FEASIBILITY OF IMPLEMENTING HEALTH PROMOTION INTERVENTIONS TO IMPROVE HEALTH-RELATED QUALITY OF LIFE Melissa M. HUDSON 1,2,6 *, Vida L. TYC 2 , Deepthi A. JAYAWARDENE 4 , Jami GATTUSO 5 , A. QUARGNENTI 3 , Carol GREENWALD 5 , Deborah B. CROM 1 , Clara MASON 1 , Deo Kumar SRIVASTAVA 4 and Pam HINDS 3 1 Department of Hematology/Oncology, St. Jude Children’s Research Hospital, Memphis, TN, USA 2 Department of Behavioral Medicine, St. Jude Children’s Research Hospital, Memphis, TN, USA 3 Department of Nursing, St. Jude Children’s Research Hospital, Memphis, TN, USA 4 Department of Biostatistics, St. Jude Children’s Research Hospital, Memphis, TN, USA 5 Department of Radiation Oncology, St. Jude Children’s Research Hospital, Memphis, TN, USA 6 Department of Pediatrics, University of Tennessee, College of Medicine, Memphis, TN, USA Survivors of childhood cancer are a growing and vulnerable population. Cure rates for pediatric cancers now exceed 60% and, by the year 2000, an estimated 1 of every 1,000 young adults will be a cancer survivor. Because this population is at increased risk for late medical and neoplastic complications that impact adversely on health-related quality of life, it is important to investigate methods to promote risk reduction by motivating survivors to practice health-promoting behav- iors. W ith this background, we initiated a prospective, ran- domized, controlled feasibility study in which survivorsattend- ing a long-term follow-up clinic were randomized to receive standard care or standard care plus an educational interven- tion. Our objectives were to determine if the intervention would improve the survivors’ knowledge about their cancer treatment and risks of late effects and increase their practice of health-protective behaviors. Since July 1995, 272 of 318 families (86%) approached about the study agreed to partici- pate. Of these, 266 are evaluable for assessment of baseline knowledge and health behaviors. D emographic features, base- line knowledge, health perceptions and health behaviors did not differ among randomized groups. Assessment of the intervention’s efficacy at changing health behaviors of survi- vors randomized to the intervention group will be available when the 1-year follow-up evaluations are completed for the study cohort. Our preliminary experience with this pilot study supports the feasibility of educational intervention research in a specialty clinic dedicated to monitoring long- term childhood cancer survivors. Int. J. Cancer Suppl. 12:138– 142, 1999.  1999 Wiley-Liss, Inc. Childhood cancer survivors are a vulnerable and growing population. With cure rates for pediatric cancers exceeding 60%, it is anticipated that by the year 2000 1 in 1,000 young adults will be a cancer survivor (Bleyer, 1990). This population is at increased risk for late medical and neoplastic complications that decrease their health-related quality of life (HRQL) and increase early mortality (Green et al., 1994; Nicholson et al., 1994; Hudson et al., 1997). Substantial data are available documenting the late sequelae of treatment for childhood cancer, but little is known about the efficacy of techniques to promote risk reduction in this population. Development of interventions is particularly important in view of our recent investigations indicating inconsistencies in the relation- ship between health beliefs and the practice of health-protective behaviors among the long-term survivors monitored at our institu- tion (Mulhern et al., 1995). That is, both parents and survivors expressed heightened health concerns related to the child’s history of malignancy, but these concerns were not correlated with the actual practice of health-protective behaviors. On a similar theme, Hollen and Hobbie (1997) indicate poor-quality decision-making by childhood cancer survivors regarding the practice of high-risk health behaviors. They observed no difference in the decision- making quality and prevalence of smoking, alcohol consumption and illicit drug use between 52 adolescent survivors and their matched peers and determined that the majority of survivors reported poor-quality decision-making regarding health behaviors. These results support the need for research designed to develop effective methods of motivating survivors to adopt health- promoting behaviors. We hypothesized that interventions designed to enhance survi- vors’ knowledge about their risks of late-treatment sequelae and to motivate them to practice health-protective behaviors can reduce morbidity and mortality. With this goal in mind, we explored the feasibility of implementing a health promotion study in an ambula- tory care pediatric oncology clinic setting. Issues discussed in planning for and implementing the clinical trial included the level of interest and participation of the targeted study population, staffing and resources of the study setting, lack of validated instrumentation and outcome measures in the pediatric oncology population, the benefits of using a model to guide the development of the behavioral intervention and analyze its efficacy, training and support of the intervention team and assuring the uniformity and integrity of the intervention. After consideration of these factors, we sought a strategy to determine if an educational intervention would increase significantly the practice of health-protective behaviors by adolescent and young adult survivors of childhood cancer and ultimately improve HRQL. In July 1995, we initiated a prospective, randomized, controlled feasibility study termed ‘‘Protect’’, in which survivors attending a long-term follow-up clinic were randomized to receive standard care (SCG) or standard care plus an educational intervention (IG). The objectives of the study were to determine if the intervention would improve the survivors’ knowledge about their cancer treatment and risks of late effects and increase their practice of health-protective behaviors. Health behaviors targeted for the study were those whose practice reduced the risk of cancer or cardiovas- cular disease or increased the likelihood of detecting cancers at earlier stages. These behaviors included preventing or stopping the use of tobacco, using sun protection, practicing self-examination, reducing dietary fat consumption, losing weight and performing regular aerobic exercise. MATERIAL AND METHODS Study setting and participants Patients eligible for participation in the study were those attending the St. Jude Children’s Research Hospital After Comple- tion of Therapy (ACT) Clinic for their annual evaluation. The ACT Clinic was established in 1984 to monitor long-term sequelae of childhood cancer and its treatment. The ACT staff has seen 800 to 900 long-term survivors each year since 1989. Patients become eligible for transfer from active-treatment clinics to the ACT Clinic when they are in remission at least 5 years from diagnosis, have been off therapy for at least 2 years and lack chronic medical Grant sponsor: National Cancer Institute; Grant number: CA 78217; Grant sponsor: American Lebanese Syrian Associated Charities. *Correspondence to: St. Jude Children’s Research Hospital, 332 N. Lauderdale, Memphis, TN 38105, USA. Fax: +1–901- 495–3058. Int. J. Cancer: Supplement 12, 138–142 (1999)  1999 Wiley-Liss, Inc. Publication of the International Union Against Cancer Publication de l’Union Internationale Contre le Cancer