Pilot Study of an Intimacy Enhancement Intervention for Couples Facing Breast Cancer
Phase: NA
Conditions: Breast Cancer
Sponsor: Fox Chase Cancer Center

Principal Investigator: Jennifer B. Reese 
Abbreviated Title: Intimacy Enhancement Pilot Study  
IRB #15-8007 
Page 1 of 26 
 
 
 
Protocol Title 
Pilot Study of an Intimacy Enhancement Intervention for Couples Facing Breast Cancer 
 
 
 
 
 
 
 
Principal Investigator 
Jennifer B. Reese, PhD 
 
Co-Investigator(s): 
Sharon Schwartz, Fox Chase Cancer Center 
Katherine Smith, Johns Hopkins University Medical Center 
Elissa Bantug, Johns Hopkins University Medical Center 
 
 
Consultants: 
Laura Porter, Duke University Medical Center 
Sharon Bober, Dana-Farber Cancer Center 
 
Interventionists: 
Sandra Corbett Feite 
Courtney McCuen-Wurst 
Kimberly Rabago 
Kevin Masturzo 
 
Staff: 
Kristen Sorice 
Natalie Oppenheimer 
 
Participating/Collaborating Institutions: 
None 
 
Statistician: 
Elizabeth Handorf 
 
Funding Source: 
NCI 1R21CA191354 
 
Initial Version Date: 05/01/2015 
 
 
Amendment #8 
 
Version date: 
10/10/2016 
 
 

Principal Investigator: Jennifer B. Reese 
Abbreviated Title: Intimacy Enhancement Pilot Study  
IRB #15-8007 
Page 2 of 26 
 
Table of Contents 
Section  
 
 
 
 
 
 
 
 
 
Page 
1.0 
Introduction…………………………………………………………………………………………………….    3 
 
 
2.0  
Objectives……………….........................................................................................    4 
 
3.0 
Background……………………………………………………………………………………………………..    4 
 
4.0 
Study Design……………………………………………………………………………………………………    7 
 
 
5.0 
Risk to Participants………………………………………………………………………………………….    15 
 
6.0 
Potential Benefits to Participants…………………………………………………………………….    16 
 
7.0 
Provisions to Maintain the Confidentiality of Data…………………………………………..   16 
 
8.0 
Costs to Participants…………………………………………………………………………………………   16 
 
9.0 
Consent Process………………………………………………………………………………………………    16 
 
10.0    Off-Study Criteria…………………………………………………………………………………………….    18 
 
11.0 
Drugs and Devices……………………………………………………………………………………………    18 
 
12.0 
Multi-Site Research Study………………………………………………………………………………..    18 
 
13.0 
Statistical Analysis……………………………………………………………………………………………   18 
 
14.0 
Data Safety Monitoring Plan……………………………………………………………………………    19 
 
15.0 
Adverse Event Reporting………………………………………………………………………………….   20 
 
16.0 
Quality Assurance Procedures and Participant Confidentiality…………………………    20 
 
17.0 
Participant Informed Consent………………………………………………………………………….    21 
 
18.0 
References……………………………………………………………………………………………………….   21 
 
19.0 
Appendices………………………………………………………………………………………………………   25 
 

Principal Investigator: Jennifer B. Reese 
Abbreviated Title: Intimacy Enhancement Pilot Study  
IRB #15-8007 
Page 3 of 26 
 
1.0 Introduction 
Background: The majority of women diagnosed and treated for breast cancer survive 5 years past diagnosis, making 
quality of life (QOL) concerns highly salient. Sexual concerns are common and distressing for many women with breast 
cancer and serve as a major source of QOL impairment. Unlike other aspects of QOL that improve over time after breast 
cancer treatment, sexual concerns often persist and do not typically resolve without intervention. Yet these concerns 
are typically neglected in patients’ care, leaving them underdiagnosed and undertreated. Addressing breast cancer 
survivors’ sexual concerns can reduce distress, support their intimate relationships, and foster effective adjustment. 
However, existing sexual QOL interventions that address the sexual concerns of breast cancer survivors suffer from 
limitations in both content and format. For instance, existing sexual QOL interventions do not include current 
management recommendations and are not generally in a format that can be widely disseminated. A telephone-based 
format is a viable, effective alternative to in person counseling that would enhance the potential for dissemination and 
be ideal for reaching long-term survivors. Previously, the PI demonstrated that a 4-session telephone-based Intimacy 
Enhancement (IE) intervention improved intimacy and sexual outcomes for colorectal cancer patients and their partners.  
 
Objective and Hypothesis: The central goal of this study is to examine the feasibility, acceptability, and preliminary 
efficacy of the IE intervention on patient and partner sexual QOL and relationship outcomes, and on patient psychosocial 
outcomes. We expect that the IE will show adequate feasibility, acceptability, and preliminary efficacy. Secondarily, 
based on the rationale that barriers exist that limit participation in intensive sexual QOL interventions for breast cancer 
survivors, an innovative secondary aim will investigate the perspectives of study-eligible patient candidates who opt out 
of participating in the pilot trial. We expect that we will be able to identify the participation barriers and intervention 
preferences of breast cancer survivors with sexual concerns who opt out of the intensive trial in order to inform the 
development of different interventions for future study.  
 
Specific Aims: (1) To pilot test the feasibility, acceptability, and preliminary efficacy of the Intimacy Enhancement 
intervention. (2) To identify participation barriers and intervention preferences of breast cancer survivors who choose 
not to participate in the Intimacy Enhancement pilot study. 
 
Study Design: In Aim 1, we will randomize approximately 30 breast cancer survivors with sexual concerns to either the IE 
intervention or to an Educational Control condition (2:1). Feasibility will be measured through study accrual, attrition, 
and session completion. Acceptability will be assessed through a validated treatment satisfaction measure. Preliminary 
efficacy will be measured through estimating the intervention effect size on improved patient and partner sexual QOL 
outcomes (sexual function, sexual satisfaction and intimacy, sexual distress) and relationship outcomes (emotional 
intimacy, sexual communication, relationship quality), and patient psychosocial outcomes (body image distress, 
psychological distress). In Aim 2, concurrent with the intervention study, brief, structured, exploratory surveys with 
study-eligible candidates who choose not to participate in the pilot intervention study will be used to investigate barriers 
to participation and willingness to participate in alternative interventions drawn from a range of formats (e.g., website; 
written materials, other counselor) and sources (e.g., clinician, peer volunteer, counselor). These are referred to as 
“developmental surveys” in this protocol. 
Significance: Addressing sexual and intimacy concerns can lead to improved relationship quality, mental health, QOL and 
even treatment adherence. Ultimately, this program of research will lead to the availability of a range of interventions 
well-equipped to address the undertreated area of sexual QOL for those with breast and potentially other cancers. 
 
 
 

Principal Investigator: Jennifer B. Reese 
Abbreviated Title: Intimacy Enhancement Pilot Study  
IRB #15-8007 
Page 4 of 26 
 
2.0 Objectives 
2.1 Primary Objectives 
 
2.1.1. Primary Objective I.  
 
To pilot test the feasibility, acceptability, and preliminary efficacy of the Intimacy Enhancement intervention. We will 
randomize 30 breast cancer survivors with sexual concerns to either the newly adapted IE intervention or to an 
Educational Control condition (2:1). Feasibility will be measured through study accrual, attrition, and session completion. 
Acceptability will be assessed through a validated treatment satisfaction measure. Preliminary efficacy will be measured 
through estimating the intervention effect size on improved patient and partner sexual QOL outcomes (sexual function, 
sexual satisfaction, sexual distress) and relationship outcomes (intimacy, sexual communication, relationship quality), 
and patient psychosocial outcomes (body image distress, psychological distress). Effects of the intervention on other 
exploratory outcomes (e.g., patient and partner cancer-specific distress) will also be examined. 
2.1.2. Primary Objective II. 
 
