Comparing Follow-Up Schedules in Patients With Newly Diagnosed Stage IB or Stage II Melanoma
NCT ID: NCT01018004
Last Updated: 2013-08-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
178 participants
OBSERVATIONAL
2006-03-31
Brief Summary
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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.
Detailed Description
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* 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.
Conditions
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Keywords
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Interventions
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follow-up care
questionnaire administration
quality-of-life assessment
Eligibility Criteria
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Inclusion Criteria
* 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
18 Years
85 Years
ALL
No
Sponsors
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University Medical Center Groningen
OTHER
Principal Investigators
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Harald J. Hoekstra, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
University Medical Center Groningen
Locations
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Medisch Spectrum Twente
Enschede, , Netherlands
University Medical Center Groningen
Groningen, , Netherlands
Medisch Centrum Leeuwarden - Zuid
Leeuwarden, , Netherlands
Isala Klinieken - locatie Weezenlanden
Zwolle, , Netherlands
Countries
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Facility Contacts
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Contact Person
Role: primary
Contact Person
Role: primary
Contact Person
Role: primary
Contact Person
Role: primary
Other Identifiers
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UMCG-MELFO
Identifier Type: -
Identifier Source: secondary_id
EU-20988
Identifier Type: -
Identifier Source: secondary_id
CDR0000659310
Identifier Type: -
Identifier Source: org_study_id