), biostatistics (Ross), pain 
management (Chwistek), physical rehabilitation (Bühler), and speech pathology (Ebersole).  
 
Data obtained from this project will be used to further refine the web-based program and submitted as 
preliminary data in support of a randomized trial to evaluate the effectiveness of the web-based program in 
enhancing QOL among HNSCC patients.  In that future study, it is hypothesized that use of the web-based 
program will contribute to enhanced patient QOL and psychosocial adjustment compared to a control 
group.  
 
2.2. Rationale  
 
Head and neck cancer and its subsequent treatment-related effects can have a significant negative impact 
on QOL, psychosocial adjustment, and interpersonal relations[3]. Psychoeducational interventions can be 
effective in improving QOL[4-5]; however, few programs have been developed for HNSCC patients despite 
preliminary data indicating a need for such programs in this patient population.  The proposed project will 
be one of the first to develop a web-based intervention for HNSCC patients.  At present, there are no 
similar existing programs for HNSCC patients despite the fact that such programs have yielded benefits for 
other cancer patient populations (e.g., breast, prostate). As such, building a theory-based resource for this 
patient population, and using the Internet to deliver such a resource, represents an innovative approach 
that may have a significant impact on QOL and psychological adjustment among a survivor population that 
experiences considerable morbidity. 
 
3.0 
OBJECTIVES 
 
The objectives of the proposed study are to: 
 
Aim 1. Develop a prototype web-based multimedia program that addresses four components, including: 1) 
Head and Neck Cancer and its Treatment; 2) Changes in Swallowing and Oral Care; 3) Changes in 
Speech; and 4) Coping with Cancer.  We will create the content and develop a prototype web-based 
program that presents both didactic information and cognitive and behavioral strategies for coping with 
treatment of HNSCC. Material presented in the web-based program will include informational text, brief 
videos, and graphics and animation. 
 
Aim 2. Evaluate acceptability and satisfaction with the prototype web-based program in a sample of up to 
75 HNSCC patients and 5 expert professionals. Specifically, the prototype developed in Aim 1 will be 

6 
evaluated by up to 75 patients who are currently undergoing or have recently completed radiation therapy 
and 5 healthcare professionals who work with the HNSCC patient population.  
 
Exploratory Aim 3.  Obtain preliminary data on potential program impact in a sample of up to 75 HNSCC 
patients.  Measures of psychosocial functioning and self-efficacy will be assessed at pre- and post-program 
assessment, in order to obtain preliminary data on potential intervention impact.  These data will be used to 
calculate potential effect sizes and support a future large-scale, randomized trial to evaluate the 
effectiveness of the web-based program in enhancing QOL among HNSCC patients.  
 
3.1 What are the dependent variables?  Aim 1 is the development of the web-based program.  For Aim 2, 
the primary dependent variables include satisfaction and acceptability of the web-based program among 
HNSCC patients and healthcare professionals.  For Aim 3, exploratory dependent variables include 
psychosocial functioning and self-efficacy. 
 
3.2 What are the independent variables?  Independent variables include demographic variables (e.g., 
age, gender, education level, race/ethnicity, income, area of residence); medical and disease-related 
factors (e.g., tumor site, stage, grade of differentiation, and performance status); treatment-related 
variables (e.g., time since treatment), and prior use of the Internet. 
  
3.3 Define endpoints.  For Aims 2 and 3, HNSCC patients will be assessed at baseline (at study entry) 
and immediately after viewing the web-based program. Healthcare professionals will provide feedback only 
once, after viewing the web-based program.  
 
4.0 SELECTION OF PARTICIPANTS 
 
 
4.1.  
Aim 1 - Prototype Development 
When programming is complete and approximately 50% of the content is in place, our collaborating experts 
will review the prototype and provide feedback as healthcare professionals who work closely with this 
patient population. In addition, we will recruit 5 HNSCC patients who have received radiation therapy within 
in the past 12 months to obtain their feedback on usability, using a modified version of the guidelines 
suggested by Usability.gov66.  Eligibility Criteria: Patients with squamous cell carcinoma of the oral cavity, 
oropharynx, hypopharynx, or larynx will be eligible. Exclusion criteria will include: 1) inability to read and/or 
communicate in English; 2) head and neck cancers of non-squamous histology (e.g., adenoid cystic 
carcinoma, acininc cell carcinoma, adenocarcinoma, sarcoma); 3) blindness or severity of visual 
impairment that precludes one’s ability to view images/text; 4) inability to provide informed consent.  
Potential participants will be identified by our collaborating physicians. 
 