To identify participation barriers and intervention preferences of breast cancer survivors who choose not to 
participate in the Intimacy Enhancement pilot study. Concurrent with the intervention study, brief structured, 
exploratory/developmental surveys with study-eligible willing candidates who choose not to participate in the pilot 
intervention study will be used to investigate barriers to participation and preferences for participation in alternative 
interventions drawn from a range of formats (e.g., website; written materials, other counselor) and sources (e.g., 
clinician, peer volunteer, counselor). 
2.2 Secondary Objectives 
2.2.1. Secondary Objective I. 
None. 
2.2.2. Secondary Objective II. 
None. 
2.3. Research Hypothesis 
2.3.1. Hypothesis I. 
We expect that the IE intervention will be considered feasible and acceptable. 
2.3.2. Hypothesis II.  
We expect that the IE intervention will show preliminary efficacy on patient and partner sexual outcomes, patient and 
partner relationship outcomes, and patient psychosocial outcomes. 
2.3.3. Hypothesis III.  
We expect to gather data from Aim 2 (developmental surveys) which will help characterize study-eligible candidates 
who choose not to enroll and to inform the development of future intervention studies.  
3.0 Background 
3.1 Scientific Background 
Sexual Concerns are Common and Distressing in Breast Cancer. Breast cancer accounted for nearly one third of all 
cancer diagnoses in women in 2013 (29%).1 Breast cancer makes up over 20% of all cancer survivors, greater than any 
other single group by cancer diagnosis.2 Over 90% of breast cancer survivors have at least a 5 year expected survivorship 
and nearly all those with localized disease have a 5-year likelihood of surviving past diagnosis (98% overall),1 making QOL 

Principal Investigator: Jennifer B. Reese 
Abbreviated Title: Intimacy Enhancement Pilot Study  
IRB #15-8007 
Page 5 of 26 
 
life concerns such as sexual function particularly salient for this group. Advances in detection and treatment improve 
survival for breast cancer, yet these life-extending treatments often come at the cost of negatively impacting sexual 
quality of life (QOL).3-5 Up to 70% of breast cancer survivors report sexual difficulties.6 Common sexual concerns include 
both physical problems (e.g., orgasmic difficulties, painful intercourse)7-9 and motivational/emotional concerns (e.g., 
loss of sexual interest, body image distress).10,11 For breast cancer survivors, surgical scarring can lead to body image 
distress11 and loss of nipple sensitivity;3 hormonal therapy and chemotherapy can alter sex hormones, leading to 
distressing vaginal symptoms (e.g., dryness) and generalized symptoms (e.g., hot flashes);9,12 and radiation and/or 
chemotherapy side effects (e.g., weight gain)13,14 can interfere with sexual function and interest. Cancer treatment can 
also significantly impact the intimate relationship generally (e.g., by reducing time for enjoyable activities)15 and through 
its effects on sexual intimacy.12 Sexual concerns are also persistent for breast cancer survivors, improving at a much 
slower rate than other domains of QOL such as pain and physical function.16-19 Breast cancer survivors rank sexual 
concerns (e.g., the ability to engage in sexual intercourse without difficulty) among their top concerns.20,21  Sexual 
problems correlate with poorer overall QOL and higher disease interference.22 In sum, for breast cancer survivors, sexual 
concerns are common, distressing,10,23 persistent, and lead to reduced QOL. 
 
Sexual Concerns are Inadequately Addressed for Breast Cancer Survivors. Sexual concerns for breast cancer survivors 
generally do not improve on their own,24 and often require intervention. Therefore, the importance of available 
empirically supported interventions that adequately address these concerns is critical. Despite this, sexual concerns are 
among the most poorly addressed of cancer-related concerns for women with cancer. In stark contrast to prostate 
cancer survivors, of whom the majority receives information about treatments on sexual function25 and for whom 
addressing sexual function has become standard practice, the minority of women with breast cancer receive such 
information.25,26 In past work with the PROMIS Sexual Function Domain committee,27 we examined patients’ experiences 
of communication about sex with their oncology providers.25 We found that although the majority of breast cancer 
survivors (75%) reported that it was important to discuss sexual concerns with providers, only 33% reported ever 
receiving information. Similarly low percentages (i.e., 10%,28 41%29) have been reported in other studies, suggesting 
that sexual issues are addressed for the minority of those treated for breast cancer. For breast cancer survivors with 
identified sexual concerns, there are few empirically supported interventions available.30-32 Alternatively, the widely 
disseminated websites and pamphlets addressing sexual issues for breast cancer survivors (e.g., American Cancer 
Society) have not been empirically evaluated. Thus, the development of empirically supported interventions that are 
easily disseminated is critically important. 
Prior Intervention Studies Have Significant Limitations. Most interventions addressing sexual issues for women with 
breast cancer have (a) focused on alleviating particular side effects that can affect sexual function (e.g., vasomotor 
symptoms like hot flashes),33 (b) included sexual concerns as one of many issues targeted,34 thus reducing the breadth of 
concerns addressed, or (c) utilized formats difficult to disseminate (e.g., home visits).35 Physical, emotional/motivational, 
and relationship factors all contribute to sexual problems and need to be dealt with in a comprehensive approach.36 
Limitations also exist with regard to the format of prior interventions. Only two prior intervention studies for breast 
cancer survivors that measured sexual outcomes have used a telephone format;37,38 both of these studies included 
sexuality as a side module rather than as the focus, neither included 
partners, and neither screened for sexual problems - which is 
important in light of an increasing focus on targeting interventions at 
the sub-populations with the greatest need.39 Finally, recent 
empirically supported guidelines for improving vaginal dryness and 
discomfort and maintaining vaginal health through physical and 
behavioral strategies40 need to be integrated in sexual QOL 
interventions. Yet as of now, no empirically supported interventions 
exist that include these strategies within the context of a couple-based approach. Thus, significant limitations to existing 
interventions exist that, if addressed, could have significant implications on research and clinical care related to the 
sexual QOL of breast cancer survivors. 
Table 1.  IE Intervention Effect Sizes for  Colorectal Cancer 
Patients (PT) and Partners (PR)  
 
Study 1 
Study 2 
Measure 
PT 
PR 
PT 
PR 
Sexual Distress 
 
-1.01 
-0.56 
.05 
-.69 
Sexual Function- Female 
1.15 
1.29 
0.85 
.18 
Sexual Function- Male 
0.22 
0.61 
0.58 
1.75 
Sexual Communication 
0.82 
0.68 
-.30 
0.97 
Intimacy  
0.29 
0.53 
-.06 
0.51 
Self-efficacy  
-- 
-- 
0.66 
0.57 

Principal Investigator: Jennifer B. Reese 
Abbreviated Title: Intimacy Enhancement Pilot Study  
IRB #15-8007 
Page 6 of 26 
 
3.2 Preliminary Studies 
Previously, the PI conducted a small uncontrolled pilot study examining a telephone-based IE intervention in 14 couples 
facing colorectal cancer (9 completed; Study 1 in Table 1).41 This intervention aimed to improve patient and partner skills 
in coping with sexual concerns related to colorectal cancer and improve physical and emotional intimacy. Findings 
showed moderate to large effects for most sexual and relationship outcomes. Dr. Reese then compared the intervention 
to a wait list control in a randomized study in 23 couples (18 completed; Study 2 in Table 1).42 Findings showed strong 
positive effects on all outcomes for partners and on sexual function and self-efficacy for patients. Importantly, across 
both of these studies the vast majority of participants (>75%) reported liking the telephone-based format; qualitative 
responses indicated that this format was appreciated for both its convenience and comfort in discussing sensitive topics.  
We recently conducted our first patient focus group within this population under IRB Protocol # 14-833 to gather data 
that will allow us to adapt the previously tested IE intervention to breast cancer, and have two more scheduled at the 
time of this submission. The objective of these groups is to identify preferences for content and structure which will be 
used to tailor the intervention to the needs of this population. We will also conduct cognitive interviews with 
approximately 5 additional breast cancer survivors to review the intervention materials and ensure their 
comprehensibility and appropriateness, and the IRB modification is currently pending approval for these cognitive 
interviews.  We anticipate that the general content and structure of this intervention, i.e., a couple-based telephone 
intervention with four sessions addressing intimacy and sexual concerns, will remain as proposed. However, once we 
have analyzed all data obtained from the exploratory focus groups in IRB Protocol #14-833, we will use that data to 
finalize the content and structure of the planned intervention. We expect changes to be relatively minor. An outline of 
the IE intervention condition is submitted in the Appendix, although minor elements of this may change without altering 
the overall aims and subject matter of this intervention. We will submit substantial changes to the intervention content 
or format that we will make based on our qualitative data using a modification to the present IRB protocol once those 
data have been analyzed.  
3.3 Significance of the Research Study 
Sexual concerns are common, severe, distressing, and persistent for breast cancer survivors making this study highly 
significant. First, while persistent sexual problems lead to impaired QOL for breast cancer survivors, addressing these 
concerns can reduce emotional distress, support relationships, and foster effective adjustment to the disease. Given that 
sexual side effects of hormonal therapies are bothersome and can lead to nonadherence, identifying and addressing 
these negative sexual side effects could potentially improve adherence to such regimens. Therefore, this study has 
significant implications for improving patient outcomes and even adherence to medication regimens, making it of 
significant interest to clinicians who treat breast cancer survivors.  
 
Second, the novel telephone-based format of the couple intervention enhances the potential for dissemination. While 
cancer patients with access to comprehensive cancer centers can benefit from the sexual health programs often 
available at these sites, patients who receive their care in community or rural cancer centers generally lack equivalent 
expertise and may therefore be unable to pursue appropriate treatment for their concerns. A telephone-based 
intervention could be easily disseminated to couples who are unable to attend in-person visits due to such geographical 
limitations, cost, or the burden of travel. Moreover, this intervention could be easily integrated into existing telephone 
counseling programs for cancer survivors such as CancerCare, which employs brief, structured evidence-based 
treatment protocols. Findings will also have implications for researchers considering telephone-based interventions for 
cancer survivors and their family members.43 The web-based format for outcome data collection further reduces 
participant burden and contributes to the novelty of the study methods.  
 
