DACG VI. Beyond Survival: Addressing Gynecological and Sexual Health in Women After Radiotherapy for Anal Cancer
Conditions: Anal Cancer
Sponsor: Aarhus University Hospital

 
 
 
 
 
 
 
DACG VI 
Beyond survival: Addressing 
gynecological and sexual health 
in women after radiotherapy for 
anal cancer 
Version 5 
Approved by the Regional Committee on Health Research Ethics (VEK) on 
March 28, 2025 

 
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Table of content 
Background ......................................................................................................................................... 3 
Purpose ............................................................................................................................................... 4 
Study design ........................................................................................................................................ 4 
Study populaƟon ................................................................................................................................. 4 
Inclusion criteria: ............................................................................................................................. 4 
Exclusion criteria: ............................................................................................................................ 4 
Inclusion procedures ....................................................................................................................... 4 
Endpoints ............................................................................................................................................ 5 
Data collecƟon .................................................................................................................................... 5 
Data management............................................................................................................................... 6 
Sample size and staƟsƟcal analysis plan ............................................................................................. 6 
Sample size ...................................................................................................................................... 6 
StaƟsƟcal analysis plan .................................................................................................................... 7 
Study schedule (tentaƟve) .................................................................................................................. 7 
Plans for disseminaƟon and reporƟng ................................................................................................ 8 
Ethical issues, safety aspects, and complicaƟons ............................................................................... 8 
Funding and Financial Disclosure ........................................................................................................ 8 
Appendix I ........................................................................................................................................... 9 
Appendix 2 ........................................................................................................................................ 12 
Appendix 3 ........................................................................................................................................ 13 
PaƩen of care quesƟonnaire: ........................................................................................................ 13 
Appendix 4 ........................................................................................................................................ 14 
Semi-Structured Interview Guide: PaƟent SaƟsfacƟon with Counseling ...................................... 14 
References ......................................................................................................................................... 16 
 
 
 

 
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Protocol organizaƟon  
The study is iniƟated by the invesƟgators and the Danish Anal Cancer Group (DACG).  
 
Study departments:  
Department of Oncology  
Aarhus University Hospital (AUH), Entry C, Level 2, Cross point C204  
Palle Juul-Jensens Bouldevard 99  
8200 Aarhus N, Denmark  
 
Department of Oncology  
Vejle Hospital, University Hospital of Southern Denmark  
Beriderbakken 4  
7100 Vejle, Denmark  
 
Department of Oncology  
Herlev and GentoŌe Hospital  
Borgmester Ib Juuls Vej 7  
2730 Herlev, Denmark  
 
Principal invesƟgator: Johanne Hollands Steﬀensen 
Department of Oncology, AUH  
E-mail: johste@rm.dk  
 
Senior responsible invesƟgator: Karen-Lise Garm Spindler, MD, DMSc, Head of DACG  
Department of Oncology, AUH  
Email: k.g.spindler@rm.dk  
 
InvesƟgator Vejle: Lars Ulrik Fokdal, MD, PhD 
Vejle Hospital, University Hospital of Southern Denmark 
E-mail: Lars.Ulrik.Fokdal@rsyd.dk 
 
InvesƟgator Herlev: Eva Serup-Hansen, MD, PhD 
Department of Oncology, Herlev and GentoŌe Hospital 
E-mail: Eva. Serup-Hansen@regionh.dk 
 
 
 
External collaborators: 
Camilla Jensenius Skovhus Kronborg, MD, PhD, Ass. Professor  
The Danish Centre for ParƟcle Therapy, Aarhus University Hospital 
 
Kathrin Kirchheiner, MSc. PhD. Assoc. Prof.  
Department of RadiaƟon Oncology, Medical University of Vienna  
 