4.2.  
Aim 2 - Evaluation of Web-based Program 
In light of our pilot data indicating that the majority of HNSCC patients prefer to receive information during 
or shortly after treatment, we will recruit up to 75 HNSCC patients who are currently undergoing or have 
recently completed radiation treatment (< 2 years). The same eligibility criteria as described in Aim 1 will 
apply to Aim 2.  HNSCC patients who are eligible to participate will be identified by our collaborating 
physicians.  Healthcare professionals (oncologists, speech therapists, physical therapists, social workers, 
etc.) who work with this patient population will also be identified by our research team members and 
recruited to participate and provide their opinions regarding the utility of this web-based program.  
 
4.3.  
Aim 3 – Exploratoration of Program Impact 
The 75 HNSCC patients recruited in Aim 2 will also serve as participants in Exploratory Aim 3. 
 
5.0 REGISTRATION PROCEDURES 
 
5.1.  
Aim 1 - Prototype Development  

7 
The prototype will be developed by Triad Interactive. The site will utilize W3C standards compliant HTML 
(HyperText Markup Language) and CSS (Cascading Style Sheets), Adobe® Flash®, ActionScript, and the 
Adobe® Flex™ framework. Encompassing the Website in a Flash-based site standardizes the code, 
eliminating the need to program workarounds for individual browsers. Triad has extensive experience 
developing similar Web-based projects, which includes user experience design, programming for Rich 
Internet Applications and other web-based projects, and quality assurance and testing. As the development 
process begins, the research team will meet with Triad Interactive to lay the groundwork for the 
development of the test website. Triad will develop the test website based on the design meeting. The test 
website will serve as a starting point for our discussions of interface "look and feel" and navigation 
elements. The research team will review the test website and agree to the interface design and 
functionality. Triad's instructional designers will work with the research team to identify appropriate 
illustrations, photographs, and other graphic content and to modify the content as appropriate for electronic 
delivery.  
 
Program Content. The following units will be developed during this pilot study:  
 How can I ease mouth and swallowing concerns? Participants will learn about potential changes in 
swallowing. Brief videos will describe strategies for managing swallowing concerns, including personal 
experiences of survivors.   
 How can I keep my mouth healthy? Proper oral care and other potential side effects of radiation therapy 
(xerostomia, mucositis) will be described.  
 How can I eat healthy?  Tips for creating nutritious meals for people with swallowing disorders will be 
provided.  
 How do I ease speech problems? This section will examine possible temporary or permanent changes 
in speech and the role of a speech language pathologist. Strategies for enhancing speech will be 
described, and physical exercises that involve mouth and tongue movement will be demonstrated. 
 How do I cope with my new normal? This section will address challenges in various life domains (e.g., 
physical health, emotional well-being) and describe how other HNSCC survivors have met these 
challenges. Behavioral strategies, social skills training, and relaxation exercises will be demonstrated 
using brief videos.  
 How do I manage my pain?  Participants will learn about pain management techniques as well as 
strategies for dealing with side effects of pain medications. 
 How can physical therapy help me?  This section will address the importance of physical therapy in 
rehabilitation following treatment for head and neck cancer.  Brief videos of various physical therapy 
exercises will be demonstrated by a licensed physical therapist. 
 
