Multimodal Mobile Intervention Application (App) to Address Sexual Dysfunction in Hematopoietic Stem Cell Transplant Survivors
Phase: NA
Conditions: Other Cancer
Sponsor: Massachusetts General Hospital

 
PROTOCOL TITLE: 
 
 Multimodal Mobile Intervention Application (app) to Address Sexual Dysfunction in 
Hematopoietic Stem Cell Transplant Survivors  
 
PRINCIPAL INVESTIGATOR: 
Dr. Areej El-Jawahri 
Bone Marrow Transplant 
617-643-4003 
ael-jawahri@partners.org 
VERSION NUMBER: 08 
DATE: 
02/3/2022

2 
 
Table of Contents 
1.0 
Objectives ................................................................................................................ 3 
2.0 
Background .............................................................................................................. 3 
3.0 
Inclusion and Exclusion Criteria .............................................................................. 7 
4.0 
Study-Wide Number of Subjects: 60 patients .......................................................... 8 
5.0 
Study-Wide Recruitment Methods: ......................................................................... 8 
6.0 
Multi-Site Research: Not Applicable ....................................................................... 9 
7.0 
Study Timelines ....................................................................................................... 9 
8.0 
Study Endpoints ....................................................................................................... 9 
9.0 
Procedures Involved............................................................................................... 10 
10.0 Data and Specimen Banking: Not Applicable ....................................................... 13 
11.0 Data Management and Confidentiality .................................................................. 13 
12.0 Provisions to Monitor the Data to Ensure the Safety of Subjects: ......................... 14 
13.0 Withdrawal of Subjects .......................................................................................... 14 
14.0 Risks to Subjects .................................................................................................... 14 
15.0 Potential Benefits to Subjects ................................................................................ 15 
16.0 Vulnerable Populations: Not Applicable ............................................................... 15 
17.0 Community-Based Participatory Research: Not Applicable ................................. 15 
18.0 Sharing of Results with Subjects ........................................................................... 15 
19.0 Setting .................................................................................................................... 15 
20.0 Resources Available............................................................................................... 15 
21.0 Prior Approvals: Not applicable ............................................................................ 16 
22.0 Recruitment Methods ............................................................................................. 16 
23.0 Local Number of Subjects: .................................................................................... 17 
24.0 Provisions to Protect the Privacy Interests of Subjects .......................................... 17 
25.0 Compensation for Research-Related Injury: Not Applicable ................................ 17 
26.0 Economic Burden to Subjects: Not Applicable ..................................................... 17 
27.0 Consent Process ..................................................................................................... 17 
28.0 Process to Document Consent in Writing .............................................................. 18 
29.0 Drugs or Devices: Not Applicable ......................................................................... 18 
30.0 References .............................................................................................................. 18 
31.0 Appendix A ............................................................................................................ 21 
32.0 Appendix B ............................................................................................................ 21 
33.0 Appendix C ............................................................................................................ 24 
34.0 Appendix D ............................................................................................................ 30 
35.0 Appendix E ............................................................................................................ 33 
36.0 Appendix F............................................................................................................. 34 
37.0 Appendix G ............................................................................................................ 36 
38.0 Appendix H ............................................................................................................ 37 
39.0 Appendix I ............................................................................................................. 38 
40.0 Appendix J ............................................................................................................. 39 
41.0 Appendix K ............................................................................................................ 40 
42.9    Appendix L ……………………………………………………………………….53 
 

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1.0 
Objectives 
The goal of this study is to develop, refine, and test the feasibility and preliminary efficacy of a self-administered, 
mobile sexual dysfunction intervention application (app) in improving outcomes of hematopoietic stem cell 
transplant (HCT) survivors. Sexual dysfunction is the most common complication post-HCT with over 40% of 
male and 60% of female survivors reporting long-term sexual dysfunction post-transplant. Importantly, sexual 
dysfunction is associated with worse quality of life (QOL), relationship dissatisfaction, and psychological distress, 
which further contributes to the morbidity in this population. HCT survivors experience a unique and wide range 
of biologic, interpersonal, psychological, and social factors that impact their sexual function. Given the 
multifactorial nature of sexual dysfunction, a multimodal approach is necessary to address patients’ specific issues 
and concerns. Despite the increasing use of HCT and the burden of sexual dysfunction in this often young patient 
population, there are currently no interventions to address their sexual dysfunction. We completed a pilot study 
in which we recruited HCT survivors with sexual dysfunction causing distress to participate in a multimodal 
intervention that entailed monthly visits with trained study nurse practitioners. We demonstrated that the 
intervention was feasible and led to statistically and clinically significant improvements in patients’ satisfaction 
and interest in sex, sexual health and function, QOL, and symptoms of depression and anxiety. Despite the success 
of our prior work, the majority of HCT survivors will not have access to clinicians with expertise to address their 
sexual dysfunction.  
 
Therefore, we are currently adapting our sexual health intervention to a mobile app, which patients can self-
administer via tablet computer to ensure the accessibility and scalability of the intervention. The sexual health 
intervention manual and the content of the app has been outlined and will be submitted as an appendix to this 
protocol. The app development is currently under way with our industry partner. We now seek IRB approval for 
this project to evaluate the feasibility and preliminary efficacy of the intervention versus enhanced standard care 
in 60 HCT survivors. If the IRB would like to view wireframes of the mobile app, or the app itself after the final 
development phase (in addition to the manual and content as outlined in the appendix), we will submit it as an 
amendment for review to the IRB prior to initiating study recruitment procedures.  
 
1.1 Specific Aims 
Specific Aim 1: To examine the feasibility of the intervention to address sexual dysfunction in 
HCT survivors.  
Specific Aim 2: To determine the preliminary efficacy of the intervention in improving patient-
reported sexual function, quality of life (QOL), and psychological outcomes.  
1.2 Hypotheses 
Hypothesis 1: The intervention will be will be deemed feasible if at least 60% of eligible patients 
enroll in the study, and of those enrolled, at least 60% engage in at least 70% of the intervention 
modules.  
Hypothesis 2: Patients randomized to the intervention will report better sexual function, QOL, 
and depression and anxiety symptoms compared to those randomized to the control arm.  
 
Exploratory Aim: to qualitatively explore patients’ general perceptions of the sexual health 
mobile app and their overall satisfaction with the intervention. 
 
2.0 
Background 
2.1 Background 

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Hematopoietic stem cell transplantation (HCT) is a commonly used and potentially curative treatment 
strategy for many hematologic conditions.1-4 The use of HCT has increased over the last decade with 
more than 20,000 transplants performed in the United States each year, with over 40% of those in 
patients younger than 45 years of age.4-7 HCT survivors experience a significant and drastic 
deterioration in their sexual function that persists for many years following their therapy. In fact, sexual 
dysfunction is the most common and persistent complication post-HCT with over 40% of male and 60% 
of female survivors reporting long-term sexual dysfunction post-transplant.8-11 Studies demonstrate that 
sexual dysfunction is associated with worse quality of life (QOL), relationship dissatisfaction, and 
psychological distress.12-18 Consequently, the National Institute of Health Late Effects Initiative 
identified sexual dysfunction as a major concern facing HCT survivors and highlighted the critical need 
to develop interventions to enhance sexual function in this population.19  
 
Despite the prevalence of sexual dysfunction in HCT survivors, interventions to improve sexual function 
are lacking.14,19,20 Addressing sexual health in this population is complicated by the multiple factors that 
contribute to dysfunction, including biologic, interpersonal, psychological, and social factors.10,12,20-30 
Common biologic factors include hormonal alterations, scarring from chronic graft-versus-host disease, 
and pain due to transplant related complications.10,12,20-26 Patients often experience interpersonal issues 
such as relationship discord, fear of intimacy, and lack of communication with their partner.14 
Depression, anxiety, and body-image concerns further exacerbate dysfuntion.27-30 Lastly, personal values 
and social norms play a substantial role in patients’ comfort addressing their sexual health.14 Thus, 
interventions that comprehensively address a wide range of factors contributing to sexual dysfunction in 
HCT survivors are needed to enhance sexual function.14 
 
We completed a pilot study to assess the feasibility and preliminary efficacy of a multimodal 
intervention to address sexual dysfunction in HCT survivors.31 Given the lack of available sexual health 
clinicians at most cancer care settings,9,26 we trained nurse practitioners to deliver the intervention 
during monthly visits integrated with patients’ routine outpatient oncology care. We demonstrated 
clinically significant improvement in patients’ satisfaction and interest in sex, as well as sexual health 
and function including orgasm, erectile function, and vaginal discomfort post-intervention. Notably, 
patients also experienced improvement in their QOL and symptoms of depression and anxiety. This 
study established the feasibility and preliminary efficacy of this intervention to enhance sexual function, 
QOL, and mood in HCT survivors. 
 
Although our pilot study had promising findings, a number of participants reported that attending monthly 
visits was burdensome, especially for those living far from their transplant center. The study nurse 
practitioners also cited the visit frequency as a barrier to broad dissemination of the intervention given 
their limited time and availability to address sexual health concerns during routine clinic visits. In addition 
to the time burdens for both the study patients and clinicians, the majority of HCT survivors will not have 
access to clinicians with expertise in sexual dysfunction, which limits the scalability of this effective 
intervention. We recently secured funds through the MGH Transformative Scholar Program to adapt our 
intervention to a mobile application (app), which patients can self-administer via tablet computer to ensure 
the accessibility and scalability of the intervention. An app also enables patients to access the intervention 
in the privacy of their homes, more easily engage their partners in the intervention, and avoid the need for 
monthly clinic visits. We are currently developing the mobile app with our industry partners. The sexual 
health intervention manual and the content of the app has been outlined and will be submitted as an 
appendix to this protocol. We now seek IRB approval to conduct a pilot randomized trial of the mobile 
app versus enhanced standard care in 60 HCT survivors to assess the feasibility and preliminary efficacy 
of the mobile app for improving patients’ sexual function, QOL, and mood. If the IRB would like to view 
wireframes of the mobile app, or the app itself after the final development phase (in addition to the manual 

5 
 
and content as outlined in the appendix), we will submit it as an amendment for review to the IRB prior 
to initiating study recruitment procedures.  
 
2.1.2 Gaps in Current Knowledge 
Despite the high prevalence of sexual dysfunction in HCT survivors, there are currently no interventions 
to address the sexual problems affecting this population. Additionally, to our knowledge, no published 
studies exist regarding the efficacy of a mobile app specifically to address sexual dysfunction. This 
study will address the high prevalence of sexual dysfunction in this population to evaluate an innovative 
intervention to ameliorate sexual health and quality of life in HCT survivors.  
2.2 Preliminary Data 
A Multimodal Intervention to Address Sexual Dysfunction in HCT survivors 
We conducted a pilot study to assess the feasibility and preliminary efficacy of a multimodal 
sexual dysfunction intervention to improve sexual function in HCT survivors. We screened all 
HCT survivors and found that 33.1% (50/151) reported significant sexual dysfunction causing 
distress. The intervention entailed monthly visits with a trained study nurse who assessed and 
treated sexual dysfunction as per a treatment guide that was developed based on a systematic 
review of the literature. Overall 94.0% (47/50) of patients who screened positive for sexual 
dysfunction causing distress agreed to participate in the study. Using a pre-post design, we 
demonstrated significant improvement in patients’ satisfaction and interest in sex as well as 
sexual health and function, QOL, and depression and anxiety symptoms post-intervention [Table 
1]. This study established the feasibility and preliminary efficacy of the multimodal sexual 
dysfunction intervention which serves as the basis for this randomized controlled trial.  
Table 1: Intervention Effects on Patient-Reported Outcomes 
Patient outcomes: 
Pre-Intervention 
Post-Intervention 
Cohen’s D 
P- Value 
Satisfaction with sex 
16.07 
29.70 
1.34 
<0.0001 
Interest in sex 
10.98 
15.39 
0.91 
<0.0001 
Climax/orgasm 
2.19 
4.22 
1.35 
<0.0001 
Erectile function 
19.58 
32.74 
1.61 
<0.0001 
Lubrication 
19.44 
34.31 
1.27 
0.0001 
Vaginal discomfort 
33.77 
14.92 
1.32 
0.0005 
QOL 
107.98 
123.88 
0.81 
<0.0001 
Depression 
4.28 
2.33 
0.60 
0.0002 
Anxiety 
4.59 
2.59 
0.49 
0.0019 
 
2.3 Significance  
Sexual dysfunction affects many hematopoietic stem cell transplant (HCT) survivors 
HCT is a potentially curative treatment for many patients with hematologic conditions.1-4 The number of 
HCT survivors is increasing with over half a million projected survivors in the United States by 2030.4,5 
Over 40% of these survivors will be younger than 45 years of age.7 Sexual dysfunction is the most 
common long-term complication in HCT survivors.8,9,12,20 Nearly half of HCT survivors are dissatisfied 
with the quality of their sexual life.32 The incidence of sexual dysfunction is 40% in male and 60%-80% 
in female HCT survivors, which is significantly higher than other cancer survivors.8-12,20 Consequently, 
the National Institute of Health Late Effect Initiative identified sexual dysfunction in HCT survivors as a 
highly unmet need that requires further research.19  
 
Sexual dysfunction has negative consequences on patients’ quality of life (QOL) and mood 

6 
 
Sexual health plays a central role in an individual’s identity, QOL, and self-esteem.20 Moreover, sexual 
dysfunction has been associated not only with worse QOL and mood in cancer survivors,14-17 but also 
with worse fatigue, relationship discord, intimacy problems, and distress.12-18 Notably, 70% of HCT 
survivors who have sexual dysfunction report substantial marital dissatisfaction post-HCT. 12-18 
Therefore, improving patient’s sexual function post-transplant may have a positive effect on their QOL, 
physical and psychological health, and intimate relationships, thereby decreasing the overall morbidity 
of HCT.  
 
The etiology of sexual function in HCT survivors is multi-factorial 
HCT survivors experience a wide range of conditions which impact their sexual function.10,12,20-30 
Biologic, interpersonal, psychological, and social factors all contribute to sexual dysfunction in this 
population. 10,12,20-30 Biologic factors secondary to HCT include decreased libido, vaginal alterations, 
erectile dysfunction, hormonal deficiency, dyspareunia, and infertility.10,12,20-25 Chronic graft-versus-host 
disease (GVHD), the most common cause of morbidity in allogeneic HCT survivors, can cause vaginal 
stenosis, and injury to blood vessels, which can manifest as erectile dysfunction in men and anorgasmia 
in women.10,26,33 Patients also struggle with interpersonal problems including relationship disruptions 
and intimacy concerns with their partner.14,27-30 Psychological factors that affect sexual function include 
depression, anxiety, and body-image concerns. 14,27-30 Lastly, personal values affect patients’ comfort 
addressing their sexual health.14 Thus, sexual dysfunction in HCT survivors is multi-factorial, requiring 
a multimodal approach to address patients’ sexual health concerns. 
 
Clinicians lack sufficient training to address sexual dysfunction in cancer survivors  
HCT survivors report having little communication with their clinicians about sexual health.8,24,34-37 
Clinicians infrequently engage in discussions with their patients about their sexual health,8,24,34,35 citing 
inadequate time, insufficient training, and patient discomfort as barriers to addressing sexual 
dysfunction.38,39 Notably, patients who reported participating in a discussion with their clinician about 
sexuality noted fewer sexual functioning problems compared to those who did not communicate with 
their clinicians.8 HCT survivors would greatly benefit from interventions to empower them to 
communicate with their clinicians about their sexual health. 
 
Interventions to comprehensively address sexual dysfunction post-HCT are lacking 
Despite the well-documented burden of sexual dysfunction on HCT survivors, there have been no 
interventions to date to improve sexual health in this population.14,19,20 Given the multi-factorial nature 
of sexual dysfunction in HCT survivors, interventions must address these diverse sexual health 
needs.14,20 The management of sexual dysfunction in HCT survivors would therefore be ideally 
addressed by a multidisciplinary team of sexual health experts, psychologists, gynecologists, and 
urologists.14,26 Although few cancer centers have a multidisciplinary sexual health clinic, the lack of 
professionals trained in addressing sexual dysfunction severely limits the dissemination of such a 
complex service model.9,26 In addition, HCT survivors often find it difficult to attend multiple clinic 
appointments and coordinate their care among various specialists.19 Novel models of care that address 
the medical and psychosocial aspects of sexual dysfunction in HCT survivors in a feasible, patient-
centered, and scalable manner are critically needed.  
 
Mobile applications (apps) can broadly disseminate innovative interventions 
Mobile health apps offer an innovative strategy to enhance the accessibility and scalability of 
interventions addressing the needs of patients who cannot access health care clinicians with particular 
expertise. Once patients receive appropriate instructions on their use, mobile interventions are highly 
acceptable to patients regardless of their age, health literacy, or computer experience.40,41 Mobile 
behavioral interventions have shown promising efficacy in addressing a variety of health problems 
including depression, anxiety, substance abuse, and insomnia.40,42-47 While some behavioral web-based 

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and mobile interventions have suffered from low adherence, mobile apps that incorporate features to 
enhance patients’ engagement including gamification, adaptive skill-building, and a record of personal 
progress through the app content have shown 85-100% usability and retention rates.48 Using mobile app 
to deliver a sexual health intervention is an innovative strategy to overcome the shortage of trained 
sexual health clinicians to care for HCT survivors. A mobile app will enable patients to access the 
intervention in the privacy of their home, engage their partners with the content, and avoid additional 
clinic visits. To our knowledge, no published studies exist regarding the efficacy of a mobile app to 
address sexual dysfunction.  
 
We propose to adapt our successful intervention for addressing sexual dysfunction to a mobile app 
We completed a pilot study of a multimodal intervention to address sexual dysfunction in HCT survivors 
(see preliminary studies).31 Participants attended monthly intervention visits with trained study nurse 
practitioners who 1) assessed the causes of their sexual dysfunction; 2) educated, normalized, and 
empowered them to address their sexual health; and 3) implemented therapies targeting their specific 
sexual health concerns. The intervention was feasible and led to statistically and clinically significant 
improvements in patients’ satisfaction and interest in sex, QOL, and symptoms of depression and anxiety. 
While we were encouraged by these results, a number of participants reported that attending monthly visits 
was burdensome, especially for those living far from their transplant center. The study nurse practitioners 
also cited the visit frequency as a barrier to broad dissemination of the intervention given their limited 
time and availability to address sexual health concerns during routine clinic visits. In addition to the time 
burdens for both the study patients and clinicians, the majority of HCT survivors will not have access to 
clinicians with expertise in sexual dysfunction, which limits the scalability of this effective intervention. 
We recently secured funds through the MGH Transformative Scholar Grant to adapt our successful 
intervention to a mobile app, which patients can self-administer to ensure the accessibility and scalability 
of the intervention. These funds can only be used for app development. We are working currently with 
our industry partners to develop the mobile app.  The sexual health intervention manual and the content 
of the app has been outlined and will be submitted as an appendix to this protocol [Appendix A]. We now 
seek IRB approval to conduct a pilot randomized trial of the mobile app versus enhanced standard care in 
60 HCT survivors to assess the feasibility and preliminary efficacy of the mobile app for improving 
patients’ sexual function, QOL, and mood. If the IRB would like to view wireframes of the mobile app, 
or the app itself after the final development phase (in addition to the manual and content as outlined in the 
appendix), we will submit it as an amendment for review to the IRB prior to initiating study recruitment 
procedures.  
 
3.0 
Inclusion and Exclusion Criteria 
We will recruit a total of 60 HCT survivors who are at least 3 months post-HCT and without evidence of 
disease from Massachusetts General Hospital Cancer Center and Dana-Farber Cancer Institute to 
participate in this randomized trial.   
3.1 Screening for Eligibility 
We will use the same successful screening, recruitment, and enrollment procedures from our 
prior pilot study. An RA and Dr. El-Jawahri will screen the weekly transplant clinic schedule to 
identify potentially eligible patients. The RA will then send an email to the treating oncology 
clinician to notify him or her that the patient is potentially eligible for study participation and 
inquire about any concerns regarding his or her study participation. If the treating clinician has 
any objections regarding the patient’s participation, the RA will document the reasons and not 
approach those individuals. If there is no concern regarding study participation, the RA or the 
oncology clinician will screen the patient for sexual dysfunction at their next scheduled visit 
using the two-question approach based on the NCCN Survivorship Guidelines: 1) “do you have 

8 
 
problems with sexual function?” and 2) “are these problems causing you distress?”. The RA will 
then offer study participation for those who screen positive for sexual dysfunction causing stress.   
3.2 Eligibility  
3.2.1 Inclusion Criteria 
1. Adult patients (≥18 years) who underwent an autologous or allogeneic HCT at least 3 months prior to 
study enrollment. 
2. Ability to speak English or able to complete questionnaires with assistance required from an interpreter 
or family member. 
3. Positive screen for sexual dysfunction that is causing distress based on the NCCN survivorship 
guidelines. 
 
3.2.2 Exclusion Criteria 
1) Recurrent disease requiring treatment 
2) Significant uncontrolled psychiatric disorder (psychotic disorder, bipolar disorder, major depression) 
or other co-morbid disease (dementia, cognitive impairment), which the treating clinician believes 
prohibits the ability to participate in study procedures. 
 
3.3 Special Populations We will not include adults unable to consent, individuals who are not 
yet adults, pregnant women, or prisoners.  
 
4.0 
Study-Wide Number of Subjects: 60 patients 
5.0 
Study-Wide Recruitment Methods:  
We will use the same successful screening, recruitment, and enrollment procedures from our 
prior pilot study. An RA and Dr. El-Jawahri will screen the weekly transplant clinic schedule to 
identify potentially eligible patients. The RA will then send an email to the treating oncology 
clinician to notify him or her that the patient is potentially eligible for study participation and 
inquire about any concerns regarding his or her study participation. If the treating clinician has 
any objections regarding the patient’s participation, the RA will document the reasons and not 
approach those individuals. If there is no concern regarding study participation, the RA or the 
oncology clinician will screen the patient for sexual dysfunction at their next scheduled visit 
using the two-question approach based on the NCCN Survivorship Guidelines: 1) “do you have 
problems with sexual function?” and 2) “are these problems causing you distress?”. The RA will 
then offer study participation for those who screen positive for sexual dysfunction causing stress.  
The RA will then review the study procedures and informed consent document and obtain 
written informed consent. 
Alternatively, if a patient is unable to be approached in-person to determine primary eligibility due to 
external factors, such as a lack of clinic space, or patient time constraints, the study team may reach out 
to potential participants over the phone. Prior to initiating phone contact, the study team will contact the 
treating oncology clinician to assess if the clinician has any reservations about study staff contacting the 
patient. Study staff will call the potentially eligible patient using the recruitment and screening phone 
script (see verbal consent) to gauge interest and screen the patient to determine eligibility. Study staff 
will not call more than three times total. If unable to reach the patient, study staff will leave a voicemail 
with staff contact information (see voicemail script). If the patient expresses interest and screens in, the 
RA will conduct informed consent over the telephone. Alternatively, study staff may approach the 

9 
 
patient at their next clinic visit to review the study procedures and the informed consent document and 
obtain written informed consent. 
 
The study team will additionally have the option of providing study information to eligible patients via 
Patient Gateway, using a template with recommended language (Appendix L). Patients will be given a 
summary of the study and will be encouraged to contact the study team using provided contact 
information if interested in hearing more about the study. 
 
*We are requesting a Waiver of Written Documentation of Consent 
This waiver is being requested to assist with patient recruitment, as a result of the COVID-19 pandemic. 
This study meets the waiver requirements given it is considered no more than Minimal Risk and all 
study procedures could be conveyed verbally. This waiver will reduce the risk to patients and is 
necessary for research procedures to continue. 
 
6.0 
Multi-Site Research: Not Applicable 
7.0 
Study Timelines 
7.1 Timelines 
We anticipate that we will need approximately 2 years to enroll the sample size for this study. 
Participants will remain on the study for up to 1 year. 
 
