Prospective Randomized Trial for the Evaluation of a Theoretical Follow-Up Schedule in Cutaneous Melanoma Patients, the MELFO-Study.
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.
Observational
N/A
Patient well-being expressed in 4 questionnaires
No
Harald J. Hoekstra, MD, PhD
Principal Investigator
University Medical Centre Groningen
Unspecified
CDR0000659310
NCT01018004
March 2006
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