Thias study entailed the development (Phase I), pilot (Phase II) and randomised controlled trial (RCT) (Phase III) of a psychosexual information booklet for women undergoing pelvic radiation therapy (PRT) for gynaecological or anorectal cancer. This was undertaken due to the high prevalence of psychosexual morbidity following PRT, and the lack of existing resources to facilitate recovery and reduce distress.
The psychosexual information booklet was developed based on the literature, input from an expert multi-disciplinary advisory group, and published standards in developing information materials for cancer consumers.
After the booklet development, a mainly qualitative retrospective pilot study was conducted which explored: a) women’s experiences and rehabilitation informational needs following PRT; b) the feasibility and acceptability of providing women with an information booklet about radiation-induced side effects potentially affecting recovery, and especially sexual functioning/vaginal changes; and c) assessed the acceptability of a measurement protocol that would be used in a later RCT. The pilot highlighted many challenges to quality of life faced by women after PRT, and revealed diverse informational needs, particularly regarding sexual rehabilitation. Overall, the pilot findings provided support for the provision of a psycho-educational resource to better support women in physical and psychosexual rehabilitation following PRT, as well as some guidance regarding improving the format of the booklet. The pilot booklet was revised based on participant feedback, as well as the recent Cochrane Review (Johnson & Miles, 2010) findings regarding vaginal dilator use. Given the high levels of acceptability of the pilot psychosexual booklet, its effectiveness was then prospectively evaluated in a multicentre randomised controlled trial (RCT).
The longitudinal quantitative RCT assessed whether the psychosexual booklet improved adherence to recommended rehabilitation strategies (dilator use, vaginal lubrication and pelvic floor muscle exercises), improved knowledge, lowered levels of anxiety, depression and PRT-related psychological distress and improved sexual activity, function and satisfaction post PRT. The RCT demonstrated that the psychosexual booklet improved knowledge and vaginal dilator use.
Table of Contents
1. Introduction
1.1 Incidence, prognosis and treatment for gynaecological and female anorectal cancers
1.2 Cancer in Australia
1.3 Gynaecological and female anorectal cancers: Incidence, prevalence and aetiology
1.3.1 Gynaecological Cancer (GC)
1.3.2 Female Anorectal Cancers (ARC)
1.4 Treatment for cancers in the pelvic region
1.4.1 Surgery for GC (CC, VC, VUC and EC) and its side effects
1.4.2 Chemotherapy for GC and its side effects
1.4.3 Surgery for RC and AC and its side effects
1.4.4 Chemotherapy for RC and AC and its side effects
1.4.5 Pelvic radiation therapy (PRT) and its side effects
1.4.5.1 Types of PRTs
1.4.5.2 General side effects of PRT
1.5 Summary
2. Vaginal changes and sexual side effects following PRT for gynaecological and female anorectal cancer patients; Psychosexual Information and support needs
2.1 Introduction
2.2.1 Physical changes after pelvic radiation therapy (PRT)
2.2.1.1 Main radiation physical damage to the vaginal canal in gynaecological and female anorectal patients: vaginal toxicity and stenosis
2.2.2 Sexual changes after pelvic radiation therapy (PRT)
2.2.3 Psychological and quality of life (QOL) sequelae of sexual dysfunction post PRT
2.3 Rehabilitation strategies: Vaginal dilators, lubricants and pelvic floor exercises
2.3.1 Vaginal dilators
2.3.1.1 Adherence to use of vaginal dilators
2.3.1.2 Barriers to vaginal dilator use post PRT
2.3.1.3 Reducing barriers to using dilators
2.3.2 Other Rehabilitation Strategies: Vaginal Moisturisers, Lubricants and Pelvic Floor Muscle Exercises (Kegel)
2.3.2.1 Lubricants and moisturisers
2.3.2.2 Pelvic floor muscle exercises (Kegel)
2.3.3 Evidence regarding the impact of dilator use
2.4 Information and supportive care needs after PRT
2.4.1 Unmet needs for information and support
2.4.2 Factors impacting on information provision
2.5 Patient-clinician communication about PRT treatment-related sexual issues
2.6 Psychoeducational psychosexual interventions and resources
2.6.1 Printed materials
3. Phase I: The development of a pelvic radiation therapy psychosexual rehabilitation information booklet for women with gynaecological and anorectal cancer
3.1 Introduction
3.2 Booklet development
3.2.1 Steps in developing and evaluating the booklet
3.2.1.1 Assess need
3.2.1.2 Assess feasibility
3.2.1.3 Defining the objectives of the aid
3.2.1.4 Identify the framework of decision support
3.2.1.5 Select the methods of decision support to be used in the aid
3.2.1.6 Select the designs and measures to evaluate the aid
3.2.1.7 Plan dissemination
3.3 Booklet development
3.5 Tailoring and acknowledging the sensitivity of the content
3.4 Ensuring rigour and quality of the booklet
3.6 Summary
4. Phase II: The pilot of the study developed pelvic radiation therapy psychosexual rehabilitation information booklet for women with gynaecological and anorectal cancer
4.1 Aims
4.2 Method
4.2.1 Design
4.2.2 Sample
4.2.3 Procedures
4.2.4 Ethics
4.2.5 Measures
4.2.5.1 Hospital Anxiety and Depression Scale (HADS) (Zigmond & Snaith, 1983)
4.2.5.2 The Impact of Event Scale-Revised (IES-R) (Weiss & Marmar, 1997)
4.2.5.3 Sexual Function Measures
4.2.5.3.1 The Female Sexual Function Index (FSFI) (Rosen et al., 2000) - the Satisfaction Subscale
4.2.5.3.2 The Sexual Activity Questionnaire (SAQ) (Thirlaway et al., 1996)
4.2.5.3.3 The Sexual Functioning After Gynaecological Illness Scale (SFAGIS) (Bransfield, Horiot, & Nabid, 1984)
4.2.5.4 Knowledge Scale
4.2.5.5 Feedback Scale
4.2.6 Demographic and Clinical information
4.2.7 Semi- structured Telephone Interview
4.2.8 Sample size
4.2.9 Data analysis
4.2.9.1 Qualitative data
4.2.9.2 Trustworthiness
4.2.9.3 Quantitative data
4.3 Results
4.3.1 Sample characteristics
4.3.1.1 Psychological Characteristics
4.3.1.2 Sexual Function and Satisfaction Outcomes
4.3.1.3 Knowledge/Understanding
4.3.2 Qualitative results
4.3.2.1 Pilot aims i) and ii) results:
4.3.2.1.1 Experiences of care in their healthcare setting for women with regards to sexuality post PRT
4.3.2.1.2 Booklet content validating sexuality for women post PRT
4.3.2.1.3 Use of booklet over the cancer journey for women undergoing PRT
4.3.2.1.4 Acceptability of the booklet content and format for women post PRT
4.3.2.1.5 Suggested improvements of booklet
4.3.2.2 Pilot aim iii) results
4.4 Discussion
4.4.1 Pilot aims i) and ii)
4.5 Limitations
4.6 Conclusion
5. Phase III: The randomised controlled trial of the study developed pelvic radiation therapy psychosexual rehabilitation information booklet for women with gynaecological and anorectal cancer
5.1 Aims and Research Design
5.2 Hypotheses
5.3 Method
5.3.1 Sample
5.3.1.1 Participants Inclusion/Exclusion criteria
5.3.1.2 Recruitment procedure
5.3.1.3. Study Procedure
5.3.2 Ethical considerations
5.3.3 Measures
5.3.3.1 Demographic and clinical characteristics
5.3.3.2 Primary Outcome Measure
5.3.3.1.1 Background of the study purpose-designed scales scoring methods
5.3.3.1.2 Adherence Scale (AS)
5.3.3.2 Secondary outcome measures
5.3.3.2.1 Perceived effectiveness of these rehabilitation strategies in aiding recovery (AS)
5.3.3.2.2 Knowledge Scale (KS)
5.3.3.2.3 Feedback Scale (FS)
5.3.3.2.4 Psychological status - Hospital Anxiety and Depression Scale (HADS) (Zigmond & Snaith, 1983)
5.3.3.2.5 Psychological status - The Impact of event Scale-Revised (IES-R) (Weiss & Marmar, 1997)
5.3.3.2.6 Sexual Function and Satisfaction - The Sexual Activity Questionnaire (SAQ) (Thirlaway et al., 1996)
5.3.3.2.7 Sexual Function and Satisfaction - Sexual Vaginal Changes Questionnaire (SVQ) (Jensen et al., 2004a)
5.3.3.2.8 Sexual Function and Satisfaction - The Sexual Functioning After Gynaecological Illness Scale (SFAGIS) (Bransfield, Horiot, & Nabid, 1984)
5.3.4 Data Analysis
5.3.4.1 Checking Assumptions and Choice of Statistics
5.3.4.2 Data Analysis Aims - Baseline
5.3.4.2.1 Confounding variables #1: Demographic and Clinical data
5.3.4.2.2 Confounding Variables #2: Psychological Variable (HADS)
5.3.4.2.3 Confounding Variables #3: Impact of Events Scale (IES-R)
5.3.4.3 Data Analysis Aims - First Follow-up
5.3.4.3.1 Analysis of clinical conditions - Baseline and First Follow Up
5.3.4.3.2 Multiple Linear Regression - Using Baseline and First Follow-up Phase Data
5.3.4.4 Data Analysis Aims - Second Follow-up
5.3.4.1.1 Analysis of clinical conditions - Baseline and Second Follow Up
5.3.4.1.2 Multiple Linear Regression - Using Baseline and Second Follow-up Phase Data
5.3.4.1.3 Multiple Linear Regression - Using First Follow-up and Second Follow-up Phase Data
5.3.4.1.4 Multiple Linear Regression - Using Baseline, First Follow-up and Second Follow-up Phase Data
5.3.4.5 Missing Value Handling
5.4. RESULTS
5.4.1 Baseline
5.4.1.1 Differences between groups at baseline on demographic and clinical characteristics
5.4.1.2 Psychological Status - Baseline
5.4.1.2.1 Hospital Depression and Anxiety Scale (HADS) - Differences between groups at baseline
5.4.1.2.2 Impact of Event Scale Revised (IES-R) - Differences between groups at baseline
5.4.1.3 Sexual Function
5.4.1.3.1 Sexual Activity Questionnaire (SAQ) - Differences between groups at baseline
5.4.1.3.2 Overall group and sample SAQ response frequencies at baseline
5.4.1.3.3 Sexual Vaginal Changes Questionnaire (SVQ) - Differences between groups at baseline
5.4.1.4 Correlation Analysis - Baseline
5.4.1.5 A summary of baseline results
5.4.2 First Follow-up
5.4.2.1 Rehabilitation Strategies - First Follow-up
5.4.2.1.1 Adherence Scale (AS) - First Follow-up
5.4.2.2 Knowledge Scale (KS) - First Follow-up
5.4.2.3 Feedback Scale (FS) - First Follow-up
5.4.2.4 Psychological Status - First Follow-up
5.4.2.4.1 Hospital Depression and Anxiety Scale (HADS) - Differences between groups at first follow-up
5.4.2.4.2 Impact of Event Scale Revised (IES-R) - Differences between groups at first follow-up
5.4.2.5 Sexual Function - First Follow-up
5.4.2.5.1 Sexual Activity Questionnaire (SAQ) - Differences between groups at first follow-up
5.4.2.3.2 Sexual Vaginal Changes Questionnaire (SVQ) - Differences between groups at first follow-up
5.4.2.5.3 The Sexual Functioning After Gynaecological Illness Scale (SFAGIS) - First follow-up
5.4.2.6 Correlation Analysis
5.4.2.7 Analysis of clinical conditions - Baseline and First Follow Up
5.4.2.8 Multiple Linear Regression - Using Baseline and First Follow-up Phase Data
5.4.2.8.1 Intimacy
5.4.2.8.2 Sexual Interest
5.4.2.8.3 Worries about sex life
5.4.2.8.4 Anxiety
5.4.2.8.5 Depression
5.4.2.8.6 IES-R
5.4.3 Second Follow-up
5.4.3.1 Rehabilitation Strategies - Second Follow-up
5.4.3.1.1 Adherence Scale (AS) - Second Follow-up
5.4.3.2 Knowledge Scale (KS) - Second Follow-up
5.4.3.3 Feedback Scale (FS) - Second Follow-up
5.4.3.4 Psychological Status - Second Follow-up
5.4.3.4.1 Hospital Depression and Anxiety Scale (HADS) - Differences between groups at Second follow-up
5.4.3.4.2 Impact of Event Scale Revised (IES-R) - Differences between groups at Second follow-up
5.4.3.5 Sexual Function - Second Follow-up
5.4.3.5.1 Sexual Activity Questionnaire (SAQ) - Differences between groups at Second follow-up
5.4.3.5.2 Sexual Vaginal Changes Questionnaire (SVQ) - Differences between groups at Second follow-up
5.4.3.5.3 The Sexual Functioning After Gynaecological Illness Scale (SFAGIS) - Second follow-up
5.4.3.6 Correlation Analysis
5.4.3.7 Analysis of clinical conditions - Baseline and Second Follow Up
5.4.3.8 Multiple Linear Regression - Using Baseline and Second Follow-up Phase Data
5.4.3.8.1 Intimacy
5.4.3.8.2 Sexual Interest
5.4.3.8.3 Anxiety
5.4.3.8.4 Depression
5.4.3.8.5 IES-R
5.4.3.9 Multiple Linear Regression - Using First Follow-up and Second Follow-up Phase Data
5.4.3.9.1 Use and frequency of use of Dilator score
5.4.3.9.2 Use and frequency of use of Moisturiser score
5.4.3.9.3 Use and frequency of use of PFME score
5.4.3.9.4 Knowledge score
5.4.3.9.5 Feedback score
5.4.3.10 Multiple Linear Regression - Using Baseline, First Follow-up and Second Follow-up Phase Data
5.4.3.10.1 Intimacy
5.4.3.10.2 Sexual Interest
5.4.3.11.3 Anxiety
5.4.3.12.4 Depression
5.4.3.13.5 IES-R
6. Overall discussion of the information booklet randomised controlled trial findings
6.1 Introduction
6.2 Primary and Secondary Outcomes
6.2.1 Primary Outcome: Adherence to rehabilitation strategies
6.2.1.1 Dilator use
6.2.1.2 Adherence to vaginal lubricant and moisturiser use
6.2.1.3 Adherence to pelvic floor muscle exercises (PFME)
6.2.2 Secondary Outcomes
6.2.2.1 Knowledge
6.2.2.2 Feedback (booklet acceptability)
6.2.2.3 Psychological status
6.2.2.3.1 PRT-related Psychological distress/Posttraumatic stress
6.2.2.3.2 Anxiety
6.2.2.3.3 Depression
6.2.2.3.4 Conclusions on psychological status
6.2.3.4 Sexual activity/function/satisfaction
6.2.3.4.1 Patient-doctor communication/information needs related to sexuality
6.3 Strengths and limitations of this study
6.3.1 Limitations
6.3.1.1 Sample size and response rate
6.3.1.2 Missing data
6.3.1.3 Control condition
6.3.1.4 Generalisability
6.3.1.5 Differing study methodologies
6.3.2 Strengths
6.4 Future Research Directions
6.5 Summary
7. Overall study conclusions
7.1 Introduction
7.2 Advantages of mixed methods
7.3 Limitations of the study
7.4 Strengths of the study
7.5 Lessons learned
7.6 Clinical Implications
7.7 Future research
Research Objectives and Themes
The primary objective of this study was to develop, pilot, and evaluate a psychosexual rehabilitation information booklet designed for women undergoing pelvic radiation therapy (PRT) for gynaecological or anorectal cancer, aiming to improve knowledge, increase adherence to rehabilitation strategies, and reduce psychosexual morbidity.
- Development of a specialized psycho-educational resource based on expert and patient input.
- Evaluation of patient information needs, feasibility, and acceptability of the resource in a pilot study.
- Prospective randomized controlled trial (RCT) assessing the impact of the booklet on clinical outcomes.
- Investigation of psychological status, sexual function, and adherence to rehabilitation protocols.
- Analysis of patient-clinician communication and barriers to information provision.
Excerpt from the Book
Coping with sexual difficulties following pelvic radiation therapy
An intimate relationship with a partner may help you to feel loved and supported as you go through your cancer treatment. The loving support of family and friends is just as important. Restoring sexual activity may take time, particularly if there are continuing side effects from your cancer treatments. Where possible, it is recommended to prevent or minimise these side effects even if you have no intention of being sexually active now or in the immediate future.
Listed below are some tips on how to anticipate, cope with and get help for common sexual difficulties that you and your partner may be experiencing.
Knowing what sexual side effects could occur before you begin your cancer treatment can help you be more prepared to deal with them as you go through treatment. If you experience side effects, find out from a qualified health professional as much as you can about what may be causing them and methods to manage them. This will help you feel more in control of the situation and be aware of all the treatment options available to you.
