Enhancing Clinical Communication About Sexual Health for Women With Gynecologic Cancer: Adaptation of a Multimedia Intervention
Phase: NA
Conditions: Gynecologic Cancer
Sponsor: Fox Chase Cancer Center

Principal Investigator: Jennifer B. Reese
Abbreviated Title: Women’s Health Communication Study
IRB # 21-1066
Page 1 of 24
Protocol Title
Enhancing Clinical Communication about Sexual Health for Women with Gynecologic Cancer: Adaptation 
of a Multimedia Intervention
Principal Investigator
Jennifer B. Reese, PhD
Participating/Collaborating Institutions:
N/A
Funding Source:
None
Initial Version Date: 10/29/2021
Amendment #
1
Version date:
1/20/2022

Principal Investigator: Jennifer B. Reese
Abbreviated Title: Women’s Health Communication Study
IRB # 21-1066
Page 2 of 24
Table of Contents
1.0
Introduction .....................................................................................................................................3
2.0
Objectives.........................................................................................................................................3
3.0
Background/Rationale.....................................................................................................................4
4.0
Study Design.....................................................................................................................................7
5.0
Consent Process .............................................................................................................................10
6.0
Measures and Self-Report Data Collection ...................................................................................10
7.0
Randomization...............................................................................................................................13
8.0
Intervention Conditions.................................................................................................................13
9.0
Risks to Participants.......................................................................................................................14
10.0
Potential Benefits to Participants..................................................................................................14
11.0
Provisions to Maintain the Confidentiality of Data ......................................................................14
12.0
Costs to Participants ......................................................................................................................15
13.0
Off-Study Criteria ...........................................................................................................................15
14.0
Drugs and Devices..........................................................................................................................15
15.0
Multi-Site Research Study..............................................................................................................15
16.0
Statistical Analysis..........................................................................................................................15
17.0
Data Safety Monitoring Plan .........................................................................................................17
18.0
Adverse Events...............................................................................................................................17
19.0
Quality Assurance Procedures and Participant Confidentiality....................................................17
20.0
Participant Informed Consent .......................................................................................................18
21.0
References......................................................................................................................................18
22.0
Appendices.....................................................................................................................................24

Principal Investigator: Jennifer B. Reese
Abbreviated Title: Women’s Health Communication Study
IRB # 21-1066
Page 3 of 24
1.0 Introduction
Background: Treatments for gynecologic cancer, including surgery, chemotherapy, and pelvic radiation, 
extend women’s survival but often at the cost of impaired sexual function,1-4 with over half of 
gynecologic cancer survivors reporting sexual problems after treatment.1,5-7 Common sexual problems 
include those that are physiological (e.g., vaginal dryness/pain, arousal difficulties),4,8,9 
emotional/motivational (e.g., loss of sexual desire, body image concerns),8,10,11 and interpersonal in 
nature (e.g., sexual inactivity with partner).8,11-13 For women with gynecologic cancer, unaddressed 
sexual problems often persist years after treatment concludes,14 leading to distress15 and compromised 
quality of life (QOL).15-17 Yet even though sexual function is included in current clinical practice 
guidelines in oncology,18-20 such concerns are surprisingly neglected in the care of women with 
gynecologic cancers.21 The vast majority (62-87%) of women with gynecologic cancer report no 
discussion of sexual health occurring during their cancer care,22-24 and only 35% of gynecologic cancer 
patients who report sexual problems actually initiate a discussion about this issue with their clinician.25 
These data are at odds with the commonly held belief that women with cancer will raise sexual health 
when experiencing problems.26 Rather, women with gynecologic cancer face formidable barriers to 
discussing sexual health with their clinicians, including a lack of preparation and skills deficits.5,25,27-29 
Interventions that foster effective patient communication could prove critical in the effort to integrate 
sexual health into cancer care for women with gynecologic cancer, yet no such interventions have been 
designed or tested.
To address this gap, we propose to evaluate a multimedia intervention, called Starting the Conversation 
(STC), aimed at facilitating effective clinical communication about sexual health concerns. We recently 
found strong evidence supporting this intervention in a controlled trial in women with breast cancer 
(N=144).30 Women receiving the STC intervention [30-minute skills training video, workbook, and 
resource guide] had nearly three-times greater odds of discussing sexual health during a routine clinic 
encounter with their cancer clinician than women receiving the resource guide alone, while also 
showing improvements in their self-efficacy (i.e., confidence) for discussing sexual concerns, and for 
sexual and psychological outcomes.30 We expect that the STC intervention will be effective in women 
with gynecologic cancer, who report similar rates and types of sexual problems31,32 and similar 
challenges to discussing sexual health as women with breast cancer.27,33 Using expert input and 
extensive literature review, we have adapted this intervention to gynecologic cancer and now plan to 
collect pilot data on this adapted that will support the funding of a larger clinical trial of this intervention 
in this new population. 
2.0 Objectives
The central goal of this study is to examine the feasibility, acceptability, and preliminary efficacy of the 
newly adapted STC intervention on patient-clinician communication about sexual health. However, 
there are additional issues that are understudied and could be informative to the design of a larger trial 
that we intend to examine through three exploratory aims. First, although we know that sexual health 
discussions be held for gynecologic cancer patients who are partnered and unpartnered, there is little 
information known about how women’s partnered status might influence the appropriateness or 
efficacy of the STC intervention. Thus, in an exploratory aim, we will examine whether women’s 
partnered status is associated with the feasibility, acceptability or preliminary effects of the STC 
intervention with any of the study outcomes. As level of sexual concerns may also play a role, we will 
examine that along with partnered status. We expect that the information we collect on partner 
participation and the preferences regarding this will be informative for our larger trial.