8.0 
Study Endpoints 
8.1 Primary endpoint: The primary endpoint of this pilot RCT is to assess the feasibility of the 
intervention. The proposed intervention app will be deemed feasible if at least 60% (95% 
CI +/- 12%) of eligible patients are enrolled in the study, and of those enrolled, at least 60% 
engage with at least 70% of the intervention modules. Modules engagement will be 
captured by the app. 
8.2 Secondary endpoints: 
• Compare patient-reported global satisfaction with sex (PROMIS Sexual Function 
and Satisfaction Measure) scores at 8 weeks between the study groups 
• Compare patient-reported interest in sexual activity (PROMIS Sexual Function 
and Satisfaction Measure – Interest in sexual activity domain) scores at 8 weeks 
between the study groups 
• Compare patient-reported global satisfaction with sex (PROMIS Sexual Function 
and Satisfaction Measure – Global satisfaction with sex domain) at 12 weeks 
between the study groups 
• Compare patient-reported interest in sexual activity (PROMIS Sexual Function 
and Satisfaction Measure – Interest in sexual activity domain) at 12 weeks 
between the study groups 
• Compare patient-reported orgasm (PROMIS Sexual Function and Satisfaction 
Measure – Orgasm domain) at 8 weeks and 12 weeks between the study groups 
• For males: compare patient-reported erectile function (PROMIS Sexual Function 
and Satisfaction Measure – Erectile function domain) at 8 and 12 weeks between 
the study groups 

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• For females: compare patient-reported lubrication and vaginal comfort (PROMIS 
Sexual Function and Satisfaction Measure – lubrication and vaginal comfort 
domains) at 8 and 12 weeks between the study groups 
• Compare patient reported QOL (FACT-BMT) at 8 and 12 weeks between the 
study groups 
• Compare patient reported anxiety and depression symptoms (HADS) at 8 and 12 
weeks between the study groups  
9.0 
Procedures Involved 
9.1 Study Design  
We will conduct a single-site pilot randomized trial in 60 HCT survivors to assess the 
feasibility and preliminary efficacy of the intervention for improving patient-reported 
sexual function, QOL, and mood. Patients will be randomized in 1:1 fashion and stratified 
by transplant type (autologous vs. allogeneic) to either receive only a sexual health visit 
with a transplant clinician specializing in sexual health or a sexual health visit with a 
transplant clinician specializing in sexual health with access to the app. This visit may be in 
clinic or conducted via secure video-based conference. As transplant type is an important 
variable that affects sexual function and recovery post-HCT, we will stratify by HCT type 
to ensure balanced representation between the study groups. Both study groups will attend 
a visit with a transplant clinician specializing in sexual health who will conduct a brief 
examination and assess the need for any treatments or medications to address sexual health 
problems; this visit may be in clinic or conducted virtually via secure video-based 
conference.. The intervention group will have access to the mobile app. We will also 
conduct qualitative interviews with 10 patients that are randomized to the mobile app 
intervention, in order to understand and assess patient experience using the app. Qualitative 
interviews will be conducted in clinic, or over the telephone. 
 
9.2 Procedures  
We will recruit 60 patients 3 months after autologous or allogeneic HCT who report having 
sexual dysfunction causing distress for this study. The research assistant (RA) will review the 
consent form with potential participants and obtain verbal or written informed consent. Upon 
study enrollment, participants will complete baseline study measures and then they will be 
randomized to the mobile app versus enhanced standard care. 
Intervention Arm: Patients randomized to the intervention will first meet with a transplant clinician, in 
clinic or via secure video-based conference, for a brief medical examination to assess the need for 
medications for erectile dysfunction, vaginal atrophy, or vulvovaginal GVHD given their prevalence in 
this population. We will then provide patients with a tablet computer that they will use to access the 
mobile app. We chose to use tablet computers for intervention delivery in this proof-of-concept study. 
However, the mobile app can be further adapted in the future to be delivered via mobile phones to 
enhance dissemination. Upon study enrollment, the RA will provide patients with a comprehensive 
tutorial and detailed instructions regarding how to use the app, in person or via secure video-based 
conference. The RA will encourage patients to engage their partners with the app content. The app will 
also prompt patients to engage their partners with specific exercises. Given the pilot nature of this study, 
we will not measure the effect of the intervention on partners. Patients will complete the intervention 
modules at their desired pace over 8 weeks. The app will prompt patients with reminders to complete 
their modules and utilize incentives to enhance patient engagement, as noted previously. The mobile app 

11 
 
will collect data on intervention fidelity (the number of completed modules, proportion of each module 
completed, time spent on each module, partner engagement with each module). Participants will 
complete additional surveys 8 and 12 weeks after clinician consult and examination. 
 
Additionally, we will conduct qualitative interviews with 10 patients who are randomized to the 
intervention arm, to understand their experience of using the application and to assess patient opinions 
regarding the app. We will purposefully sample patients to ensure adequate representation based on age 
and sex. If we see different themes emerge based on age/sex, we will amend the protocol to increase our 
sample size for these qualitative interviews. We have developed a semi-structured qualitative interview 
guide to explore 1) patients’ general experience using the SHIFT app and 2) patients’ opinions regarding 
app content (Appendix M). Qualitative interviews will be conducted after patients complete all of their 
quantitative study assessments. Trained study staff will conduct and audio-record one-on-one interviews 
with patients via telephone or in-person. The estimated time to complete the patient qualitative interview 
is approximately 30 minutes. Audio recordings of the qualitative interviews will be stored for six months 
following interview completion. 
 
Enhanced Standard Care: Patients assigned to the enhanced standard care group will not receive the 
mobile app. However, they will meet with a transplant clinician for a brief medical examination to 
assess the need for medications for erectile dysfunction, vaginal atrophy, or vulvovaginal GVHD; this 
visit will be conducted in clinic or virtually via secure video-based conference. The treating transplant 
clinician may refer patients to a psychologist, urologist, or gynecologist at the patients’ request or at 
their discretion. At MGH, < 1% of transplant survivors are referred to a specialist to address sexual 
health concerns. Importantly, we did not see an increase in rate of referral to specialists during our pilot 
study. We will also collect data on referrals to specialists in both study groups. Although most transplant 
practices across the country do not systematically screen or treat sexual dysfunction, we chose a 
conservative control group to allow us to most accurately assess the effect of the mobile app.61 
Participants will complete additional surveys 8 and 12 weeks after clinician consult and examination. 
 
Institutions will register eligible participants in the Clinical Trials Management System (CTMS) OnCore 
as required by DF/HCC SOP REGIST-101.  
 
Once the patient has been registered, a member from of the MGH Cancer Outcomes Research Program 
(CORe) team (independent from the study staff) will perform randomization procedures using a 
computer-generated randomization schema, stratified by study site and transplant type.  
 
9.3 Procedure to Lessen Risk  
9.3.1 Procedures to Lessen Risk 
We do not anticipate that participation in this study will pose risk to patients other than the risk of 
breach in confidentiality. Prior studies of psychoeducational apps demonstrated that patients utilize the 
apps without any adverse emotional reactions. Should a participant express distress while using the app 
or completing study assessments or qualitative interview, the RA will reassure the participant that they 
can stop using the app and they need not answer any of the assessment questions which they find 
upsetting. The RA will also remind the participant that study participation is voluntary. If participants 
remain distressed, both the Principal Investigator and the oncology clinician will be notified. 
Additionally, we will offer participants who remain distressed an opportunity to meet with either the 
principal investigator (Dr. Areej El-Jawahri) or a clinical psychologist (Dr. Joseph Greer, a co-
investigator) to help address their distress. 
 

12 
 
We will prevent breaches in confidentiality by keeping participant data on password protected Partners 
computers and in a locked office on MGH campus. Data logged online will be saved in password 
protected documents. Only study team will have access to the data. 
 
The MGH research team will meet on weekly basis throughout the study period and will discuss any 
issues or concerns that may arise regarding the study procedures. Should the protocol require 
modifications or amendments based on these meetings, the PI will make the necessary changes and 
submit them to the DF/HCC IRB for approval.  
 
 
 
9.3.2 Source Records 
We will administer the following measures at baseline prior to randomization, 8 weeks, and 12 weeks 
from the time of clinician consult and examination:  
• Demographic Questionnaire (only at baseline): Participants will self-report their age, sex, 
race/ethnicity, marital status, religion, and education. [Appendix B] 
• Sexual Function: We will utilize the PROMIS-2 Sexual Function and Satisfaction Measure including 
the following domains: global satisfaction with sex life, interest in sexual activity, and orgasm.49 For 
men, we will also include the erectile function domain. For women, we will also administer the 
lubrication and vaginal comfort domains. [Appendix C] 
• QOL: We will use the Functional Assessment of Cancer Therapy-Bone Marrow Transplant (FACT-
BMT) to assess QOL.50 [Appendix D] 
• Mood: We will use the Hospital Anxiety and Depression Scale (HADS) to assess symptoms of 
depression and anxiety during the past week in all study participants.51 [Appendix E] 
• Usability of mobile app (only those randomized to intervention): We will use the system usability 
scale at eight weeks post-intervention to assess the usability of the mobile app. 52[Appendix F] 
• Perceptions and satisfaction with mobile app (sample of those randomized to intervention): We 
will qualitatively assess patient experience using the intervention using a semi-structured qualitative 
interview guide. [Appendix M]  
 
 
Administration of self-report measures: We will collect and enter all patient-reported data 
electronically using Research Electronic Data Capture (REDCap). An RA will ask study participants to 
complete questionnaires in-person during clinic visits, via email, or over the telephone. 
9.4 Long-Term Follow-Up Data Collection 
We will collect demographic information, sexual function, QOL, mood, and usability of the 
mobile app (only in patients randomized to the intervention). 
 
Table 2: Quantitative Data Collection Timeline 
 
Participant 
Baseline 
8 weeks 
(+/- 1 
week) 
12 weeks 
(+/- 1 
week) 
Patient Measures:    
Demographics 
X 
 
 
PROMIS Sexual Function and Satisfaction 
Measure 
X 
X 
X 
Functional Assessment of Cancer Therapy-Bone 
Marrow Transplant (FACT-BMT) 
X 
X 
X 
Hospital Anxiety and Depression Scale (HADS) 
X 
X 
X 

13 
 
System Usability Scale (only intervention 
participants) 
 
X 
 
Medical Record Review: 
Chart review from electronic health record 
X 
 
 
 
10.0 Data and Specimen Banking: Not Applicable 
11.0 Data Management and Confidentiality 
11.1 Analysis Data analysis Aim 1 (feasibility): We will report baseline characteristics of all study 
participants. The primary endpoint of the proposed study is feasibility. The proposed intervention 
app will be deemed feasible if at least 60% (95% CI +/- 12%) of eligible patients are enrolled in 
the study, and of those enrolled, at least 60%  engage with at least 70% of the intervention 
modules (modules engagement will be captured by the app). The 60% feasibility and 
intervention module completion cut-off is commonly used in behavioral intervention studies.53-55 
We will also use descriptive statistics to examine the usability of the mobile app based on the 
system usability scale.  
Data analysis Aim 2 (preliminary efficacy): We will compare patients’ sexual function 
(PROMISE Sexual Function and Satisfaction), QOL (FACT-BMT), and depression (HADS) at 
week-8 and week-12 using analysis of covariance adjusting for baseline values. Mixed linear 
models will be fitted to adjust for selected demographic and clinical factors when examining 
change in outcomes of interest across all time points. We will also test for potential moderators 
of the intervention effect using interaction terms for the mixed linear models to assess whether 
differences in patient-reported outcomes are moderated by patient factors (age, gender, computer 
experience), or transplant type. We will use conservative (alpha=0.05) and liberal (alpha=0.25) 
values to assess statistical significance in this pilot study. When handling missing data, if data 
appear to be missing at random, we will employ multiple imputation. If data are not missing at 
random, we will employ pattern mixture modeling. 
Data analysis Exploratory aim: We will analyze the qualitative data using a multi-step process 
using coding and content analysis to explore 1) patients’ perceptions and satisfaction with the 
mobile app; 2) patients’ opinions regarding the app content. This will involve coding to structure 
data into categories and creating groups according to the broader issues or themes. We will 
identify major and minor themes within each content area and we will extract and highlight 
messages. Two independent coders will examine discrepant, unexpected, or unclear data until 
agreement is reached. To assure the trustworthiness of our findings, we will take steps to 
maximize reliability and credibility including: investigator triangulation (using a 
multidisciplinary team of investigators), and team debriefs of the interview content.  
 
11.2 Power Analysis 
The primary aim of the proposed pilot is feasibility. We chose the sample size of 60 patients based on 
the feasibility of completing the project during the proposed timeframe and the ability to assess the 
preliminary efficacy of the intervention. In a pilot study, at least 30 patients are needed in each group to 
estimate a parameter.56,57 Thus, the proposed sample size will provide us with preliminary data that can 
be used to determine the effect size and adequately power future trials. Based on our prior pilot study, 
with a sample size of 60, we would have >80% power to detect a clinically significant 7-point difference 
in satisfaction with sex (SD=8) between the two groups. 
 

14 
 
11.3 Data Security 
The research team is trained in protecting patient health information. All data will be saved in a 
password-protected document on Partners computers. Only the research team will have access to 
the document. Patient data and study identifiers will be kept in separate documents and 
information linking participants to the study will be kept in a different document that will also be 
password-protected. Paper consent forms and surveys will be stored in a locked office at 
Massachusetts General Hospital. All patient-reported data will be reported electronically using 
Research Electronic Data Capture, a tool for creating and managing online surveys (REDCap). 
Our research team has significant experience using REDCap and will design the surveys in a 
web browser, assisted by institutional information technology support. Based on preference and 
feasibility, participants will be offered either paper surveys or electronic reporting through 
REDCap on computer tablets provided by the RA at the time of consent. Participant information 
will be kept confidential throughout the study period.  
 
11.4 Quality Control 
An RA will enter hard-copy surveys into REDCap and review all surveys once. Another RA will 
perform a quality check on 10% of the surveys. If an error is found, an additional 5% will be checked 
until no errors are found.  
 
