Clinical trial NCT00414232: Prospective Assessment of Symptoms and Quality of Life in Rectal Cancer Patients Receiving Chemo-Radiotherapy
Official title: Prospective Assessment of Symptoms and Quality of Life in Rectal Cancer Patients Receiving Chemo-Radiotherapy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Rectal Cancer
Keywords: Rectal Cancer
Chemoradiation
Rectal Cancer receiving chemoradiation.
Lead sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Sponsor class: OTHER
Collaborators: name: University of Michigan
First posted: 2006-12-21
Enrollment: 13
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Males or females greater than or equal to 18 years of age with a working diagnosis of rectal cancer.

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.

Eligibility criteria: Inclusion Criteria:

* All of the following questions must be answered "yes" for a patient to be eligible for this protocol.

  1. Is there a working diagnosis of rectal cancer? YES NO
  2. Will the patient be receiving neoadjuvant concurrent chemotherapy and pelvic radiation? YES NO
  3. Is the pelvic radiation planned for a dose of 45-54 Gy and will it be delivered using a standard 3-field technique? YES NO
  4. Is the patient ≥ 18 years of age? YES NO
  5. Can the patient give informed consent? YES NO

Exclusion Criteria:

* All of the following questions must be answered "no" for a patient to be eligible for this protocol.

  1. Has there been prior radiation to the pelvis? YES NO
  2. Is the patient in the "special category" designated by the Public Health Service (patients younger than 18, pregnant women, and prisoners)? YES NO

Primary outcomes:
measure: Quality of Life (QoL)
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: The Sidney Kimmel Comprehensive Cancer Center at The Johns Hopkins University
state: Maryland
Study officials:
affiliation: Johns Hopkins University
name: Joseph Herman, M.D.
role: PRINCIPAL_INVESTIGATOR
References: