Enhancing Clinician Communication About Sexual Health in Breast Cancer
Phase: NA
Conditions: Breast Cancer
Sponsor: Fox Chase Cancer Center

Principal Investigator: Jennifer B. Reese
Abbreviated Title: Clinician Communication about Sexual Health 
IRB #18-1068
NCT04262219
Page 1 of 16
Protocol Title
Enhancing Clinician Communication about Sexual Health in Breast Cancer
Principal Investigator
Jennifer B. Reese, PhD
Co-Investigator(s):
Mary Daly, Fox Chase Cancer Center
Lauren Zimmaro, Fox Chase Cancer Center
Stephen Lepore, Temple University Health System
Mary Catherine Beach, Johns Hopkins University School of Medicine
Elaine Wittenberg, California State University
Sharon Bober, Dana-Farber Cancer Institute
Areej El-Jawahri, Massachusetts General Hospital
Antonio Wolff, Johns Hopkins University
Participating/Collaborating Institutions:
N/A
Statistician:
Elizabeth Handorf
Funding Source:
1 R03 CA235238-01
Initial Version Date: 10/10/2018
Amendment #
7
Version date:
9/3/2020
IRB#: 18-1068MOD9 Approved: 9/4/2020 Expires: 8/16/2021          

Principal Investigator: Jennifer B. Reese
Abbreviated Title: Clinician Communication about Sexual Health
IRB #18-1068
Page 2 of 16
Table of Contents
Section
Page
1.0
Introduction…………………………………………………………………………………………………….    3
2.0 
Objectives……………….........................................................................................    3
3.0
Background……………………………………………………………………………………………………..    3
4.0
Study Design……………………………………………………………………………………………………    5
5.0
Risk to Participants………………………………………………………………………………………….    8
6.0
Potential Benefits to Participants…………………………………………………………………….    8
7.0
Provisions to Maintain the Confidentiality of Data…………………………………………..   8
8.0
Costs to Participants…………………………………………………………………………………………   9
9.0
Consent Process………………………………………………………………………………………………    9
10.0   
Off-Study Criteria…………………………………………………………………………………………….    9
11.0
Drugs and Devices……………………………………………………………………………………………    9
12.0
Multi-Site Research Study………………………………………………………………………………..   9
13.0
Statistical Analysis……………………………………………………………………………………………   9
14.0
Data Safety Monitoring Plan……………………………………………………………………………    10
15.0
Adverse Event Reporting………………………………………………………………………………….   10
16.0
Quality Assurance Procedures and Participant Confidentiality…………………………    10
17.0
Participant Informed Consent………………………………………………………………………….    11
18.0
References……………………………………………………………………………………………………….   11
19.0
Appendices………………………………………………………………………………………………………   15
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Principal Investigator: Jennifer B. Reese
Abbreviated Title: Clinician Communication about Sexual Health
IRB #18-1068
Page 3 of 16
1.0 Introduction
Over ninety percent of women with breast cancer survive 5 years beyond diagnosis,1 making quality of 
life (QOL) concerns such as sexuality highly significant. Breast cancer negatively affects patients’ 
sexuality and intimacy, leading to both physical (e.g., vaginal dryness) and motivational/emotional 
problems (e.g., body image distress).2-7 Sexual problems such as these tend to persist over time even as 
other QOL concerns improve.2,8,9 If unaddressed, sexual problems can lead to significant distress for 
breast cancer patients. In recognition of the seriousness of sexual problems for breast cancer patients 
and in light of the increasing availability of evidence-based interventions to address these problems,10,11 
recent clinical guidelines have uniformly called for breast cancer clinicians to discuss sexual health with 
their patients in their routine cancer care.10,12,13 In the same vein, the vast majority of breast cancer 
patients want sexual health to be discussed with them during their cancer care.14,15 Yet the evidence 
suggests that communication about sexual health is largely absent for breast cancer patients,16,17 with 
only 30-40% of breast cancer patients reporting that their clinicians discussed sexual health with 
them.15,16,18-20 A key factor underlying this lack of communication is the inadequate training that breast 
cancer clinicians receive in how to communicate with their patients about sexual health.17-19,21 The 
absence of sexual health communication in the face of considerable patient distress thus constitutes a 
critical gap in the care of women with breast cancer. Evidence-based interventions are critically needed 
to target breast cancer clinicians’ communication about sexual health.
2.0 Objectives
The objective of the proposed study is to adapt a previously tested brief intervention aimed at 
enhancing clinicians’ communication about sexual health (iSHARE) to a mobile web-based platform 
showcasing a two-part podcast and to assess the feasibility, acceptability, and preliminary effects of the 
intervention in breast cancer clinicians.
Specific Aim 1. To assess the feasibility and acceptability of iSHARE in a mLearning format. 
Hypothesis 1. iSHARE will be judged as feasible, determined through measures of rates of participant 
enrollment, retention, and study completion.
Hypothesis 2. iSHARE will be judged as acceptable, determined through post-intervention evaluations of 
intervention satisfaction, helpfulness, and relevance, and ease of participation.
Specific Aim 2. To assess the preliminary effects of iSHARE in a mLearning format. 
Hypothesis 3. iSHARE will show positive effects on clinicians’ knowledge, beliefs (self-efficacy, outcome 
expectancies), and communication with respect to sexual health from pre-to post-intervention.
3.0 Background/Rationale
A woman in the U.S. today has a 1-in-8 chance of being diagnosed with breast cancer.22 Advances in 
detection and treatment improve survival for breast cancer, with a relative survival rate of 91% at 5 
years post-diagnosis and 85% at 15 years post-diagnosis.22 Yet these life-extending treatments come at 
the cost of substantial impact on quality of life (QOL) for many women. Sexual health problems are 
among the most distressing health problems women with breast cancer face due to their treatments.23-
25 Common sexual problems for breast cancer patients include both physical (e.g., vaginal dryness, 
IRB#: 18-1068MOD9 Approved: 9/4/2020 Expires: 8/16/2021          

Principal Investigator: Jennifer B. Reese
Abbreviated Title: Clinician Communication about Sexual Health
IRB #18-1068
Page 4 of 16
painful intercourse)26-28 and motivational/emotional types of problems (e.g., loss of sexual interest, body 
image distress).3,4 For breast cancer patients, surgical scarring can lead to body image distress, and 
hormonal therapy and chemotherapy can alter sex hormones, leading to distressing vaginal symptoms 
(e.g., dryness) and loss of sexual interest.2,28 Sexual problems are distressing4,29 and highly persistent for 
breast cancer patients improving at a much slower rate than other domains of health and function.6,30-32 
Addressing breast cancer-related sexual problems can improve women’s mental health33-35 and 
relationship quality;34-37 reducing the distressing sexual side effects of hormonal therapies can improve 
treatment adherence.38 Although sexual health is included in recent clinical cancer care guidelines 
alongside other health concerns (e.g., pain, fatigue),12,13 it is overwhelmingly neglected clinically,16,17 
making this work significant and timely. Only 10-52% of breast cancer patients receive even basic 
information from their clinicians about sexual health effects of their treatments.15,39-42 Research shows 
that most women with breast cancer want to preserve their sexual health and discuss these concerns 
with their clinicians.14,43,44 All available data, however, suggest that patient-clinician communication 
about sexual health is inadequate for breast cancer patients.16,19,45 Lack of appropriate training, 
knowledge, and basic skills for communicating about sexual health prevent clinicians from discussing 
sexual concerns with their patients.16-19,21,46,47 
Research demonstrates that very brief communication training interventions (<5 hours) can significantly 
improve clinicians’ knowledge, confidence, beliefs, and skills,48-52 particularly when targeting specific 
communication tasks (e.g., sexual history-taking,53 discussing cancer prognosis).54 In a previous study, 
we developed and tested a novel, brief communication training intervention for breast cancer clinicians 
called improving patients’ Sexual Health and Augmenting Relationships through Education (iSHARE). This 
intervention was grounded in social cognitive theory, which emphasizes individuals’ beliefs (i.e., self-
efficacy and outcome expectancies) as critical processes underlying successful behavioral 
interventions,55-59 in current models of communication skills development,59-61 and in the perspectives of 
cancer patients and clinicians from formative research.62 We found promising effects of the 
intervention, but noted challenges in its administration. Given the promise that the iSHARE intervention 
showed in our pilot trial, the need for interventions that can be widely disseminated, and the growing 
evidence supporting incorporating mobile technologies into medical practice, the overall objective of 
the proposed study is to adapt the iSHARE intervention to a mobile technology (mLearning) format and 
pilot test it. Based on the results of our preliminary work, as shown in Figure 1, we expect that iSHARE 
will improve clinicians’ (1) knowledge in key topic areas relevant to communication about sexual health, 
and (2) beliefs regarding their confidence for communicating about sexual concerns (self-efficacy) and 
that discussions will lead to a desired outcome such as successfully identifying patients with sexual 
concerns and addressing patients’ concerns (outcome expectancies). Based on research suggesting that 
self-efficacy and outcome expectancy beliefs are strongly associated with the likelihood of engaging in a 
behavior,63 we also expect that increasing clinicians’ knowledge and beliefs in these domains will lead to 
increases in key clinician communication behaviors regarding sexual health (i.e., asking questions and 
offering information about sexual health), and this is supported by the effects we found in our pilot 
work. 
IRB#: 18-1068MOD9 Approved: 9/4/2020 Expires: 8/16/2021          

Principal Investigator: Jennifer B. Reese
Abbreviated Title: Clinician Communication about Sexual Health
IRB #18-1068
Page 5 of 16
Within the possible mLearning formats, a podcast was selected because recent research shows that 
podcast use is increasing rapidly in the general population, are most likely to be listened to in a mobile 
format (i.e., on a smartphone),64,65 and have been shown to be well-received66,67 and efficacious in 
increasing clinician knowledge, beliefs/attitudes, and communication skills both within and outside of 
cancer care.66,68-70 If shown to be effective, the iSHARE intervention could ultimately be disseminated 
through existing channels offering continuing medical education (CME) or other medical education, such 
as the American Society for Clinical Oncology (ASCO), which have already incorporated podcasts into 
their web course offerings, and journals (e.g., JAMA). Finally, podcasts are consistent with many cancer 
clinicians’ preferences for interventions that are brief, convenient, and flexible,62 and would allow 
clinicians to insert the intervention into their daily routines (e.g., when commuting).   
4.0 Study Design
4.1 Recruitment and Reimbursement
In all, about 43 breast cancer clinicians (oncologists, advanced practice clinicians) will participate (6-8 
fellows in cognitive interviews; 30-35 oncologists or advanced practice clinicians in pilot trial). Due to 
attrition, we plan to recruit for the pilot trial until we reach 30 study completers. We estimate that we 
will need to consent 33 providers to the trial in order to reach 30 study completers, but may need to 
recruit a few more participants if attrition increases (i.e., due to COVID-related changes in clinician 
availability). We will recruit clinicians from Fox Chase Cancer Center, Temple University, and 
affiliate/community hospitals (e.g., MD Anderson Cooper, Einstein) using methods we successfully 
employed in our prior work, including during staff meetings, or through direct contact with the PI after 
identification through the FCCC Partners Program or through colleagues. Study collaborators may recruit 
their colleagues on behalf of the PI, using approved recruitment materials. Emails sent to study 
candidates will include the opportunity to click on a link to see the study information and be brought to 
the baseline survey directly, which may enhance feasibility. Candidates will be asked eligibility questions 
in REDCap to ensure that inclusion criteria are met before consent. Study candidates who enroll through 
this email link will be asked to provide contact information and will be asked their permission to receive 
occasional text messages about the study, such as survey reminders. Clinicians may forward the 
recruitment email to other clinicians to refer them to the study. We may also recruit through online 
websites or social media platforms such as the American Cancer Society TheoryLab, ASCO or similar 
organizations. 
Number of 
subjects per year 
projected at FCCC
Total number of 
subjects at FCCC
Number of subjects 
nationally or 
internationally (if 
applicable
Number of subjects 
at collaborating 
institutions (if 
applicable)
Up to: 8
Up to: 8
33
2
Cognitive interview participants will be reimbursed $50; pilot trial participants will be reimbursed $50 
for each of two surveys ($100 total). Compensation will be given in the form of gift cards.
4.2 Inclusion and Exclusion Criteria
Eligibility criteria are presented in Table 1 below. We will exclude clinicians who previously participated 
in the pilot study of iSHARE, as this could confound findings. For cognitive interviews, we will include 
fellows who have been through their breast oncology rotation and have therefore had experience in 
treating breast cancer patients. We have recruited fellows for a similar purpose in our prior work.
IRB#: 18-1068MOD9 Approved: 9/4/2020 Expires: 8/16/2021          