When programming is complete and approximately 50% of the content is in place, our collaborating experts 
will review the test website and provide feedback as healthcare professionals who work closely with this 
patient population.  In addition, we will recruit 5 HNSCC patients who have completed radiation therapy to 
obtain their feedback on usability.  Patients will be recruited through physician referrals from radiation 
oncology at FCCC.  Recruitment will occur either in-person or by telephone. Patients who consent to 
participate will be scheduled to view the prototype web-based program at FCCC.  Following the guidelines 
suggested by Usability.gov, participants will be observed while using the program to evaluate navigation 
ease and usability. After each participant has viewed the test web-based program, they will be asked to 
complete measures assessing: (a) appropriateness of content, and (b) level of difficulty in using the web-
based program (see Appendix A). If participants rate any particular section as not very useful or not clear, 
the research assistant or project manager will verbally solicit more detailed reactions and comments.  
Participants will also be interviewed after user testing to obtain more open-ended responses and reactions 
to the web-based program. Each participant will receive $50 for participating in the study. All web-based 
program content will be finalized based on the recommendations obtained from the usability pilot testing 
and necessary modifications (e.g., re-shooting video sequences, changing graphics, revising narration) will 
be made to correct any problems. These final modifications will then be reviewed and approved by the 
research team prior to further evaluation in Aim 2.  

8 
5.2.  
Aim 2 - Evaluation of Web-based program 
For Aim 2, HNSCC patients will be recruited via referrals from treating physicians and healthcare providers 
or identified through the tumor registry at FCCC.  A research assistant or project manager will speak with 
potential participants in-person or by telephone to describe the study procedures. Patients who are 
interested in participating will provide informed consent, complete a baseline assessment (see Appendix 
B), and be scheduled to view the web-based program at FCCC or at home, depending on the patient’s 
preference.  A member of the research team will be available for technical troubleshooting and assistance. 
After viewing the program, the participant will complete an evaluation and assessment form. In addition, the 
Project Manager will conduct a brief interview with participants to obtain additional feedback in response to 
open-ended questions concerning how one might use this web-based program, potential barriers to use, 
their preferences regarding the information provided, and satisfaction with the visual images and graphics, 
videos, and informational text. This will allow participants to elaborate on their reactions to the various 
sections of the web-based program.  Each participant will receive $50 for participating in the study.  
 
Based on physician estimates and tumor registry numbers, we anticipate that there will be a pool of 
approximately 6 patients completing radiation treatment per month at FCCC. In the first month of accrual, 
we will identify 12 patients (completed treatment in the past 2 months), and then 6 patients/month 
thereafter. We estimate that 85% of patients will meet inclusion criteria and 65% of eligible patients will 
agree to participate (based on our prior studies with this population). Over a 22-month recruitment period, 
we anticipate enrolling up to 75 patients (136 patients x 85% x 65% = 75). 
 
In addition, our collaborating physicians will identify other healthcare professionals who work with this 
patient population.  These individuals will be contacted and asked to participate in this study.  For those 
who are interested in participating and who provide informed consent, we will schedule a time for them to 
review the program and complete a brief evaluation form (see Appendix C) and short interview with the 
Project Manager or other member of the research team. Healthcare professionals will be asked whether 
they believe the information will be useful to their patients, whether they believe the web-based program 
can be an effective tool for demonstrating various exercises, and whether they would recommend the 
program to their patients.  
 
5.3.  
Aim 3 - Exploratoration of Program Impact 
Same as above for Aim 2 (see Section 5.2).  HNSCC patients will complete baseline assessments of QOL, 
psychosocial functioning, and self-efficacy (see Section 7.0).  In addition, a subset of measures 
(psychosocial functioning and self-efficacy) will be administered again after patients have viewed the web-
based program to obtain preliminary data on intervention impact. Given that patients will have only had the 
opportunity to review the program (but not engage in any practice), changes in functional status are not 
anticipated, and therefore, the QOL measures will not be re-assessed. 
 
6.0 STUDY DESIGN 
 
6.1. 
Study Overview 
This study involves the development and evaluation of a web-based program for HNSCC patients who 
have recently completed radiation therapy.  
 
6.2. 
Sample 
For Aim 1, 5 HNSCC patients will be recruited to assess usability. For Aim 2, participants will include up to 
75 HNSCC patients who are currently undergoing or have recently completed radiation treatment (< 2 
years), and 5 healthcare professionals will work with this patient population.   The 75 HNSCC patients 
enrolled in Aim 2 will also be used to complete Aim 3. 
 
6.3. 
Procedures 
Please refer to Section 5.0 for a description of the procedures.  

9 
7.0 MEASUREMENT OF EFFECT 
 
7.1.  
Aim 1 – Prototype Development  
Participants will complete a brief demographic survey and then measures assessing: (a) appropriateness 
of content, and (b) satisfaction with the web-based program.   We will also interview participants after user 
testing to obtain more detailed comments regarding any sections that were rated as not very useful or not 
clear. Program content will be revised based on the recommendations obtained from the usability pilot 
testing.  
 
