Rationale
The follow-up in cutaneous melanoma patients is controversial. The suggested aims of for follow-up are detection of recurrences, detection of second primary melanomas, quality evaluation of surgical treatment, patient reassurance and reduction of anxiety. Several authors have proposed follow-up schedules, but despite these attempts, no national or international evidence-based consensus has been achieved in the past decades. Moreover, no true evidence for the value of follow-up exists. Due to the increasing prevalence of melanoma patients, a definite high efficiency in a more evidence-based follow-up regimen for melanoma patients is required.
Objectives
To determine the difference between patients in the so-called experimental follow-up schedule and the conventional follow-up schedule, in patients? well-being, expressed in health related quality of life, level of anxiety and satisfaction with the follow-up schedule and in the sufficiency to detect recurrences and second primary melanomas. We expect to find no significant difference in patients? well-being scores between both groups. If the experimental follow-up schedule proves not to reduce patients? well-being significantly, this schedule may be proposed as the new follow-up surveillance schedule for melanoma patients and could be further elaborated and implemented in future guidelines.
Outline
In the MELFO-study AJCC stage IB-IIC cutaneous melanoma patients will be randomized between the conventional follow-up schedule derived from Dutch national guidelines and an experimental follow-up schedule adjusted to disease stage, resulting in less scheduled follow-up visits. The final outcome of the study will be determined after a minimum of 5 years of follow-up surveillance. Patients? well being will be measured at 0, 6, 12, 24, 36 48 en 60 months after diagnosis and inclusion via a questionnaire. This questionnaire consists of the RAND-36, the Impact of Events Scale, the Cancer Worry Scale, the STAI-DY and self-designed questions on ?Follow-up satisfaction?. During follow-up the incidence and types of recurrence detected, the person detecting the recurrences as well as the exact way of detection will be recorded. |
