Quality of Life (QoL) after Hypofractionated Radiation in the Treatment of Patients with Cancer

Study ID
STU 052012-039

Cancer Related

Healthy Volunteers

Study Sites

Rossana Berrios

Principal Investigator
Dong Kim


This study will measure the quality of life outcomes, convenience, and indirect cost savings of patients treated with hypofractionated radiation therapy for cancer at uT Southwestern and affiliated hospitals (Parkland and/or uT Southwestern university Hospital x Zale Lipshy) by the principal investigator, co-investigators, and current and prior faculty in the department of radiation oncology at uTSW. The information gathered for this study will be of two general types: (1) information from retrospective chart reviews of patients treated with hypofractionated radiation therapy (2) information from the quality of life and convenience questionnaires that these patients will be requested to complete either via mail, in person, or electronic portal. Patients contacted by mail will be asked to fill out the abovementioned QoL questionnaires as noted by treatment site. no more than three forms will be administered as the patients will be asked to fill out only three forms: the site specific FaCT or eoRTC-QLQ C30, eQ-5D, and the convenience and indirect cost form.

The precedence for the ability and willingness of patient to complete these forms is that our department has two open prospective trials with the first two questionnaires being administered at every follow up with the convenience questionnaire being given as a single administration at first follow demonstrating the feasibility of patients being able to fill out these forms. The studies are [Quote]Phase ii trial of Hippocampal-avoiding Whole Brain irradiation with Simultaneousintegrated Boost for Treatment of Brain Metastases[Quote] [STu 042011-050] and [Quote]a Phase i Study of Cyberknife[RegisteredTM] Partial Breast irradiation (PBi) for early Stage Breast Cancer[Quote] [STu 072010-015].

a maximum of 500 patients, who are patients of the principal investigator and/or co-investigators will also be identified. We will first call the patient to verify contact information and address. This phone contact will be a recruitment and verbal consent phone call and a script for this phone call is provided within the submission. Patients verbally consenting to participatewill then be mailed a packet with an information sheet describing the Study and requesting them tocomplete the FaCT- site specific questionnaire or eoRTC QLQ C-30, eQ-5D, and convenience and indirect cost questionnaire. Patients will be given stamped addressed returned envelopes. interested patients who do not decline the study but do not return the forms will be followed up one month after mailing and two months but no further contact will take place after two months of nonparticipation.
Since many of these patients are seen regularly in the clinic, those who have planned follow up with in the first two months of this study being activated may be contacted in person in clinic. The process of explaining the study and asking for verbal consent will be the same as above except it will be in person and not via mail.
Please see patient contact schema below for further explanation: See schema in uploaded protocol.
The data from the retrospective chart review, QoL assessments will be compiled and analyzed to better understand quality of life outcomes for patients treated with hypofractionated radiation for cancer. in many respects, this study is a feasibility project to assess quality of life on patients in our department with a specific patient population of those treated with hypofractionated radiation targeted in this study. Therefore, a power calculation and hypothesis are not as pertinent to this study as no comparisons between historical controls, cohorts, or pre treatment QoL values are planned or possible given the small number of patients, many of whom are no longer living.

Participant Eligibility

* The patients have been treated by the principal investigator and/or co investigators or current or prior faculty in the UT Southwestern Department of Radiation Oncology. The patients were treated at UT Southwestern and affiliated hospitals (Parkland, and/or UT Southwestern University Hospital x Zale Lipshy).

* The patients were treated cancer and are patients of the principal investigator and/or co-investigator or prior or current faculty in the UT Southwestern Department of Radiation Oncology

* The patients consulted in the UT Southwestern Department of Radiation Oncology at least one time between the dates of 1/1/2000 and 5/1/2012

* The patients have had hypofractionated (less fractions than the standard of care) radiation therapy for any histological type of cancer.

* Patients must be alive at the time of the study