Principal Investigator: Jennifer B. Reese
Abbreviated Title: Women’s Health Communication Study
IRB # 21-1066
Page 4 of 24
Specific Aim 1. To assess the feasibility and acceptability of the STC intervention in a pilot study in 
women with gynecologic cancer.
Hypothesis 1. STC will be judged as feasible, determined through measures of rates of 
participant enrollment, retention, and intervention completion.
Hypothesis 2. STC will be judged as acceptable, determined through post-intervention 
evaluations of intervention satisfaction, informativeness, relevance, helpfulness, ease of 
participation, approval of the format, likelihood of recommending to others, and perceived 
importance of the program for people with gynecologic cancer.
Specific Aim 2. To assess the preliminary effects of the STC intervention on patient-clinician 
communication about sexual health and on patients’ sexual and psychological health outcomes.
Hypothesis 3. STC will show positive effects on patients’ self-efficacy for clinical communication 
about sexual health concerns from baseline to post-intervention and 2-month follow-up, and 
their clinical communication about sexual health concerns (discussing sexual health concerns; 
raising the topic; asking a question about sexual health) at their post-intervention clinic 
encounter.
Hypothesis 4. STC will show positive effects on patients’ sexual function, activity, and 
psychological distress from baseline to 2-month follow-up.
Exploratory Aim 1. To explore the feasibility, acceptability, and preliminary effects of the STC 
intervention by women’s partnered status and level of sexual concerns. Additionally, exploratory 
analyses will examine baseline body compassion,34 a concept meaning acceptance and compassion 
toward the physical body, which is associated with psychological health outcomes in gynecological 
populations. As a relatively new measure within cancer survivorship research, we will examine baseline 
scores on this measure in a hypothesis-generating fashion to inform future research studies.
3.0 Background/Rationale
With 113,520 new cases in 2020, gynecologic cancer (ovarian, uterine/endometrial, cervical, 
vaginal/vulvar), ranks behind breast cancer but ahead of lung and colorectal cancer in terms of number 
of new cases diagnosed for women in the U.S.35 When diagnosed with local disease, >90% of women with 
gynecologic cancer survive at least 5 years, and survival is improving overall.35 While critical to extending 
survival, the treatments commonly used for gynecologic cancer, including surgeries (e.g., hysterectomy; 
bilateral salpingo-oophorectomy; BSO), chemotherapy, and pelvic radiation lead to sexual problems for 
women;1-7,12 as many as 87-89% of gynecologic cancer survivors report experiencing negative 
consequences to their sexual health, here defined as including sexual activity, function, body image, and 
intimate relationship)30,36 resulting from their treatment(s).1,2 Common sexual problems include those 
that are physiological (e.g., vaginal dryness, pain during sexual activity),1,5,7,9,37,38 emotional/motivational 
(e.g., loss of libido, anxiety about having sex, body/self-image image changes),10,11,37-40 and interpersonal 
in nature (decreased sexual activity, relationship issues).11-13,38,41,42 These difficulties tend to persist over 
time, with gynecologic cancer survivors up to 7 years post-treatment reporting greater frequency and 
severity of sexual problems than women with no cancer history.39,42-45 Women treated for gynecologic 

Principal Investigator: Jennifer B. Reese
Abbreviated Title: Women’s Health Communication Study
IRB # 21-1066
Page 5 of 24
cancer often report feeling grief over their loss of sexual enjoyment, underscoring how cancer-related 
sexual problems compromise their quality of life (QOL)15-17 and impact their relationships for the worse.42 
Despite the large body of research establishing sexual function as distressing for women with gynecologic 
cancer,12,22,29,41,46-48 and the fact that current clinical practice guidelines universally encourage cancer-
related sexual health to be included in routine clinical care for cancer survivors, alongside pain, fatigue, 
and other health issues,19,20 fewer than half of women with gynecologic cancer report that they have ever 
had a discussion with their clinical provider about sexual issues.30,49-52 Only 23-40% of women with 
gynecologic cancer report receiving information about potential sexual side effects of their 
treatments.24,49,53 This lack of discussion compromises women’s ability to manage sexual problems when 
they occur. For instance, in a study of women attending a vulvovaginal health clinic (N=146; 26% 
gynecologic cancer), over half of patients with moderate to severe vaginal dryness reported “never” using 
vaginal lubricants and moisturizers,54 which have proven efficacy for ameliorating this problem.20,55 Yet 
patients face formidable barriers in raising these issues with their clinicians that undermine their active 
participation in their care regarding this issue, including lack of preparation, unhelpful beliefs, and 
emotional discomfort.28,31,56 Moreover, despite common assumptions that (a) clinicians lack the 
specialized training needed to manage sexual problems for women with gynecologic cancer and (b) little 
can be done to address their patients’ sexual concerns,22,57 most women with gynecologic cancer could 
benefit from brief and focused information about sexual side effects of treatment and on simple effective 
strategies (e.g., use of vaginal lubricants and moisturizers),55,58 and/or referrals for sexual problems 
requiring further assessment and management, which do not require specialized training. Ultimately, the 
lack of discussion of sexual concerns not only conflicts with recommended guidelines for clinical care but 
is also out of sync with the preferences of women with gynecologic cancer, most of whom would like 
sexual concerns to be discussed in their care.28,31 
In light of the clear and concerning absence of routine clinical discussion of sexual health for women with 
gynecologic cancer and the substantial patient barriers to discussing these concerns, there is an obvious 
need for interventions that can effectively promote women’s active engagement in their care regarding 
sexual health concerns. To address this need, we propose to conduct a pilot test of a multimedia 
intervention, called Starting the Conversation (STC), aimed at facilitating effective clinical communication 
about sexual health for women with gynecologic cancer. This intervention contains focused skills training 
and practice in a format consisting of a 25-minute mobile-accessible narrated video and accompanying 
workbook (see Figure 1); we found this intervention to be feasible, acceptable and efficacious in a recent 
study completed in women with any stage breast cancer.30 
Women often lack awareness of common sexual issues associated with their treatments as well as 
confidence in knowing how to raise these issues effectively.28,31,56 A major aim of the proposed 
intervention is thus to improve participants’ confidence, or self-efficacy, in communicating about sexual 
concerns (Figure 1).59-61 To this end, the study design and intervention are guided by social cognitive 
theory,59,60 which emphasizes the importance of fostering self-efficacy in interventions designed to 
increase behavioral engagement in certain tasks and underlies numerous successful communication 
interventions.59,60,62-64 The STC intervention integrates theory-guided skills training and practice, and 
therefore is likely to be effective in promoting women’s active engagement in clinical discussions of sexual 
health concerns. In addition to a lack of knowledge and skills, there is continuing stigma surrounding 
discussions of sexual health in clinical care, 26,56 such that many women express timidity in expressing such 
concerns with their clinicians.56,65 For this reason, normalizing women’s sexual concerns and the 
importance of discussing sexual health, as well as clarifying expectations for patients’ and clinicians’ roles 
in the discussions (e.g., underscoring the expectation that clinicians respond to patients’ expressed sexual 
concerns) could increase patients’ comfort and thus lead to greater communication about these issues.66 

Principal Investigator: Jennifer B. Reese
Abbreviated Title: Women’s Health Communication Study
IRB # 21-1066
Page 6 of 24
We thus include these elements in the STC intervention. In sum, there is strong support for the content 
of the STC intervention as potentially efficacious in women with gynecologic cancer. 
 