Third, the complexity of sexual problems experienced by breast cancer survivors may discourage providers from raising 
the issue with their patients,44,45 contributing to inadequate identification and treatment. This study will identify the 
core issues breast cancer survivors face with respect to their sexual QOL and the key areas that should be addressed in 

Principal Investigator: Jennifer B. Reese 
Abbreviated Title: Intimacy Enhancement Pilot Study  
IRB #15-8007 
Page 7 of 26 
 
related interventions. An especially unique feature of this investigation is an exploration of barriers to participation and 
intervention preferences of patients who opt out of the IE intervention pilot trial. The information gained from this aim 
will directly inform the development of a range of interventions addressing these concerns and is thus likely to be of 
considerable utility to researchers. Moreover, equipped with available efficacious interventions to offer their patients, 
breast cancer providers may be more likely to raise the issue of sexual QOL and provide appropriate support. Therefore, 
the findings of this study will have significant implications for both research and clinicians aiming to improve the care 
and outcomes of breast cancer survivors. 
4.0 Study Design 
4.1 Study Overview 
The main objective of this study is to pilot test the IE 
intervention for breast cancer survivors and their partners (See 
Figure 1). In Aim 1, we will pilot test the IE intervention for 
feasibility, acceptability, and preliminary efficacy in a small 
randomized controlled trial in 30 couples. In Aim 2, we will 
identify barriers to participation and intervention preferences for 
study-eligible patients who opt out of the pilot trial through 
brief, structured exploratory orally-administered surveys.   
4.2 Recruitment Methods 
4.2.1 Recruitment and Reimbursement  
 
Number of subjects per 
year projected at FCCC 
Total number 
of subjects at 
FCCC 
Total number 
of subjects 
overall: 
Number of subjects 
nationally or 
internationally (if 
applicable 
Number of subjects at 
collaborating 
institutions (if 
applicable) 
Up to: 50 
 
Up to: 80 
110 
0 
0 
The human subjects in this entire project include approximately 80 breast cancer patients (N=30 for Aim 1; N=50 for Aim 
2) and 30 spouses or partners of breast cancer patients (Aim 1) who will be asked to provide their time and personal 
information as part of the study, for a total of approximately 110 participants. A lower RC target accrual is 50 (30 
patients in Aim 1; 20 patients in Aim 2), and an upper RC accrual goal is 90 (30 patients in Aim 1; 60 patients in Aim 2).  
We have included Temple University Hospital and School of Medicine as possible recruiting sites and will consider 
recruiting Temple University Hospital patients if our recruitment could benefit from this addition.  
 
Breast cancer patients are chosen for the study population because breast cancer patients experience sexual concerns 
and addressing these concerns may improve patients’ intimate relationships and quality of life. We will enroll as many 
“intervention refusers” as possible until we reach our goal of 30 couples into the intervention study, and will stop 
enrolling “intervention refusers” to Aim 2 once we have reached this goal. While we anticipate approximately 50 study-
eligible patients will refuse the trial, it is possible that a smaller number of eligible patients will refuse the trial before we 
reach our target of 30 couples enrolled in the trial. Thus the number of patients in Aim 2 may differ slightly from our 
estimate. 
 
4.2.1.1 Patient Contact and Screening  
 
Study candidates will be recruited (a) over the telephone using a study letter sent after identification of appropriate 
candidates through providers’ schedules, or after identification through the Fox Chase Cancer Registry, (2) through in-
person clinic recruitment, and (3) through advertisements in clinic and patient areas (e.g., education and resource 

Principal Investigator: Jennifer B. Reese 
Abbreviated Title: Intimacy Enhancement Pilot Study  
IRB #15-8007 
Page 8 of 26 
 
room). Pre-screening of patients’ charts by our recruitment team prior to patient contact helps to ensure that only 
potentially eligible candidates who meet initial criteria (e.g., age, breast cancer diagnosis and stage, ECOG score, English 
speaking status) will be contacted regarding participation in the study in order to minimize potential patient burden.  
The initial contact will be conducted with approval from the treating physician/provider (e.g., NP) and will be from the 
research team and/or the treating provider. For patients identified through the Registry, lists of potentially eligible 
candidates will be approved by the patients’ physician prior to sending the introductory letter. Potential candidates who 
have not called to opt out of the study or otherwise opted out will be called by a research member to confirm their 
eligibility.  
 
For interested candidates, screening will determine eligibility (see Patient Screening Script in Appendix) and will also 
include a discussion of study procedures, risks, benefits, and the voluntary nature of their participation, and the fact that 
it will not affect their medical care. Screening the patient for eligibility may occur over the telephone or in person and 
will include assessment of age, disease status and stage, partner status and age, treatment status and length of time 
since completing treatment, use of hormone therapy, hearing impairment of patient and partner, current pregnancy, 
past history of breast or gynecological cancer, current treatment for a concurrent cancer, current participation in marital 
therapy, and sexual concerns.  We are currently using many similar items, including the sexual concerns screening item, 
in protocol 14-833 and have had success with these screening items. Medical record review will confirm the patients’ 
breast cancer diagnosis, stage, and treatment status, as described in the screening script (or in pre-screening).  
 
Patient eligibility screening will occur privately due to the sensitive nature of the questions. In order to collect valuable 
eligibility data about the target population that could be used to inform our development of future studies, all screening 
items will be administered, and the data will be recorded if patients endorse the item allowing us to keep the 
information obtained during the screening discussion (see Patient Screening Script in Appendix). 
 
To ensure adequate understanding of the study by both members of the couple prior to consenting, a study team 
member must speak personally with both members of the couple and ascertain an adequate level of understanding by 
both members of the couple prior to giving them permission to consent for the study and proceed with enrolling.  
 
If the patient is eligible and is interested in considering participation in the study, the study team member will obtain 
permission from the patient to contact the patient’s spouse or partner with regard to participation, as described in the 
Screening Script. Partners will be screened for the purpose of determining their interest in participating in this study; 
there are no specific eligibility criteria for the partner except age > 21, which will be determined during the patient’s 
screening. A Partner Introductory Script is also included in the Appendix, to guide the recruiter discussion with the 
partner, once the patient gives permission to contact the partner. 
 
The patient may prefer to speak with the spouse/partner initially herself. In this case, the recruiter may follow-up with 
the patient at a later time to assess continued interest and to speak with the spouse/partner to describe the study 
and/or gauge understanding of the study procedures. In the case of in-person recruitment, the recruiter will 
nevertheless ask for permission to discuss the study with the partner, although the patient screening will occur in 
private (unless the patient indicates a preference for having the partner present during the discussion). 
 
4.2.1.2 Reimbursement 
 
4.2.1.2.1 Reimbursement for Aim 1 (intervention study) 
 
Participants will receive $25 for completing pre- and post-intervention assessments (total=$50 per couple). 
Compensation will be provided in the form of gift cards. Gift cards will be mailed to participants once both members of 
the couple have completed either the baseline or the post-treatment online survey. Once the study team members have 

Principal Investigator: Jennifer B. Reese 
Abbreviated Title: Intimacy Enhancement Pilot Study  
IRB #15-8007 
Page 9 of 26 
 
verified that the couple has completed the appropriate surveys, a member of the study team will call the participants to 
confirm that they have received the gift card and the study team member will document this in our research files.  
 
4.2.1.2.2 Reimbursement for Aim 2 (developmental surveys) 
 
Study-eligible patients who refuse the intervention study but complete brief exploratory surveys (“intervention 
refusers”) will receive $10 for participation, also in the form of gift cards. Patients will either receive these in person or 
will be mailed them, if the survey takes place over the telephone. Regardless of the method of reimbursement, a 
research team member will confirm receipt of the compensation and will document this in our research files. 
4.3. Inclusion and Exclusion Criteria  
Overall, eligible patients for this study will be adult (> 21 years) partnered breast cancer patients who have completed 
active treatment for Stage I-III non-recurrent breast cancer between 6 months and 5 years prior who report sexual 
concerns (see Table 2). Patients’ spouses or partners must also be > 21 years old.  
 
Table 2. Inclusion Criteria 
 
Female  
 
Age > 21 years  
 
Has diagnosis of non-recurrent stage I-III breast cancer  
 
Completed active treatment (e.g., chemotherapy, radiation therapy, surgery) 6 months-5 years 
ago (current use of endocrine therapy is acceptable) 
 
Is currently in a partnered relationship that could involve sexual activity (as determined by 
eligibility screening script) 
 
Has a partner or spouse who is > 21 
 
Lives with a romantic partner > 6 months 
 
Score of > 3 on Patient Care Monitor Sexual Concerns screening item46 
 
No hearing impairment in patient or partner 
Exclusion Criteria 
 
Not able to speak English, as stated in medical record or as observed by study team member  
 
ECOG Performance score > 2 OR too ill to participate as judged by physician/in medical record 
 
Overt cognitive dysfunction or psychiatric disturbance such as suicidal ideation or severe mental 
illness, as observed or judged by the researcher, referring source, or other qualified observer. 
 
