In this project we have developed a questionnaire for use in studies related to disease and treatment in patients with vulva cancer (cancer in the female outer genitals). In the first three phases of questionnaire development we have included responses and interviews with patients with the disease and health care professionals who are in close contact with this patient group during the diagnostics, treatment and follow up. By inclusion of the patient’s perspectives in the early questionnaire developmental phases we have ensured that the questions included are those that the patients find relevant and of importance for their quality of life as a cancer patients. In this final phase of questionnaire validation we include patients from 8 different countries and who have undergone different treatment regimes to evaluate how the questionnaire performs across in different settings and cultures.
The first 3 phases of questionnaire development have been completed.
Most collaborating countries have achieved or applied for ethical approval to start phase 4 of the study.
We have ensured safe data entering and storage.
The study has started patient recruitment in 4 countries by now. As soon as ethical approval has been achieved in the other countries, they will start recruitment.
We expect to finalize recruitment within 1.5 years to a total of 400 patients
Cancer treatment may cause late effects It is crucial to evaluate late effects to inform the patients and choose between equally effective treatments. Late effects are best evaluated by the patient herself. When asking the patients about symptoms, functioning, and/ or feelings, it is important to use a questionnaire that ask about issues that the patient finds important and relevant. This study concerns development of a questionnaire which evaluate symptoms and late effects related to cancer in the female external genitals.
Froeding LP, Greimel E, Lanceley A, Oberguggenberger A, Schmalz C, Radisic VB, Nordin A, Galalaei R, Kuljanic K, Vistad I, Schnack TH, Jensen PT; European Organization of Research Treatment of Cancer Quality of Life Group the Gynecological Cancer group. Assessing Patient-reported Quality of Life Outcomes in Vulva Cancer Patients: A Systematic Literature Review. Int J Gynecol Cancer. 2018 Feb 8. doi: 10.1097/IGC.0000000000001211. [Epub ahead of print]