Patient-focused interventions can significantly improve patients’ beliefs and behaviors with respect to 
clinical communication about health concerns.67-71 Within oncology, patient-focused interventions that 
aim to foster an active role for cancer patients in discussing cancer-related health issues such as pain using 
education and/or skills training have demonstrated efficacy.63,72 Importantly, even very brief patient-
focused interventions (e.g., <1 hour) have shown effects on these outcomes.69,73 In a successful trial of the 
STC intervention in women with breast cancer, we found significant effects of the STC intervention on 
both women’s self-efficacy and their communication about sexual health (raising the topic, asking a 
question) in a routine clinical encounter with their cancer clinician (see C.3.3 for preliminary data).30 Given 
that the sexual health communication practice and preferences are highly similar for women with 
gynecologic and breast cancer,27,33,74 we expect to ultimately find similar effects for the STC intervention 
in women with gynecologic cancer. 
In addition to improving women’s communication about sexual health, preliminary data suggests that 
such an intervention could also benefit their sexual health outcomes,30 perhaps because a productive 
clinical discussion may lead to information or suggestions that help women address sexual concerns 
and/or be able to engage in sexual activity.30 We plan to collect information on preliminary effects of the 
intervention on women’s sexual activity and function, which can be responsive to change due to sexuality 
interventions for women with cancer.75,76 We found positive effects of STC on women’s psychological 
outcomes, in particular, anxiety. This finding is consistent with research findings showing that positive 
communication between women and their clinicians and greater feelings of empowerment within 
women’s clinical care are associated with lower patient anxiety.77 Taken together, these findings suggest 
that by increasing women’s confidence in expressing key health concerns, the STC intervention could help 
alleviate distress associated with leaving such concerns unaddressed.30 
Prior studies have shown that certain factors such as age and partnered status might affect sexual 
concerns and/or preferences for discussions of sexual issues for women with gynecologic cancer.6,13,28 
With respect to medical factors (e.g., disease stage/site), research is inconsistent regarding their effects 
on sexual function or communication about sexual health after gynecologic cancer, with some studies 
offering evidence for effects of these factors on sexual outcomes13,37,39,42,78 and others showing no such 
effects.9,15,16,28,40 We will thus examine these factors in an exploratory aim. Findings will inform next steps, 
which could include examining such factors as potential moderators in a large trial and ultimately 
potentially tailoring the STC intervention for certain subgroups. In addition, little is known about the 
involvement of patients’ intimate partners into clinical communication interventions around the topic of 
sexual health or into these discussions themselves. Thus, we plan to examine this in a second exploratory 
aim, which will be used to guide decisions about inclusion of partners into a larger planned randomized 
controlled trial. 
Preliminary Data
Sexual Concerns for Women with Gynecologic Cancer. Research by Dr. Bober has demonstrated sexual 
problems to be significant in women with gynecologic cancer, and in particular, ovarian cancer. In a trial 
testing a sexual function intervention for women with ovarian cancer (N=46; M age=55.8), at baseline, 
mean Female Sexual Function Index (FSFI) scores (13.4; SD=7.3) fell well below the established cut-off for 
sexual dysfunction of 26.55,79 suggesting substantial sexual dysfunction within the sample; sexual desire 
scores (2.3; SD=1.4) were also well-below cut-offs for hypoactive sexual desire disorder of 5.0.80 
Moreover, sexual dysfunction did not improve during a two-month run-in period prior to receiving an 

Principal Investigator: Jennifer B. Reese
Abbreviated Title: Women’s Health Communication Study
IRB # 21-1066
Page 7 of 24
intervention. Importantly, a substantial proportion of the sample in the study (13%) were currently 
undergoing chemotherapy, suggesting that women with gynecologic cancer who are undergoing active 
treatment are nevertheless amenable to participating in a sexual health trial.  
Patient-Clinician Communication about Sexual Health in Women with Gynecologic Cancer. In a recent 
systematic review of 29 studies assessing the prevalence of sexual health communication in cancer 
conducted by the PI (Reese), 10 (34%) of these studies included data from women with gynecologic 
cancer.81 It was also reported that female patient gender predicted a lower prevalence of sexual health 
discussions. Discussions of sexual concerns occurred for only 14-47% of women;22,23,50  discussion of 
potential sexual side effects of treatment, specifically, occurred for 23-40%.24,49,53 These data demonstrate 
that discussions of sexual concerns in women with gynecologic cancer are rare and that interventions are 
needed to help close this gap in women’s clinical care. 
 
Improving Sexual Health Communication for Women with Cancer. In a recent study funded by the PI’s 
ACS Mentored Research Scholar Grant, women with breast cancer (N=144) were randomly assigned to 
either the STC intervention [20-minute video, workbook, and resource guide] or a control [resource guide 
only]. Analyzing the communication from patients’ next clinic encounter following receipt of either the 
intervention or control material revealed that women in the STC arm were significantly more likely to raise 
the topic of sexual health [51%; OR=2.62(1.02, 6.69), p=.04] and ask a sexual health question [40%; 
OR=2.85(1.27, 6.38), p=.01] during their clinic encounter than those in the control arm (30% and 19% for 
raise and ask, respectively). Further, at 2-month follow-up, we found that women in the STC arm showed 
greater improvements in sexual health communication self-efficacy (p=.009) and in anxiety symptoms 
(p=.03), and more women were sexually active at follow-up, compared to the control arm (OR=1.5, 70% 
vs. 46%, p=.04). Additionally, high rates of enrollment (88%) and retention (97%) were seen, with notable 
enrollment by women from racial/ethnic minorities. Specifically, 27% of the sample self-identified as 
Black/African-American, 6% identified as bi-racial/ “other,” and 4% identified as Hispanic/Latina, 
supporting the acceptability and efficacy of the STC intervention in women from a range of racial and 
ethnic backgrounds. Further, 15% percent of the sample had a diagnosis of metastatic cancer and 33% 
were unpartnered, supporting the appropriateness of the material to women across different stages of 
disease and relationship status. Finally, women reported high rates of using the video and workbook (rates 
>85%), suggesting high engagement with the study materials across conditions; responses to open-ended 
questions in the post-study surveys further supported acceptability. In sum, these data suggest that the 
STC intervention is feasible, acceptable, and has significant positive effects for diverse clinical 
communication and health outcomes in a sample of women with breast cancer. 
In sum, sexual concerns for gynecologic cancer survivors are inadequately addressed in clinical care. In 
this pilot study, we propose to assess the feasibility, acceptability, and preliminary effects of a brief 
multimedia intervention designed to facilitate gynecologic cancer patients’ effective communication 
about sexual health concerns. The data we collect from this study will directly inform the design of a larger 
planned randomized controlled trial, which will determine the intervention’s efficacy in this population. 
4.0 Study Design
4.1 Overall Study Design 
In this pilot study, 30-36 women with a diagnosis of any stage gynecologic cancer will be randomized 2:1 
to either the Starting the Conversation (STC) condition, a multimedia intervention aimed at enhancing 
sexual health communication consisting of a skill-building video and workbook with a resource guide, or 

Principal Investigator: Jennifer B. Reese
Abbreviated Title: Women’s Health Communication Study
IRB # 21-1066
Page 8 of 24
to a control condition offering the resource guide only. We may randomize up to 36 patients in the 
event that some participants are unable to provide communication data (e.g., due to attrition or 
cancellation of clinic visits), with the goal of collecting clinic communication data on 30 women. The 
objective of this study is assess feasibility, acceptability, and preliminary effects of the STC intervention, 
in an effort to guide the design of a larger planned randomized controlled trial to determine 
intervention efficacy. Feasibility will be measured through rates of study enrollment, retention, and 
intervention completion. Acceptability will be assessed through post-intervention evaluations of 
intervention satisfaction, informativeness, relevance, helpfulness, ease of participation, approval of the 
format, likelihood of recommending to others, and perceived importance of the program for people 
with gynecologic cancer. Preliminary efficacy will be assessed through estimating the intervention effect 
size, if appropriate, or through looking descriptively at means and confidence intervals on improved. In 
Aim 2, validated self-report measures will assess intervention-related change in patients’ self-efficacy for 
sexual health communication and sexual and psychological health outcomes from baseline to to 2-
month 
follow-up. 
Data for 
exploratory 
aims will be 
assessed 
using 
patients’ self-
report data at baseline (for socio-demographic factors), their medical chart review (for clinical factors), 
or at post-intervention (for their thoughts and preferences on partner participation).  
4.2 Recruitment and Reimbursement
Patients. In all, between 30 and 36 patients with gynecologic cancer will participate. Using methods we 
have employed in previous studies, potentially eligible patients will be identified from consented 
provider’s clinic schedules. This pre-identification process involves pre-screening of patients using their 
medical records on major characteristics (e.g., length of time since treatment, ECOG score) to reduce 
unnecessary burden of contacting patients who will not screen in or who may be ill. The research 
assistant will ask the providers’ permission to approach patients identified as medically eligible. If the 
provider approves, a letter will be sent to a candidate summarizing the research study from the patient’s 
provider including ways the patient can contact the study team to indicate that she is not interested in 
pursuing the study further. This will be in the form of informational letters or emails, and patients will be 
called by a member of the study staff for screening. Subjects will receive $20 in compensation for each 
of the three study assessments. Compensation will be given in the form of gift cards. 
Clinicians. Clinicians have been identified from the FCCC gynecologic cancer clinical team. We will enroll 
between 3-6 FCCC gynecologic cancer clinicians (gynecologic/radiation oncology). Clinicians will be 
Table 1. Recruitment Totals
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: 42
Up to: 42
N/A
N/A

Principal Investigator: Jennifer B. Reese
Abbreviated Title: Women’s Health Communication Study
IRB # 21-1066
Page 9 of 24
approached to participate in the study via clinical meetings either in-person or virtually, or through 
direct contact with Dr. Chu (Co-I), Dr. Reese (PI), or another study team member. Interested clinicians 
will be sent a link to online consent forms for self-enrollment. Clinicians will be compensated a total of 
$20 for participating, to complete a brief socio-demographic study survey, and to review the materials 
we are providing them about menopausal and sexual health concerns after gynecologic cancer. 
Compensation will be in the form of gift cards.
4.3 Inclusion and Exclusion Criteria
4.3.1. Inclusion and Exclusion Criteria for Patients
Table 2. Eligibility Criteria
Inclusion Criteria

Female 

Age > 18 years 

Diagnosis of any stage (I-IV) gynecologic cancer (uterine, ovarian, cervical, vaginal/vulvar, fallopian tube, 
peritoneal)

Receiving any treatment for gynecologic cancer or have completed acute treatment < 10 years ago 

Attending clinic visits in the course of follow-up care (i.e., not an initial consult visit)
Exclusion Criteria

Not able to speak English 

Eastern Cooperative Oncology Group (ECOG)82 Performance score > 2 

Overt cognitive dysfunction or psychiatric disturbance or severe mental illness (e.g., dementia, suicidal 
behavior, or psychosis), as observed or judged by the researcher or referring source.
Our decision to include women with any gynecologic cancer in as opposed to restricting it to women 
with a cancer of a specific tumor site is guided by findings from prior studies demonstrating similar types 
of sexual concerns and lack of communication among women in these groups, and is informed by the 
design of numerous research studies in this area.6,12,15,28 We choose to include women across a range of 
stages of disease, those who are in active treatment as well as who have completed treatment, and who 
are either partnered or unpartnered because women across all of these categories report sexual 
concerns and are in need of relevant interventions, are similarly likely to report low rates of sexual 
health communication,23,24,81 and are willing to participate in such trials.30 Although we anticipate that 
women with sexual problems will self-select into the study,83 as in our previous trial of STC, we do not 
limit participation by the presence/severity of sexual problems because women could have reason to 
discuss sexual concerns with their clinician other than for seeking management of sexual difficulties 
(e.g., to inquire about the safety of sexual activity while undergoing chemotherapy).84 However, we will 
collect information to examine this. During screening, women will be assessed for access to an 
electronic device (e.g., smartphone, tablet, computer); women assigned to STC without such access will 
be able to use a study laptop to watch the video. 

