Innovations in the Treatment of Sexual Dysfunction and Couple Intimacy After Prostate Cancer: A Randomized Trial of Mindfulness Versus Cognitive Behavioural Therapy
Phase: NA
Conditions: Prostate Cancer, Sexual Dysfunctions, Psychological, Sexual Dysfunction, Physiological, Sexual Dysfunction Male, Relationships, Marital, Prostatic Neoplasms
Sponsor: University of British Columbia

INTROSPPECT Study | Study Protocol V6  Aug 1, 2018                                                                      | 1 of 21 
 
STUDY PROTOCOL 
 
 
 
 
 
 
 
Innovations in the treatment of sexual dysfunction and couple intimacy after 
prostate cancer: A randomized clinical trial of mindfulness versus cognitive 
behavioural therapy 
 
Study nickname: The INTROSPPECT Study (Innovations in the Treatment of 
Sexual Health Post Prostate Cancer Treatment) 
 
THE STUDY TEAM: 
Principal Investigator : 
 
Lori Brotto, PhD, R. Psych 
Department of Obstetrics and Gynaecology 
University of British Columbia 
[t]: 604-875-4111 ext. 68898 
 
 
Co-Investigators: 
 
 
Jennifer Bossio, PhD 
Department of Obstetrics and Gynaecology 
Department of Urological Science 
University of British Columbia 
[t] (604) 875 4111ext. 62338 
Julia O’Loughlin, MA 
Graduate Student 
Department of Obstetrics and Gynaecology 
University of British Columbia 
[t] (604) 875 4111ext. 62338 
Celestia Higano, MD 
Department of Urological Science 
University of British Columbia 
[t] (206) 288 1152 
 
Christine Zarowski, RN 
Department of Urological Science 
Vancouver General Hospital 
[t] 604-875-4328 
 
Phil Pollock, MRes 
Vancouver Prostate Centre 
Diamond Health Care Centre 
[t] (604) 875 4111 ext. 22946 
 
Larry Goldenberg, MD 
Department of Urological Science 
Vancouver General Hospital 
[t] (604) 875 4301 
 
Study Coordinator : 
 
Faith Miller 
Department of Obstetrics and Gynaecology 
Vancouver Prostate Centre 
University of British Columbia 
[t]: 604-875-4111 ext. 62338 
 
 
 
 

INTROSPPECT Study | Study Protocol V6  Aug 1, 2018                                                                      | 2 of 21 
 
BACKGROUND/RATIONALE 
 
SUPPORTIVE CARE NEEDS OF PROSTATE CANCER SURVIVORS 
 
 
One in every 8 men[1] are affected by prostate cancer (PC). As a result of 
advances in PC treatments, the 5-, 10-, and 15-year relative survival rates are 100%, 
98%, and 95% respectively[2]. However, despite advances in PC treatments, up to 90% 
of these men will experience significant side effects[1,3]. These side effects negatively 
impact patient and partner QoL[4-6], and for some men will impact their decision to 
undergo treatment at all[7-9]. With an aging population, numbers of men treated for and 
surviving PC are expected to rise[10], and as this number grows, so does the number of 
men needing supportive care.  
 
The top unmet supportive care need of PC survivors is around sexual health and 
intimacy[11-13]. All of the side effects of PC treatments are known to impact the sexual 
lives of men and their partners, including erectile dysfunction, climacturia (loss of urine 
with ejaculation), anorgasmia (inability to reach orgasm), urinary or fecal incontinence, 
penile shortening, and/or loss of sexual desire[1,3-6,8,12]. Following PC treatments, sexual 
functioning and satisfaction sharply decline[1,2,14]. The loss of sexual intimacy can be 
devastating for partners, relationship satisfaction, health outcomes, mental-health 
outcomes, and overall QoL[4-6]. 
 
To date, research has largely focused on improving erectile functioning in PC survivors, 
specifically, restoration of an erection sufficient for penetrative intercourse. Current 
guidelines recommend oral medication (i.e., PDE5 inhibitors) as front-line treatment[15]. 
However, PDE5i’s have variable effectiveness for PC survivors[1, 16], effectiveness 
decreases over time in 50% of men[17], failure rates have been noted as high as 80%, 
and the significant financial burden is a barrier for many men[18]. Across medical 
interventions for erectile function (PDE5i’s, penile injections, vacuum erection 
device[19]), uptake rates are low (50%)[19.20], and discontinuation rates are exceedingly 
high (50-61%) irrespective of treatment effectiveness[21-26]. Inconsistent efficacy and low 
adherence suggests that medical interventions aimed at erectile function alone are 
insufficient in meeting the needs of PC survivors, perhaps because they do not address 
psychosocial sequelae. Indeed, sexuality is a complex interplay of biological, 
psychological, and social factors, and current front-line interventions fail to address the 
broader scope of contributing factors. 
 