11.5 Study-Wide Data Handling: please see description above regarding data security. We only 
have questionnaire data that will be stored electronically through REDCap. Paper 
questionnaires will be stored in a locked cabinet by the study team.  
 
12.0 Provisions to Monitor the Data to Ensure the Safety of Subjects:  
This project does not pose more than minimal risk to study participants. We do not anticipate any risks 
to study participation.  We have utilized the study questionnaires and conducted interviews in prior 
studies without any adverse events. If a participant becomes distressed due to their involvement in the 
study, both the PI and their oncology clinician will be notified. We will offer participants who remained 
distressed the opportunity to meet with the PI (Dr. El-Jawahri) or a psychologist (Dr. Greer, a co-
investigator).  
 
13.0 Withdrawal of Subjects 
Participants will be withdrawn without their consent if it is in their best interest, if the study 
procedures are demonstrated to be risky or ineffective, if any problem arises following study 
procedures, if issues arise with research funding, or any other unforeseen circumstance. 
Participants will be notified if they are removed from the study.  
14.0 Risks to Subjects 
Though the intervention involves topics of a sensitive nature, we do not anticipate risks to 
subjects other than the risk of breach of confidentiality. Participation in our pilot study was not 
associated with any negative outcomes. No adverse reactions are anticipated during the proposed 
study as a result of the study procedures.  
While no adverse or unanticipated events are expected in this behavioral trial, any such events will be 
immediately reported to the IRB. There is a minimal chance of causing harm with this study. We have 
administered all the questionnaires to over 100 transplant recipients with no adverse events. While some 

15 
 
topics probed in the app and study assessments are sensitive in nature, no adverse or unanticipated 
events occurred in previous studies discussing these topics. Additionally, our research team has 
extensive experience conducting studies using psychoeducational apps on sensitive topics without any 
adverse events. Further, our research team has experience conducting qualitative patient interviews. 
 
Should participants exhibit or express distress or anger, they will be reassured by the study staff that 
they need not answer any questions which they find upsetting. They will also be reminded that study 
participation is voluntary. If participants remain distressed, both the PI and the oncologist will be 
notified. Should several participants express distress over an individual item, the research team will 
review the questionnaire and contact the IRB to consider removing it from the study. 
 
We will prevent breaches in confidentiality by keeping participant data on password protected Partners 
computers and in a locked office on MGH campus. Data logged online will be saved in password 
protected documents. Only study team will have access to the data. 
 
15.0 Potential Benefits to Subjects 
15.1 Potential benefits 
Participants may or may not experience improved sexual function through taking part in this 
study. Participants (regardless of their study group assignment) will have the opportunity to meet 
with a transplant clinician to conduct a brief evaluation and that might be helpful in identifying 
problems related to their sexual dysfunction that can be addressed. 
15.2 Participant compensation 
Participants will not be compensated for their involvement.  
16.0 Vulnerable Populations: Not Applicable 
17.0 Community-Based Participatory Research: Not Applicable 
18.0 Sharing of Results with Subjects 
Given the nature of the population included in the study, it is not appropriate to proactively contact 
participants at the conclusion of this study. We anticipate that a proportion of our participants will 
relapse or die after completing the study. We do not wish to cause unnecessary distress to participants’ 
family members by attempting to contact participants who have died. Therefore, we provide the research 
team contact information to each participant and encourage them to contact us if they would like to 
receive updates and information on the research findings. 
 
19.0 Setting 
The research team will recruit potential subjects in the MGH Cancer Center and Dana Farber 
Cancer Institute oncology clinics. Beth Israel Deaconess Medical Center patients will be 
recruited by clinician referral. Consent and a baseline demographics survey will take place in the 
clinic or over the phone, at the time of recruitment. Participants will attend their visit with a 
transplant clinician with expertise in sexual health in the MGH Transplant Oncology Clinic; this 
visit may occur in clinic or virtually via secure video-based conference. Participants randomly 
assigned to the mobile app will use the mobile app in the privacy of their homes. Research 
procedures will occur on an out-patient basis or will occur remotely.  
20.0 Resources Available 
Team Qualifications  

16 
 
Dr. El-Jawahri, Dr. Dias and Dr. Cutler (co-investigator) have the experience to ensure the 
success of the proposed project. Dr. El-Jawahri has led several trials studying interventions to 
improve the quality of life and care of patients with cancer. Our investigative team has 
substantial expertise in developing and testing supportive care interventions, adapting these 
interventions to mobile applications, and addressing sexual health concerns in cancer survivors. 
Our team additionally has extensive experience in conducting qualitative interviews with 
patients. 
The study team will train the RA to identify potentially eligible patients, approach patients for 
study participation, obtain informed consent, and conduct qualitative interviews and provide 
patients randomized to the intervention with a comprehensive tutorial regarding how to use the 
app. Our research team has extensive experience training RA to work with medically ill cancer 
population, recognizing participants’ burden and distress, conducting qualitative patient 
interviews, as well as educating participants on the use of mobile apps. We will utilize similar 
training procedures to our prior studies. 
 
20.1 Other Resources  
The MGH Transplant Program performs approximately 200 new transplants per year and cares 
for over 700 HCT survivors. Therefore, we are confident in our ability to meet accrual goals. 
 
The research team will devote as much time as is needed to conducting and completing the 
research. Our facilities are located on the Massachusetts General Hospital main campus within 
walking distance of the transplant clinic. Our research team uses Partners computers and have 
access to Partners resources to undertake this endeavor.  
 
Though we do not anticipate adverse reactions as a result of participation in this study, 
participants who express distress will have access to psychologist Dr. Joseph Greer.  
 
The research team will have access to the protocol and documents regarding research procedures. 
Responsibilities will be communicated in a timely manner through weekly team meetings and 
email.   
21.0 Prior Approvals: Not applicable 
22.0 Recruitment Methods 
22.1 Recruitment 
Potential subjects will be recruited from the transplant clinics at Massachusetts General Hospital 
or Dana Farber Cancer Institute at their routine appointments with their oncology clinicians, or 
via telephone. Beth Israel Deaconess Medical Center patients will be recruited by clinician 
referral. A trained RA will recruit potential subjects whose transplant clinicians have no 
objections to their participation and who screen positive for sexual dysfunction causing distress 
according to NCCN guidelines. 
22.2 Source of Subjects 
Subjects will be recruited from the population of patients receiving follow up care at 
Massachusetts General Hospital Cancer Center, Beth Israel Deaconess Medical Center, or Dana 
Farber Cancer Institute. 
22.3 Identifying Potential Subjects  

17 
 
Potential subjects will be identified by screening the transplant clinic schedule at Massachusetts 
General Hospital and Dana Farber Cancer Institute. Beth Israel Deaconess Medical Center 
patients will be recruited by clinician referral. A trained RA will further determine eligibility by 
evaluating potential subjects’ medical records. The RA will then reach out to the patient’s 
oncology clinician to determine if the clinician believes participation is appropriate. The last 
screening test will be the two questions in the NCCN guidelines used to determine the presence 
of sexual dysfunction causing distress.  
22.4 Recruitment Materials 
No materials will be used to recruit subjects.  
22.5 Subject Payment 
Subjects will not be paid for participation.  
23.0 Local Number of Subjects: 
We anticipate that 60 subjects will be recruited from MGH, BIDMC and DFCI. Based on our 
prior data, approximately one third of HCT recipients will screen positive for sexual dysfunction 
causing distress. Therefore, we anticipate that we will screen approximately 200 patients to 
identify 60 subjects eligible for study participation. 10 patients randomized to the intervention 
will undergo qualitative interview to assess perceptions and experience of using the mobile 
application. 
 
24.0 Provisions to Protect the Privacy Interests of Subjects 
24.1 Privacy Interests 
Participant privacy interests will be protected by limiting individuals in the room during the time 
of consent and follow up survey or interview administration (if done in person). The RA will 
also answer any participant questions regarding who has access to participant information and 
reassure them of the steps taken to ensure confidentiality.  
24.2 Subjects’ Feeling of Ease  
The research team has significant experience interacting with this patient population as well as 
experience training RAs with these patients. During the consent process and survey or interview 
administration, the RA will remind subjects that participation is voluntary and that they can 
decline to respond to any questions that they do not wish to answer. Subjects will also be 
reminded that they can skip any mobile app modules that they find distressing.  
24.3 Research Team Information Access  
The research team is permitted to access the medical records of subjects and any subject-reported 
data collected during this research.  
25.0 Compensation for Research-Related Injury: Not Applicable 
26.0 Economic Burden to Subjects: Not Applicable 
27.0 Consent Process 
The RA will obtain consent from potential subjects in the oncology clinic at MGH, BIDMC or 
DFCI, or will obtain verbal consent over the phone. A waiting period will be available between 
approaching the potential subject and obtaining the consent if the potential subject requests it. 
The RA will remind the potential subject that participation is voluntary, and that participation or 

18 
 
refusal to participate will not impact the quality of care received. To ensure ongoing consent, the 
RA will explain the participant’s right to withdraw at any time and will explain the appropriate 
means of contacting the research team to initiate the withdrawal process. We will follow SOP: 
Informed Consent Process (CON-100). 
Non-English Speaking Subjects: Not Applicable 
Subjects who are not yet adults (infants, children, teenagers): Not Applicable 
Cognitively Impaired Adults: Not Applicable 
Adults Unable to Consent: Not Applicable 
28.0 Process to Document Consent in Writing 
We will obtain written consent using the submitted consent form, consistent with SOP: Informed 
Consent Process (CON-100). We will obtain verbal consent using the submitted verbal consent 
form. 
29.0 Drugs or Devices: Not Applicable 
 
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50. 
McQuellon RP, Russell GB, Cella DF, et al: Quality of life measurement in bone marrow 
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Borsci S, Federici S, Lauriola M: On the dimensionality of the System Usability Scale: a test of 
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Bowen DJ, Kreuter M, Spring B, et al: How we design feasibility studies. Am J Prev Med 
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21 
 
 
 
 
31.0 Appendix A 
Due to the size of this document Appendix A has been included as a separate file. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
32.0 Appendix B 
Appendix B: Demographics 
 
Patient Demographics 
Please check the appropriate box or boxes. 
1. Ethnicity 
 Hispanic or Latino 

22 
 
 Not Hispanic or Latino 
 
2. Race (please check all that apply) 
 American Indian or Alaskan native 
 Asian 
 African American or Black 
 Native Hawaiian or Other Pacific Islander 
 White 
 Other (please specify)_____________ 
 
3. Religion 
 Catholic Christian 
 Other Christian (such as Protestant, Orthodox, etc.) 
 Jewish 
 Muslim 
 Atheist 
 None 
 Other (please specify)_______________ 
 
4. Current relationship status: 
 Married or living with someone as if married 
 Non-cohabiting relationship 
 Single, never married 
 Divorced/Separated 
 Loss of long term partner/Widowed 
 
5. Please indicate your highest or current education level: 
 Grade 1-8 
 Some high school 
 Completed high school 
 General education diploma (G.E.D) 
 Associate degree 
 Some college credit 
 Graduated college 
 Masters’ degree (MA, MS, MEng, MEd, MSW, MBA) 
 Professional degree beyond a bachelors’ degree (MD, DDS, DVM, LLB, JD) 
 Doctorate degree (PhD, EdD) 
 
6. What is your annual combined household income? 
 Less than $25,000 
 $25,000 – $49,999 
 $50,000 – $99,999 
 $100,000 – $149,999 
 Greater than $150,000 
 
7. What sex were you assigned at birth? 
 Male 
 Female 
 Other (please specify):_____________ 
 
8. What is your current gender identity? 

23 
 
 Male  
 Female 
 Transgender Male/Trans Man/ Female-to-Male 
 Transgender Female/Trans Woman/Male-to-Female 
 Genderqueer, neither exclusively male or female 
 Other (please specify):_____________ 
 
9. Do you think of yourself as: 
 Heterosexual/straight  
 Gay/Lesbian 
 Bisexual 
 Something else, please specify _____ 
 Don’t know 
 
10. Please indicate who you live with (you may check more than one box): 
 By myself 
 Partner/Spouse 
 Roommate/Friend 
 Children under 18 
 Children 18 & older 
 Group home/assisted living/nursing home 
 Parent 
 Other (please specify) _____________ 
 
11. Current employment status (check all that apply):  
 Employed (full-time or part-time) 
 Caring for home or family (not currently working and not looking for paid work) 
 Unemployed and looking for work 
 Unable to work due to illness or disability 
 Retired 
 Student 
 Other (please specify)_____________ 
 
Please enter your email (will only be used if necessary):  
_____________________________________________ 
 
What is the best phone number to use if we needed to reach you? ____________________________________ 
 