Past history of any cancer other than non-melanoma skin cancer 
 
Currently participating in couple/marital therapy 
 
Currently pregnant 
 
Because male breast cancer patients may experience unique sexuality concerns, we will recruit only female breast 
cancer patients for the study patient sample. There are no exclusions based on race or ethnicity and every effort will be 
made to include a diverse patient sample for the current study. Patients are excluded if they are currently participating 
in couple or marital therapy to avoid confounding improvement in the IE intervention with improvement in co-occurring 
therapy. Further, we also exclude patients with past history of breast or gynecological cancer, as such patients may have 
prior sexual complaints and have different needs. Similarly, those with another concurrent cancer treatment are 
excluded. Pregnant patients are also excluded because they may have different sexual function and sexual concerns. 
Patients with a hearing impairment are excluded due to the nature of this intervention as occurring over the telephone 
and therefore requiring active listening. Non-English speakers are similarly excluded. Finally, patients who are too ill, as 
determined through an ECOG score, medical record, or provider, are excluded because participants are asked to engage 
in behavioral exercises between intervention sessions and patients who are too ill may not be able to participate fully in 
such study activities. Finally, because we are collecting outcome data on patients’ psychological distress and well-being, 

Principal Investigator: Jennifer B. Reese 
Abbreviated Title: Intimacy Enhancement Pilot Study  
IRB #15-8007 
Page 10 of 26 
 
and because cognitive dysfunction and psychiatric illness could interfere with study activities, patients with overt 
cognitive dysfunction and psychiatric disturbance are excluded, as described below in Table 2. 
 
Participants in Aim 2 completing the developmental surveys are patients who meet eligibility criteria for the pilot trial 
(Aim 2) but opt not to participate in the trial. This may be because they do not have time or interest in participating in 
the full trial, and the developmental survey study allows them the opportunity to contribute to these research efforts 
despite lack of availability for the pilot study. 
 
No exclusions will be made for any part of the investigation based on sexual orientation, which means that same-sex 
couples may participate in the pilot trial and those in non-heterosexual relationships may participate in Aim 2. 
 
4.4 Study Data Collection and Measures 
4.4.1 Medical Data Collection (Aim 1)  
Because patient self-report about medical history can occasionally differ from the data on the same items in patients’ 
charts (e.g., treatments received), we will collect the following data on enrolled patients through medical chart review: 
date of diagnosis and disease stage, dates and types of treatments and surgeries received for breast cancer, current 
treatment status, current medication use (including endocrine therapies), and current menopausal status (See Medical 
Records Data Collection Form in Appendix). The data abstraction will be performed by Sharon Schwartz, a Nurse 
Practitioner and Co-Investigator on our study, or another member of the study team trained or supervised by Ms. 
Schwartz, and entered into our de-identified databases. This medical chart review is documented in the consent form. 
4.4.2 Self-Report Data Collection (Aim 1). An overview of study measures and collection time points for participants in 
Aim 1 (the pilot trial), including number of items in each scale, is in Table 3. After consenting, patients and partners will 
complete pre- and post-intervention outcome measures through a web portal on their home computers using RedCap.   
4.4.2.1 Overview of Self-Report Data Collection (Aim 1).  
We have given significant thought to the outcome measures included in our study. First, given recent findings from a 
sexual QOL intervention study suggesting that long survey batteries may contribute to attrition,47 attention was given to 
selecting brief scales or the abbreviated versions of longer scales whenever possible, such as the 7-item Dyadic 
Adjustment Scale (vs. the 32-item version). These brief scales are psychometrically sound while decreasing the length of 
time required of participants. Second, the length of the total survey battery is comparable to those administered in 
many other similar studies, and is shorter than the battery given in our prior pilot studies in colorectal cancer. 
Computer-based administration of surveys is often less time-consuming for participants than paper and pencil 
completion48 and reduces the need for time spent in mailing back surveys. Finally, nearly all outcome measures chosen 
are standardized validated comprehensive scales and many are the gold standard for assessing sexual outcomes (e.g., 
FSFI/IIEF) and other measures have been used successfully by us in our prior studies (see next paragraph for further 
explanation of these measures). 
We will use RedCap to collect data for Aim 1. RedCap is a secure, web-based application that is flexible enough to be 
used for a wide variety of research studies, offers intuitive interfaces for data entry and real time data validation, and 
supports easy data manipulation with audit trails and reporting capabilities, including automated export to common 
statistical packages. RedCap for electronic data collection is preferred over paper and pencil administration for this study 
because: (1) it can be completed in less time and is therefore potentially less burdensome for participants; (2) it is less 
burdensome to the investigators in terms of both collection and data entry – essentially eliminating the need for by-
hand data entry of self-report measures; (3) it leads to fewer human errors because it obviates the need for by-hand 
data entry. Participants without computer or internet access will be able to complete data collection through the mail 
using paper and pencil versions of the electronic data forms, printed out by the couple if possible or sent to the couple 

Principal Investigator: Jennifer B. Reese 
Abbreviated Title: Intimacy Enhancement Pilot Study  
IRB #15-8007 
Page 11 of 26 
 
by a study team member.  If sent through the mail, surveys will be sent (along with consent forms, if necessary) in 
separate envelopes with instructions to complete these independently from one another. 
In addition to our collection of the measures assessing preliminary efficacy of the IE intervention (described below in 
4.4.2.2), we will also collect data on patients’ and partners’ self-efficacy for coping with sexual problems with three 
items we have used in our recent trial,49 and on frequency of patient sexual activities and use of sexual aids assessed 
with items from the PROMIS Sexual Function measure50 to generate effect sizes for the future trial. We also include two 
items that we developed and assessed in a prior prospective study in colorectal cancer that assess the extent to which 
sexuality is important to the individual, based on a theoretical model of flexible coping developed by the PI.51  In 
addition, we will collect data from both patients and partners on cancer-specific distress,52 which has become 
commonplace in couple-based cancer interventions 53and is important to track given the distress experienced by 
patients’ spouses in confronting their partners’ cancer diagnoses.54 Demographic characteristics (e.g., age, 
race/ethnicity) will be assessed through self-report. Additionally, both patients and partners will complete a validated 
self-report version of the Charlson Comorbidity Index,55 which will provide a measure of medical illness comorbidity. This 
is relevant given the relation between medical illnesses (e.g., cancer, diabetes, heart disease) and sexual function. 
Particularly for men, but also for women, medical comorbidity is a major determinant of sexual dysfunction.56  
4.4.2.2 Preliminary Efficacy (Aim 1) will be measured through the following measures shown in Table 3, all of which 
have been validated and psychometrically tested in the context of cancer: patient and partner sexual QOL outcomes 
(sexual function, sexual satisfaction, sexual intimacy, sexual distress) and relationship outcomes (emotional intimacy, 
sexual communication, relationship quality), and patient psychosocial outcomes (body image distress, psychological 
distress. These measures are included in the Self-Report Materials in the Appendix. 
4.4.2.3 Feasibility (Aim 1) will be measured through study accrual, attrition, and session completion. Participants will 
also complete a measure of adherence to study recommendations or review of materials taught within sessions in both 
conditions through the web portal immediately prior to sessions 2-4 (Materials Review Form; See Self-Report Materials 
in Appendix) that will help us assess the extent to which engagement in study activities was feasible, while also serving 
as a potential mediator of change. Couples will be instructed to complete these independently using online survey links. 
This survey is the same for participants in both conditions and thus does not assess intervention-specific skills or 
information.  
4.4.2.4 Acceptability (Aim 1) will be assessed with the post-intervention assessment through the Client Satisfaction 
Questionnaire-8 item version (CSQ-8),57  a validated measure that elicits the client’s perspective on the value of services 
received. Participants in both conditions will complete the CSQ-8. For comparability with the prior pilot studies, all 
participants will complete items used in those trials that capture ease of participation, relevance, helpfulness of the 
intervention, and therapist rapport. In addition, IE participants will be asked about their preferences regarding attending 
a follow-up “booster” session at the end of the four telephone sessions, which may be implemented in future larger 
trials using this intervention.  Going forward, IE participants will be asked these items as part of the post-treatment 
assessment. IE participants who have already completed the post-treatment assessment will be contacted by the study 
team to assess their preferences for a follow-up session. Finally, those assigned to the IE condition will complete items 
assessing the ease and frequency of use, and helpfulness of skills taught in the intervention (e.g., communication; See 
Self-Report Materials in Appendix).41  
Table 3. Outcome Measures 
 
 
 
 
 
 
 
 
Measure  
Construct 
# Items Baseline Session 
1 
Session 
2 
Session 
3 
Session 
4 
Post-
Treatment 
Patient and Partner Sexual QOL 
Outcomes 
 
 
 
 
 
 
 
