comparing follow-up schedules in patients with newly diagnosed stage ib or stage ii melanoma

Conditions: Melanoma (Skin)

Summary: rationale: gathering information over time from follow-up visits may help doctors plan the best follow-up schedule. it is not yet known which follow-up schedule is more effective in improving patient quality of life. purpose: this randomized clinical trial is comparing follow-up schedules to see how well they work in patients with newly diagnosed stage ib or stage ii melanoma.

objectives: * to determine the difference between conventional versus experimental follow-up schedules, in terms of patient well-being, expressed health-related quality of life, level of anxiety, and satisfaction with the follow-up schedule in patients with newly diagnosed stage ib or ii cutaneous melanoma. * to determine the ability of these schedules to detect recurrences and second primary melanomas in these patients. outline: patients are stratified according to ajcc stage (i vs ii). patients are randomized to 1 of 2 follow-up arms. * arm i (experimental follow-up schedule): patients undergo a thorough history and physical examination periodically for 5 years. patients are followed up according to the experimental schedule: * for stage ib disease: patients are followed up annually for 5 years. * for stage iia disease: patients are followed up biannually for years 1 and 2 and annually for years 3, 4, and 5. * for stage iib or iic disease: patients are followed up every 4 months during years 1 and 2, every 6 months during year 3, and annually during years 4 and 5. * arm ii: (conventional follow-up schedule): patients undergo a thorough history and physical examination periodically for 5 years. patients are followed up according to the conventional schedule: * for all stage disease: patients are followed up every 3 months for year 1, every 4 months for year 2, and every 6 months for years 3-5. in both arms, patient well-being is measured at 0, 6, 12, 24, 36, 48, and 60 months after primary diagnosis, using the following questionnaires: the health-related quality of life questionnaire (rand-36), the anxiety questionnaire (stai version dy-1 \[state\] and dy-2 \[trait\]), the cancer worry scale, and follow-up satisfaction questionnaire, and the self-designed specific questions regarding self-examination and follow-up satisfaction. all patients are instructed at primary diagnosis and receive the melanoma-patient-education-package (mpep), which consists of information on melanoma (kwf folder "melanoma") and additional instruction on self-examination. data on type of recurrence (locoregional versus distant), the person detecting the recurrence, progression of recurrence at time of detection, the way the recurrence was detected (e.g., self-examination, accidentally, or at follow-up by physical examination or imaging) and information regarding treatment and further follow-up are collected at each follow-up visit and the outcomes are compared in both groups. outcomes of independent questionnaires are also compared in both groups.

Eligibility criteria:
disease characteristics: * pathologically confirmed newly diagnosed cutaneous melanoma * ajcc stage ib or ii disease * received curative treatment * completed the first set of questionnaires patient characteristics: * able to speak and understand dutch or english * must be able to participate in the follow-up schedule (e.g., permanently living in the netherlands) * no known second malignancy prior concurrent therapy: * see disease characteristics

Keywords: stage ib melanoma stage ii melanoma