Advertisement

Topics

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

2014-07-24 14:10:50 | BioPortfolio

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.

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.

Study Design

N/A

Conditions

Melanoma (Skin)

Intervention

follow-up care, questionnaire administration, quality-of-life assessment

Location

Medisch Spectrum Twente
Enschede
Netherlands
7500 KA

Status

Recruiting

Source

National Cancer Institute (NCI)

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-07-24T14:10:50-0400

Clinical Trials [6126 Associated Clinical Trials listed on BioPortfolio]

Prospective Measurement of Post-Treatment Lymphedema

The goal of this study is to measure the amount of limb swelling (lymphedema) that sometimes occurs after melanoma treatment, and to find out how people feel and react to the diagnosis and...

Health-Related Quality of Life in Patients With Bladder Cancer

RATIONALE: Gathering information about quality of life in patients with cancer may improve the ability to plan treatment and may help patients live more comfortably. PURPOSE: This clinica...

Measuring Patient Satisfaction With Facial Appearance: Development and Validation of a New Patient-Reported Outcome Measure

RATIONALE: Developing a questionnaire that patients can use to assess their quality of life related to the appearance of their face after surgery may help doctors plan the best treatment f...

A Web-Based Stem Cell Transplant Support System or Standard Care in Young Patients Undergoing Stem Cell Transplant and Their Families

RATIONALE: A Web site for stem cell transplant health information and support may be effective in helping parents improve their health-related knowledge, skills, and quality of life, which...

Nurse-Provided Care or Standard Care in Treating Patients With Pancreatic Cancer

RATIONALE: Meeting with a nurse to assess symptoms and quality of life may be more effective than standard care in treating patients with pancreatic cancer. PURPOSE: This clinical trial i...

PubMed Articles [32763 Associated PubMed Articles listed on BioPortfolio]

Perhaps quality of life should not be used as a trigger for discussing resuscitation and advance care plans.

As a subjective measure, quality of life should not be used as a trigger for discussing resuscitation, goals of care or advanced care plans. Limitations and challenges in measurement and assessment of...

Long-term uveal melanoma survivors: measuring their quality of life.

Patients with uveal melanoma (UM) undergo lifelong follow-up as metastases can occur more than 20 years after diagnosis. Little is known about the quality of life (QoL) of UM survivors over such an e...

APPLICABILITY OF A GENERIC QUESTIONNAIRE FOR QUALITY OF LIFE ASSESSMENT FOR ASTHMATIC CHILDREN.

To determine the applicability of the generic instrument Pediatric Quality of Life Inventory (PedsQL 4.0) to assess health-related quality of life of asthmatic children compared to the specific instru...

Validity and feasibility of the Wound-QoL questionnaire on health-related quality of life in chronic wounds.

Chronic wounds have a major socio-economic impact due to their frequency, chronicity and societal costs. Patients experience substantial quality of life (QoL) impairments. The use of questionnaires fo...

Unmet supportive care needs, health status and minimum costs in survivors of malignant melanoma.

We explored the relationship between unmet care needs, health status, health utility and costs in people treated for melanoma via a cross-sectional follow-up survey (N = 455) 3 months to 5 years a...

Medical and Biotech [MESH] Definitions

Activities and programs intended to assure or improve the quality of care in either a defined medical setting or a program. The concept includes the assessment or evaluation of the quality of care; identification of problems or shortcomings in the delivery of care; designing activities to overcome these deficiencies; and follow-up monitoring to ensure effectiveness of corrective steps.

A measurement index derived from a modification of standard life-table procedures and designed to take account of the quality as well as the duration of survival. This index can be used in assessing the outcome of health care procedures or services. (BIOETHICS Thesaurus, 1994)

A nursing specialty concerned with care of patients facing serious or life-threatening illnesses. The goal of palliative nursing is to prevent and relieve suffering, and to support the best possible quality of life for patients and their families. Hospice nursing is palliative care for people in their final stages of life.

A quality-of-life scale developed in the United States in 1972 as a measure of health status or dysfunction generated by a disease. It is a behaviorally based questionnaire for patients and addresses activities such as sleep and rest, mobility, recreation, home management, emotional behavior, social interaction, and the like. It measures the patient's perceived health status and is sensitive enough to detect changes or differences in health status occurring over time or between groups. (From Medical Care, vol.xix, no.8, August 1981, p.787-805)

Component of the NATIONAL INSTITUTES OF HEALTH. It conducts and supports clinical and basic research to establish a scientific basis for the care of individuals across the life span, from the management of patients during illness and recovery to the reduction of risks for disease and disability; the promotion of healthy lifestyles; the promotion of quality of life in those with chronic illness; and the care for individuals at the end of life. It was established in 1986.

More From BioPortfolio on "Comparing Follow-Up Schedules in Patients With Newly Diagnosed Stage IB or Stage II Melanoma"

Advertisement
Quick Search
Advertisement
Advertisement

 

Relevant Topics

Clincial Trials
In a clinical trial or interventional study, participants receive specific interventions according to the research plan or protocol created by the investigators. These interventions may be medical products, such as drugs or devices; procedures; or change...

Melanoma
Melanoma is a highly malignant tumor of melanin-forming cells (melanocytes) There are most commonly found in the skin (resulting from sunlight exposure), but also in the eyes and mucous membranes. Metastasis to other regions of the body is also common....


Searches Linking to this Trial