 
Female Sexual Function Index (FSFI)*58,59 
International Index of Erectile Function 
(IIEF)60 
Sexual function 19/15 
X 
 
 
 
 
X 

Principal Investigator: Jennifer B. Reese 
Abbreviated Title: Intimacy Enhancement Pilot Study  
IRB #15-8007 
Page 12 of 26 
 
PROMIS Sexual Satisfaction Items61 
Sexual 
satisfaction 
5 
X 
 
 
 
 
X 
Female Sexual Distress Scale-Revised* 
(FSDS-R)62 
Sexual distress  13 
X 
 
 
 
 
X 
PAIR Sexual Intimacy Subscale63 
Sexual Intimacy 6 
X 
 
 
 
 
X 
Beliefs (self-efficacy)64,65 
Self-efficacy 
3 
X 
 
 
 
 
X 
Intimate Activities and Use of Sexual Aids 
(PROMIS Items)27,61* 
Frequency of 
sexual 
activity/use of 
aids 
8 
X 
 
 
 
 
X 
Patient and Partner Relationship 
Outcomes 
 
 
 
 
 
 
 
 
PAIR Emotional Intimacy Scale63 
Emotional 
Intimacy  
6 
X 
 
 
 
 
X 
Dyadic Sexual Communication Scale 
(DSCS)66 
Sexual 
communication  
13 
X 
 
 
 
 
X 
Dyadic Adjustment Scale-7 item (DAS-7)  Relationship 
quality 
7 
X 
 
 
 
 
X 
Patient Psychosocial Outcomes – 
ONLY COMPLETED BY PATIENT 
 
 
 
 
 
 
 
 
Body Image Scale (BIS)67 
Body image 
distress 
10 
X 
 
 
 
 
X 
Patient Health Questionnaire-9 item 
(PHQ-9)68  
Distress 
(depression)  
9 
X 
 
 
 
 
X 
Generalized Anxiety Disorder 7-item 
(GAD-7)69  
Distress 
(anxiety) 
7 
X 
 
 
 
 
X 
Additional Items Completed by 
Patients/Partners 
 
 
 
 
 
 
 
 
Baseline demographic information for 
patient/partner 
Demographic 
data 
12/7 
X 
 
 
 
 
 
Post-treatment demographic items 
Demographic 
data 
2 
 
 
 
 
 
X 
Charlson Comorbidity Index55 
Medical 
comorbidity 
11 
X 
 
 
 
 
 
Impact of Events Scale52 
Cancer-Specific 
Distress 
22 
X 
 
 
 
 
X 
Sexual Self-View (importance of sexuality 
to self) 
Sexual self-view 2 
X 
 
 
 
 
X 
Total # of items in baseline scales 
   Patients 
   Partners 
 
153 
95 
 
 
 
 
 
 
 
Intervention Process Forms (completed 
individually) 
 
 
 
 
 
 
 
 
Program Evaluation Form 
Credibility 
7 
 
X 
 
 
 
 
Materials Review Form 
Adherence 
7 
 
 
X 
X 
X 
 
CSQ-857   
Acceptability 
8 
 
 
 
 
 
X 
Additional Acceptability Questions64,65 
Acceptability 
18 
 
 
 
 
 
X 
Skills Assessment**64,65  
Utilization of 
skills 
3 
 
 
 
 
 
X 
Additional Information Completed by 
Patients 
 
 
 
 
 
 
 
 
Post-treatment demographic information 
Demographic/ 
medical data 
2 
 
 
 
 
 
X 
Total # of items in post-treatment scales 
   Patients 
 
169 
 
 
 
 
 
 
 

Principal Investigator: Jennifer B. Reese 
Abbreviated Title: Intimacy Enhancement Pilot Study  
IRB #15-8007 
Page 13 of 26 
 
   Partners 
118 
* indicates that patients only complete this 
measure 
** indicates that only IE participants 
complete this measure 
 
 
 
 
 
 
 
 
4.4.3 Self-Report Data Collection (Aim 2) 
All data collected from participants in Aim 2 (developmental survey study) will be collected using the Developmental 
Survey (See Developmental Aim Draft Survey in Appendix), which will be administered verbally, rather than by the 
patients and is thus in an interview style, or over the web. This survey collects information on patients’ reasons for lack 
of interest in participating, preferences for resources or programs addressing sexual/intimacy concerns, and 
race/ethnicity. More information about this survey can be found in section 4.7. In addition, if patients endorse the item 
from the screening script with regard to keeping their information from the screening, we will enter these information 
(e.g., age, breast cancer data) into our de-identified research files for further descriptive information about this sub-
sample.  
4.5.1 Overview of Randomization and Intervention Conditions (Aim 1) 
Couples will be randomized with an allocation ratio of 2:1 to either the IE or the Educational Control (Living Healthy 
Together) condition, in order to maximize data generated on the active condition, with stratification by age at diagnosis 
(< 45 vs. > 45) using the age obtained by patients during the screening. Because of the broad intimacy targets of this 
intervention, outcomes may not differ by menopausal status and therefore we will not stratify by this variable. However, 
because sexual function can differ by menopausal status, we will investigate menopausal status as a possible moderator 
of outcome in the intervention group for future research. 
Randomization will occur once both members of the couple have consented, completed baseline surveys, and are 
scheduled for their first intervention session. At this time, the couple will be sent sealed study materials along with the 
instructions to leave the envelopes sealed until they “meet” with their interventionist for session 1. It is important to 
keep the study condition a secret from participants until Session 1 to reduce the chances for unequal drop-out prior to 
Session 1, which could occur if patients/partners are more motivated to attend sessions in one study group as opposed 
to the other.  
4.5.1.2 Interventionists (Aim 1) 
All sessions will be conducted by an experienced and trained counselor. The interventionists have Master’s degrees or 
above (doctorate) in social work or counseling/psychology and are either licensed to engage in clinical services  or have 
equivalent educational background and/or experience. Interventionists also have years of relevant clinical experience 
including conducting CBT. Some of the current interventionists have also had experience conducting couple therapy 
sessions on Sharon Manne’s couple-based studies and are thus familiar with utilizing intervention manuals in conducting 
interventions as part of a research study.  Interventionists will be trained to deliver both types of intervention sessions 
through an in-person training workshop or viewing a recording of the in-person training workshop that will include 
review of couple therapy approaches and about the topic area, review of study intervention manual and patient 
handouts, and interactive role plays with feedback. The precise content of each interventionist’s training procedures 
could differ slightly depending on their prior experience and comfort with the material. Interventionists may also listen 
to session recordings as a part of their training. All interventionists will be certified by the PI as adequately trained prior 
to scheduling them for sessions with intervention participants.  Regular supervision sessions among the interventionists 
led by Dr. Reese, the PI and developer of the IE intervention, will be held to ensure adequate quality of the delivered 
interventions. All supervision sessions are confidential; no identifiable information about participants is retained in 
supervision records. The quality assurance procedures regarding the delivery of the intervention are described further in 
section 16.0. 

Principal Investigator: Jennifer B. Reese 
Abbreviated Title: Intimacy Enhancement Pilot Study  
IRB #15-8007 
Page 14 of 26 
 
