Pernille Tine Jensen

LONGITUDINAL STUDY OF SEXUAL FUNCTION AND VAGINAL CHANGES AFTER RADIOTHERAPY FOR CERVICAL CANCER

PURPOSE To investigate the longitudinal course of self-reported sexual function and vaginal changes in patients disease free after radiotherapy (RT) for locally advanced, recurrent, or persistent cervical cancer. MATERIALS AND METHODS A total of 118 patients referred for RT were included. The patients were assessed, using a validated self-assessment questionnaire, at the termination of RT and 1, 3, 6, 12, 18, and 24 months later. The results were compared with an age-matched control group from the general population. RESULTS Persistent sexual dysfunction and adverse vaginal changes were reported throughout the 2 years after RT, with small changes over time: approximately 85% had low or no sexual interest, 35% had moderate to severe lack of lubrication, 55% had mild to severe dyspareunia, and 30% were dissatisfied with their sexual life. A reduced vaginal dimension was reported by 50% of the patients, and 45% were never, or only occasionally, able to complete sexual intercourse. Despite sexual dysfunction and vaginal adverse effects, 63% of those sexually active before having cancer remained sexually active after treatment, although with a considerably decreased frequency. CONCLUSIONS Patients who are disease free after RT for locally advanced, recurrent, or persistent cervical cancer are at high risk of experiencing persistent sexual and vaginal problems compromising their sexual activity and satisfaction.

Early-stage cervical carcinoma, radical hysterectomy, and sexual function. A longitudinal study.

Limited knowledge exists concerning the impact of radical hysterectomy (RH) alone on the sexual function of patients with early‐stage cervical carcinoma. The authors investigated the longitudinal course of self‐reported sexual function after RH.

The European Organization for Research and Treatment of Cancer (EORTC) Quality-of-Life questionnaire cervical cancer module: EORTC QLQ-CX24.

The authors report on the development and validation of a cervical cancer module for the European Organization for Research and Treatment of Cancer (EORTC) Quality‐of‐Life (QoL) questionnaire (QLQ), which was designed to assess disease‐specific and treatment‐specific aspects of QoL in patients with cervical cancer.

Self-assessment in Cancer patients referred to palliative care: A study of feasibility and Symptom epidemiology

Research in palliative care is considered difficult due to the poor health of patients. However, patient‐provided data are essential for a thorough description of patient symptomatology and for the evaluation of care.

Psychometric validation of the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Endometrial Cancer Module (EORTC QLQ-EN24).

AIM A validation study was conducted to evaluate the psychometric properties of the European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Endometrial Cancer Module (EORTC QLQ-EN24). This module was designed to assess disease and treatment specific aspects of the quality of life (QoL) of patients with endometrial cancer. METHODS Two hundred and sixty-eight women with endometrial cancer were recruited in different phases of treatment: after pelvic surgery (Group 1); during adjuvant chemotherapy and/or radiotherapy (Group 2); after completion of treatment (Group 3). Patients completed the EORTC QLQ-C30, the endometrial cancer module and a short debriefing questionnaire. RESULTS Multi-trait scaling analyses confirmed the hypothesised scale structure of the QLQ-EN24. Internal consistency reliability was good with Cronbachs alpha coefficients ranging from 0.74 to 0.86 (lymphoedema 0.80, urological symptoms 0.75, gastrointestinal symptoms 0.74, body image problems 0.86 and sexual/vaginal problems 0.86). Convergent and discriminant validity did not show any scaling errors for the subscales. The QLQ-EN24 module discriminated well between clinically different groups of patients. All items exhibited a high completion rate with less than 2% missing values except for the sexuality items (19%). CONCLUSION The validation study supports the reliability, the convergent and divergent validity of the EORTC QLQ-EN24. This newly developed QLQ-EN24 module is a useful instrument for the assessment of the QoL in patients treated for endometrial cancer in clinical trials.