24 
 
 
33.0 Appendix C 
Appendix C: The PROMIS Sexual Function and Satisfaction Measures  
Global Satisfaction with Sex Life 
 
IN THE PAST 30 DAYS 
How satisfied have you been with your 
sex life? 
1. Not at all 
2. A little bit 
3. Somewhat 
4. Quite a bit 
5. Very 
How much pleasure has your sex life 
given you? 
1. None 
2. A little bit 
3. Somewhat 
4. Quite a bit 
5. A lot 
How often have you thought that your 
sex life is wonderful? 
1. Never 
2. Rarely 
3. Somewhat 
4. Often 
5. Always 
How satisfied have you been with your 
sexual relationship(s)? 
0. have not had a sexual partner in the past 30 days 
1. Not at all 
2. A little bit 
3. Somewhat 
4. Quite a bit 
5. Very 
When you have had sexual activity, 
how much have you enjoyed it? 
1. Not at all 
2. A little bit 
3. Somewhat 
4. Quite a bit 
5. Very much 
 
 
 
 
 
 
 
 
 

25 
 
Interest in Sexual Activity 
IN THE PAST 30 DAYS 
How interested have you been in sexual 
activity? 
1. Not at all 
2. A little bit 
3. Somewhat 
4. Quite a bit 
5. Very 
How often have you felt like you 
wanted to have sexual activity? 
1. Never 
2. Rarely 
3. Sometimes 
4. Often 
5. Always 
How often have you had sexual 
thoughts or fantasies while you were 
awake? 
1. Never 
2. Rarely 
3. Somewhat 
4. Often 
5. Always 
How often were you interested enough 
to start a sexual activity? 
1. Never 
2. Rarely 
3. Sometimes 
4. Often 
5. Always 
Orgasm 
IN THE PAST 30 DAYS 
How much pleasure have your orgasms 
or climaxes given you? 
1. None 
2. A little bit 
3. Some 
4. Quite a bit 
5. Very much 
How often have your orgasms or 
climaxes been satisfying? 
0. Never 
1. Rarely 
2. Sometimes 
3. Often 
4. Always 
How satisfying have your orgasms or 
climaxes been? 
0. Not at all 
1. A little bit 
2. Somewhat 
3. Quite a bit 
4. Very 
 
 
 
 
 
 
 
 

26 
 
Erectile Function (males only) 
 
IN THE PAST 30 DAYS 
How often were you able to get an 
erection (get hard) during sexual activity? 
1. Almost never/never 
2. A few times (much less than half the time) 
3. Sometimes (about half the time) 
4. Most times (much more than half the time) 
5. Almost always/always 
When you had erections with sexual 
stimulation how often were your erections 
hard enough for penetration? 
1. Almost never/never 
2. A few times (much less than half the time) 
3. Sometimes (about half the time) 
4. Most times (much more than half the time) 
5. Almost always/always 
When you attempted sexual intercourse 
how often were you able to penetrate 
(enter) your partner? 
0. Did not attempt intercourse 
1. Almost never/never 
2. a few times (much less than half the time) 
3. Sometimes (about half the time) 
4. Most times (much more than half the time) 
5. Almost always/always 
During sexual intercourse how often were 
you able to maintain your erection (stay 
hard) after you had penetrated (entered) 
your partner? 
0. Did not attempt intercourse 
1. Almost never/never 
2. A few times (much less than half the time) 
3. Sometimes (about half the time) 
4. Most times (much more than half the time) 
5. Almost always/always 
During sexual intercourse how difficult 
was it to maintain your erection (stay 
hard) to completion of intercourse? 
0. Did not attempt intercourse 
1. Extremely difficulty 
2. Very difficult 
3. Difficult 
4. Slightly difficult 
5. Not difficult 
Please rate your ability to have an 
erection.  
If you use any aids to help you get an 
erection (e.g. pills, injections, or a penis 
pump) please answer this question thinking 
about the times you used these aids 
0. Very poor 
1. Poor 
2. Fair 
3. Good 
4. Very good 
How difficult has it been for you to get an 
erection (get hard) when you wanted to? 
If you use any aids to help you get an 
erection (e.g. pills, injections, or a penis 
pump) please answer this question thinking 
about the times you used these aids 
0. Have not tried to get an erection (get hard) in the 
past 30 days 
5. Not at all 
4. A little bit 
3. Somewhat 
2. Quite a bit 
1. Very  
How often have you been able to keep an 
erection (stay hard) as long as you wanted 
to? 
0. Have not had an erection (been hard) in the past 
30 days 
1. Never 
2. Rarely 
3. Sometimes 
4. Often 

27 
 
5. Always 
 
 
IN THE PAST 30 DAYS 
 
How hard have your erections been? 
0. Have not had an erection in the past 30 days 
1. Penis was large but not hard 
2. Penis was hard but not hard enough for 
penetration 
3. Penis was hard enough for penetration but not 
completely hard 
4. Penis was completely hard 
How would you describe the usual 
QUALITY of your erections? 
1. Not at all 
2. Not firm enough for any sexual activity 
3. Firm enough for masturbation and foreplay only 
4. Firm enough for intercourse 
How would you describe the FREQUENCY 
of your erections 
1. I NEVER had an erection when I wanted one 
2. I had an erection LESS THAN HALF the time I 
wanted one 
3. I had an erection ABOUT HALF the time I wanted 
one 
4. I had an erection MORE THAN HALF the time I 
wanted one 
5. I had an erection WHENEVER I wanted one 
 
 
 
 

28 
 
 
Vaginal Discomfort (females only) 
 
IN THE PAST 30 DAYS 
How would you describe the comfort of 
your vagina during sexual activity 
1. Very comfortable 
2. Comfortable 
3. Uncomfortable 
4. Very uncomfortable 
How often have you had difficulty with 
sexual activity because of discomfort or 
pain in your vagina? 
1. Never 
2. Rarely 
3. Sometimes 
4. Often 
5. Always 
How often have you had discomfort 
inside your vagina during sexual 
activity? 
1. Never 
2. Rarely 
3. Sometimes 
4. Often 
5. Always 
How often have you had discomfort 
from feelings of rubbing or burning 
inside your vagina during sexual 
activity? 
1. Never 
2. Rarely 
3. Sometimes 
4. Often 
5. Always 
How often have you had discomfort 
from feelings of pulling or ripping inside 
your vagina during sexual activity? 
1. Never 
2. Rarely 
3. Sometimes 
4. Often 
5. Always 
How often have you had pain inside 
your vagina during sexual activity? 
1. Never 
2. Rarely 
3. Sometimes 
4. Often 
5. Always 
How often did you have discomfort or 
pain during vaginal penetration? 
(Vaginal penetration is when something 
is put inside your vagina) 
1. Never 
2. Rarely 
3. Sometimes 
4. Often 
5. Always 
How often did you have discomfort or 
pain after vaginal penetration? 
(vaginal penetration is when something 
is put inside your vagina) 
5. Never 
6. Rarely 
7. Sometimes 
8. Often 
9. Always 
When you have had sexual activity, 
how much discomfort have you felt 
inside your vagina? 
1. None 
2. A little bit 
3. Some 
4. Quite a bit 
5. A lot 

29 
 
When you have had sexual activity, 
how much pain have you felt inside 
your vagina? 
1. None 
2. A little bit 
3. Some 
4. Quite a bit 
5. A lot 
IN THE PAST 30 DAYS 
 
How would you rate your level (degree) 
of discomfort or pain during or after 
vaginal penetration? 
(vaginal penetration is when something 
is put inside your vagina.) 
1. Very low or none at all 
2. Low 
3. Moderate 
4. High 
5. Very high  
 
Lubrication (women only) 
IN THE PAST 30 DAYS 
How often have you felt your vagina 
was lubricated (“wet”) enough during 
sexual activity? 
1. Never 
2. Rarely 
3. Sometimes 
4. Often 
5. Always 
How difficult was it to become 
lubricated (“wet”) during sexual activity 
or intercourse? 
1. Extremely difficult or impossible 
2. Very difficult 
3. Difficult 
4. Slightly difficult 
5. Not difficult  
How difficult was it to maintain your 
lubrication(“wetness”) until completion 
of sexual activity or intercourse? 
1. Extremely difficult or impossible 
2. Very difficult 
3. Difficult 
4. Slightly difficult 
5. Not difficult 
How difficult has it been for your vagina 
to get lubricated (“wet”) when you 
wanted it to? 
0. Have not tried to get lubricated in the past 30 days 
1. Very 
2. Quite a bit 
3. Somewhat 
4. A little bit 
5. Not at all 
How often did you become lubricated 
(“wet”) during sexual activity or 
intercourse? 
1. Almost never or never 
2. A few times (less than half the time) 
3. Sometimes (about half the time) 
4. Most times (more than half the time) 
5. Almost always or always 
 
 
 
 
 

30 
 
34.0 Appendix D 
Appendix D: Patient Quality of Life (FACT-BMT) 
Below is a list of statements that other people with your illness have said are important. Please circle or 
mark one number per line to indicate your response as it applies to the past 7 days. 
 
 
 
PHYSICAL WELL-BEING 
 
Not 
at all 
A little 
bit 
Some-
what 
Quite 
a bit 
Very 
much 
GP1 
I have a lack of energy 
0 
1 
2 
3 
4 
GP2 
I have nausea 
0 
1 
2 
3 
4 
GP3 
Because of my physical condition, I have trouble 
meeting the needs of my family 
 
0 
 
1 
 
2 
 
3 
 
4 
GP4 
I have pain 
0 
1 
2 
3 
4 
GP5 
I am bothered by side effects of treatment 
0 
1 
2 
3 
4 
GP6 
I feel ill 
0 
1 
2 
3 
4 
GP7 
I am forced to spend time in bed 
0 
1 
2 
3 
4 
 
 
SOCIAL/FAMILY WELL-BEING 
 
Not 
at all 
A little 
bit 
Some-
what 
Quite 
a bit 
Very 
much 
GS1 
I feel close to my friends 
0 
1 
2 
3 
4 
GS2 
I get emotional support from my family 
0 
1 
2 
3 
4 
GS3 
I get support from my friends 
0 
1 
2 
3 
4 
GS4 
My family has accepted my illness 
0 
1 
2 
3 
4 
GS5 
I am satisfied with family communication about my 
illness 
 
0 
 
1 
 
2 
 
3 
 
4 
GS6 
I feel close to my partner (or the person who is my main 
support) 
 
0 
 
1 
 
2 
 
3 
 
4 
Q1 
Regardless of your current level of sexual activity, please 
answer the following question. If you prefer not to answer it, 
please mark this box           and go to the next section. 
 
 
 
 
 
GS7 
I am satisfied with my sex life 
0 
1 
2 
3 
4 

31 
 
Please circle or mark one number per line to indicate your response as it applies to the past 
7 days. 
 
 
 
EMOTIONAL WELL-BEING 
Not 
at all 
A little 
bit 
Some-
what 
Quite 
a bit 
Very 
much 
GE1 
I feel sad 
0 
1 
2 
3 
4 
GE2 
I am satisfied with how I am coping with my illness 
0 
1 
2 
3 
4 
GE3 
I am losing hope in the fight against my illness 
0 
1 
2 
3 
4 
GE4 
I feel nervous 
0 
1 
2 
3 
4 
GE5 
I worry about dying 
0 
1 
2 
3 
4 
GE6 
I worry that my condition will get worse 
0 
1 
2 
3 
4 
 
 
 
 
FUNCTIONAL WELL-BEING 
 
Not 
at all 
A little 
bit 
Some-
what 
Quite 
a bit 
Very 
much 
 
GF1 
I am able to work (include work at home) 
0 
1 
2 
3 
4 
GF2 
My work (include work at home) is fulfilling 
0 
1 
2 
3 
4 
GF3 
I am able to enjoy life 
0 
1 
2 
3 
4 
GF4 
I have accepted my illness 
0 
1 
2 
3 
4 
GF5 
I am sleeping well 
0 
1 
2 
3 
4 
GF6 
I am enjoying the things I usually do for fun 
0 
1 
2 
3 
4 
GF7 
I am content with the quality of my life right now 
0 
1 
2 
3 
4 
 

PROTOCOL TITLE: Pilot Study of a Sexual Health Intervention Mobile Application (app) to Address 
Sexual Dysfunction in Hematopoietic Stem Cell Transplant Survivors 
32 
 
Please circle or mark one number per line to indicate your response as it 
applies to the past 7 days. 
 