7.2.  
Aims 2 and 3 – Evaluation of Web-Based Program  
 
7.2.a. Baseline Assessment 
 
Demographic variables including age, gender, race and ethnicity, education, income and occupation, 
and marital status will be assessed.  In addition, participants’ prior use of the Internet (both general use and 
for seeking health information) will be measured.  
 
Disease characteristics including tumor site, disease stage, grade of differentiation, and Karnofsky 
performance status (KPS)71 will be obtained by research staff from medical chart review. Treatment 
variables including length of treatment and dosage will be obtained by research staff from medical chart 
review.   
 
To obtain preliminary effect sizes for future trials (Exploratory Aim 3), we will also assess quality of 
life, psychosocial functioning, and self-efficacy. Quality of life (QOL) and Head and Neck-specific QOL will 
be measured using the EORTC Quality of Life Questionnaire (EORTC QLQ-C3072) and the Head and Neck 
Module (EORTC-H&N3573), respectively. The EORTC QLQ-C30 is a validated cancer-specific self-report 
questionnaire25,26,74-76 that consists of a global quality-of-life scale, 5 functional scales, and 9 symptoms 
scales.  The EORTC QLQ-H&N35 is designed to be used together with the QLQ-C30 and has good 
reliability and validity among patients with head and neck cancer77,78.  Psychosocial functioning (namely, 
general and cancer-specific distress) will be measured using the Brief Symptom Inventory-18 (BSI-1879), an 
18-item instrument that has been used extensively with medical populations80 and in our prior studies. The 
BSI-18 is highly reliable and valid and yields a composite score (Global Severity Index) and three subscale 
scores: somatization, depression, and anxiety. Cancer-specific distress will be measured using the Impact 
of Events Scale (IES), which is a well-validated self-report measure of avoidant and intrusive ideation53. 
Self-efficacy for coping with cancer-related stressors and activities will be assessed using the brief version 
of the Cancer Behavior Inventory (CBI-B)81, which is a 14-item shortened version of the original CBI. 
 
A subset of psychosocial measures (general and cancer-specific distress, self-efficacy) will be 
administered again after patients have viewed the website to obtain preliminary data on intervention 
impact. Given that patients will have only had the opportunity to review the web-based program (but not 
engage in any practice), changes in functional status are not anticipated, and therefore, the QOL measures 
will not be re-assessed. 
 
 
7.2.b. Patient Evaluation of the Web-based Program 
 
Patients will evaluate the web-based program in the following four areas: (1) Satisfaction with the web-
based program; (2) Identification of material that patients liked and disliked; (3) Plans to use the web-based 
program and/or recommend it to others; and (4) Overall evaluation of program content and format.  Sample 
assessment questions are: a) Overall, how informative was this web site? (rated on a scale from 1-Not 
informative to 5-Extremely informative); b) How useful was the section on treatment side effects? (rated on 
a scale from 1-Not useful to 5-Extremely useful); c) How useful was the section on changes in swallowing? 
(similar questions to be asked for each topic unit, e.g., changes in speech, coping with cancer); d) Were 
the physical therapy videos useful?; e) If you could access this web-based program at home, how easily 
would you be able to use this on your own?; f) Overall, I would rate this program… (from 1 – “Poor” to 5 – 
“Excellent”); g) Overall, I would be likely to use this web-based program... (1–“Not at all” to 5–“Frequently”); 
h) Overall, I wish I had access to a web-based program like this now (1–“Strongly disagree” to 5–“Strongly 
agree”); i) Was there anything that was unclear? If yes, please note which section; j) What other types of 

10 
information would you like to have available on this web site?.   
 
7.2.c.  Healthcare Provider Evaluation of the Web-based Program  
 
Similarly, 5 healthcare professionals will be asked to provide ratings after viewing the web-based 
program regarding the usefulness of this program for their patients.  Sample items include “The information 
presented in this program would be useful to my patients” (to be rated from 1 – “Strongly disagree” to 5 - 
“Strongly agree”) and “I would recommend this program to my patients”. 
 
