Surgery for penile cancers in our clinical set up mostly involves partial or total penectomy in majority of the cases as patients tend to seek medical help late because of the social stigma attached with disorders related to genitals. Such a surgery is associated with an adverse impact on the morale if the patient. With patients having to cope with loss of sexual life and a low self-esteem, over and above the hardships one has to face while dealing with the diagnosis of a potentially lethal cancer. Moreover many of these patients will need inguinal lymph node block dissection during the course of their treatment which is a major surgical procedure with potential long lasting complications like lower limb lymphedema.
The published data regarding surgical outcomes and survival etc, are plenty but the impact on the overall quality of life of such a disfiguring disease and treatment is lacking. Moreover the sparse data that is available is also mostly from western studies which do not always reflect well on to our population.
Departments involved : Department Of Urology KMC Manipal
Study period : 6 months
Sample size : 79 patients who have undergone treatment for penile cancer in 164 hospital admissions ( hospital Numbers attached)
Materials and methods:
Inclusion Criteria
1. All patients who have undergone surgery for penile cancer in the past 5 years who come for follow up during the study period.
Exclusion Criteria
2. Patients who have had recurrence of the cancer
3. Patients developing new co-morbidities/ worsening of pre existing co-morbidities post carcinoma penis surgery
4. Patients unwilling to fill the questionnaire
Biological materials required (type - blood, tissue etc and quantity) : NIL
Statistical methods: Determinants will be analyzed using chi square test and Fischer’s Exact Test. The analysis of the EORTC scores raw data will be done as per the scoring and assessment manual provided by EORTC.
The correlation of the obtained quality of life scores with the duration post treatment when the scoring was done will be done using Pearson’s correlation.
Tools used: European Organization for Research and Treatment of Cancer quality of Life Questionnaire (EORTC QLQ C30). This is an internationally accepted quality of life questionnaire which has also been translated into Kannada. And this translated questionnaire has also been validated. Permission for the use of the said questionnaire has been obtained from the EORTC Quality of Life Group.
Detailed description of procedure / processes:
All patients who have undergone treatment for carcinoma penis in the last 5 years in our hospital have been included in the study. These patients as a part of their post treatment follow up need to be evaluated in the outpatient department at least once in 6 months.
Therefore these patients will be contacted and informed to attend the urology outpatient clinic when their next visit is due. On attendance at the OPD the patients will be explained in detail about the ongoing study. If willing to participate, apart from the clinical evaluation and imaging as part of the patients’ follow-up they will be asked to fill the EORTC QLQ C30 questionnaire in the language of their choice (ie English or Kannada).
10. Outcome measures : EORTC QLQ C30 score using EORTC QLQ C30 scoring manual
11. Potential risks and benefits:
Risks- Potential to make the patient uncomfortable and reluctant to continue treatment at our center for having asked him to fill a questionnaire regarding the mental issues faced by him in dealing with the cancer.
The study carries the risk of being biased as the patients who will be eventually included in the study are the ones who are regular in their follow-up and attend the out-patient clinic. As the
Subjects dealing with severe adjustment issues as a consequence of the disease may be lost to follow-up. Hence not included in the study.
Benefits- A better understanding of the quality of life of carcinoma penis survivors. With Carcinoma penis treatment having very good results the next step is to assess and strive to improve the quality of life in such patients.
Ethical considerations and methods to address issues:
The data collection and handling shall be done by the investigators only. The identity of the patients participating in the study will not be revealed to anyone outside the team. Any patient no willing to participate in the study will not be forced to do so and his treatment/ follow- up for his disease will not be effected in any way.
Review of literature:
Penile cancer is a disease with high morbidity and mortality and is rare in developed countries. In the developing world, the incidence is significantly higher, and accounts for 1–2% of malignant disease in men. With incidence in India reported to be 1.8 per lakh adult male population. Penile cancer is associated with delayed diagnosis, often due to psychological factors. Consequently, patients often present with locally advanced tumors and a high risk of invasive disease. Given the potentially significant embarrassment associated with the diagnosis of penile cancer, men may use the information available on the internet prior to seeking medical attention thus, highâ€quality, readily accessible and accurate information on penile cancer is an important part of encouraging men to seek medical services.
The primary treatment for penile cancer is surgery. Surgical treatment involves the removal of the primary tumor lesion with or without performing inguinal lymphadenectomy, depending on clinical indications or the histopathology of the original change. The removal of primary lesion in penile cancer involves circumcision/glansectomy/ partial or total amputation of the penis, subsequently forming an exit for the urethra into the perineum. With inguinal lymph- node dissection when indicated.
Total amputation of the penis as a most debilitating procedure, which clearly adversely affects the patient’s quality of life, particularly one’s sex life. Also a radical procedure like inguinal lymph node dissection is associated with multiple complications and long lasting side effects like lymphedema of the lower limbs. These can adversely affect the mental and physical wellbeing of the patient. The quantity and quality of data available in the medical literature to substantiate such predictions is scarce, which significantly limits the quality of the publication. However, one should bear in mind that penile carcinoma is a rare disease and there is only a limited pool of patients available for clinical research. And most published data available are from the developed world. For this reason, there are no standardized research tools for the evaluation of subsequent quality of life. Various tools are used and they are often not validated, making comparison of any results difficult. Due to the limitations presented above, we plan on doing a structured assessment of the quality of life of penile cancer survivors.