ADDITIONAL CONCERNS 
 
Not 
at all 
A little 
bit 
Some-
what 
Quite 
a bit 
Very 
much 
BMT1 
I am concerned about keeping my job (include work at 
home) 
 
0 
 
1 
 
2 
 
3 
 
4 
BMT2 
I feel distant from other people 
0 
1 
2 
3 
4 
BMT3 
I worry that the transplant will not work 
0 
1 
2 
3 
4 
BMT4 
The effects of treatment are worse than I had imagined 
0 
1 
2 
3 
4 
C6 
I have a good appetite 
0 
1 
2 
3 
4 
C7 
I like the appearance of my body 
0 
1 
2 
3 
4 
BMT5 
I am able to get around by myself 
0 
1 
2 
3 
4 
BMT6 
I get tired easily 
0 
1 
2 
3 
4 
BL4 
I am interested in sex 
0 
1 
2 
3 
4 
BMT7 
I have concerns about my ability to have children 
0 
1 
2 
3 
4 
BMT8 
I have confidence in my nurse(s) 
0 
1 
2 
3 
4 
BMT9 
I regret having the bone marrow transplant 
0 
1 
2 
3 
4 
BMT10 
I can remember things 
0 
1 
2 
3 
4 
Br1 
I am able to concentrate 
0 
1 
2 
3 
4 
BMT11 
I have frequent colds/infections 
0 
1 
2 
3 
4 
BMT12 
My eyesight is blurry 
0 
1 
2 
3 
4 
BMT13 
I am bothered by a change in the way food tastes 
0 
1 
2 
3 
4 
BMT14 
I have tremors 
0 
1 
2 
3 
4 
B1 
I have been short of breath 
0 
1 
2 
3 
4 
BMT15 
I am bothered by skin problems (e.g., rash, itching) 
0 
1 
2 
3 
4 
BMT16 
I have trouble with my bowels 
0 
1 
2 
3 
4 
BMT17 
My illness is a personal hardship for my close family 
members 
 
0 
 
1 
 
2 
 
3 
 
4 
BMT18 
The cost of my treatment is a burden on me or my 
family 
 
0 
 
1 
 
2 
 
3 
 
4 

PROTOCOL TITLE: Pilot Study of a Sexual Health Intervention Mobile Application (app) to Address 
Sexual Dysfunction in Hematopoietic Stem Cell Transplant Survivors 
33 
 
 
35.0 Appendix E 
Appendix E: Hospital Anxiety and Depression Scale (HADS):  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
1. I feel tense or "wound up."  
 
a. Most of the time 
b. A lot of the time 
c. From time to time, occasionally 
d. Not at all 
2. I still enjoy the things I used to enjoy. 
a. Definitely as much 
b. Not quite as much 
c. Only a little 
d. Hardly at all 
3. I get a sort of frightened feeling as if  
something awful is about to happen.  
a. Very definitely and quite badly 
b. Yes, but not too badly 
c. A little, but it doesn't worry me 
d. Not at all 
4. I can laugh and see the funny side of 
things. 
a. As much as I always could 
b. Not quite so much now 
c. Definitely not so much now 
d. Not at all 
5. Worrying thoughts go through my 
mind.  
a. A great deal of the time 
b. A lot of the time 
c. From time to time but not too often 
d. Only occasionally 
6. I feel cheerful.  
a. Not at all 
b. Not often 
c. Sometimes 
d. Most of the time 
7. I can sit at ease and feel relaxed. 
a. Definitely 
b. Usually 
c. Not often 
d. Not at all 
8. I feel as if I am slowed down.  
a. Nearly all the time 
b. Very often 
c. Sometimes 
d. Not at all 
9. I get a sort of frightened feeling like 
"butterflies" in the stomach. 
a. Not at all 
b. Occasionally 
c. Quite often 
d. Very often 
10. I have lost interest in my appearance.  
a. Definitely 
b. I don't take so much care as I should
c. I may not take quite as much care 
d. I take just as much care as ever 
11. I feel restless as if I have to be on the 
move.  
a. Very much indeed 
b. Quite a lot 
c. Not very much 
d. Not at all 
12. I look forward with enjoyment to 
things. 
a. As much as I ever did 
b. Rather less than I used to 
c. Definitely less than I used to 
d. Hardly at all 
13. I get sudden feelings of panic.  
a. Very often indeed 
b. Quite often 
c. Not very often 
d. Not at all 
14. I can enjoy a good book or radio or 
TV program. 
a. Often 
b. Sometimes 
c. Not often 
d. Very seldom 

PROTOCOL TITLE: Pilot Study of a Sexual Health Intervention Mobile Application (app) to Address 
Sexual Dysfunction in Hematopoietic Stem Cell Transplant Survivors 
34 
 
36.0 Appendix F 
Appendix F: The System Usability Scale 
Please check the box that best indicates how much you agree with the following 
statements about the SHIFT mobile app. 
1. I think that I would like to use this system frequently. 
Strongly 
Disagree 
1 
 
2 
 
3 
 
4 
Strongly Agree 
5 
 
 
 
 
 
 
2. I found the system unnecessarily complex. 
Strongly 
Disagree 
1 
 
2 
 
3 
 
4 
Strongly Agree 
5 
 
 
 
 
 
 
3. I thought the system was easy to use. 
Strongly 
Disagree 
1 
 
2 
 
3 
 
4 
Strongly Agree 
5 
 
 
 
 
 
 
4. I think that I would need the support of a technical person to be able to use 
this system. 
Strongly 
Disagree 
1 
 
2 
 
3 
 
4 
Strongly Agree 
5 
 
 
 
 
 
 
5. I found the various functions in this system were well integrated. 
Strongly 
Disagree 
 
2 
 
3 
 
4 
Strongly Agree 
5 

PROTOCOL TITLE: Pilot Study of a Sexual Health Intervention Mobile Application (app) to Address 
Sexual Dysfunction in Hematopoietic Stem Cell Transplant Survivors 
35 
 
1 
 
 
 
 
 
 
6. I thought there was too much inconsistency in this system. 
Strongly 
Disagree 
1 
 
2 
 
3 
 
4 
Strongly Agree 
5 
 
 
 
 
 
 
7. I would imagine that most people would learn to use this system very quickly. 
Strongly 
Disagree 
1 
 
2 
 
3 
 
4 
Strongly Agree 
5 
 
 
 
 
 
 
8. I found the system very cumbersome to use. 
Strongly 
Disagree 
1 
 
2 
 
3 
 
4 
Strongly Agree 
5 
 
 
 
 
 
 
9. I felt very confident using the system. 
Strongly 
Disagree 
1 
 
2 
 
3 
 
4 
Strongly Agree 
5 
 
 
 
 
 
 
10. I needed to learn a lot of things before I could get going with this system. 
Strongly 
Disagree 
1 
 
2 
 
3 
 
4 
Strongly Agree 
5 
 
 
 
 
 
 
 

PROTOCOL TITLE: Pilot Study of a Sexual Health Intervention Mobile Application (app) to Address 
Sexual Dysfunction in Hematopoietic Stem Cell Transplant Survivors 
36 
 
37.0 Appendix G 
Appendix G: Email to transplant clinicians 
 
Hi _____,  
 
You have a patient eligible for the SHIFTstudy coming to clinic DAY OF WEEK, 
DATE. 
  
PATIENT NAME (MRN) 
  
As a reminder, SHIFTis a randomized clinical trial investigating the effect of a sexual 
health intervention hematopoietic stem cell transplantation survivors vs. standard 
transplant care. We would like to approach Ms. NAME during her appointment at TIME 
and offer them the study. 
  
Would you have any objections or concerns with offering Ms. NAME the 
study? Please let us know at your earliest convenience so that we would have a chance to 
enroll them in the time window. If we do not hear from you in 24 hours, we will assume 
there are no objections to approaching. 
  
Thank you and feel free to email back with any questions or concerns. 
  
Best,  
  
[Name of Study Coordinator] 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

PROTOCOL TITLE: Pilot Study of a Sexual Health Intervention Mobile Application (app) to Address 
Sexual Dysfunction in Hematopoietic Stem Cell Transplant Survivors 
37 
 
38.0 Appendix H 
Appendix H: Letter for participants completing questionnaires by mail 
 
 
Date 
Dear Mr. or Ms.                        , 
 
I am pleased to be in touch with you regarding the mobile app research study 
in which you are enrolled at the Massachusetts General Hospital.  As part of 
the study, we ask that you complete this questionnaire by [end of 
questionnaire window date] and mail it back using the included envelope. 
Thank you again for your continued participation and feel free to call with 
any questions. 
 
Sincerely, 
[Name of study coordinator] 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

PROTOCOL TITLE: Pilot Study of a Sexual Health Intervention Mobile Application (app) to Address 
Sexual Dysfunction in Hematopoietic Stem Cell Transplant Survivors 
38 
 
39.0 Appendix I 
 
Appendix I: Verbal telephone script for study questionnaire administration for 
patients 
 
Hello—is [name of patient/or caregiver] there? Hi, my name is [research 
coordinator’s name] I work at the MGH Cancer Center, and I am calling 
about the mobile app research study in which you are participating. Is now a 
good time to talk briefly? 
 
If yes→ Move on to next section.  
If no→  “Is there a better time at which I could call back? ” 
 
As part of the study procedures, we would like to ask you to complete a 
questionnaire over the phone. Do you have about 20 minutes to complete it 
with me now? 
 
If yes→“Great, thank you.” Proceed to administering the questionnaire. 
If no→  “Is there a better time at which I we could complete the 
questionnaire?” 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

PROTOCOL TITLE: Pilot Study of a Sexual Health Intervention Mobile Application (app) to Address 
Sexual Dysfunction in Hematopoietic Stem Cell Transplant Survivors 
39 
 
40.0 Appendix J 
 
Appendix J: Email for participants completing questionnaires by email 
 
Dear Mr. or Ms.                        , 
 
I am pleased to be in touch with you regarding the mobile app research study 
in which you are enrolled at the Massachusetts General Hospital. As part of 
the study, we ask that you complete another questionnaire just like the one 
you completed in the clinic by following the link in this email. 
 
If possible, we ask that you please complete the survey by [end of 
questionnaire window date].  Again, feel free to email or call with any 
questions, and we greatly appreciate your participation in the study. 
 
Sincerely, 
[Name of study coordinator] 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

PROTOCOL TITLE: Pilot Study of a Sexual Health Intervention Mobile Application (app) to Address 
Sexual Dysfunction in Hematopoietic Stem Cell Transplant Survivors 
40 
 
41.0 Appendix K 
Protocol Title:  Multimodal Mobile Intervention Application (App) To Address Sexual 
Dysfunction in Hematopoietic Stem Cell Transplant Survivors 
 
DF/HCC Principal Research Doctor / Institution:  Areej El-Jawahri MD/MGH 
 
 
 
Main Consent 
 
 
 
INTRODUCTION AND KEY INFORMATION 
 
All research is voluntary.  It is your choice whether you take part in this research 
or not.   
 
The following is a short summary of this research study to help you decide 
whether you would like to be a part of this study.  More detailed information is 
provided later in this form.  
  
For purposes of this research, you will be referred to as a “participant.”   
 
1. Why am I being invited to take part in a research study? 
You are invited to take part in in this research study, because you have 
undergone stem cell transplantation. 
 
2. Why is this research being done? 
Frequently survivors of stem cell transplantation report significant problems with 
their sexual function that impacts their quality of life, mood, and their intimacy 
and relationship with their partners.  These issues can be very distressing to 
patients and their loved ones.  The study doctors want to know if the use of a 
mobile app intervention focused on improving sexual function may improve your 
overall care.  
 
 
 
3. What does this research study involve and how long will it last? 
This research study involves screening for eligibility and a series of 
questionnaires to measure your quality of life and sexual function. Study 
questionnaires can be completed in the hospital, clinic, over email, through the 
mail, or telephone with assistance as provided.  

PROTOCOL TITLE: Pilot Study of a Sexual Health Intervention Mobile Application (app) to Address 
Sexual Dysfunction in Hematopoietic Stem Cell Transplant Survivors 
41 
 
 
You will be in this research study for up to twelve weeks after you consent. Each 
questionnaire should take you about 20 minutes to complete. We will keep track 
of your medical information only by reviewing your medical record and we will not 
be contacting you again in the future. Once you finish your last questionnaire at 
twelve weeks after enrollment, you will not be contacted by us again. However, 
we will keep track of your medical information only by reviewing your medical 
record for the next 2 years. 
   
It is expected that about 60 people will take part in this research study.  
 
Information about you and your health is personal and private.  Generally, it 
cannot be obtained without your written permission. By signing this form, you are 
providing that permission and your information may be obtained and used in 
accordance with this informed consent and as required or allowed by law. This 
means that researchers may obtain information regarding your past medical 
history, as well as specimens and samples from previous health care providers 
such as hospitals and labs. 
 
4. What are the risks to participating in this study? 
There are risks to taking part in any research study. However, this particular 
study does not have any physical risks. You may find it upsetting to answer some 
of the items on the questionnaire. The research assistant will be available to you 
during your participation in the study. If you feel upset by any aspect of the study, 
the research assistant, along with your oncologist, will be available to talk with 
you. We can arrange for you to meet with our psychologist for additional 
counseling if needed. 
 