 
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Background 
Anal cancer (AC) is a rare malignancy, with approximately 200 new cases diagnosed annually in 
Denmark 1. This cancer predominantly aﬀects women and is strongly associated with human 
papillomavirus (HPV) infecƟon. The standard treatment for localized anal cancer (AC) is 
chemoradiotherapy (CRT). In Denmark, the standard approach involves delivering a total radiaƟon 
dose of 54-60 Gy to the primary tumor and pathological lymph nodes, administered in fracƟons of 
1.8-2 Gy per session. ElecƟve lymph node regions are typically treated with a lower dose of 45-50 
Gy2. This regimen has proven highly eﬀecƟve, achieving excellent rates of disease control and 
survival3,4. However, the long-term adverse eﬀects of CRT remain a criƟcal concern, one of them 
being gynecological and sexual health. These domains are oŌen underreported and insuﬃciently 
addressed in rouƟne clinical pracƟce5. 
Radiotherapy for AC frequently aﬀects adjacent organs at risk (OAR), including the female genital 
tract. This exposure can result in complicaƟons such as vaginal stenosis, dyspareunia, and broader 
sexual dysfuncƟon6. The reported prevalence of these complicaƟons varies widely across studies. For 
example, some invesƟgaƟons report sexual dysfuncƟon in up to 85% of female survivors (Yerramilli et 
al., 2019)7, while others, such as De Francesco et al. (2016)8, note that only 2 out of 21 women 
idenƟﬁed an impact on sexual relaƟonships. 
The wide variaƟon in prevalence rates may be aƩributed to methodological heterogeneity in 
measuring vaginal symptoms. Many studies rely on diﬀering assessment tools, complicaƟng eﬀorts to 
synthesize ﬁndings. Furthermore, research oŌen focuses on sexually acƟve individuals, potenƟally 
underesƟmaƟng symptom prevalence among sexually inacƟve paƟents and leaving a signiﬁcant 
proporƟon of aﬀected women unrepresented. AddiƟonally, physician-reported outcomes are seldom 
based on physical examinaƟons, further undermining the reliability and comprehensiveness of 
available data. This lack of standardized assessment methods highlights a criƟcal knowledge gap and 
adds to the variability in reported outcomes. 
Another signiﬁcant challenge is the poorly understood relaƟonship between radiaƟon dose and 
vaginal toxicity aŌer AC treatment, which complicates the establishment of clinically relevant dose 
constraints for sexual OARs. While some studies have explored dose-response relaƟonships, ﬁndings 
remain inconsistent. For instance, Arzola et al. (2023)9 suggested that keeping the dose to 50% of the 
anterior vaginal wall <48 Gy could reduce the risks of impaired sexual funcƟon. Similarly, Son et al. 
(2015)10 proposed that mean vaginal doses below 43 Gy were associated with a reduced risk of 
severe vaginal stenosis. Conversely, other studies, including Joseph et al. (2016)11, have failed to 
demonstrate signiﬁcant correlaƟons between vaginal dose metrics and sexual dysfuncƟon outcomes 
measured through standardized instruments like the EORTC-CR29. 
These discrepancies underscore the urgent need for further research into the mechanisms and 
clinical predictors of gynecological morbidity and sexual health following CRT. Exploring dose 
constraints could pave the way for enhanced survivorship care in women treated for anal cancer. 
Secondary prevenƟve strategies 
Despite well-documented risks, the implementaƟon of secondary prevenƟve strategies for miƟgaƟng 
long-term complicaƟons sƟll needs to be revised. Evidence supports that vaginal dilator use and 
sexual counseling can reduce the risk and severity of late eﬀects following radiaƟon therapy12-15. 
Currently, all Danish cancer treatment centers rouƟnely provide vaginal dilators to female paƟents 
aŌer the end of radiaƟon therapy with basic informaƟon on their use. The general recommendaƟon 