Principal Investigator: Jennifer B. Reese
Abbreviated Title: Women’s Health Communication Study
IRB # 21-1066
Page 10 of 24
Because gynecologic cancer affects individuals who are biologically female, we do not include biological 
males in the current study. For simplicity, the term “women with gynecologic cancer” is used in 
describing the study population. However, we will assess self-identified gender, and will not exclude 
individuals who identify as male while being treated for a gynecologic cancer (i.e., as in the case of trans 
men, who may identify as men yet can still be diagnosed with a disease of the female genital tract if 
these organs are intact). Considering that communication of sexual health can be especially fraught for 
individuals who are of a sexual or gender minority,85-87 including such individuals in our study could help 
us determine whether the STC intervention is generalizable to this underserved population. 
4.3.2 Inclusion and Exclusion Criteria for Clinicians
Clinician participants will be gynecologic oncology clinicians or radiation oncologists treating gynecologic 
cancer patients (physicians, advanced practice clinicians). They will be identified through direct contact 
by Dr. Chu (Co-I) or by the PI (Reese), or through staff or clinical meetings. 
4.4 Screening
Patients. Patients who do not contact the study team to opt out after receiving the recruitment letter 
will be called by the research assistant to conduct a telephone screening or may be approached in 
person (i.e., in the FCCC clinic), who will review the study procedures, risks, benefits, and emphasize to 
patients that their decision to participate will not affect their care. Screening will assess accessibility of 
computer/devices, and will include a brief assessment of health-related quality of life (e.g., level of 
sexual concerns, pain, fatigue), and offer a detailed discussion of the study procedures. Recruitment 
tracking will be done using a combination of password-protected Excel files and REDCap forms. For 
women who opt out prior to completing screening (e.g., leave us a voicemail saying they do not want to 
enroll, or refuse over the phone before screening is undertaken), we will collect and retain minimal 
information (i.e., name, study status) that will allow us to refrain from contacting them again with 
regard to the study and thus respecting their wishes.  Minimal information related to sexual dysfunction 
issues will be retained for possible grant submission.  This information may guide the study design in the 
future.  This information may reveal that patients without any symptoms are less likely to agree to 
participate.  This is considered preparatory to research and will not be used for any purpose other than 
to guide a future proposal. 
Clinicians. All clinicians will be identified in advance as appropriate for the study, negating the need for 
formal screening procedures.
5.0 Consent Process
For clinicians, consent forms will be presented at that time of contact about the study; Informed consent 
documents will be presented via paper or web (i.e., REDCap) consents according to the clinicians’ 
preferences. 
We have utilized similar online consent processes in multiple patient and provider studies. For patients, 
consent will occur primarily using a subject specific REDCap form, which will be obtained prior to 
patients’ completion of baseline surveys, which are also online. 

Principal Investigator: Jennifer B. Reese
Abbreviated Title: Women’s Health Communication Study
IRB # 21-1066
Page 11 of 24
For patients who are unable to complete online consents, they will be given the option of signing paper 
consents either in person or via mail. 
All participants will be given the opportunity to ask questions about the study and their involvement 
prior to consent, and all candidates will be ensured that their participation is voluntary and will not 
affect their care (if patients) or employment (if providers) at Fox Chase. Only English speakers will be 
enrolled, so there will not be any consent forms in other languages. No children or minors will be 
enrolled. 
6.0 Measures and Self-Report Data Collection
6.1. Clinician Measures. Clinician self-report data include socio-demographic and clinical self-report 
items (e.g., length of time in practice, clinical role) and are collected at the time of consent.
6.2. Patient Measures. Patients will complete self-report surveys immediately after enrolling (baseline; 
T1), at an in-person clinic encounter with their gynecologic cancer clinician several weeks after receiving 
the intervention materials (post-intervention; T2), and at 2-month follow-up (T3). Self-report data 
collection will generally be completed using REDCap, a secure, HIPAA-compliant web-based application 
used successfully in multiple trials in our lab, with paper-and-pencil versions available for those who lack 
computer access. T2 surveys, which are completed in-clinic immediately following the clinic encounter, 
will be paper-and-pencil. For patients who are unable to stay in-person to complete their paper survey, 
online versions of the form will be sent via email to the patient for completion using a link to the online 
survey with instructions for the patient to complete the survey as soon as possible. Medical data will be 
gathered through chart review by a qualified member of the research team.
Aim 1. Aim 1 measures include those pertaining to the feasibility and acceptability of the STC 
intervention in women with gynecologic cancer. 
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. 
Acceptability of the STC intervention will be measured through self-report program evaluation survey 
administered at post-intervention (after clinic encounter). The main items considered outcomes for this 
aim are: intervention satisfaction, informativeness, helpfulness, relevance, ease of participation, 
approval of the format, likelihood of recommending to others, and perceived importance of the 
program for people with gynecologic cancer. Other items in the program evaluation will assess other 
aspects of the intervention and may include open-ended items to gather further information that could 
be useful in improving the intervention content for the larger trial.
Aim 2. Aim 2 measures include self-report outcome measures that will help assess preliminary effects of 
the STC intervention on patient-clinician communication (beliefs about sexual health, communication 
behaviors), and on patients’ sexual and psychological health outcomes, as shown in Table 3, as well as 
standard socio-demographic and clinical data collected at baseline through self-report or medical chart 
review. Self-report surveys will be administered at three time points: Baseline, occurring at the time of 
consent; Post-intervention (T2), occurring immediately following the clinic encounter; and 2-month 

