Prospective Assessment of Symptoms and Quality of Life in Rectal Cancer Patients Receiving Chemo-Radiotherapy
1. Only the principal investigator, sub-investigators, and research nurse will be
approaching potential participants. The above listed also will be the only consentors
for the study. The recruitment process will occur during the outpatient visits being
held at the Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins. HIPAA (Health
Insurance Portability and Accountability Act ) and guidelines and good clinical
practice will be followed at all times to ensure that the privacy of participants
included in the recruitment process are strictly guarded.
2. Patients will be registered by the Radiation Oncology clinical subjects coordinator
after eligibility is confirmed and informed consent is obtained.
3. The EORTC (European Organization for Research and Treatment of Cancer)QLQ- C30 (Quality
of Life Questionnaire), QLQ-CR38 (Quality of Life Questionnaire), and QLQ-CR29 (Quality
of Life Questionnaire) forms will be completed by patients at the following time
1. Within 3 weeks prior to start of radiotherapy
2. During the 4th week of radiotherapy (when treatment-related symptoms are expected
3. Approximately one month after completion of radiotherapy during a follow-up visit
4. The QOL forms (QLC-C30, QLQ-CR38, and CR29) will be self-administered surveys. A nurse
or other healthcare provider will be available to help the patient with any questions
regarding the QOL forms.
5. The symptom inventory will be collected in an interview by a nurse or other healthcare
provider at the following time points: d. Within 3 weeks prior to start of radiotherapy
e. Once weekly during radiotherapy f. Approximately one month after completion of
radiotherapy during a follow-up visit.
Observational Model: Case-Only, Time Perspective: Prospective
Quality of Life (QoL)
Assessment of Quality of Life of Patients post standard of care radiation therapy
Joseph Herman, M.D.
Johns Hopkins University
United States: Institutional Review Board
|The Sidney Kimmel Comprehensive Cancer Center at The Johns Hopkins University||Baltimore, Maryland 21231|