Comparing Follow-Up Schedules in Patients With Newly Diagnosed Stage IB or Stage II Melanoma
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|ClinicalTrials.gov Identifier: NCT01018004|
Recruitment Status : Unknown
Verified July 2010 by National Cancer Institute (NCI).
Recruitment status was: Recruiting
First Posted : November 23, 2009
Last Update Posted : August 26, 2013
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.
|Condition or disease||Intervention/treatment|
|Melanoma (Skin)||Other: follow-up care Other: questionnaire administration Procedure: quality-of-life assessment|
- 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.
|Study Type :||Observational|
|Estimated Enrollment :||178 participants|
|Official Title:||Prospective Randomized Trial for the Evaluation of a Theoretical Follow-Up Schedule in Cutaneous Melanoma Patients, the MELFO-Study.|
|Study Start Date :||March 2006|
|Estimated Primary Completion Date :||December 2011|
- Patient well-being expressed in 4 questionnaires
- Occurrence and type of recurrence (locoregional versus distant metastases) that develop
- Person detecting the recurrences and the exact way of detection
- Progress of recurrent disease and consequences for its treatment
- Well-being of patients per group and of recurred patients
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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 firstname.lastname@example.org|
|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 Center Groningen|