PURPOSE/ OBJECTIVES: To report the experience of a group of researchers who have had a year of experience in a clinical trial with homecare hospice patients. SAMPLE: 150 hospice patients with cancer and their primary caregivers who were accrued to a National Cancer Institute-funded clinical trial focusing on quality of life. METHODS: The investigative team kept careful records of the numbers of patient/caregiver dyads accrued to the study and the reasons for nonaccrual as well as reasons for attrition. Data were analyzed using descriptive statistics. FINDINGS: During a nine-month period, the hospice admitted 2,517 patients; 75% had cancer and 95% had caregivers, making them eligible for the study. However, after further screening, only 19% were eligible for contact and only 5% finally were accrued to the study. For the 125 patient/caregiver dyads actually accrued to the study, baseline data were obtained on only 50% and evaluable follow-up data on only 50%. CONCLUSIONS: Accruing patients to clinical trials and retaining them when they are critically ill and near death are extraordinarily difficult tasks. The inability to recruit and retain subjects for clinical trials has implications for integrity of data, data analysis, success of the project, and the cost of conducting such projects in the future.
RCT Entities:
PURPOSE/ OBJECTIVES: To report the experience of a group of researchers who have had a year of experience in a clinical trial with homecare hospice patients. SAMPLE: 150 hospice patients with cancer and their primary caregivers who were accrued to a National Cancer Institute-funded clinical trial focusing on quality of life. METHODS: The investigative team kept careful records of the numbers of patient/caregiver dyads accrued to the study and the reasons for nonaccrual as well as reasons for attrition. Data were analyzed using descriptive statistics. FINDINGS: During a nine-month period, the hospice admitted 2,517 patients; 75% had cancer and 95% had caregivers, making them eligible for the study. However, after further screening, only 19% were eligible for contact and only 5% finally were accrued to the study. For the 125 patient/caregiver dyads actually accrued to the study, baseline data were obtained on only 50% and evaluable follow-up data on only 50%. CONCLUSIONS: Accruing patients to clinical trials and retaining them when they are critically ill and near death are extraordinarily difficult tasks. The inability to recruit and retain subjects for clinical trials has implications for integrity of data, data analysis, success of the project, and the cost of conducting such projects in the future.