It may also just simply take time for you to regain your sexual function after cancer treatment. While that can be frustrating it is good to remember that if you had a positive and satisfying sex life before cancer you’ll likely resume that after your treatment. A rewarding intimacy with your partner is not dependant on sexual intercourse.
Summary of Chapters
CHAPTER 1 - Introduction: This chapter provides an overview of the incidence, prognosis, and treatment options for gynaecological and female anorectal cancers, including the side effects of pelvic radiation therapy.
CHAPTER 2 - Vaginal changes and sexual side effects following PRT for gynaecological and female anorectal cancer patients; Psychosexual Information and support needs: The chapter explores the impact of PRT on sexual health, quality of life, and the role of rehabilitation strategies and communication in managing these effects.
CHAPTER 3 - Phase I: The development of a pelvic radiation therapy psychosexual rehabilitation information booklet for women with gynaecological and anorectal cancer: This chapter details the systematic development of the information booklet based on guidelines and expert advisory group input.
CHAPTER 4 - Phase II: The pilot of the study developed pelvic radiation therapy psychosexual rehabilitation information booklet for women with gynaecological and anorectal cancer: This chapter presents the results of a pilot study investigating the feasibility and acceptability of the newly developed information booklet.
CHAPTER 5 - Phase III: The randomised controlled trial of the study developed pelvic radiation therapy psychosexual rehabilitation information booklet for women with gynaecological and anorectal cancer: This chapter outlines the methodology and results of the multicentre randomized controlled trial evaluating the effectiveness of the booklet.
CHAPTER 6 - Overall discussion of the information booklet randomised controlled trial findings: This chapter discusses the primary and secondary outcomes of the study, including adherence, knowledge, and psychological status, and reviews the strengths and limitations of the research.
CHAPTER 7 - Overall study conclusions: The final chapter summarizes the study's overall conclusions, advantages of the mixed-methods approach, clinical implications, and directions for future research.
Keywords
Pelvic Radiation Therapy, Gynaecological Cancer, Anorectal Cancer, Psychosexual Rehabilitation, Vaginal Dilators, Sexual Function, Quality of Life, Information Booklet, Psychoeducation, Cancer Survivorship, Pelvic Floor Muscle Exercises, Sexual Dysfunction, Patient-Clinician Communication, Randomized Controlled Trial, Adherence
Frequently Asked Questions
What is the core focus of this research?
The research focuses on addressing the unmet psychosexual needs of women undergoing pelvic radiation therapy for gynaecological or anorectal cancer through the development and evaluation of a specialized information resource.
What are the primary themes investigated in this work?
The work examines physical and sexual side effects of PRT, patient information needs, communication barriers between patients and clinicians, and the feasibility of rehabilitation strategies like vaginal dilators.
What is the main objective or research question?
The study aims to determine if a purpose-designed psychosexual information booklet can improve patient knowledge, increase adherence to recommended rehabilitation strategies, and reduce anxiety and psychological distress post-treatment.
Which scientific methods were employed?
The study utilized a multi-phase approach, beginning with booklet development, followed by a qualitative pilot study (Phase II), and culminating in a longitudinal, multicentre randomised controlled trial (RCT) (Phase III) with quantitative measures.
What content is covered in the main body of the thesis?
The body covers a review of the literature on post-PRT effects, the iterative development and pilot testing of the booklet, the implementation of an RCT to evaluate its effectiveness, and a final discussion of findings and clinical implications.
Which keywords define this research?
Key terms include Pelvic Radiation Therapy, Psychosexual Rehabilitation, Gynaecological Cancer, Sexual Function, Adherence, Patient Information, and Randomised Controlled Trial.
How does the information booklet specifically support vaginal health?
The booklet provides evidence-based guidance on the regular use of vaginal dilators, lubricants, and moisturisers, as well as pelvic floor muscle exercises to mitigate radiation-induced vaginal stenosis and improve overall comfort.
What conclusion did the author reach regarding the impact of the booklet?
The author concluded that while the booklet significantly improved patient knowledge and adherence to vaginal dilation, it did not significantly impact broader psychological outcomes, suggesting the need for additional supportive interventions.
- Arbeit zitieren
- Franchelle P. Lubotzky (Autor:in), 2015, The development, pilot and randomised controlled trial of a psychosexual rehabilitation information booklet for women undergoing pelvic radiation therapy for gynaecological or anorectal cancer, München, GRIN Verlag, https://www.grin.com/document/337610
