Protocol Title:

Prospective Assessment of Symptoms and Quality of Life in Rectal Cancer Patients Receiving Chemo-Radiotherapy

Protocol Status:

Open

Protocol Number:

J-06109

Type of Cancer:

Rectal

Principal Investigator:

Joseph Herman, M.D.

Research Nurse:

Shirl DiPasquale, R.N.

Phase Number:

Prospective Assessment

General Eligibility:

Rectal cancer patients planned to receive neoadjuvant concurrent chemotherapy and pelvic radiation. Patients of all ages ≥18, both sexes and all races will be included in this study.

Purpose:

To prospectively establish the distribution of Quality of Life parameters in rectal cancer patients treated with neoadjuvant chemo-radiotherapy, as measured by 3 questionnaires. To determine the frequency and severity of disease- and treatment-related symptoms, as graded by our institutional symptom inventory, before, during, and following chemoradiotherapy. To pilot the logistics of obtaining quality of life data from rectal cancer patients prior to, during, and following completion of chemo-radiation. To pilot the logistics of multi-institutional collaboration in collection of said data.

Treatment:

Patients will be registered by the Radiation Oncology clinical subjects coordinator after eligibility is confirmed and informed consent is obtained. The 3 questionnaires 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), and approximately one month after completion of radiotherapy during a follow-up visit. The 3 questionnaires 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. If the patient is unable to return to the clinic for follow-up, the QOL forms may be mailed to the patient to complete and send back to the Department of Radiation Oncology. The symptom inventory will be collected in an interview by a nurse or other healthcare provider at the following time points: within 3 weeks prior to start of radiotherapy, once weekly during radiotherapy,  and approximately one month after completion of radiotherapy during a follow-up visit. If the patient is unable to return to the clinic for follow-up, the symptom inventory may be collected via telephone.