4.5.1.3 Intervention Format (Aim 1) 
All sessions will be delivered over the telephone. In our prior work, participants found the telephone-based format 
desirable for addressing the intimate topic of sexuality and many preferred it over face-to-face.64 This format is also 
well-suited to reach post-treatment and long-term breast cancer survivors, who report the greatest interest in obtaining 
help for their sexual concerns,70 and to whom eligibility for this study is limited. Audio calls will be made using Skype (not 
video calls), cell phone, or landline service to the couple’s preferred mobile or landline phone (no Skype username or 
subscriptions needed for couples) using speakerphone. All sessions will be recorded, and these audio recordings 
destroyed when the study is completed.  
4.5.2 Intimacy Enhancement (IE) Intervention (Aim 1). The proposed IE intervention content is outlined in Table 5 (See 
Appendix for a draft outline of the intervention)41,49 and includes four structured sessions. A couple-based intervention is 
ideal for breast cancer survivors because most survivors want to address their sexual concerns in a couple-based 
format25 and because couple-based interventions are more effective at improving sexual outcomes in this 
population.30,71 The first session is intended to be longer (approximately 75 minutes) because of the nature of the first 
session as involving rapport-building, information gathering, and providing education. Subsequent sessions will last 
approximately 60 minutes.  
The IE intervention includes both educational content and cognitive and behavioral skills training with the aim of 
reducing sexual distress and avoidance, increasing coping skills of both patients and partners, and improving physical 
and emotional intimacy. A unique feature of this intervention is that it addresses a range of both physical and emotional 
intimacy targets, such as loss of sexual interest and activity, and behavioral couple-based skills to adjust to sexual 
changes (e.g., sensual touching). Such skills are critical elements of successful programs addressing sexual concerns for 
breast cancer survivors71 and Dr. Reese has published previously on an Intimacy Enhancement intervention teaching 
these skills.64,65 Techniques are also included from (a) sex therapy, including sensate focus (sensual touching exercises),72 
(b) couple therapy (e.g., communication skills),73 and (c) cognitive behavioral therapy (e.g., restructuring 
negative/inflexible thoughts).51,74A cornerstone of the IE intervention is an approach to coping with sexual difficulties 
proposed previously by the PI that emphasizes flexibility in thoughts and behaviors.51 Participant handouts will reinforce 
educational topics, provide opportunities for interactive exercises, or otherwise reinforce skills learned during the 
sessions. Weekly home behavioral skills practice are reviewed at the beginning of each session, including proceeding 
through a stepped set of sensate focus exercises with the goal of reducing avoidance of sensual behaviors and increasing 
intimacy.  
4.5.3 Educational Control Condition (Aim 1). The Educational Control condition (called Living Healthy Together or LHT) is 
a stringent control condition which equates with the active condition for time and attention from a therapist, and 
Table 5. Proposed content of IE Intervention   
Session 
Topic 
Education Topics 
Skills 
Home practice 
1  
(75 min) 
Understanding 
Impact of BC on 
Sex and Intimacy 
1. Models of female sexual function 
2. Effects of BC on sex and intimacy 
3. Identify and normalize problems 
4. Introduce sensate focus 
1. Goal-setting  
2. Behavioral physical intimacy coping  
3. Coping with sexual difficulties 
1. Read educational 
material 
2. Sensate focus  
2  
(60 min) 
Communication 
about Sex/ 
Intimacy 
1. Effective communication 
2. Communicating about intimacy 
3. Feedback on in vivo practice 
1. Communication 
2. Behavioral physical intimacy coping 
1. Communication 
practice 
2. Sensate focus  
3  
(60 min) 
Problem-solving 
and Changing 
Thoughts 
1. Impact of BC on body image 
2. Using problem-solving vs acceptance 
3. Current physical/medical treatments  
4. Model of cognitions and intimacy 
5. Broadening range of intimate activities 
1. Identify/restructure inflexible thoughts 
2. Emotional intimacy through 
engagement in activities 
3. Coping with sexual difficulties 
4. Behavioral physical intimacy coping 
1. Novel intimate activity 
2. Sensate focus  
4  
(60 min) 
Planning Ahead 
and Preparing for 
Challenges 
1. Review of skills and education 
2. Evaluate progress toward goals 
3. Plan for continued skill practice  
4. Anticipate/ plan for challenges 
1. Goal-setting 
2. Behavioral physical intimacy coping 
1. Complete post-
intervention measures 

Principal Investigator: Jennifer B. Reese 
Abbreviated Title: Intimacy Enhancement Pilot Study  
IRB #15-8007 
Page 15 of 26 
 
receiving education from a credible source. However, in contrast with the IE condition, LHT focuses on education and 
support rather than skills training (See Appendix for outline) and it also does not include specific education on sexuality 
or intimacy. Like the IE condition, the LHT condition follows a structured outline for each session though the discussions 
can depend on participants’ interests and the sessions are designed to last as long as IE sessions.  
Topics to be discussed include breast cancer and its treatments (e.g., staging, common treatments, side effects), sleep 
and energy, stress and stress management, nutrition/diet. All of these topics are relevant to sexual function75  and 
therefore make up an appropriate and highly credible control condition for patients screened for sexual concerns. Unlike 
in the IE condition, participants in LHT will not be explicitly encouraged to engage in particular activities or management 
strategies but rather will be encouraged to read the materials given to them provided at each session. Their engagement 
with the material will be assessed at each session using the Materials Review Form, just as in the IE condition.  
4.6 Time Commitment for Participants (Aim 1) 
On average, we anticipate that participants will take about 6 weeks to complete the study from consent to post-
treatment assessment. Baseline and post-treatment surveys will take approximately 30-45 minutes to complete. We 
expect that consent will occur no more than 2 weeks prior to the initiation of the first intervention session, although 
participants can begin participation in the intervention as soon as both members of the couple complete the baseline 
survey. The intervention sessions are intended to be delivered at weekly intervals, however, realizing that patient and 
partner health or other circumstances may arise that can delay sessions, we will allow for the four sessions to be 
completed within 12 weeks (from the start of the first session). Completion of the post-treatment survey by both 
members of the couple should occur 2-7 days after completing the last intervention session (but if they need more time 
to complete it, we will allow this). Thus, the minimum study duration would be approximately 5 weeks, and the 
maximum study duration would be approximately 14 weeks.  
 
4.7 Developmental Survey (Aim 2) Procedures 
 
Eligible patients who refuse the pilot trial will be given the opportunity to participate in the research (Aim 2) by engaging 
in a brief telephone survey (or in-person,  or over the web, depending on the method of recruitment) assessing their 
reasons for not participating and preferences for interventions addressing sexual concerns (See Developmental Aim 
Draft Survey in Appendix).  
 
The administration of this survey will likely occur at the time of screening but may occur at a later time if necessary (but 
no later than one month post-screening, if a patient is willing but unable to complete the survey at the time of 
screening). This survey will be administered only once and contains 8 items. Questions assess patients’ reasons for non-
participation in the intervention study, about intervention preferences, and about preferences for resources, as well as 
two questions on race/ethnicity. If administered through the web, the recruiter will send the patient a link for 
completing the online survey and the items will be identical regardless of the format. 
 
Patients will be asked the survey questions privately; if necessary, partners will be asked to leave the room to ensure 
patient privacy. This is particularly important because one item specifically asks whether the patient would like the 
partner included in programs. If the patient does not want to be interviewed alone, we will not proceed.  
 
The time commitment for participants in Aim 2 is approximately 10 minutes. 
5.0 Risks to Participants 
The major risks for study subjects are (1) discomfort at answering study questions during the focus group, on surveys, or 
during intervention sessions and (2) loss of privacy or confidentiality. Due to the protections we will have in place, we 
believe these risks to be minimal. Additionally, there is some risk that couples in Aim 1 who are distressed may 

Principal Investigator: Jennifer B. Reese 
Abbreviated Title: Intimacy Enhancement Pilot Study  
IRB #15-8007 
Page 16 of 26 
 
experience additional distress during intervention discussions about sensitive topics. Based on our previous experience 
with couple-based interventions, we expect this risk to be minimal.  
We are concerned with ensuring that study questions pertaining to sexuality are handled in a sensitive manner. We have 
chosen standardized sexuality assessment tools that have been widely used and validated to every extent possible, and 
have made every attempt to ensure that the sexuality items used in the current study are minimally intrusive and 
appropriate.  If patients do not want to answer the screening question assessing their degree of sexual concerns or 
discuss this topic further, they may choose not to answer this question and not to participate in the study. They will also 
be informed as to the nature of the items in the study that will be asked of them, and will be assured in the consent 
forms that they do not have to answer any questions that make them uncomfortable. We will make it clear that whether 
or not they answer the screening items or agree to participate in the research study will not affect their care. 
6.0 Potential Benefits to Participants 
While we hope that the Intimacy Enhancement intervention will benefit patients and partners, there may be no direct 
benefit to the study participants. It is possible that the Intimacy Enhancement intervention may address patients’ sexual 
concerns and therefore have a beneficial effect on patient and partner sexual quality of life outcomes, relationship 
outcomes, and on patient psychosocial outcomes. Couples in the Educational Control condition may also benefit from 
having the support of a professional for an equivalent length of time and from the educational material provided. 
Findings from the pilot trial will inform the design of a larger multi-site trial which has the potential to improve patient 
health and quality of life, once disseminated. Findings from the developmental aim may inform future research on 
interventions that may be well-suited to addressing the sexual concerns of a large number of breast cancer survivors. 
The minimal risks to subjects are reasonable in relation to potential benefit in improving the health and quality of life of 
women with breast cancer, especially in light of the dearth of available evidence-based interventions addressing sexual 
concerns for this population. 
7.0 Provisions to Maintain the Confidentiality of Data 
7.1. General Provisions to Maintain the Confidentiality of Data 
In order to minimize the risks associated with discomfort in answering questions, participants will be told that they do 
not have to answer any research questions and that, if they change their mind about participating, they can stop at any 
time. All information collected for this study will be kept confidential.  Subjects will be told that all information will be 
kept in strict confidence.  All patient discussions about the study and training sessions will occur in private areas or over 
the telephone.  
 
In order to minimize the risks associated with loss of confidentiality, all patient data (including audio recordings of 
intervention sessions) will be kept confidential and secure, will be de-identified for analytic purposes, and none of the 
patients’ information will be released to their physician, health care organization, or any other third party without the 
patient’s permission, except as required by law. All computer files with patient or provider data will be password 
protected with access restricted to study investigators, and all data forms will be kept in locked cabinets. The file that 
links subject names to identifying numbers will not be kept with the data, and will not leave the institution.  
 