Principal Investigator: Jennifer B. Reese
Abbreviated Title: Clinician Communication about Sexual Health
IRB #18-1068
Page 6 of 16
Table 1. Inclusion and Exclusion Criteria for Trial
Inclusion Criteria

Is a medical oncologist or medical oncology advanced practice clinician (Nurse Practitioner, Physician 
Assistant) who treats breast cancer patients  

Did not participate in the pilot study of iSHARE
4.3 Study Procedures
4.3.1 Cognitive Interviews
Prior to the cognitive interviews, the PI will draft a mock-up of iSHARE in its new mLearning format 
based on the following: iSHARE template, a review of evaluations from clinicians in our pilot study, 
expert team feedback, and a review of the literature.71 The objective of the cognitive interviews (N=6-8; 
60 min; led by PI or other trained staff member such as a post-doctoral fellow) will be to review the 
appropriateness and comprehensibility of the materials. Cognitive interviews will be completed with 
oncology fellows at FCCC in a private office or conference room and will be audio recorded. After signing 
a consent form and completing a brief demographic survey, the fellows will be asked to read through 
scripts of the podcasts and pause their reading to comment on aspects of the material that are 
especially (a) helpful/relevant, (b) unhelpful/irrelevant, or (c) unclear and a standard set of follow-up 
items will be administered to supplement this information. In addition, after the participants have 
completed the “off the cuff” part of the interview, the interviewer will ask a set of standard questions 
about the content and format of the program (see Cognitive Interview). Using methods we have found 
helpful previously, participants’ responses will be summarized in a matrix to facilitate synthesis of their 
comments72 according to type of comment (e.g., content, structure, wording/phrasing used) and by 
order of frequency of appearance (i.e., number of participants commenting on that issue).73 Using this 
list, the PI will draft a list of modifications to be made, which will be reviewed by study team experts. 
Potential examples of changes that could be made using the cognitive interview data are: changing 
details of the case examples given, modifying wording or language, or adding clarification or emphasis. 
Although substantive changes will be made after the themes have been tallied across the interviews, 
modifications to the program scripts or other materials may also be made intermittently in between 
interviews in an iterative process when necessary. For instance, if a participant identifies an aspect of 
the script that is unhelpful or inappropriate, this should be changed prior to the upcoming interviews so 
that time is not spent in upcoming interviews on an obvious needed change. We may stop recruiting for 
the cognitive interviews after a minimum of 6, assuming that we have obtained adequate information 
that will be used to inform the intervention. 
4.3.2 Intervention 
All participants will receive the iSHARE podcast intervention. This will consist of a two-part 
podcast series with expert guests. Part 1 (Education) will include information on rates, 
types, and causes of breast cancer patients’ problems related to sexual health, models of 
sexual response (function),74 current evidence-based approaches for addressing sexual 
concerns (e.g., information from recent key randomized controlled trials),75,76 and 
information about patient resources. Part 2 (Skills) will target basic clinician 
communication skills, with a major focus being teaching the stepped-care model of sexual 
health care known as PLISSIT77 (see Figure 2), and an emphasis on the first two steps in the 
model, i.e., Permission and Limited Information. The major behavioral targets for 
IRB#: 18-1068MOD9 Approved: 9/4/2020 Expires: 8/16/2021          