Over the past 10 years, psychosocial interventions aimed at improving sexual outcomes 
following PC treatments have been developed and tested. However, the efficacy of 
these interventions has fallen short of expectations: sexual functioning, intimacy, and 
relationship satisfaction are minimally improved[27,28]. We hypothesize that poor 
outcomes are due, at least in part, to the lack of evidence-based practices in existent 
psychosocial interventions for PC survivors. 
 
 
 
 

INTROSPPECT Study | Study Protocol V6  Aug 1, 2018                                                                      | 3 of 21 
 
 
MEETING PSYCHOSOCIAL NEEDS WITH EVIDENCE-BASED PRACTICE 
 
 
This research program focuses on an important gap in the field of PC, namely 
improving supportive care for sexual health, intimacy, and overall QoL for men and their 
partners following PC treatment. This study utilizes a randomized clinical trial (RCT) 
design to develop, assess, and compare two treatment groups using evidence-based 
psychological principles that have been shown to improve people’s sexual lives, and 
their ability to cope with a cancer diagnosis: mindfulness and cognitive behavioural 
therapy (CBT), as well as a control group.  
 
 
MINDFULNESS 
 
 
Mindfulness refers to non-judgemental present-moment awareness[30]. Efficacy 
of this treatment modality has been demonstrated in individuals with a variety of health-
related problems[31,32]. In samples of men with PC, mindfulness training improves 
psychological outcomes such as mood, QoL[33,34], and physiological variables, like 
immunological parameters[33]. Recent advances in sexual health research supports the 
benefits of mindfulness for women with a variety of sexual dysfunction, including low 
sexual desire, genital pain, and sexual dysfunction secondary to gynaecological 
cancer[30,35-37]. Mindfulness has also been used with couples who do not have cancer to 
improve intimacy[38]. Presently, members of our research team have developed a 
mindfulness-based treatment group to improve couples’ intimacy after PC. Preliminary 
data supports the feasibility of mindfulness for this population. Mindfulness is 
hypothesized to improve attentional focus, thus reducing distractions related to poor 
erectile functioning, body image, or distress from a cancer diagnosis/treatments, and in 
turn improve sexual and relationship outcomes. 
 
 
COGNITIVE BEHAVIOURAL THERAPY  
 
 
Cognitive behavioural therapy (CBT) is an evidence-based practice in which 
negative thought patterns are recognized and challenged in order to improve emotional 
or behavioural outcomes[39]. There is a great deal of empirical support for CBT as an 
effective intervention for mood, anxiety, and health concerns[40]. Some studies have 
demonstrated improvements in coping and pain[41] in cancer patients following CBT. 
Similar to mindfulness, there is evidence to suggest that CBT is effective in improving 
sexual outcomes for individuals[42,43] and couples[44] who do not have cancer. CBT is 
believed to be effective for sexual dysfunction as it teaches patients the tools to 
acknowledge and change maladaptive thoughts that can negatively impact sexual 
functioning and intimacy. 
 
 
CONTROL GROUP 
 
Participants who are randomized to the control group will not receive mindfulness 
or CBT treatment. They will proceed with whatever course of treatment they were 
receiving prior to enrollment in the study. As resources for couples dealing with changes 
to their sexual lives after prostate cancer are limited, we anticipate that the majority of 

INTROSPPECT Study | Study Protocol V6  Aug 1, 2018                                                                      | 4 of 21 
 
these patients will have no treatment targeting sexual intimacy during the 6-week period 
between completing the first and second questionnaire. 
 
 
 
ROLE OF PARTNERS IN PROSTATE CANCER 
 
 
Partners play a critical role in coping and QoL for men with PC[45-48], thus PC is 
widely considered a couple’s issue, and psychosocial interventions should treat it as 
such[45]. Partners improve PC survivors’ adherence to psychosocial interventions[49,50], 
which can otherwise be low[28]. Further, partners’ response to a PC diagnosis is 
predictive of patient’s outcomes, including relationship and sexual satisfaction[52]. This is 
important, as a patients’ cancer diagnosis produces higher levels of stress in female 
partners than the patient themselves[51], including significant concerns about patients’ 
post-treatment sexual functioning and how it might impact their relationship/intimacy[53]. 
Following PC treatment, post-treatment sexual dysfunction is related to worse sexual 
outcomes in female partners[55,56], which is tied to poorer relationship outcomes[56-58], 
and worse overall adaptation chronic/life threatening disease for the patient[59-61]. 
Including partners in this treatment study will maximize outcomes for both men and their 
partners. It should be noted, that we will specifically target same-sex couples in our 
recruitment process, as no research exists on the potentially unique needs of these 
couples in the context of psychosocial interventions.  
 