We will use RedCap to capture patient/partner outcome data, which is a secure, web-based application that supports 
easy data manipulation with audit trails and reporting capabilities, including automated export to SPSS (which we will 
use to maintain outcome data, in a de-identified data set), which we will use. Data that are exported to SPSS are de-
identified. REDCap was developed around HIPAA-Security guidelines, and all web-based information transmissions are 
encrypted. All data will be stored on a server maintained by the FCCC Information Systems and Technology Department 
in a secure data center. The server is backed up to tape on a daily basis and is protected from inappropriate outside 
access by commercial grade firewalls.  
 

Principal Investigator: Jennifer B. Reese 
Abbreviated Title: Intimacy Enhancement Pilot Study  
IRB #15-8007 
Page 17 of 26 
 
All audio recordings of intervention sessions will be destroyed when the study is complete. RedCap data storage is 
HIPAA-compliant with efforts to keep patient data confidential; data that are exported from RedCap for analytic 
purposes are de-identified prior to export. 
8.0 Costs to Participants 
There are no costs to participants for their participation in the study.  
9.0 Consent Process 
9.1. Overview of Consent Processes  
If a participant consents to participate in Aim 1, the couple-based intervention study, they are consenting to completing 
survey data online about their physical, sexual, and emotional health, to allow us to obtain limited medical data from 
their medical records, and to participating in telephone sessions with their partners that either address intimacy 
concerns or that deal with healthy living topics, as well as completing surveys about their participation in the 
interventions.  
Those who participate in Aim 2 are consenting to providing information about their reasons for lack of participation and 
intervention preferences on a brief survey interview.  
9.1.1. Consent Process for Aim 1 
 
First, the recruiter or study team member will engage in a discussion with candidates (both patients and partners) with 
respect to the study procedures, risks, and benefits. This will generally occur during the screening process.  Once 
candidates indicate their intent to participate and an adequate understanding of the study procedures, as judged by the 
recruiter, the recruiter will give them instructions regarding how to consent using the web-based consent process and 
for completing the consent and surveys. They will be given the chance to ask questions during these verbal 
conversations, as well as the PI’s information should they require it before moving to the next step in this process.  
 
Next, as mentioned above, patients and partners will be sent a link (one for patients, one for partners) which they will 
use at home in order to complete the consent process. Completion of the consent is necessary prior to having access to 
the online survey. The consent form also contains a question in which the participant can indicate that he or she is 
willing or not willing to be contacted directly about similar studies in the future. It is clear that the participant can 
participate in the current study regardless of his/her response to this item. 
 
If patients and/or partners are unable to complete the consent process online, they will be given the option to complete 
a written consent form either through the mail or in person. If necessary, we will send self-addressed stamped return 
envelopes for the return of these consents along with paper and pencil surveys (if necessary), and will return signed 
copies to the couple.  
 
In order to reduce the likelihood that web-based survey completion will lead to attrition, as can occur when the consent 
process takes place outside of an in-person clinic situation, the study team will engage in several reminder calls to the 
patient and/or partner to assist with completion (approximately 3 but no more than 6). These may include phone calls 
by the PI or recruiter, and email reminders, as well as attempting to set up an “appointment” with the patient and/or 
partner for consent and survey completion.  Once the reminders have reached the maximum, we will cease to contact 
the patient or partner about the study and will note this in our files.  
 
Once both members of the couple have completed consent, the couple is considered to be enrolled. If only one member 
of the couple completes consent and the other decides not to participate, this couple is not enrolled because only 
couples can participate in this intervention study.  
 

Principal Investigator: Jennifer B. Reese 
Abbreviated Title: Intimacy Enhancement Pilot Study  
IRB #15-8007 
Page 18 of 26 
 
Only English speaking patients will be enrolled.  Children will not be enrolled in this study. 
 
9.1.2 Consent Process for Aim 2  
 
After screening and refusal of the pilot trial, as documented on the patient screening script, using a brief IRB-approved 
oral consent process by a recruiter/research coordinator, the participant will be given information about the voluntary 
nature of the study, their ability to stop at any time, and study risks and benefits (see Developmental Aim Consent Script 
in Appendix).  
 
For the following reasons, we have submitted a Request for Waiver of Documentation of Informed Consent form 45 CFR 
46.117(c)(1)(2): 1) The research is not subject to FDA regulations; 2) the research involves no more than minimal risk or 
harm to participants; and 3) the research involves no procedures for which written consent is normally required outside 
of a research setting.  
 
Patients who agree to this brief study will be given a written print-out of the written oral consent document 
(distinguished from the oral consent script), either in person, if they are recruited in person, or they will be sent this 
through the mail if they have been recruited over the telephone. Oral consent will be obtained irrespective of the 
method of recruiting. The person obtaining the consent shall sign and date the consent script as a record that the oral 
consent discussion occurred. 
 
10.0 Off-Study Criteria 
Any participant may leave the study at any time due to distress or other reasons. We do not have a priori reasons for 
letting participants off the study. An exception would be if a patient or partner experiences significant psychological or 
marital distress during the study such that it is deemed detrimental for them to continue in our study at the expense of 
receiving psychological or mental health services. If this happens, we will follow the procedures listed below for Adverse 
Event reporting, and will recommend that the couple not continue in this study but rather receive appropriate referrals, 
as described below in section 15.0. We will track such events, as described below, and we expect them to be extremely 
rare. 
 
In the case of attrition after randomization to either intervention, the participant and his or her partner may be asked if 
they would be willing to remain in the study for data collection in four weeks which will enable us to conduct intent-to 
treat analyses (or the length of time that would coincide with the end of their treatment sessions).  
 
If a patient’s disease recurs or needs to start active treatment during the study, they will be allowed to remain on the 
study, if they choose, and this information will be tracked in their research files pertaining to their medical records. 
Because the duration of the study involvement is relatively brief, we expect these circumstances to be infrequent. 
11.0 Drugs and Devices 
Not applicable. 
12.0 Multi-Site Research Study 
Not applicable. 
13.0 Statistical Analysis 
13.1. Statistical Analyses for Aim 1 
13.1.1. Primary and Secondary Outcome Variables 

Principal Investigator: Jennifer B. Reese 
Abbreviated Title: Intimacy Enhancement Pilot Study  
IRB #15-8007 
Page 19 of 26 
 
13.1.1.1. Primary outcomes are feasibility and acceptability of the study. Feasibility will be measured through study 
accrual, attrition, and session completion. Acceptability is measured using the CSQ-8 (See Self-report Materials in 
Appendix).  
  
13.1.1.2. Secondary outcomes are preliminary efficacy of the study in patient and partner sexual outcomes (sexual 
function, sexual satisfaction and intimacy, sexual distress), patient and partner relationship outcomes (emotional 
intimacy, sexual communication, relationship quality), and patient psychosocial outcomes (body image distress, 
psychological distress). The measures assessing these outcomes can be found in Table 3 above.  
13.1.2. Analyses 
13.1.2.1. Feasibility. Analyses will be descriptive. We aim for accrual at a rate of 30% to match our prior study,42 but a 
rate over 20% will be acceptable. Attrition at levels greater than those found by similar studies47 (e.g., 30%) will be 
considered unfeasible. 80% of participants completing the 4 sessions is considered adequate.  
13.1.2.2. Acceptability. Analyses will be descriptive. Adequate acceptability of the study will be indicated by a group 
median score > 28 on the CSQ-8,76 representing a fairly high score across a range of studies, including a behavioral 
marital therapy randomized controlled trial.77  
13.1.2.3. Preliminary efficacy. Preliminary efficacy of the IE intervention on patient and partner sexual outcomes, 
patient and partner relationship outcomes, and patient psychosocial outcomes will be established using an effect size 
calculation method that is appropriate for small sample sizes34 that our team has employed previously.34,49 First, pre-
post changes scores are calculated for each participant. Second, the between-group effect size is calculated by 
subtracting the mean control group change score from the mean IE group change score. This difference is then divided 
by the standard deviation of the pooled change score. Given that multilevel dyadic analyses are questionable in small 
sample sizes,78 we will consider dyadic analyses, including actor-partner effects,79 in the planned R01.  
Because our primary goal through the analyses for this aim is to generate effect sizes for a larger planned study, we will 
conduct the analyses described above using data from study completers. However, we will also attempt to obtain post-
treatment surveys even for couples who have dropped out of the study during the intervention phase, to allow us to 
conduct intent-to-treat analyses. Patients without any post-treatment data will have baseline data used in these 
analyses. 
13.2. Statistical Analyses for Aim 2 
13.2.1. Primary Outcomes  
The primary outcomes from the intervention refuser surveys are the candidates’ responses regarding barriers/reasons 
for choosing not to participate and preferences for resources or interventions. Analyses of responses will focus on 
identifying the areas for consideration in future intervention development and will be descriptive in nature.  
13.2.2. Secondary Outcomes 
There are no secondary outcomes. 
13.2.3. Analyses 
Analyses of responses will focus on identifying the areas for consideration in future intervention development. We will 
conduct descriptive analyses such as measures of central tendency when possible from numerical responses (i.e., 
frequencies, means, standard deviations). Open-ended responses will be analyzed qualitatively and descriptively when 
possible (e.g., frequency of certain responses). 
13.2.4. Sample Size Calculations 

