Comparing Follow-Up Schedules in Patients With Newly Diagnosed Stage IB or Stage II Melanoma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. 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
Information provided by:
National Cancer Institute (NCI)

Brief 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.

Condition or disease Intervention/treatment
Melanoma (Skin) Other: follow-up care Other: questionnaire administration Procedure: quality-of-life assessment

Detailed Description:


  • 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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Melanoma

Primary Outcome Measures :
  1. Patient well-being expressed in 4 questionnaires

Secondary Outcome Measures :
  1. Occurrence and type of recurrence (locoregional versus distant metastases) that develop
  2. Person detecting the recurrences and the exact way of detection
  3. Progress of recurrent disease and consequences for its treatment
  4. Well-being of patients per group and of recurred patients

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • Pathologically confirmed newly diagnosed cutaneous melanoma

    • AJCC stage IB or II disease
  • Received curative treatment
  • Completed the first set of questionnaires


  • 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


  • See Disease Characteristics

Information from the National Library of Medicine

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 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   
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      
Sponsors and Collaborators
University Medical Center Groningen
Principal Investigator: Harald J. Hoekstra, MD, PhD University Medical Center Groningen Identifier: NCT01018004     History of Changes
Other Study ID Numbers: CDR0000659310
First Posted: November 23, 2009    Key Record Dates
Last Update Posted: August 26, 2013
Last Verified: July 2010

Keywords provided by National Cancer Institute (NCI):
stage IB melanoma
stage II melanoma

Additional relevant MeSH terms:
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms, Nerve Tissue
Nevi and Melanomas