AIMS 
 
This project builds on an already established multi-step research program with the long-
term goal of optimizing the standards of care for the treatment of sexual dysfunction and 
sexual intimacy in couples post-prostate cancer treatment. The aim of this study is to 
adapt an existing and effective treatment found to improve women’s sexual functioning 
now to the couple context for survivors of PCa and their partners. We will evaluate the 
comparative efficacy of each treatment to one another and to “usual care” that patients 
receive within the Prostate Cancer Supportive Care (PCSC) Program at VPC. We will 
also identify which treatment works best for whom. The long-term aim is to disseminate 
this information as treatment manuals to other centres that treat PC nation-wide in order 
to expand the program. Helping men and their partners reclaim intimacy after PC will 
improve the recovery process and quality of life. 
 
OBJECTIVES 
 
OBJECTIVE 1. Evaluate two evidence-based psychological treatments (mindfulness-
based therapy and cognitive behavioural therapy; CBT) for PC survivors and their 
partners, compared to controls in the short- (immediately post-treatment) and long-term 
(6-months follow up). 
 
OBJECTIVE 2: Explore moderators of improvement in outcomes of intimacy and QoL 
with treatment. 
 
 

INTROSPPECT Study | Study Protocol V6  Aug 1, 2018                                                                      | 5 of 21 
 
HYPOTHESES 
 
HYPOTHESIS 1a: Compared to controls, we predict that couples who undergo 
mindfulness-based therapy or CBT will show improvements at follow-up (immediately 
and 6-months post-treatment) in: 
a. Primary endpoints of self-reported intimacy outcomes (i.e., relationship 
satisfaction, sexual satisfaction/distress, sexual function, frequency/range 
of sexual activities). 
b. Secondary endpoints of self-reported QoL outcomes (i.e., psychological 
well-being (depression, anxiety), distress, overall QoL).  
 
HYPOTHESIS 1b: The two active treatments (mindfulness and CBT) will not 
significantly differ from one another with respect to patient outcomes. 
 
HYPOTHESIS 2: Improvements in either treatment arm will be moderated by:  
a. Treatment adherence factors (e.g., motivation at baseline, (greater) 
expectations for change, participant’s expectations for treatment, amount 
participants practice the therapeutic skills taught in session).  
b. Individual factors (e.g., personality variables, state/trait mindfulness, pre-
treatment relationship satisfaction, pre-treatment sexual health, previous 
experience with mindfulness or CBT). Improvements in mindfulness are 
predicted to will mediate improvements in the mindfulness group only.  
c. Secondary endpoints. That is, the role of secondary quality of life 
endpoints (mentioned above) as moderators to primary endpoints of 
intimacy outcomes will also be assessed. 
 
RESEARCH METHODS 
 
STUDY DESIGN. This is a randomized clinical trial study designed to assess and 
compare efficacy of two treatment manuals for couples with sexual difficulties 
secondary to PC treatment: mindfulness-based therapy and CBT. A third arm, where 
couples receive no intervention will act as a control group. N = 141, with 47 in each arm. 
Couples will be invited to participate through the VPC’s PCSC Program at Vancouver 
General Hospital. Recruitment is also open to interested couples from the community. 
 
Eligible couples will be randomized to either 4 consecutive weeks of mindfulness-based 
therapy, CBT, or no intervention (4-6 couples per group). All couples will complete an 
online questionnaire package to assess primary, secondary, and tertiary endpoints at 
the time of study enrolment (Time 1). All couples will be invited to complete a Time 2 
questionnaire once approximately 6 weeks after they complete the pre-treatment 
questionnaire (for couples randomized to the treatment arms, this will be immediately 
after the end of treatment). All participants will be invited to complete the Time 3 follow 
up questionnaire 6 months after they complete the Time 2 (post-treatment) 
questionnaire. 
 

INTROSPPECT Study | Study Protocol V6  Aug 1, 2018                                                                      | 6 of 21 
 
For couples randomized to a treatment arm, treatment will consist of a 4-week group 
lead by a trained clinician. Sessions are 2hrs in length and take place in consecutive 
weeks, with daily homework recommended between sessions. The therapeutic content 
presented in each treatment arm is manualized. The mindfulness-based treatment was 
developed based on pre-existing mindfulness-based cognitive therapy treatment groups 
for sexual dysfunction developed by Dr. Lori Brotto at the UBC Sexual Health 
Laboratory, mindfulness in Sex therapy and Intimate Relationships (MSIR) treatment 
group developed by Kocsis and Newbury-Helps (2016), and expert input. The CBT 
treatment was adapted from the mindfulness-based treatment, but all mentions of 
mindfulness have been replaced with CBT principles. Sessions consist of either 
mindfulness-based training or CBT tools, as well as sex therapy techniques and 
education.  
 