8.0 STUDY PARAMETERS 
Table 1 presents the measures to be obtained at each assessment time point:  
 
Aims 2 and 3:  Measures and Assessment Time Points 
Questionnaire Name 
# of Items 
Time to Complete 
Baseline 
Follow-up 
Demographics 
7 
5 min 
X 
 
Internet Use 
4 
5 min 
X 
 
EORTC QOL & H&N35 
65 
10 min 
X 
 
Brief Symptom Inventory 
18 
5 min 
X 
X 
Impact of Events Scale 
15 
5 min  
X 
X 
Cancer Behavior Inventory 
14 
5 min 
X 
X 
Program Evaluation* 
22 
10 min 
 
X 
Total 
143 
 
35 minutes 
25 minutes 
* Healthcare professionals complete a 7-item program evaluation form only. 
 
 
9.0 
PHARMACOKINETIC STUDIES 
 
Not applicable to the proposed study. 
 
10.0 
OFF-STUDY CRITERIA 
 
The off-study criteria include the following: 1) participants who no longer wish to participate in the study; 2) 
participants who do not evaluate the web-based program.   
 
11.0 
DRUG FORMULATION AND PROCUREMENT INFORMATION 
 
Not applicable to the proposed study. 
 
 
12.0 
STATISTICAL CONSIDERATIONS 
 
12.1. Data Management 
All participants will be assigned a unique study identification number upon entry into the study. Data will be 
collected onto hardcopy instruments and entered by project staff into a secure database using PRESAGE. 
Completed hardcopy instruments will be filed in locked cabinets.  
 
12.2. Statistical Data Analysis  
Descriptive statistics will be compiled to characterize participants’ demographic and medical 
characteristics.  Given that Aim 1 is the development of the web-based program, a data analytic plan is 
presented only for Aims 2 and 3.    
 

11 
12.2.a. Approach and Analysis.  Descriptive statistics (e.g., means with associated two-sided 95% 
confidence intervals) will be used to characterize participant satisfaction, usage, acceptability of the 
program and the time participants spend in each section of the program.   
 
Responses to open-ended questions will be categorized into themes and used to characterize issues that 
are consistently raised (e.g., 50% of patients commented that the actor in the first video was unattractive or 
unappealing to them).  In general, this is not a qualitative study; however, any qualitative data that are 
obtained in response to the open-ended questions can be coded (e.g., combing the data for themes, ideas 
and categories and then marking similar comments with a code label so that they can easily be retrieved at 
a later stage for further comparison and analysis) to facilitate making comparisons (e.g., between male and 
female patients, older and younger patients) and to identify any patterns that require further 
investigation[82].  The process of coding (associating coding labels with the text) will be performed by the 
PI and the Project Manager. The PI has received training in qualitative data analysis and recently 
completed 2 qualitative analysis courses at Temple University (January, 2011). Themes that are identified 
will be discussed together with the research team. To provide information relevant to the further 
development of the program, we will also explore whether demographic factors (gender, age, education 
level) or disease characteristics (stage of disease, tumor location) are associated with participant ratings or 
time spent exploring the web-based program.  Spearman’s correlation or Kruskal-Wallis tests will be used 
to assess associations between satisfaction, usage and acceptance with continuous and categorical 
covariates, respectively.  
 
For Aim 3, descriptive statistics (e.g., means with associated two-sided 95% confidence intervals) will be 
used to characterize levels of QOL, psychosocial functioning, and self-efficacy.  As noted in section 5.2, the 
sample size for this study is based on the duration of funded recruitment provided by the grant.   With data 
from at least 45 participants, the two-sided 95% confidence interval around a mean will be ±0.29σ, the two-
sided 95% confidence interval around a binomial proportion will be no greater than 0.15, and we will be 
able to detect correlations of ±0.4 with 80% power using a test with 5% type I error. The preliminary data 
obtained from Aims 2 and 3 will be used to support future applications to evaluate the effectiveness of such 
a web-based program in enhancing QOL among HNSCC patients. 
 