 
Major known risks to participating in this research study include:  
• Disclosure of sensitive personal information may result is a loss of 
privacy 
• Possible emotional distress due to personal questions 
• Significant amount of time required to complete questionnaires (online 
and/or in person) 
 
5. Will being in this study benefit me in any way? 
 
Taking part in this research study may or may not benefit you. We hope the 
information learned from this research study will provide more information about 
how a mobile app intervention can improve our management of sexual health 
symptoms for stem cell transplant survivors.  
 

PROTOCOL TITLE: Pilot Study of a Sexual Health Intervention Mobile Application (app) to Address 
Sexual Dysfunction in Hematopoietic Stem Cell Transplant Survivors 
42 
 
We do not know if taking part in this study will benefit you. This study may help 
researchers learn information that could help people in the future. 
 
 
6.  What are my options? 
 
If you decide to participate, please sign and date at the end of this form.  
 
We will give you a copy and you can refer to this consent form at any time during 
the research study. 
 
If you choose not to participate in this research study, the research doctors will 
discuss other treatment options with you and/or refer you back to your primary 
doctor. 
 
 

PROTOCOL TITLE: Pilot Study of a Sexual Health Intervention Mobile Application (app) to Address 
Sexual Dysfunction in Hematopoietic Stem Cell Transplant Survivors 
43 
 
A. WHY IS THIS RESEARCH STUDY BEING DONE? 
 
This research study is being done to evaluate whether the use of a mobile app 
can help transplant survivors experiencing sexual health problems. 
 
In this research study, we are:  
• Testing whether using the mobile app is feasible in addressing sexual 
health problems in transplant survivors.  
• The app is called “SHIFT: Sexual Health and Intimacy Following 
Transplant.” It was developed by clinicians at MGH.  
• Previous research shows that mobile apps can be effective in helping 
people with issues like anxiety and we want to see if we can similarly 
address sexual health problems. 
• We are hoping to learn if using the app to address sexual health problems 
is acceptable and useful to transplant survivors.  
 
The main purpose of this study is to compare two types of care – the mobile app 
intervention versus enhanced standard care which includes having a one-time 
visit with a transplant clinician to conduct a brief medical examination and asses 
the needs for medications or treatments to address sexual health problems.  
 
B. WHAT OTHER OPTIONS ARE THERE? 
 
Instead of being in this research study, you have other options which may include 
the following:  
• Decide not to participate in this research study. 
• Participate in another research study. 
 
If you choose not to participate, are not eligible to participate, or withdraw from 
this research study, this will not affect your present or future care and will not 
cause any penalty or loss of benefits to which you are otherwise entitled.  
 
We encourage you to take some time to think this over, to discuss it with other 
people and your primary doctor, and to ask questions now and at any time in the 
future. 
 
 
C. WHAT IS INVOLVED IN THE RESEARCH STUDY? 
 
 
 
Before the research starts: Prior to signing this consent form, our research 
team reviewed your medical record to determine that you were eligible to 
participate in this research study.  We also asked your oncology team for 
permission to approach you to participate in the study.  

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After you sign this consent form:  You will first be asked to answer a few 
questions about yourself on a laptop tablet computer, such as your race, 
ethnicity, religion, relationship status, education, income, and living situation. 
 
You will then be asked to complete a baseline questionnaire on the laptop which 
contains questions about your mood, quality of life (including your general, 
physical, social, and emotional well-being), and sexual function. If you are not 
able to use the laptop, you may fill out the baseline questions on paper. 
 
Assignment to study group: 
Because no one knows which of the study option is best, you will be randomized 
into one of the study groups: 
• Enhanced Standard Care 
• Multimodal Intervention mobile app to address sexual health 
problems 
 
Randomization means that you are put into a group by chance.  It is like flipping 
a coin.  Neither you nor your doctor will choose which arm you are assigned to.  
You will have an equal chance of being placed in either group. 
 
Study procedures: 
If you are randomized to enhanced standard care: 
• You will receive standard oncology care by your oncology team 
• You will attend a clinic visit with a transplant clinician specializing in 
sexual health who will conduct a brief examination and assess the 
need for any treatments or medications to address your sexual 
health problems. 
• You will be asked to complete study questionnaires on the laptop 
computer at 8 and 12 weeks after enrolling in the study. These 
questionnaires are expected to take up to 20 minutes each.  You 
will have the option of completing these questionnaires during one 
of your routine clinic visits, or remotely through a secure web link or 
over the phone, or through the mail. 
 
If you are randomized to the Multimodal Intervention app: 
• You will receive standard oncology care by your oncology team. 
• You will attend a clinic visit with a transplant clinician specializing in 
sexual health who will conduct a brief examination and assess the 

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need for any treatments or medications to address your sexual 
health problems. 
• You will be provided with instructions on how to use the mobile app. 
You will be asked if you have your own iPad that you would be 
willing to use for the study. If you don’t have an iPad, you will be 
provided with an iPad that allows you to engage with the mobile 
app at your convenience at home over an eight-week period.  
• You will be asked to complete study questionnaires on the laptop 
computer at 8 and 12 weeks after enrolling in the study. These 
questionnaires are expected to take up to 20 minutes each.  You 
will have the option of completing these questionnaires during one 
of your routine clinic visits, or remotely through a secure web link, 
or over the phone, or through the mail.  
 
After the last assessment:  
Your oncologist, as well as the research team, will be available to discuss any 
questions or concerns that you may have. Once you complete the last 
questionnaire you will not be contacted by us again. We would like to keep track 
of your medical condition by reviewing your electronic medical record for the next 
2 years. 
 
 
D. WHAT ARE THE RISKS OR DISCOMFORTS OF THE RESEARCH STUDY? 
 
There are risks to taking part in any research study. However, this particular 
study does not have any physical risks. You may find it upsetting to answer some 
of the items on the questionnaire. The research assistant will be available to you 
during your participation in the study. If you feel upset by any aspect of the study, 
the research assistant, along with your oncologist, will be available to talk with 
you. We can arrange for you to meet with our psychologist for additional 
counseling if needed. 
 
There is also a small risk of a breach of confidentiality. 
 
 
During the research study, you will be provided with any new information that 
may affect your health or willingness to participate.  You may be asked to sign a 
new consent form that shows that you have been informed of new information 
relating to this research study. 
 
 
E. WHAT WILL HAPPEN IF I AM REMOVED FROM THE STUDY OR DECIDE TO END MY 
PARTICIPATION IN THE RESEARCH? 
 
You may be taken off the research study for any reason including: 

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• It is considered to be in your best interest 
• The study treatment or procedures are found to be unsafe or ineffective 
• There is any problem with following study treatments and procedures 
• Your condition worsens 
• A decision is made to end the study 
• Or for other unforeseen reasons that make it necessary to stop your 
participation in the research study 
 
You can also choose to stop participating in the research study at any time.  Tell 
the research doctor if you are thinking about stopping or decide to stop.  He or 
she will tell you how to stop.  Leaving the research study will not affect your 
medical care outside of the research study.   
 
F. WILL I BE PAID TO TAKE PART IN THIS RESEARCH STUDY? 
 
You will not be paid for participating in this study.  
 
G. WHO IS SUPPORTING THIS RESEARCH? 
 
Massachusetts General Hospital is supporting this research study by providing 
funding.   
 
H. WHAT ARE YOUR COSTS? 
 
Taking part in this research study will not lead to added costs to you or your 
insurance company. You will not be billed or incur any co-pays for your visit with 
the transplant clinician to address sexual health problems as part of this study. 
 
 
I. WHAT HAPPENS IF I AM INJURED OR BECOME SICK BECAUSE I TOOK PART IN 
THIS RESEARCH STUDY? 
 
If you think you have been injured as a result of taking part in this research 
study, tell the person in charge of this research study as soon as 
possible.  The research doctor’s name and phone number are listed in this 
consent form. 
 
The treating hospital will offer you the care needed to treat injuries directly 
resulting from taking part in this research.  These treatments may be billed 
to you or your insurance company.  You will be responsible for 
deductibles, co-payments and co-insurance.  There are no plans to pay 
you or give you other compensation for the injury.  
 
You do not give up your legal rights by signing this form.  

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We will need to collect certain personal information about you for 
insurance or payment reporting purposes, such as your name, date of 
birth, gender, social security number or Medicare identification number 
and information related to this research study. We may be required to 
report this information to the Centers for Medicare & Medicaid Services. 
We will not use this information for any other purpose. 
 
If you go to the Emergency Room or to another hospital or doctor it 
is important that you tell them that you are in this research.  If 
possible, you should give them a copy of this consent form. 
 
 
J. WHOM DO I CONTACT IF I HAVE QUESTIONS ABOUT THE RESEARCH STUDY? 
 
If you have questions about the study, please contact the research doctor or 
study staff as listed below: 
 
Massachusetts General Hospital: 
• Areej El-Jawahri, MD: (617) 726-2000, beeper #18734 
• 24-hour contact: Areej El-Jawahri, MD: (617) 726-2000, beeper 
#18734 
 
For questions about your rights as a research participant, please contact a 
representative of the Office for Human Research Studies at Dana-Farber Cancer 
Institute (617) 632-3029. This can include questions about your participation in 
the study, concerns about the study, a research related injury, or if you feel/felt 
under pressure to enroll in this research study or to continue to participate in this 
research study.  
 
 
K. RETURN OF RESEARCH RESULTS 
Most tests done on samples in research studies are only for research and have no clear meaning 
for health care.  If the research with your identifiable information or samples gives results that do 
have meaning for your health, the researchers will not contact you to let you know what they 
have found.   
 
 
L. CLINICALTRIALS.GOV (CT.GOV) 
 
A description of this clinical trial will be available on http://www.ClinicalTrials.gov, 
as required by U.S. Law.  This web site will not include information that can 
identify you.  At most, the web site will include a summary of the results.  You 
can search this web site at any time. 
 
 

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M. CONFIDENTIALITY 
 
We will take measures to protect the privacy and security of all your personal 
information, but we cannot guarantee complete confidentiality of study data.   
 
Medical information created by this research study may become part of your 
hospital medical record and may be forwarded to your primary doctor. 
Information that does not become part of your medical record will be stored in 
your study file.  It may also become part of a DF/HCC research database called 
CORIS.   
 
The questionnaires will not become part of your medical record but will be stored 
in a research file with a specific study code identifier without your name.   
 
Your answers to all the survey questionnaires will remain confidential. 
 
The study team plans to publish the results of this research study and when we 
do, we may be asked to make the data we collect available to other researchers. 
We will not include information that identifies you in any publications or to the 
researchers who request the data to do additional research. 
 

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There is a risk that deidentified research data that is shared with outside 
collaborators may be reidentified.  When deidentified data and specimens are 
shared with outside collaborators agreements limit what the outside collaborators 
can do with the information to help prevent reidentification.   
 
N. GENETIC RESEARCH 
 
This research will not involve genomic or germline testing. 
 
O. PRIVACY OF PROTECTED HEALTH INFORMATION (HIPAA AUTHORIZATION) 
 
The Health Insurance Portability and Accountability Act (HIPAA) is a federal law 
that requires Dana-Farber/Harvard Cancer Center (DF/HCC) and its affiliated 
research doctors, health care providers, and physician network to protect the 
privacy of information that identifies you and relates to your past, present, and 
future physical and mental health conditions (“protected health information”).  If 
you enroll in this research study, your “protected health information” will be used 
and shared with others as explained below. 
 
1. What protected health information about me will be used or shared with 
others during this research? 
 
• Existing medical records, including mental health records. 
• New health information created from study-related tests, procedures, 
visits, and/or questionnaires 
 
2. Why will protected information about me be used or shared with others? 
 
The main reasons include the following: 
• To conduct and oversee the research described earlier in this form; 
• To ensure the research meets legal, institutional, and accreditation 
requirements;  
• To conduct public health activities (including reporting of adverse events 
or situations where you or others may be at risk of harm); and 
• To provide the study sponsor with information arising from an adverse 
event or other event that relates to the safety or toxicity of the drug(s) 
used in the study and for the purpose of this or other research relating the 
study drug(s) and their use in cancer;  
• To better understand the diseases being studied and to improve the 
design of future studies; and, 

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• Other reasons may include for treatment, payment, or health care 
operations.  For example, some medical information produced by this 
research study may become part of your hospital medical record because 
the information may be necessary for your medical care. (You will also be 
given a notice for use and sharing of protected health information.) 
 
3. Who will use or share protected health information about me? 
 
• DF/HCC and its affiliated research doctors and entities participating in the 
research will use and share your protected health information.  In addition, 
other DF/HCC offices that deal with research oversight, billing or quality 
assurance will be able to use and share your protected health information. 
 
4. With whom outside of DF/HCC may my protected health information be 
shared? 
 
While all reasonable efforts will be made to protect the confidentiality of your 
protected health information, it may also be shared with the following entities: 
 
• Outside individuals or entities that have a need to access this information 
to perform functions relating to the conduct of this research such as 
analysis by outside laboratories on behalf of DF/HCC and its affiliates (for 
example, data storage companies, insurers, or legal advisors). 
• The sponsor of the study, its subcontractors, representatives, business 
partners, and its agents. 
• Other research doctors and medical centers participating in this research, 
if applicable 
• Federal and state agencies (for example, the Department of Health and 
Human Services, the Food and Drug Administration, the National 
Institutes of Health, and/or the Office for Human Research Protections), or 
other domestic or foreign government bodies if required by law and/or 
necessary for oversight purposes. A qualified representative of the FDA 
and the National Cancer Institute may review your medical records. 
• Hospital accrediting agencies 
• A data safety monitoring board organized to oversee this research, if 
applicable 
 
Some who may receive your protected health information may not have to satisfy the 
privacy rules and requirements.  They, in fact, may share your information with 
others without your permission.  
 

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5. For how long will protected health information about me be used or shared 
with others? 
 
• There is no scheduled date at which your protected health information that 
is being used or shared for this research will be destroyed, because 
research is an ongoing process.   
 
6. Statement of privacy rights: 
 
• You have the right to withdraw your permission for the research doctors 
and participating DF/HCC entities to use or share your protected health 
information.  We will not be able to withdraw all the information that 
already has been used or shared with others to carry out related activities 
such as oversight, or that is needed to ensure quality of the study. To 
withdraw your permission, you must do so in writing by contacting the 
researcher listed above in the section: “Whom do I contact if I have 
questions about the research study?” 
• You have the right to request access to your protected health information 
that is used or shared during this research and that is related to your 
treatment or payment for your treatment, but you may access this 
information only after the study is completed.  To request this information, 
please contact the researcher listed above in the section: “Whom do I 
contact if I have questions about the research study?” 
 
 
P. DOCUMENTATION OF CONSENT 
 
My signature below indicates: 
• I have had enough time to read the consent and think about 
participating in this study; 
• I have had all of my questions answered to my satisfaction; 
• I am willing to participate in this study; 
• I have been told that my participation is voluntary and I can withdraw at 
any time 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Signature of Participant 
 
 
 
Date 
or Legally Authorized Representative   
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Relationship of Legally Authorized Representative to Participant   
 

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My signature below indicates: 
• I have had enough time to read the consent and think about 
participating in this study; 
• I have had all of my questions answered to my satisfaction; 
• I am willing to participate in this study; 
• I have been told that my participation is voluntary and I can withdraw at 
any time 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Second Signature of Legally Authorized Representative 
Date 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Relationship of Legally Authorized Representative to Participant   
 

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To be completed by person obtaining consent: 
 
Adult Participant 
 
 
The consent discussion was initiated on   
 (date). 
 
Signature of individual obtaining consent:  
 
 
Printed name of above:   
 
 
Date:  
 
 
 A copy of this signed consent form will be given to the participant or legally authorized 
representative. 
 1)  The participant is an adult and provided consent to participate. 
 
 1a)  Participant (or legally authorized representative) is a non-English speaker and 
 
signed the translated Short Form in lieu of English consent document: 
 
As someone who understands both English and the language spoken by the participant, I 
interpreted and/or witnessed, in the participant’s language, the researcher’s presentation 
of the English consent form.  The participant was given the opportunity to ask questions.  
Signature of Interpreter/Witness:  
 
Printed Name of Interpreter/Witness:  
 
Date:  
 
 
 
 1b)  Participant is physically unable to sign the consent form because:  
 
 
 
 The participant is illiterate. 
 
 
 
 The participant has a physical disability. 
 
 
 
 Other (please describe): _________________________________________ 
 
The consent form was presented to the participant who was given the opportunity  
 
to ask questions and who communicated agreement to participate in the research.  
Signature of Witness:  
 
Printed Name of Witness:  
 
Date:  
 
 
 2)  The participant is an adult who lacks capacity to provide consent and his/her legally 
authorized representative: 
 2a) gave permission for the adult participant to participate  
 2b) did not give permission for the adult participant to participate  
 
 

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42.0     Appendix L 
                                
< Date> 
<First Name> <Last Name> 
<Address 1>   
 
 
 
ID Number: <xxxxxx> 
<City>, <State> <ZIP> 
 
Dear <First Name>, 
We are writing to you because you have undergone a bone marrow or blood stem cell 
transplant. As part of the Dana Farber Harvard Cancer Center Bone Marrow Transplant 
Survivorship Initiative, we have created a research program to address patient concerns 
regarding sexual health and intimacy after transplant. Prior studies have shown that 
many patients who have gone through transplant struggle with issues pertaining to their 
sexual health and intimacy, which are not adequately addressed in clinical practice. 
These issues can be distressing to patients and their loved ones. The study doctors 
want to know if the use of a mobile app focused on improving sexual function may 
improve your overall care. 
 
This research program is designed for all transplant survivors. The program 
includes: 
 
1. A consultation visit with a transplant clinician trained to comprehensively address 
your sexual health and intimacy needs 
2. The use of a mobile app on an iPad to reinforce the treatment plan that was 
discussed during the consultation visit. If you do not have an iPad, the research 
team will provide you with one 
3. Three brief questionnaires to understand your sexual health concerns and overall 
quality of life  
 
If you are at all interested in this program and would like to hear more, please 
reply to this gateway message or contact the following research coordinator: 
<Research Coordinator Name> (<Research Coordinator Email> / <Research 
Coordinator Phone>) 
 
We hope you are doing well and look forward to hearing from you! 
Cordially, 
 
 
Areej El-Jawahri MD 
Director, BMT Survivorship Program 
 

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43.0     Appendix M 
 
Qualitative Interview Guide for Patients  
 
INTRODUCTION 
You recently took part in a study that was designed to improve the sexual function and 
quality of life of patients who have undergone stem cell transplantation through the use of 
a mobile intervention application (the SHIFT app). We are now interested to know about 
your satisfaction with different aspects of the SHIFT app so that we can continue to shape 
how to best provide it to patients. There is no right or wrong answer. Your answers will 
be kept confidential and will not affect your participation in future research studies or 
your access to medical care. 
 
I would like to audio-record this interview because I will not be able to write all of this 
information down.  The interview will be transcribed word for word and will allow us to 
capture your thoughts and feelings in your own words.  No identifying information, such 
as your name or names of others, will be included in the transcript. This interview will 
take approximately 30 minutes to complete.  
 
- 
Do I have your permission to audio record this interview? 
- 
Before we start, do you have any questions about what we are doing here today? 
 
GENERAL EXPERIENCE 
I will begin by asking about your general experience using the SHIFT mobile app.  
 
1. How difficult was it to use the SHIFT app? 
 
A. 
Difficult  
 
 
Additional Comments: 
B. 
Not Difficult 
 
 
C. Not sure 
 
 
 
 
2. How helpful was the SHIFT app in addressing your sexual health and intimacy concerns? 
 
A. 
Helpful 
 
 
Additional Comments: 
B. 
Not helpful 
 
 
C. Not sure 
 
 
 
 

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3. What did you like most about the SHIFT app? 
 
 
 
 
 
 
 
4. What did you like least about the SHIFT app? 
 
 
 
 
 
 
 
 
5. How satisfied were you with the mobile app format overall? 
 
A. 
Satisfied 
 
 
Additional Comments: 
B. 
Not Satisfied 
 
 
C. Not sure 
 
 
 
 
6. During this study, you accessed the SHIFT mobile app using an i-pad. How convenient was it 
to use an i-pad to access the app?  
 
A. 
Convenient 
 
 
Additional Comments: 
B. 
Not convenient 
 
 
C. Not sure 
 
 
 
 
7. Did you experience any technical difficulties while using the SHIFT app? 
 
A. 
Yes 
 
 
Additional Comments: 
B. 
No 
 
 
C. Not sure 
 
 

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8. How do you feel about the length of the modules in the SHIFT app? 
 
 
 
 
 
 
 
 
 
 
9. If you did not complete the SHIFT app, were there any reasons that made you decide to not 
complete the entire SHIFT app? 
 
 
 
 
 
 
 
 
10. How do you feel about the duration of the allotted 8-week period over which you were to 
complete the app modules? 
 
A. 
Too long 
 
 
Additional Comments: 
B. 
Too short 
 
 
C. Just right 
 
 
 
11. Throughout the SHIFT app, you may have played games to reinforce your learning. How 
helpful were these games? 
 
A. 
Helpful 
 
 
Additional Comments: 
B. 
Not helpful 
 
 
C. Not sure 
 
 
 
12. How do you feel about the frequency of the games in the SHIFT app? 
 
A. 
Too little 
 
Additional Comments: 

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B. 
Just right 
 
 
C. Too much 
 
 
 
13. What were the games that you liked the most in the SHIFT app? 
 
 
 
 
 
 
 
 
14. What were the games that you liked the least in the SHIFT app? 
 
 
 
 
 
 
 
 
 
15. How could we modify the SHIFT app to increase your engagement with the content? 
 
 
 
 
 
 
 
 
APP CONTENT 
Now I am going to ask some questions about the specific material covered in the app. We 
would like to ask you your opinion about the content of the app: 
 
1. Education about sexual health and intimacy 
The app included educational content regarding the causes of sexual health problems 
after transplant and expected trajectory of sexual health recovery. 
 
A. How helpful was it to have this educational content? 
 
A. 
Helpful 
 
 
Additional Comments: 

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B. 
Not helpful 
 
 
C. Not sure 
 
 
 
B. How difficult was it to understand the educational content? 
 
A. 
Difficult 
 
 
Additional Comments: 
B. 
Not difficult 
 
 
C. Not sure 
 
 
 
 
C. Were there remaining topics that you wished were addressed regarding sexual health and 
intimacy? 
 
 
 
 
 
 
 
2. Communication about your sexual health concerns 
The app included information on how to best communicate with your medical team 
and your partner regarding your sexual health concerns. 
 
A. How helpful was the content focused on communication with your medical team? 
 
A. 
Helpful 
 
 
Additional Comments: 
B. 
Not helpful 
 
 
C. Not sure 
 
 
 
B. How helpful was the content focused on communication with your partner about your 
sexual health concerns? 
 
A. 
Helpful 
 
 
Additional Comments: 
B. 
Not helpful 
 
 
C. Not sure 
 
 

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C. Do you have additional feedback about the modules focused on communication in the 
SHIFT app? 
 
 
 
 
 
 
 
 
 
3. Intimacy exercises: 
The app incorporated multiple exercises to improve physical and non-physical 
intimacy, such as pleasure mapping, sensate focus exercise, exposure tower, and 
intimacy chest 
 
A. How helpful were these intimacy exercises? 
 
A. 
Helpful 
 
 
Additional Comments: 
B. 
Not helpful 
 
 
C. Not sure 
 
 
 
B. How often did you use the intimacy exercises that you learned from the SHIFT app? 
 
A. 
Often 
 
 
Additional Comments: 
B. 
Not Often 
 
 
C. Not sure 
 
 
 
C. What were the intimacy exercises that you liked the most in the SHIFT app? 
 
 
 
 
 
 
 
 
 
 

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D. What were the intimacy exercises that you liked the least in the SHIFT app? 
 
 
 
 
 
 
 
 
 
E. Any additional feedback regarding the intimacy exercises in the SHIFT app? 
 
 
 
 
 
 
 
 
 
4. Coping with sexual health and intimacy concerns 
The SHIFT app focused on helping you cope most effectively with your sexual health 
concerns. The app discussed problem-focused and emotion-focused coping strategies 
to address your sexual health concerns. 
 
A. How helpful were the coping strategies in the SHIFT app?  
 
A. 
Helpful 
 
 
Additional Comments: 
B. 
Not helpful 
 
 
C. Not sure 
 
 
B. How often did you use the coping strategies (i.e. such as mindfulness, acceptance) 
that you learned from the SHIFT app? 
 
A. 
Often 
 
 
Additional Comments: 
B. 
Not Often 
 
 
C. Not sure 
 
 
 
C. What coping strategies you found most useful in the SHIFT app? 
 
 
 

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D. What coping strategies you found least useful in the SHIFT app? 
 
 
 
 
 
 
 
 
 
E. Any additional feedback regarding the intimacy exercises in the SHIFT app? 
 
 
 
 
 
 
 
 
Is there anything else you would like to add that we have not discussed? 
 
 
 
 
 
 
 
 
We have now reached the end of this interview. Thank you for being a part of the study. 
We appreciate your thoughtful responses and participation in research.