Prospective Assessment of Symptoms and Quality of Life in Rectal Cancer Patients Receiving Chemo-Radiotherapy
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00414232|
Recruitment Status : Completed
First Posted : December 21, 2006
Last Update Posted : January 8, 2013
|Condition or disease|
- 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.
|Study Type :||Observational|
|Actual Enrollment :||13 participants|
|Official Title:||Prospective Assessment of Symptoms and Quality of Life in Rectal Cancer Patients Receiving Chemo-Radiotherapy|
|Study Start Date :||November 2006|
|Actual Primary Completion Date :||October 2010|
- Quality of Life (QoL) [ Time Frame: 1 year ]Assessment of Quality of Life of Patients post standard of care radiation therapy
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|