Ignite Creation Date:
2025-12-24 @ 9:58 PM
Ignite Modification Date:
2026-02-25 @ 5:54 PM
Study NCT ID:
NCT00414232
Status:
COMPLETED
Last Update Posted:
2019-11-26
First Post:
2006-12-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Prospective Assessment of Symptoms and Quality of Life in Rectal Cancer Patients Receiving Chemo-Radiotherapy
Sponsor:
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Organization:
Study Overview
Official Title:
Prospective Assessment of Symptoms and Quality of Life in Rectal Cancer Patients Receiving Chemo-Radiotherapy
Status:
COMPLETED
Status Verified Date:
2019-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Prospective Assessment of Symptoms and Quality of Life in Rectal Cancer Patients Receiving Chemo-Radiotherapy.
Detailed Description:
STUDY PLAN
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 point:
1. Within 3 weeks prior to start of radiotherapy
2. During the 4th week of radiotherapy (when treatment-related symptoms are expected to peak)
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.
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 point:
1. Within 3 weeks prior to start of radiotherapy
2. During the 4th week of radiotherapy (when treatment-related symptoms are expected to peak)
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| NA_00004324 | OTHER | JHM IRB | View |