Comparing Follow-Up Schedules in Patients With Newly Diagnosed Stage IB or Stage II Melanoma
Recruitment status was Recruiting
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.
Other: follow-up care
Other: questionnaire administration
Procedure: quality-of-life assessment
|Official Title:||Prospective Randomized Trial for the Evaluation of a Theoretical Follow-Up Schedule in Cutaneous Melanoma Patients, the MELFO-Study.|
- Patient well-being expressed in 4 questionnaires [ Designated as safety issue: No ]
- Occurrence and type of recurrence (locoregional versus distant metastases) that develop [ Designated as safety issue: No ]
- Person detecting the recurrences and the exact way of detection [ Designated as safety issue: No ]
- Progress of recurrent disease and consequences for its treatment [ Designated as safety issue: No ]
- Well-being of patients per group and of recurred patients [ Designated as safety issue: No ]
|Study Start Date:||March 2006|
|Estimated Primary Completion Date:||December 2011 (Final data collection date for primary outcome measure)|
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01018004
|Medisch Spectrum Twente||Recruiting|
|Enschede, Netherlands, 7500 KA|
|Contact: Contact Person 31-53-487-2000|
|University Medical Center Groningen||Recruiting|
|Groningen, Netherlands, 9700 RB|
|Contact: Contact Person 31-50-361-2317 email@example.com|
|Medisch Centrum Leeuwarden - Zuid||Recruiting|
|Leeuwarden, Netherlands, 8934 AD|
|Contact: Contact Person 31-58-286-6666|
|Isala Klinieken - locatie Weezenlanden||Recruiting|
|Zwolle, Netherlands, NL-8000 GM|
|Contact: Contact Person 31-38-424-2000|
|Principal Investigator:||Harald J. Hoekstra, MD, PhD||University Medical Centre Groningen|