12.2.b. Indicators of Success.  The following criteria will be used to indicate high satisfaction and 
acceptability with the web-based program: 1) Satisfaction and acceptability – Mean ratings of 4 or 
greater on a 5-point rating scale will indicate a high degree of patient satisfaction with the information 
presented; 2) Amount of material that patients liked - Mean patient ratings of 4 or greater on the 
“usefulness” scale for at least 3 of the 4 units presented (units that are rated lower will either be dropped or 
extensively modified); 3) Plans to use the website - At least 75% of patients indicating that they would 
use such a website, if available; 4) Overall evaluation – overall patient evaluation ratings of 4 or greater 
on a 5-point rating scale; 5) Healthcare professional ratings - mean ratings of 4 or greater on a 5-point 
scale indicating that the information presented will be useful to their patients and their beliefs that the 
website can be an effective tool for demonstrating various strategies and exercises.  In addition, at least 
80% (4 of 5 healthcare professionals) would agree or strongly agree with the statement that they would 
recommend such a web-based program to their patients.  We will conclude that the web-based program is 
worthy of further investigation if at least 3 of the 5 criteria above are satisfied. 
 
13.0 
ADVERSE EVENT REPORTING 
 
13.1. Data Safety and Monitoring.   Two FCCC committees – the Research Review Committee (RRC) 
and the Institutional Review Board (IRB) – will monitor the protection of human subjects and the safe and 
confidential storage of data.  These committees assess all proposed studies before initiation and then 
review protocols annually.  The objective of these committees is to ensure the scientific, technical, and 
statistical soundness of the research and to guarantee that all necessary methods for the ethical and safe 
treatment of human subjects are utilized. These committees heavily scrutinize the scientific and ethical 

12 
aspects of protocols and provide an objective and ongoing assessment of the study's scientific and ethical 
integrity. 
 
13.2. Adverse Event Reporting.  The potential risks associated with the proposed project are minimal. 
Possible risks include: feeling worried, uncomfortable, or fatigued while viewing the web-based program; 
feeling anxious, uncomfortable or fatigued while completing the questionnaires or when speaking with the 
Project Manager. All participants are informed of the potential for possible adverse psychological reactions 
associated with participating in the study during the informed consent process.  
 
Any unexpected or adverse event that occurs during data collection or study procedures is reported 
immediately to the Principal Investigator, who is responsible for documenting all adverse events with the 
FCCC Protocol Office or Institutional Review Board.  For participants who are experiencing psychological 
distress reactions, the Principal Investigator will be alerted and the patients will be provided with a referral 
to appropriate services in the Department of Social Work or Psychiatry (in the Department of Medicine).   
 
13.3. Commercial Drugs.   Not applicable to the proposed study. 
 
13.4. Investigational Drugs.  Not applicable to the proposed study. 
 
 
14.0  PATHOLOGY REVIEW 
 
Not applicable to the proposed study. 
 
15.0  RECORDS TO BE KEPT 
 
FCCC Population Studies Facility (PSF) programmers will design, develop and maintain a relational 
database management system (RDMS) to meet the needs of this project. The software will run on a 
distributed computing system consisting of multiple Sun Microsystems computers and use the Oracle (V9i) 
database engine at the backend. All data will be entered by project staff via web-enabled data entry 
screens designed and developed by PSF programmers.  Project staff will also use this interface to access 
tabular study event reports and accrual statistics and to manage activities specific to individual study 
subjects. 
 
Every precaution will be taken to ensure that all data are kept strictly confidential.  All collected data will be 
used solely for the purpose of the present research study and treated with full confidentiality.  Specifically, 
each participant will be assigned a code number, which will be used in place of his/her name.  The key that 
links each participant's name to his/her respective code number and all completed questionnaires will be 
stored in a locked cabinet in the principal investigator's office.  All data will be analyzed using code 
numbers only.  The results of the study will be presented in a summary fashion.  
 
16.0  PATIENT INFORMED CONSENT 
 
Participants will be recruited either in-person or by telephone contact.  A staff member will describe the 
study rationale and procedures before obtaining informed consent.  All eligible patients will be asked to 
review and sign the informed consent document (see Appendix D) prior to participation in the study.  
Participants will be informed that they can withdraw from the study anytime during or after the informed 
consent process without consequence for their current or future medical care.   

13 
 
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18.0  MULTICENTER TRIALS 
Not applicable to the proposed study.