Prospective Assessment of Symptoms and Quality of Life in Rectal Cancer Patients Receiving Chemo-Radiotherapy
Prospective Assessment of Symptoms and Quality of Life in Rectal Cancer Patients Receiving Chemo-Radiotherapy.
|Study Design:||Observational Model: Case-Only
Time Perspective: Prospective
|Official Title:||Prospective Assessment of Symptoms and Quality of Life in Rectal Cancer Patients Receiving Chemo-Radiotherapy|
- Quality of Life (QoL) [ Time Frame: 1 year ] [ Designated as safety issue: No ]Assessment of Quality of Life of Patients post standard of care radiation therapy
|Study Start Date:||November 2006|
|Primary Completion Date:||October 2010 (Final data collection date for primary outcome measure)|
- 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.
- Patients will be registered by the Radiation Oncology clinical subjects coordinator after eligibility is confirmed and informed consent is obtained.
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 point:
- Within 3 weeks prior to start of radiotherapy
- During the 4th week of radiotherapy (when treatment-related symptoms are expected to peak)
- Approximately one month after completion of radiotherapy during a follow-up visit
- 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.
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00414232
|United States, Maryland|
|The Sidney Kimmel Comprehensive Cancer Center at The Johns Hopkins University|
|Baltimore, Maryland, United States, 21231|
|Principal Investigator:||Joseph Herman, M.D.||Johns Hopkins University|