Principal Investigator: Jennifer B. Reese 
Abbreviated Title: Intimacy Enhancement Pilot Study  
IRB #15-8007 
Page 20 of 26 
 
The objective of this study is to pilot test the newly adapted Intimacy Enhancement study and to allow us to calculate 
effect sizes that will inform a larger R01 trial that is expected to follow from this study. We selected 30 couples to 
participate in this trial because it is a large enough sample to provide ample pilot data while maintaining adequate 
feasibility in the time allotted. Further, we have chosen a 2:1 allocation to the Intimacy Enhancement condition, which 
allows us to gather greater information from participants in this condition, our primary interest, relative to the Couple 
Education condition.   
14.0. Data Safety Monitoring Plan 
The PI will take responsibility for monitoring the safety of all phases of the research study. The research assistant will 
contain the contact information for the PI and the Institutional Review Board (IRB). A DSMB is not required for the 
current study. 
15.0. Adverse Event Reporting 
Because of the nature of the research as involving procedures without significant risk (e.g., surveys; telephone 
discussions) there are unlikely to be any serious adverse events and adverse events are likely to be rare.  Possible risks 
include feeling worried, anxious, or concerned during questionnaire completion or during the intervention sessions. 
Adverse events include significant distress or psychological reactions experienced during the study procedures (e.g., in 
the case of severe untreated depression, suicidal intent, or extreme marital conflict). A mild emotional reaction to 
discussions during the intervention by the patient or partner (e.g., tearfulness) is a very common reaction to the nature 
of the issues discussed during a cancer-related intervention, and would therefore not be considered an adverse event. 
Minor experiences of boredom, fatigue or discomfort during survey completion are also generally not considered to be 
adverse events.  All participants are informed of the very minor risks of psychological reactions possibly associated with 
participating in the study during the informed consent process.  
           
Any unexpected or adverse event that occurs during data collection or study procedures is reported immediately to the 
Principal Investigator, who is responsible for documenting all adverse events with the FCCC IRB within 24 hours. The 
research study team will bring any questionable adverse events to the attention of the Principle Investigator, and 
discussions will include colleagues or members of the IRB if it is unclear whether an event qualifies as an adverse event. 
For participants who are experiencing significant psychological distress reactions that warrant referrals to appropriate 
psychological services, the study team member or research assistant alerts the Principal Investigator, who would provide 
the participant with a referral to appropriate services. At FCCC counselors in the Department of Social Work are trained 
to provide psychological support services or to make specific referrals to other psychological counseling or psychiatric 
services in the area as needed. Moreover, participants experiencing relationship distress extreme enough that 
continuation in the study is contraindicated will be referred to appropriate marital or couple therapists if necessary and 
recommended to discontinue participation in the study, as previously described.  
 
The research team will keep a log tracking the number, nature, and frequency of adverse events as part of each phase of 
the research plan. In accordance with FCCC guidelines, this protocol will employ the following mechanisms for adverse 
event reporting: 1) alert the FCCC review committees of any and all reports of adverse events; 2) inform all members of 
the study team of any all reports of adverse events.  If 3 or more adverse events are reported, the study team will assess 
potential causes of the adverse events and, if events are clearly linked to study participation, discontinue the study.  
16.0. Quality Assurance Procedures and Participant Confidentiality 
16.1. Overview of Quality Assurance Procedures 
 
We have a number of features in place to ensure a high level of quality in our intervention study.  
 
First, we are using a randomization procedure and a stringent control condition that equates for therapist time and 
attention. Second, we will assess patient and partner intervention credibility to determine whether credibility of both 

Principal Investigator: Jennifer B. Reese 
Abbreviated Title: Intimacy Enhancement Pilot Study  
IRB #15-8007 
Page 21 of 26 
 
conditions is equivalent (see 16.1.1 for further explanation). Third, we are employing a manualized approach to 
treatment, in which all interventionists will use the manual to deliver both intervention conditions. Adherence to the 
manual will be assessed using the procedure described below in section 16.1.2. Fourth, the PI will not be involved in any 
assessment procedures to ensure adequate blinding; similarly, the interventionists will advise participants explicitly not 
to share their responses to credibility items (Program Evaluation Form) or the Materials Review (e.g., homework 
completion) with the interventionists (See Self-Report Materials in Appendix) which could bias participant reports. 
Interventionists must know which condition participants are receiving because they themselves deliver them (and in this 
way, cannot be truly blinded like with a placebo drug study). However, in the training of interventionists, we will 
emphasize that both conditions are likely to be perceived as helpful by participants and will call the conditions by their 
names (Intimacy Enhancement; Living Healthy Together) as opposed to “active condition” and “control condition”, thus 
attempting to reduce interventionist bias in favor of the active condition. Fifth, the intervention sessions will be 
delivered by experienced interventionists with a minimum of a Master’s degree in a mental health profession (e.g., 
social work) who have experience in counseling, and preferably with experience in delivering manualized individual or 
couple-based interventions, thus ensuring a high level of experience and training in the interventionists delivering the 
interventions (see more detailed descriptions of the backgrounds of interventions in the Interventionists section 
(4.5.1.2). Finally, all interventionists will be trained to deliver both interventions (Intimacy Enhancement; Living Healthy 
Together). Interventionists will be trained by the PI and allowed to begin delivering sessions only once approved by the 
PI. Training will include role plays of these sessions to ensure that the interventionists have had a chance for skills 
practice and feedback prior to leading sessions. Regular supervision sessions among the interventionists with the PI will 
be held once the interventionists have begun to lead sessions with couples and will ensure a forum for ongoing 
discussion of cases, solving problems or answering questions about delivery of the intervention, and to reinforce use of 
the intervention manuals.  
 
16.1.1. Intervention Credibility. Intervention credibility refers to the extent to which the intervention conditions are 
both perceived as by participants as credible and likely to be helpful. Participants will complete an 8-item Program 
Evaluation Form adapted from those used in other randomized controlled trials conducted by the PI and her colleagues 
to assess credibility immediately following session 1 through RedCap (See Self-Report Materials in Appendix), separately 
by patients and partners using online links. They will be instructed by the interventionists not to share any of their 
responses with the interventionist. Data from this form will be analyzed after overall study data collection is completed 
to compare the credibility across the groups.  
 
16.1.2. Intervention Adherence. Adherence refers to the extent to which the interventionist delivers the intervention 
according to the intervention manuals. This differs from unstructured psychotherapy, and allows us to have faith that 
the interventions we intend to deliver are, in fact, delivered by interventionists as well as being replicable in future 
studies. Telephone sessions will be audio-recorded. A reviewer with familiarity with the material (e.g., the PI, Laura 
Porter, a consultant and expert in couple-based interventions) will listen to a random sample of 15-20% of cases and 
evaluate the adherence of the interventionist to the manual using the session checklists as a guide. Adherence to 
session checklists >85% will be considered satisfactory. In addition to the independent reviewer sessions may also be 
listened to by members of the study team or consultants for educational or training purposes.  
 
16.2. Participant Confidentiality. Information about study subjects will be kept confidential and managed according to 
the requirements of the Health Insurance Portability and Accountability Act of 1996 (HIPAA). Those regulations required 
a signed subject authorization informing the subject of the following: The protected health information (PHI) that will be 
collected from patient; who will have access to that information and why; who will use or disclose that information; the 
rights of a research subject to revoke their authorization or use their PHI. In the event that a participant revokes 
authorization to collect or use PHI, the investigator, by regulation, retains the ability to use all information prior to the 
revocation of subject authorization.  To ensure confidentiality identifiers will be recorded and used with electronic data 
collected and all records will be secured in a locked location. 

Principal Investigator: Jennifer B. Reese 
Abbreviated Title: Intimacy Enhancement Pilot Study  
IRB #15-8007 
Page 22 of 26 
 
17.0. Participant Informed Consent 
See Informed Consent documents 

Principal Investigator: Jennifer B. Reese 
Abbreviated Title: Intimacy Enhancement Pilot Study  
IRB #15-8007 
Page 23 of 26 
 
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IRB #15-8007 
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19.0. Appendices 
 
Consent Forms 
o Web-based version of Aim 1 Consent 
o Paper version of Aim 1 Consent 
o Aim 2 Developmental Survey Consent Script 
o Aim 2 Developmental Survey Written Consent Document  
o Request for Waiver of Documentation of Consent (for Aim 2)  
 
Surveys or Data Collection Tools 
o Self-Report Materials 
o Developmental Survey 
o Medical Records Data Collection Form 
 
Recruitment Materials 
o Study Brochure 
o Study Flyer 
o Patient Recruitment Screening Script 
o Partner Recruitment Introductory Script 
o Study Introductory Letter 
 
Intervention Content 
o Intimacy Enhancement Outline 
o Living Healthy Together Outline