Principal Investigator: Jennifer B. Reese
Abbreviated Title: Women’s Health Communication Study
IRB # 21-1066
Page 12 of 24
Follow-Up (T3), occurring 2-months after the clinic encounter. Self-report outcome surveys carry an 
estimated response burden of no more than 30 minutes. Measures of covariates and other study 
surveys are estimated to take < 10 minutes. Table 3 below shows self-report measures used to assess 
outcomes and a schedule of assessment time points.
Patient-Clinician Communication. Self-Efficacy for Communicating about Sexual Health. Two items assess 
patients’ self-efficacy (confidence) for communicating with their gynecologic cancer clinician about sexual 
health concerns in terms of either talking (item 1) or asking (item 2) about sexual health. Response options 
use an 11-point scale (0=not at all confident to 10=extremely confident). Mean scores will be used. Self-
efficacy items were developed according to social cognitive theory guidelines59,88 with input from a trans-
disciplinary team, were used successfully in similar studies,89,90 and had excellent reliability (Cronbach’s 
alpha > .97).91 Patients’ Communication Behaviors. Patients’ clinical communication about sexual health 
will be assessed via self-report measure completed immediately following the patient’s T2 clinic 
encounter, and will be assessed as the proportion of clinic encounters in which the patient reports (1) 
discussing any sexual concerns with her clinician, (2) raising the topic of sexual health, and (3) asking a 
question pertaining to sexual health. Analyses of data from our previous trial of the STC intervention in 
women with breast cancer showed a high kappa coefficient between dialogue coded for discussions of 
sexual concerns and patients’ self-report of discussing a sexual health topic (kappa =.71), suggesting that 
using self-report to collect the communication data is appropriate. Further, in our prior work, we have 
found that when sexual health concerns are salient for patients, as they will likely be for most participants, 
patients tend to be more accurate in their self-reports of sexual health communication during a clinic 
encounter.92 As in our previous work,30,36 the self-report assessment about sexual health will assess 
whether following topics are discussed, whether the patient raised the topic, and whether the patient 
asked about any of these topics: sexual activity, function (desire, arousal, orgasm, pain/discomfort), 
intimate relationships, general sexual concerns, or body image. 
Sexual and Psychological Health Outcomes. Sexual activity will be assessed using the PROMIS sexual 
activity screener item, obtained from the PROMIS SexFS Brief Profile Version 2.0,91,93,94 which has 
significant data supporting its validity in women with cancer. This screener assesses any sexual activity 
(partnered or unpartnered; examples are “masturbation, oral sex, and intercourse”) within the past 30 
days. Sexual function will be assessed using the 19-item Female Sexual Function Index (FSFI).95 The FSFI is 
a widely used comprehensive sexual function measure with established validity in women with cancer,96-
98 which assesses biological, psychological, and social dimensions of women’s sexual experiences including 
desire, arousal, pain, and satisfaction with sexual activity.76,99,100 Total scores, reflecting women’s overall 
sexual function, capture increases in response to participation in behavioral (non-medical) sexual function 
intervention trials in women with cancer76,101 and will be used. Psychological distress is measured by the 
Hospital Anxiety and Depression Scale anxiety (HADS-A) and depressive symptoms (HADS-D) subscales.102 
Both subscales have had good reliability in prior studies (Cronbach’s alpha=.86 and .83, respectively). 
Exploratory Aim and Other Measures. The exploratory aim assesses any associations between patients’ 
partnered status or initial sexual concerns score and feasibility, acceptability, and preliminary effects of 
the STC intervention, Socio-demographic characteristics, such as age, race/ethnicity, sexual orientation, 
education, socio-economic status, and partnered status will be assessed using the baseline (T1) survey. 
Patients’ sexual concerns will be assessed using a standard item from the Patient Care Monitor, which will 
be assessed during screening, along with other PCM items (e.g., pain, fatigue, vaginal dryness). These 
items are assessed using a 0-10 scale and have proven valid and informative in our prior research.36,92 
Clinical variables including stage of disease, tumor site, and dates and types of surgeries and medical 
treatments will be obtained using medical records. In addition, we will also assess patients’ use of sexual 

Principal Investigator: Jennifer B. Reese
Abbreviated Title: Women’s Health Communication Study
IRB # 21-1066
Page 13 of 24
aids (e.g., vaginal health aids such as lubricant or moisturizer) using a validated item from the PROMIS 
SexFS, as an exploratory measure that could help us determine whether assessing this in the larger trial 
makes sense. Ultimately, if patients’ communication about sexual health is successful, they may employ 
sexual aids and we want to capture this. Body Compassion. We will assess body compassion, a concept 
denoting acceptance and compassion toward the physical body, using five items comprising the 
Acceptance Subscale of the Body Compassion Scale,34 at baseline. There is growing research suggesting 
that body image concerns including body compassion are predictors of psychosocial health outcomes for 
women with gynecologic cancer.12 Therefore, we will include this measure at baseline to obtain 
exploratory data that we may use to generate hypotheses for future studies.  Medical comorbidity for 
patients will be obtained by  the Self-Administered Comorbidity Questionnaire (SCQ)103. In addition to 
these measures, we will obtain information from patients at the time of screening on health concerns, 
including sexual concerns, pain, and fatigue, using validated items from the Patient Care Monitor. These 
items are scored using a 0-10 scale and we have found them to be highly valid in our prior research. 
7.0 Randomization
Randomization will occur once the patient has consented and completed the baseline (T1) survey. Using 
a similar approach as was used successfully in our prior breast cancer trial, patients will be randomized 
with an allocation ratio of 2:1 to either the STC intervention (video, workbook, and resource guide) or 
control condition (resource guide only). The statistician (Dr. Handorf) will generate the randomization 
sequences using an automated randomization procedure in REDCap that limits prediction of allocation 
and protects masking of allocations. The automated randomization function in REDCap will inform the 
Research Lab Manager of the patient’s assigned treatment condition. Randomization in blocks of six will 
guarantee that, after every six assignments, the study arms will have equal numbers.
Table 3. Patient Aim 2 Study Self-Report Outcome Measures
Measure
Baseline
Post-
Intervention
2-Month 
Follow-up
Patient-Clinician Communication (Primary)
Self-efficacy (Beliefs)88
X
X
X
Communication Behaviors (Discuss, Raise Topic, Ask a 
Question)92
-
X
-
Patient Sexual and Psychological Health Outcomes 
(Secondary) 
Sexual Activity (PROMIS-SexFS Sexual Activity 
Screener)91,93,94
X
-
X
Female Sexual Function Index (FSFI)95
X
-
X
HADS-Anxiety (HADS-A)102
X
-
X
HADS-Depression (HADS-D)102
X
-
X
Other Measures (Exploratory)
   Socio-Demographics
X
-
-
   Health-Related Quality of Life (HRQOL)
X
X
-
Sexual Aids (PROMIS SexFS)93
X
-
X
Body Compassion Scale – Acceptance Subscale34
X
-
-
   Self-Administered Comorbidity Questionnaire (SCQ)
X
-
-
   Program Evaluation
-
X
-