Pelvic Radiotherapy and Sexual Function in Men and Women

INTRODUCTION Despite the decrease in overall cancer incidence and mortality rates in developed countries since the early 1990 s, cancer remains a major public health problem. Sexual dysfunction is one of the more common consequences of cancer treatment. AIM To shortly review the literature and level of evidence on sexual dysfunction in men and women following pelvic radiotherapy. MAIN OUTCOME MEASURES Male and female sexual dysfunction. METHODS Literature review. RESULTS Sexual dysfunction in cancer patients is multidimensional and may result from biological, psychological, and social factors. Anatomic changes caused by surgery and/or radiotherapy, physiological changes following hormonal manipulation, and the secondary effect of medical intervention may impede or preclude sexual functioning, even when sexual desire is intact. Pelvic irradiation constitutes the primary or adjuvant treatment for a large number of both female and male cancers. No randomized controlled trials could be identified regarding the effect of radiotherapy on sexual dysfunction. However, prospective and clinical controlled trials all demonstrated a severe negative effect on sexual functioning in men and women following radiotherapy for a pelvic cancer. Following pelvic radiotherapy for prostate cancer, a positive effect of phosphodiesterase type 5 inhibitors on erectile dysfunction has been demonstrated, whereas no significant effect on female sexuality was found. Few studies evaluated treatment of female sexual dysfunction following radiotherapy; hormone replacement therapy and the use of vaginal dilator in combination with psycho-educational support is recommended. CONCLUSION Pelvic radiotherapy plays a significant negative role in the complex scenario of male and female sexual dysfunction. The literature has focused on sexual dysfunction and intervention in prostate and cervical cancer patients. Sexual dysfunction following pelvic radiotherapy for cancer in other pelvic organs, e.g., bladder, rectum, and anus, requires more attention in future studies. Health care providers should pay attention to and provide psychological and medical support regarding sexual dysfunction to all patients who have received pelvic radiotherapy.

Quality of life characteristics inpatients with cervical cancer

AIM Annually about 500,000 women worldwide are diagnosed with cervical cancer. For many patients, young age at the time of diagnosis and a good prognosis regarding the disease imply a long life with the side-effects and sequels of various treatment options. The present study investigated the extent to which different quality of life (QoL) domains in patients during and after treatment for cervical cancer are affected according to menopausal status, treatment status and treatment modality. METHODS QoL data from 346 cervical cancer patients from 14 countries who were included in a cervical cancer module validation study of the European Organisation for Research and Treatment of Cancer (EORTC) Quality of life Group were analysed according to menopausal status, treatment status and treatment modality. QOL was assessed using the EORTC Quality of life Questionnaire (QLQ)-C30 and the QLQ-CX24 module. Statistical analyses were performed using descriptive statistics and analysis of covariance. RESULTS Active treatment had the strongest negative impact on 13 different QoL domains: physical, role, emotional, cognitive, social functioning, global health/QoL, fatigue, nausea and emesis, pain, appetite loss, constipation, symptom experience and sexual enjoyment. Irradiation alone ± other therapy was associated with most symptoms of diarrhoea. Age had the most negative impact on sexual activity and the strongest positive effect on sexual worry. CONCLUSION Our results revealed that patients with cervical carcinoma had different side-effects with different impacts on QOL depending on the menopausal status and therapy modalities. Patients should be informed about the possibility that therapy may have a negative impact on QoL.

Pulsed dose rate (PDR) brachytherapy as salvage treatment of locally advanced or recurrent gynecologic cancer

PURPOSE Pulsed dose rate (PDR) brachytherapy is a new treatment option permitting dose distribution optimization in interstitial implants. It possesses the advantage of equipment simplification and radiation protection to the staff, compared to the manually afterloading technique. This study presents the first clinical results from The Finsen Center with PDR-brachytherapy in patients with locally advanced or recurrent gynecologic cancer. METHODS AND MATERIALS Between June 1993 and August 1996, 34 patients with gynecologic malignancies (22 pelvic recurrences, 12 primary locally advanced) have been treated with external irradiation, four-field box technique, to 46 Gy/23 fractions, 5 F/week and 192Ir-interstitial PDR-brachytherapy in pulses of 0.6 Gy, one pulse per hour to a total of 30 Gy. The Martinez Universal Perineal Interstitial Template applicator was used for all implantations. RESULTS The overall complete response rate was 74%. At median 14 months follow-up (range 3-40) 15 patients were alive with no evidence of disease. Seven of 14 patients with a second recurrence or progressive disease were still alive. The overall 1- and 2-year survival was 71% and 63%, respectively. There was no difference in survival probability when stratifying the patients by primary diagnosis (recurrent vs. primary advanced), relapse locations (central vs. central + pelvic wall mass) or treatment volume. Seventeen chronic grade III complications were observed in 10 patients. Large treatment volumes significantly correlated to severe gastrointestinal complications. Fifteen of 17 chronic grade III complications were observed in patients treated for recurrent disease. CONCLUSION PDR-brachytherapy in combination with external irradiation is an effective treatment option for patients with locally advanced or recurrent gynecologic cancer, although substantial toxicity is observed in patients with large treatment volumes and recurrent disease.