In order to improve our understanding of the lived experience of patients who take part 
in the treatment groups or control arm, we will invite all participants to take part in an 
exit interview after their Time 2 (post-treatment) questionnaire is completed. An 
individual who was not a treatment facilitator will conduct the exit interviews. This 
information will then be transcribed and used for qualitative data analyses.  
 
The doctor or healthcare provider referring their patient to the study, be it from 
Vancouver Prostate Centre/PCSC program or from the broader community, will be 
notified if their patient chose to enroll in the study (i.e., signed the consent form) in order 
to follow standard clinical practice. If the healthcare provider is within Vancouver 
Prostate Centre or PCSC Program, notification will be done internally through the 
secure and confidential EMR system. If the healthcare provider is external to our 
program, a confidential fax will be sent to their office. These notifications will be kept 
brief, secure, and follow patient-provider confidentiality. Please see box 9.7 for a 
template. 
  
RANDOMIZATION. Once consent has been received from both members of the 
participating couple, they will be assigned a study ID and then be randomized to their 
group (CBT, mindfulness, or control). Time 1 baseline measures will then be 
administered to start data collection. 
 
A randomization list will be created using the random number generator at 
www.researchrandomizer.org (Urbaniak, & Plous, 2013). A value of 1 indicates 
randomization to the mindfulness-based intervention, a value of 2 indicates the CBT 
intervention, and a value of 3 indicates the no treatment control group. 
 
The random number generator will be run after the study has opened to recruitment and 
before the first potential participant is approached for the study. The randomization list 
will be stored electronically, in a password-protected document on the secure 
Vancouver Prostate Centre network by a person independent of the study with a 
nominated back-up in case they are absent. 
 

INTROSPPECT Study | Study Protocol V6  Aug 1, 2018                                                                      | 7 of 21 
 
At the time of randomization, the Study Coordinator/Assistant will contact the 
randomization list holder to request the treatment allocation and then inform the 
participants by phone.   
 
RECRUITMENT.  
 
Interested couples with sexual complaints secondary to prostate cancer 
treatments (N = 141, based on anticipated small effect size, α = .05, power = 0.8) will be 
recruited from existing waitlists at VPC and the PCSC Program and outside sources. 
This is 47 couples per study arm. 
Note that, as this is a study evaluating group treatment for couples, both 
members of the couple are required to consent in order to be eligible to participate. If 
one member of the couple decides with withdrawal their consent at any point during the 
study, then both members of the couple with be removed from the treatment group (if 
applicable). However, if one member of the couple still wishes to take part in the study, 
they will be given the option to arrange individual sessions with a group facilitator to 
ensure that they receive the full treatment intervention. This individual will not be invited 
to complete follow up questionnaires or the optional follow up interview.  
 
The following recruitment pathways will be followed: 
 
 
1. 
Prospective recruitment in Person at the PCSC Program 
 
 
During a scheduled Sexual Health Service (SHS) appointment, patients who are 
identified by the Sexual Health Clinician as being possibly eligible to participate in the 
study will be provided with a study advertisement (see Section 9.4). At this point, one of 
two recruitment pathways may be taken: 
 
 
(a) The patient will have the option to contact the Study Coordinator (contact 
information is included in the study advertisement) at a later date. 
 
 
(b) If the patient expresses interest in the study to the clinician, or would like 
additional information, they have the option to speak with a trained member of the study 
team (e.g., the Study Coordinator or Research Assistant) in person at that time following 
conclusion of their appointment. At this meeting, the patient will be fully informed about 
the study protocols and provided with a consent form. They are under no obligation to 
consent to participate during that initial meeting. 
 
If the patient has read the study information, had an opportunity to ask any questions, 
and is willing to participate, they and their partner will be asked to complete the 
screening interview. If they are deemed eligible to participate, they will be given the 
option to sign the study consent form, or, if the patient prefers or perhaps if their partner 
is not present at the clinic, they have the option to take the information home and have 
decide later whether they’d like to participate. They have the option to be followed-up by 
a telephone call later (up to two weeks) at an agreed time. If the patient is willing to take 
part in the study, consent will be obtained either electronically (signed and scanned) or 

INTROSPPECT Study | Study Protocol V6  Aug 1, 2018                                                                      | 8 of 21 
 
through the mail (they will be provided a pre-addressed stamped envelope upon 
request).  
 
For participants who complete the screening interview but indicate that they are not 
interested in providing consent to participate, or if it deemed that the study is not a good 
fit for them, the information they provided during the screening interview will be 
destroyed.  
 
Note that all email correspondence between the researcher and participants is done 
using the researcher’s Prostate Centre email, which is a secure emailing service hosted 
through the Vancouver Prostate Centre network. Electronic versions of the signed 
consent forms are stored on the secure Prostate Centre Network. Original hard copies 
are stored in a secure, locked cabinet housed in the UBC Sexual Research Lab. 
 