Principal Investigator: Jennifer B. Reese
Abbreviated Title: Clinician Communication about Sexual Health
IRB #18-1068
Page 7 of 16
communication skills training that will be emphasized are initiating a conversation about sexual health, 
asking effective questions to patients about sexual health or concerns, offering information about the 
impact of breast cancer treatment(s) on patients’ sexual health, and initiating a referral for a patient, 
when appropriate. Key topics within patients’ sexual health that will be discussed could include vaginal 
dryness and discomfort during sexual activity, sexual desire or interest, safety of sexual activity during 
treatments, and body image or appearance. Information from the most updated NCCN Survivorship 
Guidelines, which provide guidelines for assessing and managing sexual function for cancer survivors, 
may also be included such as suggested wording for initial questions for clinicians to ask patients. 
Content could also include recognition of common patient and clinician barriers to effective 
communication about sexual health,62,78-81 patient preferences for communication about this topic,62,82 
and discussion of contextual/socio-cultural factors, such as the partner’s presence in the room, a gender 
mismatch between the patient and clinician, patient sexual minority status, or ethnic or religious 
differences.62,78,83 Other relevant information may also be added during the refinement phase.
4.3.3 Measures and Self-Report Data Collection
Clinicians who participate in the cognitive interviews will be asked to complete a brief demographic 
survey (6 items) prior to listening to the podcast draft, either in person or online. Clinicians who 
participate in the pilot trial will be asked to complete an online consent form and baseline survey. Table 
2 shows the self-report measures that will be administered to pilot trial participants. Paper copies of 
consents and surveys will be provided for participants who prefer to complete hard copies of these 
forms. Web consents and surveys will be sent to participants using a REDCap link. REDCap is a secure, 
web-based application that is flexible enough to be used for a wide variety of research studies, offers 
intuitive interfaces for data entry and real time data validation, and supports easy data manipulation 
with audit trails and reporting capabilities, including automated export to common statistical packages. 
REDCap for electronic data collection is preferred over paper and pencil administration for this study 
because: (1) it can be completed in less time and is therefore potentially less burdensome for 
participants; (2) it is less burdensome to the investigators in terms of both collection and data entry – 
essentially eliminating the need for by-hand data entry of self-report measures; (3) it leads to fewer 
human errors because it obviates the need for by-hand data entry. Participants will be asked to 
complete two additional surveys throughout the study: one after podcast episode 1, which includes 
knowledge quiz items and the episode 1 program evaluation (acceptability items), and another one after 
podcast episode 1, which contains the knowledge items, the acceptability items, and the outcome 
measures (e.g., communication, beliefs). 
Table 2. Pilot Self-Report Measures
Measure
# Items
Minutes to 
Complete
Baseline
Post-
Episode 1
Post-
Episode 
2
Demographics
6
3
X
-
-
Knowledge
T1: 10
Post Ep 1: 5
T2: 5
3
X
X
X
Self-efficacy (Beliefs)84
3
1
X
-
X
Outcome Expectancies (Beliefs)59
7
3
X
-
X
Communication Behaviors
10
5
X
-
X
COVID-19 Clinic Assessment
13
5
X
-
-
Program Evaluation
12
5
-
X
X
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Principal Investigator: Jennifer B. Reese
Abbreviated Title: Clinician Communication about Sexual Health
IRB #18-1068
Page 8 of 16
4.3.3.1 Outcome Measures
Aim 1. (1) Feasibility will be measured through measures of participant enrollment defined as the 
percent of eligible candidates approached who enroll, retention to study completion, defined as 
completion of all study surveys, and rates of intervention completion, defined by self-report responses 
on the program evaluation. We are also collecting self-report information on the amount of each of the 
two podcast episodes that participants listened to. If possible, we will also collect data on intervention 
usage through tracking whether each participating clinician clicked on the REDCap links sent to them 
and submitted online forms documenting completion of the intervention. If these data appear reliable, 
we may use these for the intervention completion data either alongside or instead of the self-report 
data. (2) Acceptability will be measured primarily through self-report surveys assessing clinicians’ 
perceptions of each podcast episode, and specifically: satisfaction, informativeness, relevance, ease of 
listening, likelihood of recommending to colleagues, and likelihood of impacting practice. Additional 
items assess distracting or interruptions during the podcast, mind-wandering during the podcast, 
problems or difficulties occurring in listening, one takeaway message clinicians had from the podcast, 
and thoughts on how the podcast could be improved. Most of these items were successfully 
administered in the initial pilot study.  
Aim 2. Preliminary effects of the iSHARE intervention will be assessed using self-report surveys at three 
time points (Pre-intervention, Post-episode 1, and Post-episode 2) and will assess clinicians’ knowledge, 
beliefs (self-efficacy, outcome expectancies), and communication about sexual health (See Table 2). In 
accordance with current recommendations to include specific communication behaviors as outcomes in 
communication training trials85 and with findings of recent reviews on outcomes with proven sensitivity 
to communication interventions86,87 including our own iSHARE pilot project, the key outcomes will be 
clinicians’ self-reported (1) knowledge across three major areas (sexual response/breast cancer-related 
sexual side effects, common approaches and resources for these problems, and basic communication 
skills pertaining to sexual health), assessed through 10 true/false or multiple-choice items developed for 
this study that were adapted from items used in similar research by the study team and found to be 
sensitive to communication interventions,87-89 (2) two aspects of clinicians’ beliefs, assessed using items 