 
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is to iniƟate dilator use approximately six to eight weeks post-radiaƟon treatment, with a suggested 
frequency of three Ɵmes per week. 
In Denmark, paƟents can be referred to specialized sexual health nurses for counseling on sexual 
dysfuncƟon aŌer treatment for anal cancer. AddiƟonally, all centers have access to late-eﬀects clinics 
for further support. However, systemaƟc documentaƟon regarding the type and extent of counseling 
provided is lacking, as is a comprehensive insight into paƟents’ saƟsfacƟon with these services. 
Greater paƟent involvement in reﬁning guidance and care strategies is crucial to meeƟng unmet 
needs and enhancing survivors’ quality of life. 
Purpose 
The primary objecƟve of this study is to examine the prevalence and severity of vaginal morbidity in 
women following treatment for localized anal cancer and to idenƟfy predicƟve factors, including the 
potenƟal dose-response relaƟonship between radiaƟon exposure and morbidity. Furthermore, the 
study seeks to invesƟgate possible correlaƟons between vaginal morbidity and paƟent-reported 
sexual dysfuncƟon.    
The secondary objecƟve is to invesƟgate paƩerns of care related to managing gynecological toxicity 
and sexual dysfuncƟon, including the use of dilators and hormone therapy. The study also evaluates 
paƟent saƟsfacƟon with the guidance provided to idenƟfy areas for improvement, aiming to support 
the development of standardized, high-quality pracƟces that ensure consistent and paƟent-centered 
care across Denmark’s three anal cancer treatment centers. 
Study design  
This is a naƟonal mulƟcenter, cross-secƟonal study that collects quanƟtaƟve and qualitaƟve data 
from gynecological examinaƟons, quesƟonnaires, and semi-structured interviews. 
Study populaƟon 
Inclusion criteria: 
• 
Female paƟents aged 18 or older. 
• 
Diagnosed with AC and treated with CRT with curaƟve intent. 
• 
6–36 months post-CRT.  
• 
Willing and able to provide informed consent. 
Exclusion criteria:  
• 
History of pelvic radiotherapy for condiƟons other than the current diagnosis. 
• 
Treatment with electron beam radiotherapy. 
• 
Non-Danish speaking 
Inclusion procedures  
ParƟcipants will be idenƟﬁed during follow-up consultaƟons (6-36 months) at Aarhus University 
Hospital, Vejle Hospital, and Herlev and GentoŌe Hospital. When a potenƟal parƟcipant is idenƟﬁed, 
the treaƟng physician responsible for the consultaƟon will provide both oral and wriƩen informaƟon 
about the study. ParƟcipants will be informed that they have the right to have a companion or 
support person present during the iniƟal oral informaƟon consultaƟon. To ensure suﬃcient Ɵme for 
consideraƟon, parƟcipants will be oﬀered an inclusion consultaƟon at least 24 hours aŌer the iniƟal 

 
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consultaƟon. During this consultaƟon, further quesƟons can be addressed, and parƟcipants are 
welcome to bring a companion or relaƟve. 
WriƩen informed consent will be obtained at this inclusion consultaƟon before study parƟcipaƟon. 
PaƟents will be assured of conﬁdenƟality. PaƟents will be informed that their parƟcipaƟon is enƟrely 
voluntary and that they can withdraw their consent at any Ɵme without aﬀecƟng their future care.  
If they consent, the gynecological examinaƟon will either be performed shortly aŌer consent or 
scheduled for their next follow-up visit, depending on paƟent preference and clinical feasibility. 
Endpoints  
Primary endpoint: 
• 
Prevalence of vaginal stenosis grade 2 or higher. 
Secondary endpoints: 
• 
Gynecological ﬁndings: vaginal elasƟcity, adhesions, telangiectasias, ulceraƟon, and bleeding. 
• 
RadiaƟon Dose to sexual organs at risk   
• 
PaƟent-reported outcomes on sexual health issues 
• 
PaƩern of care;  dilator use, lubricaƟon, hormone treatment(local/systemic), received 
specialized sexual counseling.  
• 
PaƟent saƟsfacƟon with the exisƟng sexual rehabilitaƟon program 
Data collecƟon 
1. Sociodemographic data 
Sociodemographic data will be collected via a case report form (CRF) during the consultaƟon 
where the gynecological examinaƟon is performed. This data includes age, smoking status, 
menopausal status, relaƟonship status, WHO performance status, and comorbidiƟes. (ﬁrst 
part of Appendix 1)  
 
2. Clinical data 
Clinical data will be extracted from medical records. They will encompass details of the anal 
cancer diagnosis, including tumor locaƟon (with speciﬁc informaƟon on vaginal invasion if 
present), tumor volume and length, histological type, and TNM classiﬁcaƟon. InformaƟon 
about the treatments received will be detailed, including radiaƟon dose and fracƟonaƟon 
schedule, as well as chemotherapy regimens. AddiƟonally, data on any salvage surgery or 
recurrence will be collected, along with details of any subsequent treatments provided for 
the recurrence. Access to these records will be granted to the principal invesƟgator and 
relevant regulatory authoriƟes for research purposes, including monitoring, quality control, 
and compliance with required oversight. 
3. Gynecological examinaƟons: 
Comprehensive vaginal morbidity will be assessed using an electronic case report form, as 
detailed in Appendix 1. The morbidity assessment form is based on vaginal morbidity 
documentaƟon following radiotherapy for cervical cancer, as described by Kirchheiner 
(2012)16. This methodology has also been employed in Suvaal (2023)17. 