We have also created a study recruitment poster (see section 9.4) to be displayed in 
the clinic rooms at the Diamond Health Care Centre and to be used in the Prostate 
Cancer Supportive Care (PCSC) program and other suitable advertising spaces. For 
instance, the PCSC has a quarterly newsletter that is disseminated to patients, loved-
ones, and staff, in which the approved recruitment poster or information can be 
appended. In addition, the PCSC facilitates educational modules for diagnosed patients 
and their partners to learn skills and information in coping with prostate cancer, for 
example workshops on intimacy, sexual rehabilitation, exercise, nutrition etc. We will 
leave the same recruitment materials (section 9.4) at these module workshops and 
make quick announcements about the study when appropriate (see section 9.7 for a 
sample script). It is important to note that, because of the personal and sensitive nature 
of topics, these PCSC education modules are kept confidential not only between the 
facilitators and attendees but also between attendees. Thus, these modules serve as a 
safe place for potential participants to learn more about the study and ask questions.  
 
 
2. Recruitment by Invitation at the PCSC Program, Vancouver Prostate 
Centre/Prostate Clinic, and BC Cancer Agency 
 
 
For PCSC and Vancouver Prostate Centre, patients who may be eligible to 
participate will be identified from SHS clinic lists held in the electronic medical record 
(EMR) by the SHS clinician or the Study Coordinator/Research Assistant, who all have 
access to the EMR database. Patients active in the SHS (i.e. seen in clinic in the past 
12 months) will be contacted. There are two extensive databases of patients who have 
provided permission to contact (PTC) for prostate cancer research; one is termed 
SPIRIT Databank (H16-02295) for patients enrolled into the PCSC program and the 
other is the Prostate Clinic at Vancouver General Hospital patient database. Patients 
identified on EMR will be cross-referenced with the research consent databases, and 
those who have provided PTC will be contacted via telephone, email, or mail see box 
9.7 for example dialogue/text. Members of the research team have access to both EMR 
and the PTC databases. To minimize participant burden, we will not contact patients 
who are currently participating in other Prostate Centre projects that have high time 
commitment as noted in the database. 

INTROSPPECT Study | Study Protocol V6  Aug 1, 2018                                                                      | 9 of 21 
 
 
 
For those patients from either the PCSC or Prostate Clinic database who have 
not yet provided PTC, they will be sent an invitation letter in the mail (see section 9.6). 
This letter is signed by Dr. Larry Goldenberg, the head of the Vancouver Prostate 
Centre. The patient will be provided with the reasons why the study is being carried out, 
a description of the study, reasons why the patient is being invited to participate, and 
what the study involves, in compliance with the Initial Letter of Contact template 
designed by the Vancouver Coastal Health Privacy Office. This letter may also be sent 
out to patients who have consented for future contact and who have not been reached 
by phone or email as another recruitment method. An approved study brochure will also 
be included in the envelope for further information. The Study Coordinator will follow up 
with the potentially eligible participant by phone in approximately two weeks’ time after 
the letter was sent to ensure that it was received, and to inquire as to whether the 
patient is interested in participating in the study. Telephone contact will only be 
attempted during typical office hours on weekdays. No voicemail will be left if the patient 
does not answer the phone. 
 
 
Lastly for Recruitment by Invitation, we will recruit by mail invitation through the 
BC Cancer Agency Registry database in the same manner as the step described 
above. We will request data from this registry through the BC Cancer Agency's stringent 
Data Access Request process. A list of names and addresses of patients who have a 
confirmed prostate cancer diagnoses and permission to contact for research will be 
exported through approved BC Cancer Agency protocol and staff (e.g., data will be 
transferred using a password encrypted file and network, stored in an institutional 
computer, and will be destroyed at the earliest possibility). Only the principal 
investigator, the designated study lead, and the study coordinator will have access to 
this list to perform the mail out. Similar to above, the letter sent to BC Cancer Agency 
Registry patients is signed by Dr. Larry Goldenberg. The patient will be provided with 
the reasons why the study is being carried out, a description of the study, reasons why 
the patient is being invited to participate, and what the study involves, in compliance 
with the Initial Letter of Contact template designed by the Vancouver Coastal Health 
Privacy Office (see section 9.6). An approved study brochure will also be included in the 
envelope for further information. The Study Coordinator will follow up with the potentially 
eligible participant by phone in approximately two weeks’ time after the letter was sent 
to ensure that it was received, and to inquire as to whether the patient is interested in 
participating in the study. Telephone contact will only be attempted during typical office 
hours on weekdays. No voicemail will be left if the patient does not answer the phone. 
 
 
 
3. Community Outreach 
 
 
We intend to recruit participants from the Greater Vancouver Area to participate 
in this study. One method in which we will do so is via outreach to General Practitioners 
(GPs) and Urologists in the community. In contacting physicians, we will send a letter to 
their offices with information about the current study (see section 9.7) and copies of the 
study advertisements either by email, fax, or regular mail and ask permission to display 
the advertisements in their office. The advertisement material informs potential 

INTROSPPECT Study | Study Protocol V6  Aug 1, 2018                                                                      | 10 of 21 
 
participants about the current study, and provides contact information for the study team 
(see section 9.4, same advertisement as above). Offices are free to decline our request 
if they do not wish to display the materials, at that point they may disregard our 
package. We will follow up with the office by phone approximately 2 weeks later to 
ensure that they received the letter and to confirm whether they would like more 
advertisement material sent to their office. After the agreeing physician's office has 
received the advertisement material, the healthcare providers are free to share the 
information about the study to any patients whom might be a fit for the study. No patient 
contact information will be sent from the GP offices to the research team. Rather, 
interested patients must contact our research team through the provided phone or 
email. 
  
 
In addition to physician offices, the approved study ads (box 9.4) will be posted 
in relevant health settings with permission from the authorizing administrator(s). These 
include but are not limited to: Vancouver General Hospital, UBC Hospital, St. Paul’s 
Hospital, Men’s Health Initiative, community health outreach events (e.g., Movember) 
etc. 
 
 
We will also post advertisements throughout community center bulletin boards 
and gathering spaces with permission from the respective administrator. We will place 
advertisements in community newspapers such as the Vancouver Courier through an 
agency called Glacier Media, see box 9.4 for sample newspaper advertisement. 
 
 
4. Online Recruitment 
 
We will post advertisements online through social media, email, and websites relevant 
to the prostate cancer population. In addition, we will post advertisements through 
Glacier Media which will display online content (box 9.4) throughout the web and on 
social media such as Facebook and Instagram.  All online advertisements will be 
passive, meaning interested individuals will need to click on web links to find our contact 
information and the advertisements will be posted on public domains. These ads can be 
shared and disseminated by any community member. Where possible, comments will 
be disabled in order to protect the privacy of potential participants i.e., to prevent names 
and information from being inadvertently posted. 
 
Examples include but are not limited to:   
 
Twitter: @UBCSexualHealthLab, @VCHRI, @PCSC_Program 
 
Facebook pages: UBC Sexual Health Lab, Vancouver Coastal Health Research 
Institute PCSC Program 
 
Websites (box 9.4 for draft of sample material): 
- 
www.prostatecentre.com  
- 
www.prostatecancer.ca 
- 
www.clinicaltrials.gov  

INTROSPPECT Study | Study Protocol V6  Aug 1, 2018                                                                      | 11 of 21 
 
- 
www.pcscprogram.ca  
- 
http://brottolab.med.ubc.ca/  
 
 
 
The Vancouver Coastal Health Research Institute (VCHRI) provides a webpage 
for all approved studies. The same information as the advertisement in box 9.4 in 
VCHRI formatting will be posted on their registry https://www.vchri.ca/participate. This is 
for ease of access and can be forwarded by word-of-mouth and email among interested 
individuals.  
 
VCHRI E-Blast is a free service which emails all VCH staff about research studies. The 
approved materials (VCHRI Format Ad) will be forwarded to all interested individuals 
who have opted to be part of this mailing list. Moreover, we will also be sending E-
Blasts to subscribers of other relevant email lists, for example prostate cancer survivors 
or family members of survivors, with the permission of the respective list administrator. 
Examples of email lists include but are not limited to: Prostate Cancer Canada, Ride to 
Conquer Cancer, and BC Cancer Agency. Emails will be sent directly to the individuals’ 
inboxes with no identifying link to the information of others. It is important to note that 
these emails are sent to subscribers of these lists who have expressed previous interest 
in knowing up-to-date information on prostate cancer resources rather than uninterested 
individuals. The frequency of emails will be limited to once every three months at 
minimum as per VCHRI guidelines. Uninterested individuals may also unsubscribe from 
these lists at any point. Please see “INTROSPPECT Study E-Blast Sample Text” in box 
9.4 for sample text that will be sent via E-Blasts. Other approved materials (e.g., 
brochure or poster) in box 9.4 may also be attached in the emails for reference. 
 
Potential participants who contact the lab will then be given more information about the 
study. Those who are interested in participating will be provided with the option to 
complete a screening interview over the phone or in person. In the event that they 
choose to undergo the screening interview over the phone, an electronic copy of the 
consent form will be sent to them, which they can either (a) print, sign, and scan, or (b) 
sign electronically and send back to the Study Coordinator/Research Assistant via 
email. In the event that a participant prefers a hard copy of the consent form, one will be 
sent to them, along with a self-addressed stamped envelope for their convenience. 
Participants from outside sources will have the opportunity to consider the study with 
their partner before signing the consent form in the same manner as the other 
recruitment avenues above. 
 