Sexual Functioning and Vaginal Changes after Radical Vaginal Trachelectomy in Early Stage Cervical Cancer Patients: A Longitudinal Study

INTRODUCTION Radical vaginal trachelectomy (RVT) offers low complication rate, good survival, and possibility for future childbearing for young women with early stage cervical cancer. However, the literature on quality of life (QOL) and sexual functioning in patients undergoing RVT is scarce. AIM The aims of this study were to prospectively assess sexual function after RVT and to compare scores of sexual function in patients operated by RVT and radical abdominal hysterectomy (RAH) with those of age-matched control women from the general population. METHODS Eighteen patients with early stage cervical cancer operated with RVT were prospectively included and assessed preoperatively, and 3, 6, and 12 months postoperatively using validated questionnaires. RAH patients were included consecutively and assessed once at 12 months postsurgery, while an age-matched control group of 30 healthy women was assessed once. MAIN OUTCOME MEASURE Sexual dysfunction total score as measured by the Female Sexual Function Index (FSFI) was the main outcome measure. RESULTS During the 12 months posttreatment, RVT patients tended to have persistent sexual dysfunction as measured by FSFI (mean overall score <26.55 at each assessment) and Female Sexual Distress Scale (mean overall score > 11). Sexual worry (P < 0.001) and lack of sexual desire (P = 0.038) were more frequently reported among patients in both treatment groups compared with control women. Sexual activity increased significantly during the observation time for the RVT group (P = 0.023) and reached that of healthy women. Global Health Status score improved over time for the RVT group but never reached that of healthy control women (P = 0.029). CONCLUSIONS Our data suggest that patients treated with RVT for early stage cervical cancer experience persistent sexual dysfunction up to one year post surgery influencing negatively on their QOL.

Validation of a questionnaire for self-rating of urological and gynaecological morbidity after treatment of gynaecological cancer

BACKGROUND AND PURPOSE Patient self-assessment of symptom severity provides clinicians and researchers with important information. It is crucial to evaluate the validity of a self-assessment questionnaire in the context of its intended use. The objective of this study was to evaluate the validity of the uro-gynaecological questionnaire (UGQ), a new instrument for patient self-assessment of urological-, genital-, menopausal-, and pain symptomatology in gynaecological cancer patients. MATERIAL AND METHODS The UGQ was developed after literature review, patient- and expert interviews and pilot testing. From February 1992 to October 1992, 88 gynaecological cancer patients were invited to participate in a validation study after the initiation of their primary radiotherapy or chemotherapy. The method of validation investigated whether patients and researchers interpreted the items of the questionnaire in the same way. The patients written response before interview was compared with an observer rating of the patients open-ended audio-taped responses to the same questionnaire, administered as an interview. Qualitative recordings by the observer were made to describe potential misinterpretations. RESULTS The agreement between the patients and the observers ratings was high: the median overall agreement was 0.91 (range 0.71-1.00) and the median kappa was 0.88 (range 0.45-1.00). The quantitative and the qualitative results identified a few minor validity problems; especially, the issue of selective reporting, i.e. some patients only reporting those symptoms they considered relevant for the study, which may lead to systematic errors. CONCLUSIONS The results strongly suggest that patients interpret the UGQ items as intended, i.e. they are valid. The UGQ is recommended for patient self-assessment of uro-gynaecological morbidity in gynaecological cancer patients.