developed for the initial iSHARE study based on social cognitive theory,55,84 that showed sensitivity in the 
pilot project and are rated on a 0-10 point scale where 0=not at all confident or do not agree at all and 
10=extremely confident or very strongly agree, namely (a) self-efficacy for communicating with breast 
cancer patients about sexual health (3 items; Cronbach’s alpha in pilot =.77), and (b) outcome 
expectancies for communicating with breast cancer patients about sexual concerns (7 items; Cronbach’s 
alpha in pilot =.90), and (3) communication behaviors, assessed using two sets of items, (a) clinicians’ 
perceived comfort in engaging in key communication tasks (e.g., asking the patient if she has any sexual 
concerns, discussing the patient’s loss of sexual interest or desire; 7 items), and (b) items adapted from 
those published in a similar trial90 and captures the frequency of engaging in three key types of 
communication about sexual health with breast cancer patients (e.g., initiating a conversation about 
sexual health, offering information about the impact of breast cancer treatment(s) on sexual health; 3  
items), rated on a 1 to 5 scale where 1=never/almost never and 5=always/almost always. 
4.3.3.2 Additional Measures
Totals
-
Baseline (T1)
-
Post-Episode 1
-
Post-Training (T2)
49
17
37
20
8
17
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Principal Investigator: Jennifer B. Reese
Abbreviated Title: Clinician Communication about Sexual Health
IRB #18-1068
Page 9 of 16
COVID-19 Clinic Assessment. Due to the current coronavirus pandemic, we anticipate that clinicians are 
experiencing changes to the format and volume of their clinics. Thus, we have added 13 items to the 
baseline survey assessing these changes including format (e.g., use of telehealth and availability of 
support staff), volume, and length of visits, and whether any of these changes may have had an impact 
on clinicians’ ability or priority level regarding discussing sexual health with their patients. These items 
were drafted with the input of the multidisciplinary study team. Because these items were drafted after 
several clinicians had completed the study, these clinicians will be re-consented  with a modified, 
abbreviated informed consent form and asked to complete only the COVID items.
5.0 Risks to Participants
This study involves participation in qualitative interviews, or participation in a behavioral intervention 
study with minimally invasive assessments (i.e., self-report). The major risks for study subjects are (1) 
discomfort at answering study questions or during discussions with clinicians, (2) loss of privacy or 
confidentiality. Due to the protections we will have in place, we believe these risks to be minimal. There 
are no procedures that will be conducted as part of the study.
6.0 Potential Benefits to Participants
There may be no direct benefit to the study participants. It is possible that the provider intervention will 
be effective at improving their knowledge, beliefs, and communication skills with respect to sexual 
health, and therefore have a beneficial effect on patient care or on patient-provider relationships, but 
this cannot be guaranteed. The research may inform future research to improve the quality of care given 
to patients with breast cancer. The minimal risks to subjects are reasonable in relation to potential 
benefit in improving clinicians’ communication and clinical care of patients.
7.0 Provisions to Maintain the Confidentiality of Data
In order to minimize the risks associated with discomfort in answering questions, participants will be 
told that they do not have to answer any research questions and that, if they change their mind about 
participating, they can stop at any time. All information collected for this study will be kept confidential.  
Subjects will be told that all information will be kept in strict confidence.  All data will be stored on 
computer files or in locked filing cabinets to which only select members of the research staff will have 
access. All discussions about the study and training sessions will occur in private areas or over the 
telephone. In order to minimize the risks associated with loss of confidentiality, all will be kept 
confidential and secure, will be de-identified for analytic purposes, and none of the participants’ 
information will be released to their employer or any other third party without the clinician’s 
permission, except as required by law.
8.0 Costs to Participants
There are no costs to participants for their participation in the study. 
9.0 Consent Process
Consent from participants will be obtained at the following time points: For the cognitive interviews, in-
person immediately before the interview, in the location where the qualitative interview will be held, by 
the PI or other consent designee (clinicians may also consent online via REDCap link in advance of their 
interview); for the pilot study, electronic consent will be obtained through REDCap or, for clinicians who 
prefer paper and pencil consents, written consent will be obtained in person or through US Mail. Only 
Participants will be given time to ask questions privately before they sign consent forms. Only English 
speaking clinicians will be enrolled.
10.0
Off-Study Criteria
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Principal Investigator: Jennifer B. Reese
Abbreviated Title: Clinician Communication about Sexual Health
IRB #18-1068
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Any participant may leave the study at any time due to distress or other reasons. We do not have a 
priori reasons for letting participants off the study.
11.0
Drugs and Devices
N/A
12.0
Multi-Site Research Study
N/A
13.0
Statistical Analysis
We plan to enroll 30-35 providers to the pilot study, in order to collect complete data from 30 study 
completers; this sample 
size will be adequate to 
achieve the study 
objectives of testing the 
feasibility, acceptability, 
and preliminary effects of 
the iSHARE intervention. 
Descriptive analyses (e.g., 
frequencies, measures of 
central tendency) will 
determine the feasibility 
and acceptability of the intervention. The operating characteristics of the feasibility/acceptability criteria 
under favorable and unfavorable characteristics are shown in Table 3. For example, if the true retention 
rate is high (80%), we will have a 94% chance of meeting the feasibility criteria of 70%, but if the true 