 
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To ensure uniform grading of vaginal morbidity across the study sites, a dedicated seminar 
will be held before the iniƟaƟon of paƟent inclusion. This seminar will involve all relevant 
physicians responsible for assessments at the three parƟcipaƟng centers to align 
understanding and grading pracƟces, minimize inter-observer variability, and ensure 
consistency in evaluaƟons throughout the study. 
4. PaƟent-reported outcome measures: 
Electronic surveys will be sent following the control visit where the gynecological 
examinaƟon is performed. A reminder email will be sent aŌer one week if a response is 
missing. If the paƟent cannot access the survey electronically, it will be handed in on paper 
form during the consultaƟon and entered electronically aŌerward. 
The survey will include validated quesƟonnaires:  the European OrganizaƟon for the 
Research and Treatment of Cancer Quality of Life Core QuesƟonnaire (EORTC QLQ-C30) with 
the Anal Cancer Module (EORTC-QLQ-ANL27), EORTC Sexual Health QuesƟonnaire (EORTC-
QLQ-SH22), and Female Sexual FuncƟon Index (FSFI). See Appendix 2 for details on these 
quesƟonnaires.  
In addiƟon to the quesƟonnaires menƟoned, there will be quesƟons regarding paƩerns of 
care, see Appendix 3 
5. RadiaƟon Dose parameter: 
The principal invesƟgator will retrospecƟvely delineate the vagina on therapy scans from the 
included parƟcipants in accordance with applicable delineaƟon guidelines. Based on this, a 
retrospecƟve analysis of dose-volume histograms will be performed to idenƟfy correlaƟons 
between vaginal morbidity and radiaƟon exposure. 
6. Interviews: 
Semi-structured interviews with early parƟcipants will be conducted over the telephone 
using the interview guide provided in Appendix 4. The interviews will be conducted with 
notes taken on themes and quotes during the sessions for further analysis. 
Data management 
All data will be entered into a secure electronic database (REDCap) hosted at Aarhus University 
Hospital. Compliance with GDPR and Danish data protecƟon regulaƟons will be ensured.  
Sample size and staƟsƟcal analysis plan 
Sample size  
Annually, approximately 120 women in Denmark undergo treatment for anal cancer, with roughly 
stage distribuƟons of 25% (Stage I), 52% (Stage II), 17% (Stage III), and 6% (Stage IV)18. Using survival 
data from the RTOG 98-11 trail19, we calculated 1-, 2-, and 3-year survival rates assuming a linear 
decline from 100% survival at treatment iniƟaƟon to the reported 5-year survival rates of 82% for 
Stage I, 74% for Stage II, 57% for Stage III, and 42% for Stage IV. From these calculaƟons, women 
treated three years ago contributed approximately 99 women alive, those treated two years ago 
contributed 106, and those treated one year ago contributed 113, yielding a total of 318 women who 
have received treatment for anal cancer within a period of three years are alive and eligible for 
follow-up. Given the sensiƟve nature of topics such as gynecological toxicity and sexual dysfuncƟon, 

 
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we conservaƟvely esƟmate a parƟcipaƟon rate of 30%. This results in an expected inclusion of 80 
parƟcipants.  
This sample size of approximately 80 parƟcipants will allow us to achieve 80% staƟsƟcal power to 
detect a correlaƟon between radiaƟon dose and vaginal stenosis, with a signiﬁcance level of 0.05 and 
an assumed moderate correlaƟon coeﬃcient of r=0.3. This power calculaƟon ensures that the study 
is adequately designed to invesƟgate the potenƟal dose-response relaƟonship 
For the semi-structured interview sub-study, 20 parƟcipants are iniƟally included to explore paƟent 
saƟsfacƟon with the sexual rehabilitaƟon program. ThemaƟc analysis will guide data collecƟon and 
analysis, following an iteraƟve approach to idenƟfy saturaƟon. SaturaƟon is deﬁned as the point 
where no new themes, paƩerns, or insights emerge, ensuring data uƟlity is maximized. 
If themaƟc saturaƟon is not reached aŌer the iniƟal sample, addiƟonal parƟcipants will be included 
in batches of 5 parƟcipants. This approach ensures robust, comprehensive ﬁndings aligned with the 
research objecƟves while maintaining methodological rigor 20 
StaƟsƟcal analysis plan 
Vaginal stenosis grade 2 or above, will be calculated as the proportion of participants meeting the 
criteria out of the total number of participants. A 90% confidence interval (CI) will be used to 
indicate the uncertainty surrounding the prevalence estimate. 
Physician-reported vaginal outcomes: Variables such as adhesions, elasticity, telangiectasias, 
ulcerations, and bleeding will be summarized using descriptive statistics  
Patient-reported outcomes (PROs): Data from the Female Sexual Function Index (FSFI), EORTC-QLQ-
SH22 and EORTC-QLQ-C30 with the ANL24 supplement will be analyzed. Scores will be calculated 
according to the respective guidelines, transforming raw data into standardized scores. Comparisons 
across groups (e.g., stenosis vs. no stenosis) will be made using appropriate tests such as t-tests or 
Mann-Whitney U tests. 
 