The utmost sensitivity will be used during the recruitment processes, and all contact will 
comply with Vancouver Coastal Health Privacy Office standards. Given the high number 
of men diagnosed and treated for prostate cancer, the exceedingly high numbers of 
men who go on to experience distress related to treatment side effects, and the limited 
community access to sexual health experts with training in prostate cancer in British 
Columbia, we believe that many patients will appreciate learning about the study via the 
abovementioned means. 
 
 

INTROSPPECT Study | Study Protocol V6  Aug 1, 2018                                                                      | 12 of 21 
 
STUDY OUTCOMES 
 
As part of baseline measures, participants will be asked for basic demographic 
variables such as age, gender-identification, marital status etc. for basic reporting 
purposes. They will also be asked about information regarding sex including orientation, 
circumcision status, time since prostate cancer treatment etc. Full demographic 
questionnaire can be found in section 9.5 of the application. As we are aware of 
participant burden, the questionnaire packages will take no longer than 30 minutes to 
complete at each time point. 
 
The primary endpoints of the current study are self-reported intimacy correlates. 
They will be assessed using the following measures: 
 
 
Relationship satisfaction 
Adapted dyadic adjustment scale (A-DAS66). The A-DAS is a 
validated, 7-item measure that assesses relationship adjustment. 
 
Sexual 
satisfaction/distress 
Female sexual distress scale (FSDS67). The FSDS is a 13-item 
measure that assesses sexual distress. Although named for it’s 
use with women, this measure has been validated as a measure 
of sexual distress in women and men. 
 
Sexual functioning 
International Index of Erectile Functioning (IIEF68). The IIEF is a 
15-item validated measure of men’s self-reported sexual 
functioning; it is considered the gold-standard measure in the 
sexual-dysfunction literature. 
OR  
International Index of Erectile Functioning for Men who have sex 
with men (IIEF-MSM69). The IIEF-MSM is a 22-item measure of 
sexual dysfunction that has been adapted from the IIEF for use 
with men who have sex with men (MSM).  
OR  
Female Sexual Functioning Index (FSFI70). The FSFI is a 19-item 
measure of self-reported sexual dysfunction in women. 
 
Sexual behaviours 
Sexual activity scale. This is a questionnaire developed by the 
study lead that asks individuals to rate the frequency of times that 
they engaged in a range of sexual activities over 3 time-periods: 
(a) ever, (b) since their/their partner’s prostate cancer surgery, 
and (c) in the past 4 weeks.   
 
 
The secondary endpoints of the current study are mental and health-related quality of 
life indices. They will be assessed using the following measures: 
 
Psychological well-
being 
Hospital Anxiety and Depression Scale (HADS71). The HADS is a 
validated, 14-item measure of depression and anxiety. 
 

INTROSPPECT Study | Study Protocol V6  Aug 1, 2018                                                                      | 13 of 21 
 
Distress 
Distress Thermometer72. The distress thermometer is a single-item 
distress screening scale, which has been shown to be a valid 
measure of cancer-specific distress among prostate cancer 
patients and their partners. Participants indicate their current level 
of distress on an 11-point scale. 
 
Overall quality of life 
World Health Organization Quality of Life – BREF (WHOQOL-
BREF73). This is a 26-item measure that assesses overall quality of 
life in the domains of physical health, psychological well-being, 
social relationships, and environmental well-being. 
 
 
The tertiary endpoints of the current study are treatment mechanisms factors. These 
will be assessed using the following measures: 
 
Treatment adherence  
Expectations for treatment. A 4-item questionnaire, designed for 
and used in our approved mindfulness-based treatment study for 
women with provoked vestibulodynia (H12-02358) 
 
 
Therapeutic Skills Practice. This is a questionnaire designed by the 
experimenters to assess the amount that participants practice the 
skills taught in treatment. Participants will indicate the skills 
practices each day, and number of minutes they spent practicing 
each skill. This log will be completed as a separate, online 
questionnaire that participants will access daily. Participants have 
the option of completing a paper-version of this log, which they will 
give to the Study Coordinator each week. 
 
Individual factors  
Five Facets of Mindfulness questionnaire; Short form (FFMQ-SF74). 
The FFMQ-SF is a validated, 24-item measure of different aspects 
of mindfulness.. 
 
 
Big Five Inventory - 10 (BFI-1075). An adapted, brief 10-item 
measure of personality characteristics.  
 
 
Pre-treatment sexual functioning. This is an experimenter derived 
questions asking participants to indicate if they have a history of 
sexual dysfunction that preceded their own/their partner’s prostate 
cancer treatments. 
 
 
Treatment and Medical History  
This measure will review date of diagnosis, disease severity, any 
treatments, treatment duration, and the time elapsed from prostate 
cancer treatment to enrollment.  
This will take place at time 1 and reviewed at time 3 to capture 
changes.  
  
 
 

INTROSPPECT Study | Study Protocol V6  Aug 1, 2018                                                                      | 14 of 21 
 
The qualitative data analyses will explore meaningful treatment outcomes from the 
perspective of men and their partners. This will be assessed using a semi-structured 
interview. The interview contains a series of investigator-derived questions about 
participant experience in the study, including questions about participation in treatment 
groups (for those randomized to the treatment arm), or the experience of not taking part 
in a treatment group (i.e., the control arm). The interviewer will follow up on responses 
as needed to ensure all meaningful information is discussed. See section 9.5 for 
interview questions. 
 
 
DATA ANALYSIS 
 
HYPOTHESIS 1a. Our primary hypothesis—that intimacy correlates will improve 
following treatment—will be assessed using repeated-measures multiple analysis of 
variance (MANOVA), comparing outcomes at three time points [Time 1 (pre-treatment), 
Time 2 (post-treatment), Time 3 (6-month follow-up)] for the 3 treatment arms 
(mindfulness, CBT, control). Primary endpoint measures will be used as the dependent 
variables in a single MANOVA (e.g., dyadic adjustment scale scores, female sexual 
distress scale scores, IIEF/IIEF-MSM/FSFI scores). Relevant demographic variables 
(e.g., age) will be included as covariates to control for their effects.  
 
HYPOTHESIS 1a. Our secondary hypothesis—that quality of life endpoints will 
improve following treatment—will be assessed using repeated-measures MANOVAs 
again comparing outcomes at three time points [Time 1 (pre-treatment), Time 2 (post-
treatment), Time 3 (6-month follow-up)] for the 3 treatment arms (mindfulness, CBT, 
control). Secondary endpoint measures will be used as dependant variables in a single 
MANOVA (e.g., HADS scores, Distress Thermometer score, WHOQOL-BREF score). 
Again, relevant demographic variables (e.g., age) will be included as covariates to 
control for their effects. 
 
HYPOTHESIS 1b. The hypothesis that the two active treatments (mindfulness and 
CBT) will not significantly differ from one another with respect to patient outcomes will 
be assessed in the abovementioned MANOVAs, as treatment arm (mindfulness, CBT, 
control) is an independent variable included in the analysis. Main effect of treatment arm 
will be assessed, and follow-up ANOVAs will be carried out in the event of a significant 
main effect. We expect mindfulness and CBT will not significantly differ from one 
another, but both will show significant improvements compared to the control arm.  
 
 
HYPOTHESIS 2a. The tertiary hypothesis—that the couple’s outcomes will be 
moderators by treatment adherence factors—will be assessed using moderator 
analyses. In these moderator analyses, primary endpoint measures will be the 
dependent variable (i.e., intimacy measures mentioned above), time-point (Time 1, 
Time 2, Time 3) will be the independent variable, and treatment adherence variables 
(e.g., expectations for treatment questionnaire scores, amount of therapeutic skills 
practice) will be entered as moderators.  

INTROSPPECT Study | Study Protocol V6  Aug 1, 2018                                                                      | 15 of 21 
 
 
HYPOTHESIS 2b. The tertiary hypothesis—that couple’s outcomes will be moderated 
by individual factors—will be assessed using moderator analyses mentioned above 
with individual factors (e.g., five factors of mindfulness questionnaire scores, big five 
inventory scores, pre-treatment sexual functioning scores) as moderators. 
 
HYPOTHESIS 2c. The tertiary hypothesis—that couple’s primary intimacy outcomes 
will be moderated by secondary quality of life outcomes will be assessed using 
moderator analyses as well, with QOL outcomes (i.e., HASD scores, distress 
thermometer rating, WHOQOL-BREF scores) included as moderators.  
 
ADDITIONAL EXPLORATORY ANALYSIS OF MODERATORS: We also intend to 
include multiple regression analyses to determine predictors of treatment efficacy. In 
these analyses, regression analyses will be conducted with each primary outcome as 
the independent variable (dyadic adjustment scale scores, female sexual distress scale 
scores, IIEF/IIEF-MSM/FSFI scores), and secondary quality of life outcomes as well as 
tertiary treatment factors (e.g., treatment adherence factors, individual factors) included 
as predictors.   
 
EXPLORATORY ANALYSES: As the current study offers a novel exploration of 
mindfulness-based and CBT interventions as a treatment for couple’s sexual difficulties, 
we also intend to include hypothesis-generating exploratory analyses with our data 
analyses. These analyses will be born from the abovementioned core statistical 
analyses that we propose with this study. 
 
QUALITATIVE ANALYSES: Finally, qualitative data analyses using a Grounded 
Theory Approach76 will be conducted on the transcribed qualitative exit interviews. 
Themes will be identified and extracted by independent reviewers.  
 
 
 
 

INTROSPPECT Study | Study Protocol V6  Aug 1, 2018                                                                      | 16 of 21 
 
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