HEALTH RELATED OUTCOMES FOR HODGKINS DISEASE SURVIVORS – COG ALTE04N1

by Dr. Debra Friedman Source: CCCF Newsletter, Fall/Winter 2007

This is an important study for survivors of Hodgkin disease who were treated from 1987 to the present. It is being conducted in a number of institutions in the Children’s Oncology Group (COG). We are looking for study participants and we invite you to learn more about this study.

WHY ARE WE DOING THIS STUDY?

Survival from pediatric Hodgkin disease now exceeds 85%, resulting in a growing cohort of survivors who may be at risk for late effects. With changes in therapy over time, the prevalence, incidence, and spectrum of such effects is likely to change. While there are data on late effects for patients treated in the 1960’s through the early 1980’s, there is little collected information regarding similar outcomes for patients treated in the more contemporary era from 1987 to the present. During this period, we designed studies in part to reduce long-term adverse effects. Examples of changes in therapy included a reduction in the use of alkylating agents, anthracyclines and radiotherapy, specifically to decrease late effects in areas of cardiopulmonary, endocrine, reproductive, and psychological health and to decrease the incidence of secondary malignant neoplasms.

Current late effects screening recommendations are largely based on studies of Hodgkin disease survivors treated in the earlier era of chemotherapy and radiotherapy, and may not be applicable to more contemporarily treated patients. Survivors treated with less intensive therapy may need different screening, if indeed the risk profile has changed. Similarly, the spectrum and incidence of late effects experienced by these patients can inform us with respect to the design of future risk-adapted therapeutic trials.

WHAT ARE THE SPECIFIC AIMS OF THE STUDY?

Aim 1: Characterize the prevalence and spectrum of selected adverse physiologic and psychosocial outcomes, and report the cumulative incidence at 5, 10 and 15 years from diagnosis.

Aim 2: Compare the prevalence, cumulative incidence and spectrum of these targeted adverse outcomes, using selfreport, with a cohort of patients treated from 1970-1986. Aim 3: Compare self-reported healthrelated outcomes with those detected by clinical evaluation or medical record review.

WHO IS ELIGIBLE?

Hodgkin disease survivors, treated between 1987 and 2002 with chemotherapy and/or low-dose radiation (< 30 Gy or 3000 cGy) therapy, who were less than 22 years of age at the time of treatment are eligible for this study. You can be any age currently to participate.

WHERE IS THIS STUDY TAKING PLACE?

The study is taking place at the following institutions. Patients need to have received their treatment at one of these institutions or be seen in the long-term follow-up program for this evaluation.

• Children’s Hospital of Seattle
• Children’s Hospital of Philadelphia
• Rhode Island Hospital, Brown University
• Yale University
• University of Texas Southwestern
• St Jude Children’s Research Hospital
• Texas Children’s Hospital
• University of Rochester
• Memorial Sloan Kettering
• Hackensack Medical Center
• University of Chicago
• Stanford University
• Columbia University
• Cincinnati Children’s Hospital

WHAT WILL THIS STUDY INVOLVE?

1. Medical Record abstraction

All patients will have been enrolled on, or treated with identical therapy as cooperative group or consortium clinical trials. The institutional principal investigator will be responsible for providing treatment data (cumulative chemotherapy doses and radiation treatment fi elds and volumes) to correlate with health outcomes. The source of the treatment information (individual chart abstraction, clinical trials database) will be recorded.

1. Self report data

All subjects will complete the following self-report questionnaires, which can be completed at home, and brought to the institution on the day of the clinical evaluation, or mailed in.

• Childhood Cancer Survivor Study Questionnaire
• Post-traumatic stress Questionnaire
• Fatigue Questionnaire
• QOL (Quality of Life) Questionnaire

1. Clinical evaluation

All subjects will receive a comprehensive risk-adapted clinical evaluation using the COG Late Effects Screening Guidelines as appropriate for Hodgkin disease and specifi c therapeutic exposures. For each guideline, the prevalence of both symptomatic and asymptomatic physiologic and psychologic health outcomes will be determined. Data on patient, physician and third party payer refusal to perform recommended screening will be collected for each guideline. Since medical followup and the tests being done are now considered standard of care, you will be charged for this evaluation. Generally insurance covers these long-term follow-up visits, but you will want to check with the institution.

The clinical evaluation will include:

• Complete health history and review of systems
• Review of documented medical problems from the medical record
• Complete physical examination
• Laboratory and diagnostic studies as determined by the COG Late Effects guidelines, by specific chemotherapy and radiotherapy exposure.
• Receipt of a comprehensive treatment summary for you and your primary health care provider.

WHAT DO YOU NEED TO DO IF YOU ARE INTERESTED IN PARTICIPATING IN THE STUDY?

If you were treated at one of the participating institutions or are currently being followed there, contact their survivorship long-term follow-up clinic and let them know that you want to participate.

If you were not treated at any of these institutions but are still interested, or want to know more about the study, contact the principal investigator Dr. Debra Friedman at: dfriedma@fhcrc.org; 206-667-5935.

We look forward to having you join this study!!!