Dose-response relationship: This will be explored using logistic regression, assessing the relationship 
between radiation dose and vaginal stenosis grade 2 or above. A dose-response curve will also be 
generated using spline regression to visualize potential non-linear relationships. 
Patient care satisfaction: Data from semi-structured interviews will be analyzed using thematic 
analysis to identify key themes and patterns related to patient satisfaction with guidance and 
counseling on gynecological and sexual issues post-treatment. Notes will be coded in an exploratory 
manner, allowing themes to emerge from the data and ensuring a comprehensive understanding of 
patient experiences and perspectives.  
All analyses will be conducted using a predefined statistical significance level of 0.05. Results will be 
reported with appropriate measures of uncertainty, such as confidence intervals. Quantitative data 
analyses will be performed using StataSE18 software, and qualitative data will be analyzed using 
NVivo14 software. 
Study schedule (tentaƟve)  
Protocol approved: AwaiƟng  

 
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Inclusion start: 01.05.2025 
Inclusion end: 01.05.2026 2026 
End of data collecƟon: June 2026 
Data analysis and interpretaƟon: Fall 2026 
 
Plans for disseminaƟon and reporƟng 
The ﬁndings of this study will be disseminated to ensure academic and public access to the results. 
Planned acƟviƟes include publishing study results in peer-reviewed scienƟﬁc journals and 
presentaƟons at naƟonal and internaƟonal conferences focusing on oncology, radiaƟon therapy, and 
survivorship care. All results, whether posiƟve, negaƟve, or inconclusive, will be published to 
contribute to the broader evidence base. 
Eﬀorts will also be made to communicate the key ﬁndings in layperson-friendly formats, such as 
paƟent-oriented brochures or updates to clinical pracƟce guidance, to beneﬁt survivors and 
healthcare professionals involved in anal cancer care. 
The principal invesƟgator (Johanne Hollands Steﬀensen) will be ﬁrst author on the papers. All 
invesƟgators will be invited for a co-authorship according to the Vancouver regulaƟons  
Ethical issues, safety aspects, and complicaƟons 
The study will adhere to ethical standards and obtain approval from relevant medical ethics 
commiƩees. All parƟcipants will provide wriƩen and oral informed consent before inclusion in the 
study. No serious complicaƟons are expected from the gynecological examinaƟon. In the short term, 
some individuals may experience temporary discomfort during the procedure. AddiƟonally, 
discussing inƟmate topics may be emoƟonally distressing for some parƟcipants. While no long-term 
risks are known, unforeseen burdens related to parƟcipaƟon cannot be enƟrely ruled out. If you 
experience discomfort, you have the right to withdraw from the study at any Ɵme or choose not to 
answer speciﬁc quesƟons.Emphasis will be placed on minimizing discomfort and safeguarding 
parƟcipant conﬁdenƟality. The anƟcipated beneﬁts of the research include improved treatment 
outcomes and enhanced quality of life for future paƟents. 
Funding and Financial Disclosure 
The study is invesƟgator-iniƟated, with the invesƟgator independently designing and conducƟng the 
research.  
ParƟcipants in this study are covered by the Danish Act on Complaints and CompensaƟon within the 
Healthcare System, and any complaints can be submiƩed to the Danish Agency for PaƟent 
Complaints in accordance with applicable regulaƟons. 
A grant from the Independent Research Fund Denmark (DKK 2.112.424) covers expenses related to 
the project-speciﬁc invesƟgaƟons. The grant funds are administered by Aarhus University. None of 
the researchers involved have ﬁnancial interests in the project or aﬃliaƟons with the funding 
provider. No ﬁnancial compensaƟon will be provided to study parƟcipants. 
 