retention rate is low (55%), we will only have a 7% chance of falsely declaring feasibility. 
Feasibility will be measured through study accrual, retention, and intervention completion. The 
following rates will be used as benchmarks for feasibility: Enrollment > 40% of eligible candidates; 
retention > 70%; and intervention completion > 60%. Although we achieved very high enrollment, 
retention, and completion rates in our previous pilot study, these estimates are lowered as we will be 
recruiting a larger sample of clinicians, many of whom will be from outside FCCC. Acceptability will be 
determined in two stages. First, at the individual level, we determine whether the individual met our 
acceptability criteria, which means endorsing 75% of the 6 primary acceptability items for both podcast 
episodes (12 items total; satisfaction, informativeness, relevance, ease of listening, likelihood to 
recommend, likelihood to impact practice) favorably (“Quite a bit”/“Very”). For participants who 
complete only one set of these items, as in the case that they listen only to podcast episode 1 and 
complete that survey but not the one after episode 2, we will consider 5/6 items rated favorably as 
meeting the threshold for acceptability. Second, if 75% of the sample (shown above at the minimal 
number needed to meet the completion benchmark, or 18) meets that definition, then we will be able 
to say that overall the study meets the standard set for acceptability. 
Other data obtained from the acceptability surveys (e.g., length of time listened to each podcast, 
qualitative survey responses) will be analyzed descriptively or using thematic analysis as appropriate. 
Exploratory intervention usage data will be analyzed descriptively.
Prior to conducting analyses of outcome data, we will conduct analyses of internal reliability on the 
outcome measures. The sum of all items answered correctly will be used as the score for knowledge in 
analyses; if there are missing data on the item level, we may substitute percentage correct for the sum 
Table 3. Feasibility and Acceptability Determination
Criterion
Decision rule
True 
favorable 
rate
True 
unfavorable 
rate
Probability 
correctly 
declaring 
feasibility 
Probability 
incorrectly 
declaring 
feasibility 
Enrollment
>40% (≥ 30/75 approached)
50%
30%
97%
4%
Retention
≥70% (≥21/30 enrolled)
80%
55%
94%
7%
Completion ≥60% (≥18/30 enrolled)
70%
45%
92%
7%
Acceptability ≥75% (≥14/18 endorsing)
85%
55%
88%
4%
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Principal Investigator: Jennifer B. Reese
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IRB #18-1068
Page 11 of 16
of correct answers. For beliefs and communication behaviors, mean scores across all items on these 
scales will be used as the scores for these measures in analyses, assuming that the internal reliability for 
these measures is acceptable (Cronbach’s alpha > .60). Otherwise, individual item scores may be used. 
We may also present data on individual items in an exploratory fashion to facilitate interpretation of 
findings.  In line with recommendations for the analysis of data from pilot studies,91,92 preliminary 
outcome data will be analyzed descriptively, 95% confidence intervals will be calculated, and these data 
will be used to summarize the data at the three assessments. 
14.0
Data Safety Monitoring Plan
The PI will take responsibility for monitoring the safety of all phases of the research study. Because of 
the nature of the research as involving procedures without significant risk (e.g., surveys; listening to 
audio podcasts) there are unlikely to be any adverse events. Study staff will report any adverse events 
they observe to the PI within 24 hours. The consent form will contain the contact information for the PI 
and the Institutional Review Board (IRB), and state that participant may contact her or the IRB at any 
time. A DSMB is not required for the current study.
15.0
Adverse Events
Because of the nature of the research as involving procedures without significant risk (e.g., qualitative 
interviews; surveys; listening to an audio podcast) there are unlikely to be any serious adverse events 
and adverse events are likely to be rare.  Possible risks include feeling worried, anxious, or concerned 
during questionnaire completion, during the cognitive interview, or while listening to the podcast. All 
participants are informed of 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 IRB within 24 hours. For participants who are experiencing psychological distress reactions, the 
study team member or research assistant alerts the Principal Investigator, who would provide the 
participant with a referral to appropriate services. At FCCC counselors in the Department of Social Work 
are trained to provide psychological support services or to make specific referrals to other psychological 
counseling or psychiatric services in the area as needed.
The research team will keep a log tracking the number, nature, and frequency of adverse events as part 
of each phase of the research plan. In accordance with FCCC guidelines, this protocol will employ the 
following mechanisms for adverse event reporting: 1) alert the FCCC review committees of any and all 
reports of adverse events; 2) inform all members of the study team of any all reports of adverse events.  
If 3 or more adverse events are reported, the study team will assess potential causes of the adverse 
events and, if events are clearly linked to study participation, discontinue the study. 
16.0
Quality Assurance Procedures and Participant Confidentiality
Information about study subjects will be kept confidential and managed according to the requirements 
of the Health Insurance Portability and Accountability Act of 1996 (HIPAA). Those regulations required a 
signed subject authorization informing the subject of the following: The protected health information 
(PHI) that will be collected from participant; who will have access to that information and why; who will 
use or disclose that information; the rights of a research subject to revoke their authorization or use 
their PHI. In the event that a participant revokes authorization to collect or use PHI, the investigator, by 
regulation, retains the ability to use all information prior to the revocation of subject authorization.  To 
ensure confidentiality identifiers will be recorded and used with electronic data collected and all records 
IRB#: 18-1068MOD9 Approved: 9/4/2020 Expires: 8/16/2021          

