Clinical Assistant Professor
Research Summary
This project was conducted in collaboration with Celia B. Fisher, Ph.D., Jessica K. Masty, M.A./Center for Ethics Education at Fordham University; and Jessica Reisman, L.C.S.W.
NYUMC/Stephen D. Hassenfeld Center for Children's Cancer & Blood Disorders.
Clinical research trials investigators are to obtain assent from child/adolescent patients as well as parental informed consent. Federal regulations allow the assent requirement to be waived given the patient's age, maturity, and psychological state. Thus, many young cancer patients begin clinical trials based on parental permission alone. To examine how parents, adolescent cancer patients, and research staff view the contribution of teenagers in the informed consent process for clinical trials in pediatric oncology, we developed the Family Decision-Making Questionnaire (FDMQ). The FDMQ has 30 items that assess views on : what information teen patients should receive regarding research; how patient and family characteristics affect the decision to allow teens to participate in research; the degree to which teens should have a say in participation decisions; and if teens should dictate when research should be stopped. The FDMQ was administered to 20 patients, 14 parents whose children had participated in oncology research trials, and 7 clinical trials research staff, in English or Spanish. The obtained date showed most participants to be in favor of patient involvement in research decision-making. Seventy percent of patients and 50% of parents believed that patients shoud have a say in research participation decisions. Some patients and the majority of parents felt that characteristics of the patient should be taken into account. Fifty-eight percent of patients and 64% of parents indicated that they were not clear about whteher they were/had been research participants. These data replicate other studies findings on how informed consent processes may be inadequate in conveying important aspects of cancer research to families. Families need more education about reasearch and on how to support the adolescent patients' role in the informed consent process.
Clinical research trials investigators are to obtain assent from child/adolescent patients as well as parental informed consent. Federal regulations allow the assent requirement to be waived given the patient's age, maturity, and psychological state. Thus, many young cancer patients begin clinical trials based on parental permission alone. To examine how parents, adolescent cancer patients, and research staff view the contribution of teenagers in the informed consent process for clinical trials in pediatric oncology, we developed the Family Decision-Making Questionnaire (FDMQ). The FDMQ has 30 items that assess views on : what information teen patients should receive regarding research; how patient and family characteristics affect the decision to allow teens to participate in research; the degree to which teens should have a say in participation decisions; and if teens should dictate when research should be stopped. The FDMQ was administered to 20 patients, 14 parents whose children had participated in oncology research trials, and 7 clinical trials research staff, in English or Spanish. The obtained date showed most participants to be in favor of patient involvement in research decision-making. Seventy percent of patients and 50% of parents believed that patients shoud have a say in research participation decisions. Some patients and the majority of parents felt that characteristics of the patient should be taken into account. Fifty-eight percent of patients and 64% of parents indicated that they were not clear about whteher they were/had been research participants. These data replicate other studies findings on how informed consent processes may be inadequate in conveying important aspects of cancer research to families. Families need more education about reasearch and on how to support the adolescent patients' role in the informed consent process.
Research Information
Research Interests
-Psychosocial effects of chronic illness
-Co-morbidity of depression and anxiety with chronic illness;
-Perception of pain and coping strategies (alternative medicine; relaxation techs.; hypnosis);
-End of life issues.
-Culture, migration, ethnicity
-Parenting stress
-Psychology and the Arts(dance/movement therapy)
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