 

 
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Appendix I 
VAGINAL MORBIDITY AT GYNAECOLOGICAL EXAMINATION 
It is advised to manually assess adhesions before inserƟng the speculum for gynecological 
examinaƟon. In addiƟon to grading, it is mandatory to specify the exact locaƟon of toxicity on the 
provided 3D vaginal map, divided into upper, middle, and lower thirds. 
ParƟcipant ID 
 
Time since last RT  
 
Date 
 
Family status 
 
 no partner  
 partner  
Menopausal status 
 
 premenopausal 
 postmenopausal 
Smoking status   
 
  Never 
  Previous  
  AcƟve  
WHO performance 
status 
 
  P0 
  P1 
  P2 
  P3 
Specify co-
morbidiƟes  
 
 
Vaginal stricture 
(CTCAE v. 5) 
 
 None  
 AsymptomaƟc; mild vaginal shortening or narrowing  
 Vaginal narrowing and/or shortening not interfering with physical 
examinaƟon  
 Vaginal narrowing and/or shortening interfering with the use of tampons, 
sexual acƟvity, or physical examinaƟon  

 
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Vaginal Adhesions  
 
 no adhesions 
 
 
 
 adhesions in the upper third 
 
 
 
 adhesions in the middle third 
 
 
 
 
 adhesions in the lower third 
Vaginal ElasƟcity 
 
 Ɵssue soŌ and mobile 
 Ɵssue a liƩle ﬁrm and mobile 
 Ɵssue quite hard with limited mobility 
 Ɵssue hard and immobile 
 complete obliteraƟon, not accessible 
Vaginal Fibrosis 
 
 no ﬁbrosis 
 
 
 ﬁbrosis in the upper third 
 
 
 ﬁbrosis in the middle third 
 
 
 ﬁbrosis in the lower third 
 
 
 
 
 
Middle third 
Upper third 
Lower third
Middle third 
Upper third
Lower third

 
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Vaginal 
Telangiectasia  
 
 no telangiectasia  
 
 
 telangiectasia in the upper third 
 
 
 telangiectasia in the middle third 
 
 
 telangiectasia in the lower third 
 
Vaginal 
Telangiectasia 
contact bleeding 
 
 no telangiectasia  
 TA without contact bleeding 
 TA with contact bleeding 
Vaginal Fragility / 
Bleeding                      
with examinaƟon  
 
 none / robust 
 development of erythema or petechiae, no surface bleeding 
 moderate surface fragility with minimal trace bleeding 
 overt/obvious bleeding with examinaƟon  
Vaginal UlceraƟon   
 
 none 
 
 limited (<1cm2) superﬁcial ulceraƟon                                                             
   (loss of surface epithelium) 
 
 widespread (>1cm2) or deep ulceraƟon 
(loss/devitalisaƟon of deeper Ɵssue layers/necrosis) 
Middle third 
Upper third 
Lower third 
Middle third 
Upper third 
Lower third 

 
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Appendix 2 
 
 
Instrument 
Description 
Number 
of Items 
Sub-scales 
Answer 
Categories 
References 
FSFI 
Measures 
female sexual 
function 
across six 
domains. 
19 Desire 
Arousal 
Lubrication orgasm 
Satisfaction 
Pain 
0 (no 
activity) to 
5 (optimal 
function). 
Rosen (2000)21 
Wiegel (2005)22 
Meston (2020)23 
EORTC QLQ-
C30 
Core QoL 
questionnaire 
for cancer 
patients in 
clinical trials. 
30 Functional (physical, role, 
emotional, cognitive, 
social)  
Symptoms (fatigue, 
nausea/vomiting, pain) 
Global health   
 
Single items (e.g., 
insomnia) 
1 to 4 
Likert scale 
(1 to 7 for 
global 
health 
status). 
Aaronson(1993)24
Osoba (1997)25 
EORTC QLQ-
ANL27 
Anal cancer-
specific QoL 
module 
supplementing 
QLQ-C30. 
27 Bowel symptoms 
(with/without stoma)  
Pain/discomfort  
Stoma-care  
Vaginal symptoms 
 
Urinary frequency and 
urgency, swelling in legs, 
self-cleaning, planning 
activities, sex life,  
sexual interest, painful 
intercourse, and erectile 
problems.  
1 to 4 
Likert scale. 
Sodergren 
(2023)26 
EORTC QLQ-
SH22 
Sexual health 
assessment 
for cancer 
patients/surviv
ors. 
22 Sexual satisfaction 
Sexual pain 
 
Sexual activity, decreased 
libido, incontinence, 
fatigue, treatment, 
communication with 
professionals, 
partnership, confidence 
erection 
body image (male), body 
image (female), vaginal 
dryness 
1 to 4 
Likert scale. 
Greimel (2021)27 

 
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Appendix 3 
PaƩern of care quesƟonnaire:  
AŌer your radiotherapy treatment, have you, at 
any point, performed vaginal dilaƟon, either by 
using vaginal dilators or through vaginal 
intercourse? 
 
 No 
 
 Yes 
 
 If No:  
Why have you not performed vaginal dilaƟon?  
 
 
-------------------------------------- 
 
 If Yes:  
How oŌen did you perform vaginal dilaƟon 
during the ﬁrst 6-12 months aŌer radiotherapy, 
either by using vaginal dilators or through 
vaginal intercourse?  
If you have not reached 12 months aŌer 
compleƟng radiotherapy, how oŌen have you 
performed vaginal dilaƟon since radiotherapy, 
either by using vaginal dilators or through 
vaginal intercourse? 
 
 Not at all 
 Less than/or one Ɵme per month 
 
 1-4 Ɵmes per month 
 
 2-3 Ɵmes per week or more 
 
 Don’t remember  
 
How oŌen have you performed vaginal dilaƟon 
in the past 3 months, either by using vaginal 
dilators or through vaginal intercourse? 
 
 Not at all 
 Less than/or one Ɵme per month 
 
 1-4 Ɵmes per month 
 
 2-3 Ɵmes per week or more 
 
 Don’t remember  
 
If Not at all: 
When did you stop?  And why? 
 
-------------------------------------- 
 
Do you use any hormone therapy? 
 
 No 
 Lokal hormone treatment (e.g. Vagifem)  
 
 Systemic hormone treatment  
AŌer compleƟng radiotherapy, have you had 
one or more consultaƟons with specialized 
sexual health nurses or another sexologist to 
discuss sexual issues related to your cancer 
treatment? 
 
 No, I have not had any consultaƟons. 
 
 No, but I would have liked to. 
 
 Yes, I have had one or more consultaƟons 
 
 
 
 

 
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Appendix 4 
Semi-Structured Interview Guide: PaƟent SaƟsfacƟon with Counseling 
IntroducƟon 
Welcome 
"Thank you for parƟcipaƟng. My name is [your name], and I would like to discuss your experiences 
with guidance regarding gynecological and sexual issues aŌer radiaƟon therapy for anal cancer." 
"Your input will help us improve how we support paƟents in the future. ParƟcipaƟon is voluntary, 
and you can skip quesƟons or end the interview anyƟme. Your answers will remain conﬁdenƟal." 
"Before we begin, do you have any quesƟons for me?" 
SecƟon 1: Background informaƟon  
• 
Have you experienced any side eﬀects related to gynecological issues or sexual dysfuncƟon, 
such as localized pain in the vaginal area, vaginal bleeding, narrowing of the vagina, 
abnormal discharge, or more general eﬀects on sexual funcƟon or desire, including impacts 
on body image? 
 
SecƟon 2: InformaƟon received 
• 
What and When: 
Can you describe what informaƟon you were given about gynecological and sexual side 
eﬀects? 
When during your treatment journey were you informed about these potenƟal side eﬀects? 
And by who? 
• 
Adequacy of informaƟon: 
What do you think about the Ɵming and amount of informaƟon on the topic you were given? 
 
SecƟon 3: Preparedness and Support  
• 
Preparedness: 
Did the guidance you received make you feel adequately prepared to handle these side 
eﬀects? Why or why not? 
• 
Barriers: 
Were there any barriers for you to discuss gynecological or sexual issues with healthcare 
providers? 
If yes, what were these barriers (e.g., discomfort, lack of Ɵme, cultural factors)? 
 
SecƟon 4: Preferences for CommunicaƟon  
• 
Preferred Healthcare Professional: 
Is there a parƟcular type of healthcare professional you feel most comfortable discussing 
these issues with (e.g., nurse, doctor, counselor)? 

 
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• 
SuggesƟons for Improvement: 
Do you have any suggesƟons on how guidance about these side eﬀects could be improved 
for future paƟents? 
Conclusion 
• 
Wrap-Up: 
Is there anything else you would like to share about your experience or the guidance you 
received? 
• 
Thank You: 
Thank the parƟcipant for their Ɵme and valuable insights. 
 
 

 
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