Clinical trial NCT01018004: Comparing Follow-Up Schedules in Patients With Newly Diagnosed Stage IB or Stage II Melanoma
Official title: Prospective Randomized Trial for the Evaluation of a Theoretical Follow-Up Schedule in Cutaneous Melanoma Patients, the MELFO-Study.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Melanoma (Skin)
Keywords: stage IB melanoma
stage II melanoma
Lead sponsor: National Cancer Institute (NCI)
Sponsor class: NIH
First posted: 2009-11-23
Enrollment: 178
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no

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.

Detailed description: 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.

Eligibility criteria: DISEASE CHARACTERISTICS:

* 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

Primary outcomes:
measure: Patient well-being expressed in 4 questionnaires
Secondary outcomes:
measure: Occurrence and type of recurrence (locoregional versus distant metastases) that develop
measure: Person detecting the recurrences and the exact way of detection
measure: Progress of recurrent disease and consequences for its treatment
measure: Well-being of patients per group and of recurred patients
Other outcomes:
Locations:
city: Enschede
country: Netherlands
facility: Medisch Spectrum Twente
city: Groningen
country: Netherlands
facility: University Medical Center Groningen
city: Leeuwarden
country: Netherlands
facility: Medisch Centrum Leeuwarden - Zuid
city: Zwolle
country: Netherlands
facility: Isala Klinieken - locatie Weezenlanden
Study officials:
affiliation: University Medical Center Groningen
name: Harald J. Hoekstra, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: