• Children's Oncology Group. Long-term follow-up guidelines for survivors of childhood, adolescent, and young adult cancers. Sections 1-2: any cancer experience. Bethesda (MD): Children's Oncology Group; 2006 Mar. 4 p. [50 references]

This is the current release of the guideline.

This guideline updates a previous version: Children's Oncology Group. Long-term follow-up guidelines for survivors of childhood, adolescent, and young adult cancers. Version 1.2. 2004 Mar.

Late effects, including psychosocial and mental health disorders, resulting from therapeutic exposures used during treatment for pediatric malignancies

Note: These guidelines are intended for use beginning two or more years following the completion of cancer therapy, and provide a framework for ongoing late effects monitoring in childhood cancer survivors; however, these guidelines are not intended to provide guidance for follow-up of the pediatric cancer survivor's primary disease.

Evaluation
Management
Prevention
Screening

Family Practice
Internal Medicine
Obstetrics and Gynecology
Oncology
Pediatrics
Psychiatry
Psychology

Advanced Practice Nurses
Nurses
Physician Assistants
Physicians
Psychologists/Non-physician Behavioral Health Clinicians
Social Workers

• To provide recommendations for screening and management of late effects in survivors of pediatric malignancies
• To increase quality of life and decrease complication-related healthcare costs for pediatric cancer survivors by providing standardized and enhanced follow-up care throughout the life-span that (a) promotes healthy lifestyles, (b) provides for ongoing monitoring of health status, (c) facilitates early identification of late effects, and (d) provides timely intervention for late effects

Asymptomatic survivors of childhood, adolescent, or young adult cancers who present for routine exposure-related medical follow-up

Thorough history and physical examination, including psychosocial assessment, and targeted screening evaluations

Not stated

Hand-searches of Published Literature (Primary Sources)
Hand-searches of Published Literature (Secondary Sources)
Searches of Electronic Databases

Pertinent information from the published medical literature over the past 20 years (updated as of October 2005) was retrieved and reviewed during the development and updating of these guidelines. For each therapeutic exposure, a complete search was performed via MEDLINE (National Library of Medicine, Bethesda, MD). Keywords included "childhood cancer therapy," "complications," and "late effects," combined with keywords for each therapeutic exposure. References from the bibliographies of selected articles were used to broaden the search.

Not stated

Expert Consensus (Committee)
Weighting According to a Rating Scheme (Scheme Given)

"High-level evidence" (recommendation category 1) was defined as evidence derived from high quality case control or cohort studies.

"Lower-level evidence" (recommendation categories 2A and 2B) was defined as evidence derived from non-analytic studies, case reports, case series, and clinical experience.

Systematic Review with Evidence Tables

The guidelines were scored by the multidisciplinary panel of experts using a modified version of the National Criteria: Comprehensive Cancer Network "Categories of Consensus" system. Each score reflects the expert panel's assessment of the strength of data from the literature linking a specific late effect with a therapeutic exposure, coupled with an assessment of the appropriateness of the screening recommendation based on the expert panel's collective clinical experience. "High-level evidence" (category 1) was defined as evidence derived from high quality case control or cohort studies. "Lower-level evidence" (categories 2A and 2B) was defined as evidence derived from non-analytic studies, case reports, case series and clinical experience. Rather than submitting recommendations representing major disagreements, items scored as "Category 3" were either deleted or revised by the panel of experts to provide at least a "Category 2B" score for all recommendations included in the guidelines.

Expert Consensus

In 2002, the leadership of the Children's Oncology Group Late Effects Committee and Nursing Discipline appointed a 7-member task force, with representation from the Late Effects Committee, Nursing Discipline, and Patient Advocacy Committee. The task force was convened to review and summarize the medical literature and develop a draft of clinical practice guidelines to direct long-term follow-up care for pediatric cancer survivors. The task force followed a modified version of the guideline development process established by the National Comprehensive Cancer Network (NCCN), integrating available literature with expert opinion using reiterative feedback loops.

The original draft went through several iterations within the task force prior to initial review. Multidisciplinary experts in the field, including nurses, physicians (pediatric oncologists and other subspecialists), patient advocates, behavioral specialists, and other healthcare professionals, were then recruited by the task force to provide an extensive, targeted review of the draft, including focused review of selected guideline sections. Revisions were made based on these recommendations. The revised draft was then sent out to additional multidisciplinary experts for further review. A total of 62 individuals participated in the review process. The guidelines subsequently underwent comprehensive review and scoring by a panel of experts in the late effects of pediatric malignancies, comprised of multidisciplinary representatives from the COG Late Effects Committee.

Revisions

In order to keep the guidelines current and clinically meaningful, the COG Late Effects Committee organized 18 multi-disciplinary task forces in March 2004. These task forces were charged with the responsibility for monitoring the medical literature in regard to specific system-related clinical topics relevant to the guidelines (e.g., cardiovascular, neurocognitive, fertility/reproductive), providing periodic reports to the Late Effects Committee, and recommending revisions to the guidelines and their associated health education materials and references (including the addition of therapeutic exposures) as new information became available. Task force members were assigned according to their respective areas of expertise and clinical interest. A list of these task forces and their membership is included in the "Contributors" section of the original guideline document. The revisions incorporated into the current release of these guidelines (Version 2.0 – March 2006) reflect the contributions and recommendations of these task forces.

All revisions proposed by the task forces were evaluated by a panel of experts, and if accepted, assigned a score (see "Rating Scheme for the Strength of the Evidence"). Proposed revisions that were rejected by the expert panel were returned with explanation to the relevant task force chair. If desired, task force chairs were given an opportunity to respond by providing additional justification and resubmitting the rejected task force recommendation(s) for further consideration by the expert panel. A total of 34 sections and 9 Health Links were added to Version 2.0 of these guidelines.

Each score relates to the strength of the association of the identified late effect with the specific therapeutic exposure based on current literature, and is coupled with a recommendation for periodic health screening based on the collective clinical experience of the panel of experts. This is due to the fact that there are no randomized clinical trials (and none forthcoming in the foreseeable future) on which to base recommendations for periodic screening evaluations in this population; therefore, the guidelines should not be misconstrued as representing conventional "evidence-based clinical practice guidelines" or "standards of care".

Each item was scored based on the level of evidence currently available to support it. Scores were assigned according to a modified version of the National Comprehensive Cancer Network "Categories of Consensus," as follows:

1  There is uniform consensus of the panel that (1) there is high-level evidence linking the late effect with the therapeutic exposure, and (2) the screening recommendation is appropriate based on the collective clinical experience of panel members.

2A  There is uniform consensus of the panel that (1) there is lower-level evidence linking the late effect with the therapeutic exposure, and (2) the screening recommendation is appropriate based on the collective clinical experience of panel members.

2B  There is non-uniform consensus of the panel that (1) there is lower-level evidence linking the late effect with the therapeutic exposure, and (2) the screening recommendation is appropriate based on the collective clinical experience of panel members.

3  There is major disagreement that the recommendation is appropriate.

A formal cost analysis was not performed and published cost analyses were not reviewed.

External Peer Review
Internal Peer Review

The initial version of the guidelines (Version 1.0 – Children's Oncology Group Late Effects Screening Guidelines) was released to the Children's Oncology Group (COG) membership in March 2003 for a six-month trial period. This allowed for initial feedback from the COG membership, resulting in additional review and revision of the guidelines by the Late Effects Committee prior to public release.

Revisions

All revisions proposed by the task forces were evaluated by a panel of experts, and if accepted, assigned a score (see "Rating Scheme for the Strength of the Evidence"). Proposed revisions that were rejected by the expert panel were returned with explanation to the relevant task force chair. If desired, task force chairs were given an opportunity to respond by providing additional justification and resubmitting the rejected task force recommendation(s) for further consideration by the expert panel.

None provided

The type of supporting evidence is identified and graded for each recommendation (see "Major Recommendations")

Although several well-conducted studies on large populations of childhood cancer survivors have demonstrated associations between specific exposures and late effects, the size of the survivor population and the rate of occurrence of late effects does not allow for clinical studies that would assess the impact of screening recommendations on the morbidity and mortality associated with the late effect. Therefore, scoring of each exposure reflects the expert panel's assessment of the level of literature support linking the therapeutic exposure with the late effect coupled with an assessment of the appropriateness of the recommended screening modality in identifying the potential late effect based on the panel's collective clinical experience.

Potential benefits of implementing these guidelines into clinical practice include earlier identification of and intervention for late onset therapy-related complications in this at-risk population, potentially reducing or ameliorating the impact of late complications on the health status of survivors. In addition, ongoing healthcare that promotes healthy lifestyle choices and provides ongoing monitoring of health status is important for all cancer survivors.

Potential harms of guideline implementation include increased patient anxiety related to enhanced awareness of possible complications, as well as the potential for false-positive screening evaluations, leading to unnecessary further workup. In addition, costs of long-term follow-up care may be prohibitive for some patients, particularly those lacking health insurance, or those with insurance that does not cover the recommended screening evaluations.

• The information and contents of each document or series of documents made available by the Children's Oncology Group relating to late effects of cancer treatment and care or containing the title "Long-Term Follow-Up Guidelines for Survivors of Childhood, Adolescent, and Young Adult Cancers" or the title "Health Link," whether available in print or electronic format (including any digital format, e-mail transmission, or download from the website), shall be known hereinafter as "Informational Content." All Informational Content is for informational purpose only. The Informational Content is not intended to substitute for medical advice, medical care, diagnosis, or treatment obtained from a physician or healthcare provider.
• To cancer patients (if children, their parents or legal guardians): Please seek the advice of a physician or other qualified healthcare provider with any questions you may have regarding a medical condition and do not rely on the Informational Content. The Children's Oncology Group is a research organization and does not provide individualized medical care or treatment.
• To physicians and other healthcare providers: The Informational Content is not intended to replace your independent clinical judgment, medical advice, or to exclude other legitimate criteria for screening, health counseling, or intervention for specific complications of childhood cancer treatment. Neither is the Informational Content intended to exclude other reasonable alternative follow-up procedures. The Informational Content is provided as a courtesy, but not intended as a sole source of guidance in the evaluation of childhood cancer survivors. The Children's Oncology Group recognizes that specific patient care decisions are the prerogative of the patient, family, and healthcare provider.
• While the Children's Oncology Group has made every attempt to assure that the Informational Content is accurate and complete as of the date of publication, no warranty or representation, express or implied, is made as to the accuracy, reliability, completeness, relevance, or timeliness of such Informational Content.
• No liability is assumed by the Children's Oncology Group or any affiliated party or member thereof for damage resulting from the use, review, or access of the Informational Content. You agree to the following terms of indemnification: (i) "Indemnified Parties" include authors and contributors to the Informational Content, all officers, directors, representatives, employees, agents, and members of the Children's Oncology Group and affiliated organizations; (ii) by using, reviewing, or accessing the Informational Content, you agree, at your own expense, to indemnify, defend and hold harmless Indemnified Parties from any and all losses, liabilities, or damages (including attorneys' fees and costs) resulting from any and all claims, causes of action, suits, proceedings, or demands related to or arising out of use, review or access of the Informational Content.
• Ultimately, as with all clinical guidelines, decisions regarding screening and clinical management for any specific patient should be individually tailored, taking into consideration the patient's treatment history, risk factors, co-morbidities, and lifestyle. These guidelines are therefore not intended to replace clinical judgment or to exclude other reasonable alternative follow-up procedures. The Children's Oncology Group recognizes that specific patient care decisions are the prerogative of the patient, family, and healthcare provider.

Living with Illness
Staying Healthy

Effectiveness
Patient-centeredness

• Children's Oncology Group. Long-term follow-up guidelines for survivors of childhood, adolescent, and young adult cancers. Sections 1-2: any cancer experience. Bethesda (MD): Children's Oncology Group; 2006 Mar. 4 p. [50 references]

Not applicable: The guideline was not adapted from another source.

2003 Sep (revised 2006 Mar)

Children's Oncology Group - Medical Specialty Society

This work was supported by the Children's Oncology Group grant U10 CA098543 from the National Cancer Institute.

Children's Oncology Group Nursing Discipline and Late Effects Committee

Melissa M. Hudson, MD
Vice-Chair – COG Late Effects Committee
Member, Department of Hematology-Oncology
Director, After Completion of Therapy Clinic
St. Jude Children's Research Hospital
Memphis, Tennessee

Wendy Landier, RN, MSN, CPNP, CPON®
Chair – COG Nursing Clinical Practice Subcommittee
Clinical Director - Survivorship Clinic
City of Hope Comprehensive Cancer Center
Duarte, California

Smita Bhatia, MD, MPH
Chair – COG Late Effects Committee
Professor and Chair, Division of Population Sciences
City of Hope Comprehensive Cancer Center
Duarte, California

All Children's Oncology Group (COG) members have complied with the COG conflict of interest policy, which requires disclosure of any potential financial or other conflicting interests.

This is the current release of the guideline.

This guideline updates a previous version: Children's Oncology Group. Long-term follow-up guidelines for survivors of childhood, adolescent, and young adult cancers. Version 1.2. 2004 Mar.

This NGC summary was completed by ECRI on May 4, 2007. The information was verified by the guideline developer on June 11, 2007.

This NGC summary is based on the original guideline, which is subject to the guideline developer's copyright restrictions.