Principal Investigator: Jennifer B. Reese
Abbreviated Title: Women’s Health Communication Study
IRB # 21-1066
Page 14 of 24
8.0 Intervention Conditions
8.1. Starting the Conversation. The STC intervention consists of a 25-minute video accessible via 
smartphone, computer or tablet, and an accompanying 5-page workbook providing information and 
targeted skills training for communicating with providers about sexual concerns. In addition, women will 
receive a 2-page resource guide consisting of information about institutional and external resources on 
sexual and menopausal health related to gynecologic cancer and its treatment.30 The video includes a 
slideshow with narration and will be made available through a link sent to participants via email; the 
workbook in in paper format and will be sent via mail. All participants will be sent the resource guide 
several weeks prior to an upcoming scheduled clinic visit with instructions to read it prior to their visit. 
Women in the STC intervention arm will also be sent a link via email to the video with instructions to 
watch the video and complete the exercises in the accompanying workbook prior to their upcoming 
visit. Participants in both conditions will receive a reminder call close to their scheduled visit, and those 
who have not reviewed materials close to their visit will be offered the opportunity to come early to 
their visit and view the materials using a study tablet immediately prior to their clinic encounter in a 
private space. 
STC intervention content was initially developed based on formative qualitative work with breast cancer 
patients and clinicians on knowledge and skills gaps and intervention preferences84 and by principles of 
social cognitive theory,59 which emphasize building self-efficacy through learning skills for effectively 
discussing sexual health concerns. Menopausal issues were also included because the treatments 
commonly given to women with hormonal-dependent breast cancer eliminate estrogen (e.g., aromatase 
inhibitors, chemotherapy, ovarian suppression) and therefore cause both distressing sexual and 
menopausal symptoms.104-107 To maintain consistency with the initially tested intervention while 
enhancing relevance for gynecologic cancer, we include menopausal issues but focus on genito-urinary 
symptoms of menopause (e.g., vaginal symptoms, urinary symptoms), since they tend to be highly 
associated with women’s sexual function difficulties.4,39
8.2. Control. Women in the control condition will receive the Resource Guide30 only. The guide will be 
sent via email to facilitate easy use of webpages by clicking directly on listed links.
9.0 Risks to Participants
This is a behavioral study with few risks. The major risks for study subjects are: (1) discomfort at 
answering study questions on surveys, or during discussions with clinicians that occur during the trial, 
although women are free to choose how and what they say during their visit with their clinician to 
participate and are not required to change anything about their communication, and (2) loss of privacy 
or confidentiality. Due to the protections we will have in place, we believe these risks to be minimal. 
Patients will be informed that they do not have to answer any survey items that cause distress or 
discomfort, and that they are not required to discuss any topics related to sexual health with their 
clinicians if they do not wish.
10.0
Potential Benefits to Participants
We hope that participants will receive some benefit through participating in the study. However, they 
may receive no benefit. Patients in both the STC condition or the control condition will receive a 
handout with reputable resources and evidence-based information about effects of gynecologic cancer 
on sexual and menopausal health, and they may find this information useful in addressing concerns or in 

Principal Investigator: Jennifer B. Reese
Abbreviated Title: Women’s Health Communication Study
IRB # 21-1066
Page 15 of 24
suggesting resources (e.g., websites) that they could turn to for further information. Patients assigned to 
the STC intervention may gain skills related to clinical communication about sexual health, which may 
have a beneficial effect on patient-provider interactions or on aspects of their health, including their 
sexual health or function, but this cannot be guaranteed. Findings from this study may inform future 
research on patient-provider communication and sexuality in gynecologic cancer as well as guide the 
development of interventions to improve the quality of care for patients with gynecologic cancer and 
potentially other types of cancer or medical conditions. The minimal risks to subjects are reasonable in 
relation to potential benefit in improving the care of patients with gynecologic cancer.
11.0
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. In order to minimize the risks associated with loss of 
confidentiality, all patient data will be kept confidential and secure and will be de-identified for analytic 
purposes. All computers with patient or provider data will be password protected with access restricted 
to study investigators, and all paper data forms will be kept in locked cabinets. Each participant will have 
an identifying number that links to his/her name. Access to the linkage list will be limited to study team 
members and kept in a secure file. A second log will be used to track the number of patients invited to 
participate, the number who agreed, and the number who refused. This second log will have no 
personal identifying information, only the patient study number (for patients), the decision on whether 
to participate, and the reason for refusal, if any. We are concerned with ensuring that our questions 
about sexuality are handled in a sensitive manner and will assure patients that participation in the 
research study will not affect their clinical care. In the case that a patient shows increased psychological 
distress such that continuation in the study is contraindicated, the patient’s participation will be 
terminated and the patient will be given resources including contact information for appropriate mental 
health professionals.  
12.0
Costs to Participants
There are no costs to participants in this study. Self-report data will be obtained at an already scheduled 
clinic encounter of the patient and parking is free, so there are no costs associated with extra visits or 
parking. 
13.0
Off-Study Criteria
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.
14.0
Drugs and Devices
Not applicable. 
15.0
Multi-Site Research Study
Not applicable. 
16.0
Statistical Analysis

Principal Investigator: Jennifer B. Reese
Abbreviated Title: Women’s Health Communication Study
IRB # 21-1066
Page 16 of 24
16.1. Statistical Analyses for Aim 1
16.1.1. Primary and Secondary Outcome Variables
16.1.1.1. Primary outcomes are feasibility and acceptability of the study. Feasibility will be measured 
through study enrollment, retention (defined as completion of the final survey), and intervention 
completion (defined as engaging in some or all of the intervention components (i.e., video and 
workbook; STC arm only)). We will also assess completion of the resource guide across both study 
conditions, although these data will not be used to determine feasibility. Acceptability is measured using 
standard self-report items obtained at post-intervention (immediately following clinic encounter); 
specifically, these items assess intervention satisfaction, informativeness, helpfulness, relevance, ease of 
participation, liking the format, likelihood of recommending to others, and perceived importance of the 
program for people with gynecologic cancer. 
16.1.2.1. Feasibility. The proportion of study subjects meeting each feasibility measure will be 
calculated. The following rates will be used as benchmarks for feasibility: Enrollment > 60% of eligible 
candidates; retention > 80%; and intervention completion > 70%.  For enrollment, we will approach 
patients until clinical communication data are collected on 30 participants, and then stop approaching 
patients.  If we meet our target of 30 enrollments by approaching 50 or fewer patients, the intervention 
will be declared as feasible.  
16.1.2.2. Acceptability. At the individual level, we will determine whether the individual met our 
acceptability criteria, which we define as endorsing 75% of the 8 acceptability items for the core 
components of the STC intervention (video and workbook; at least 6 out of 8 items). If 75% of the STC 
sample (n=15) 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 
spent using intervention materials, qualitative survey responses) will be analyzed descriptively or using 
thematic analysis as appropriate. These items will be analyzed across both conditions.
16.1.2.3. Preliminary efficacy. Prior to analyzing outcome data, we examine internal reliability of the 
outcome measures. In line with recommendations for the analysis of data from pilot studies108 
preliminary outcome data will only be analyzed descriptively, and no formal hypothesis testing will be 
conducted.  Instead we will calculate means and mean differences (from baseline to follow-up 
assessments) with their respective standard deviations and 95% confidence intervals. Standard effect 
sizes will also be calculated.  These results will inform power calculations for a larger, definitive study.
Analyses for Exploratory Aims. The exploratory aim will characterize the feasibility, acceptability, and 
preliminary effects of the STC intervention by women’s partnered status and level of sexual concerns. 
We will generate standard descriptive statistics within strata defined by partnered status (partnered vs. 
not partnered) and level of sexual concerns obtained on the HRQOL scale at baseline.  Frequencies, 
proportions, means, medians, and standard deviations will be calculated and presented. In addition, we 
will conduct exploratory hypothesis-generating analyses on the novel measure of body compassion, 
which is assessed only at baseline. For the body compassion data (obtained at baseline only), similar 
descriptive statistics will first be conducted, as well as exploratory correlational analyses between the 
body compassion scale and study outcomes, and socio-demographic/clinical correlates or Chi-square for 
categorical factors.   
16.1.2 Sample Size 