Principal Investigator: Jennifer B. Reese
Abbreviated Title: Clinician Communication about Sexual Health
IRB #18-1068
Page 12 of 16
will be secured in a locked location. All computers with participant data will be password protected with 
access restricted to study staff. All participant data will be de-identified for analytic purposes, and none 
of the participants’ information will be released to their employer, health care organization, or any other 
third party without the participants’ permission.
17.0
Participant Informed Consent
Separate informed consent documents exist for participation in the cognitive interviews and the podcast 
pilot trial. Cognitive interview participants will sign written or online consent prior to completing the 
demographic survey and beginning the qualitative interview. Pilot trial participants will sign written or 
online consent after being approached for the study which will include consent to complete self-report 
surveys before the intervention, at post-episode one, and at post-episode two, and to participate in the 
iSHARE intervention. 
18.0
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IRB#: 18-1068MOD9 Approved: 9/4/2020 Expires: 8/16/2021          

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Abbreviated Title: Clinician Communication about Sexual Health
IRB #18-1068
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IRB#: 18-1068MOD9 Approved: 9/4/2020 Expires: 8/16/2021          

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Abbreviated Title: Clinician Communication about Sexual Health
IRB #18-1068
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Abbreviated Title: Clinician Communication about Sexual Health
IRB #18-1068
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IRB#: 18-1068MOD9 Approved: 9/4/2020 Expires: 8/16/2021          

Principal Investigator: Jennifer B. Reese
Abbreviated Title: Clinician Communication about Sexual Health
IRB #18-1068
Page 16 of 16
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19.0
 Appendices

Consent Forms
o
Web and paper versions of cognitive interview consent
o
Web and paper versions of pilot trial consent
o
HIPAA Authorization

Surveys
o
Cognitive Interview demographic survey
o
Pilot Trial baseline, post-intervention surveys

Sample questions for Cognitive Interviews
IRB#: 18-1068MOD9 Approved: 9/4/2020 Expires: 8/16/2021