HRQOL in Thyroid Cancer and Thyroid Tumours

Summary

Participation Requirements

Description

Most patients with thyroid cancer have a long life expectancy, and it has been assumed among health professionals that therefore the quality of life (QOL) is good. Some European studies have shown that the QOL among thyroid cancers is worse than the general population, and almost as low as other can...

Most patients with thyroid cancer have a long life expectancy, and it has been assumed among health professionals that therefore the quality of life (QOL) is good. Some European studies have shown that the QOL among thyroid cancers is worse than the general population, and almost as low as other cancer diagnoses, with a worse prognosis and a more burdening treatment. This study aims to examine the quality of life in patients undergoing diagnostic surgery for thyroid tumour(s), or thyroid surgery as part of a cancer treatment. Participants will undergo standard work up and treatment for their thyroid tumour(s). Clinical data will be extracted from medical records at Oslo University Hospital (OUH). Questionnaires on Health related quality of life (HRQOL) are be filled out before surgery and at follow up visits at 6 and 12 months after surgery. Participants that do not meet at follow-up, will receive the questionnaires by mail. At the end of the study there will be three subgroups of participants: (a) Benign tumour, (b) Malignant tumour with radioiodine treatment, (c) Malignant tumour without radioiodine treatment. Questionnaires from European Organization for Research and Treatment of Cancer (EORTC) will be used, as they are well validated and relatively widely used. The EORTC QLQ C30 was chosen for a general view on HRQOL, as well as an available Norwegian general population for comparison. For a more disease specific questionnaire, the EORTC THY47 is used, a module of EORTC QLQ C30 on thyroid cancer. In addition we wish to capture a possibly important element in participants undergoing thyroid surgery, and where a fraction of participants may be hypothyroid for a period of time - therfore a fatigue module, the EORTC FA12 was added. Calculations on sample size were performed by statistician R Sørum Falk at the Centre of Biostatistics and Epidemiology of Oslo University Hospital. The global score on EORTC QLQ C30 in the general population had shown to be 78.0. The primary endpoint is a difference in quality of life (defined as global score) before and after surgery of more than 10%. Assuming an alpha of 5% , a Power of 80% and a standard error of the difference of 15, the number of 32 participants in each subgroup is needed. To compensate for dropouts, an additional 10% had to be included, i.e. 71 participants. Intraobserver analysis of plotting and calculations is planned.

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