Principal Investigator: Jennifer B. Reese
Abbreviated Title: Women’s Health Communication Study
IRB # 21-1066
Page 17 of 24
This study will enroll a total of 30-36 patients, of which 20-24 will be assigned to the intervention and 
10-12 assigned to control. The objective of this study is to pilot test the newly adapted STC intervention 
for women with gynecologic cancer and to allow us to calculate effect sizes, if appropriate, that will 
inform a larger R01 trial that is expected to follow from this study. We selected 30 participants to 
participate in this trial because it is a large enough sample to provide ample pilot data while maintaining 
adequate feasibility in the time allotted. The target sample size is similar to those used in successful 
prior pilot trials used by the study team.109 Further, we have chosen a 2:1 allocation to the STC 
condition, which allows us to gather greater information from participants in this condition, our primary 
interest, relative to the control condition.  The operating characteristics of the feasibility and 
acceptability rules for this pilot study are given in Table 4.  Although we may over-recruit to ensure 
adequate communication data, feasibility and acceptability rules (see Table 4) will be conducted using 
the first 30 participants.  Probabilities were calculated using the negative binomial distribution for 
enrollment, and using the binomial distribution for all other feasibility and acceptability benchmarks.
Table 4: Operating characteristics of feasibility and acceptability decision rules
Criteria
Decision rule
Favorable 
condition
Unfavorable 
condition
Probability 
of 
declaring 
success if 
favorable
Probability 
of declaring 
success if 
unfavorable
Enrollment
> 60% enrolled (30 accrued with ≤50 
approached)
75%
45%
99%
2%
Retention
> 80% enrolled (≥ 24/30 enrolled)
90%
65%
97%
6%
Completion
≥70% complete (≥14/20 on STC arm)
80%
50%
91%
6%
Acceptability
≥75% endorse at least 6/8 items (≥15/20 on 
STC arm)
85%
55%
93%
6%
17.0
Data Safety Monitoring Plan
The PI will take responsibility for monitoring the safety of all phases of the research study. The research 
assistant or other study team member will report any adverse events he or she observes to Dr. Reese 
immediately. The study consent forms have the contact information for the study PI and the 
Institutional Review Board (IRB), and patients may contact her or the IRB at any time. The research team 
will keep a log tracking the number, nature, and frequency of adverse events that occur in both 
recruiting sites and overall. Because of the nature of the research as involving procedures without 
significant risk (e.g., surveys; online video intervention) there are unlikely to be any related adverse 
events. Given the minimal risk of this study, it is determined that a Data and Safety Monitoring Board is 
not necessary for the proposed study. 
18.0
Adverse Events
Because of the nature of the research as involving procedures without significant risk (e.g., surveys; brief 
communication skills training program) 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 or during the intervention. All participants are informed of possible adverse 
psychological reactions associated with participating in the study during the informed consent process.

Principal Investigator: Jennifer B. Reese
Abbreviated Title: Women’s Health Communication Study
IRB # 21-1066
Page 18 of 24
    
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. 
19.0
Quality Assurance Procedures and Participant Confidentiality
We have designed standardized procedures for every aspect of study administration, from the candidate 
screening process to administration of the study conditions. Second, all outcome measures have 
demonstrated excellent psychometric properties and have prior research supporting their 
appropriateness in the study population and sensitivity to interventions. Third, REDCap, a secure web-
based application, will be used for data collection and for randomization, with an automated procedure 
that limits prediction of allocation and protects masking of allocations. Paper versions of surveys (e.g., 
post-intervention surveys collected in clinic) will be entered into REDCap by study staff, and the paper 
versions of the surveys will be locked in a file cabinet containing no identifying information (e.g., surveys 
are labeled with a random study ID). Only study staff will have access to the REDCap database and the 
paper versions of the surveys. All files related to study participation (e.g., tracking files) will be kept on 
Dr. Reese’s drive on the Fox Chase network and will be password protected. Finally, to facilitate 
unbiased data collection and analysis the following steps are taken: 1) the data analyst will conduct 
outcome data analyses on data in which study condition is masked; 2) outcome data collection is 
completed in an automated fashion using REDCap, minimizing the need for contact with participants to 
collect study data. On an annual basis, adverse events will be reviewed across study conditions. During 
the annual review of adverse events, the presence of significant between-group differences could 
potentially warrant unmasking of the study conditions by the study biostatistician. 
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 patient; 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 
will be secured in a locked location.
20.0
Participant Informed Consent

Principal Investigator: Jennifer B. Reese
Abbreviated Title: Women’s Health Communication Study
IRB # 21-1066
Page 19 of 24
See separate Informed Consent document
21.0
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IRB # 21-1066
Page 20 of 24
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IRB # 21-1066
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Abbreviated Title: Women’s Health Communication Study
IRB # 21-1066
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Principal Investigator: Jennifer B. Reese
Abbreviated Title: Women’s Health Communication Study
IRB # 21-1066
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22.0
 Appendices

Surveys or Data Collection Tools
o
Self-Report Materials
o
Medical Records Data Collection Form

Recruitment Materials
o
Recruitment letter/email
o
Recruitment script
o
Recruitment flyer/brochure