Trial Information

Assessing the Clinical Significance of Real-time Quality of Life Data in Cancer Patients Treated With Radiation Therapy

OBJECTIVES:

- To determine if patient-reported quality of life (QOL) can be improved by the real-time
use of QOL data in patients with primary lung, head and neck, or gastrointestinal
cancer undergoing radiotherapy.

- To obtain preliminary estimates for effect sizes on differences in key QOL domains
between patients receiving real time QOL data and those not receiving QOL data.

- To obtain preliminary estimates of differences in patient satisfaction between patients
receiving real time QOL data and those not receiving QOL data.

- To determine whether the availability of real-time QOL assessments in a radiation
oncology practice increases the acceptance and utilization of QOL data by a clinical
oncology team.

- To evaluate clinician attitudes towards the incorporation of real-time QOL data into
oncology patient management.

- To evaluate the use of a set of clinical pathways for the incorporation of real time
QOL data into oncology patient management.

- To evaluate the potential impact on the quality of the patient-physician relationship
with real-time use of QOL data compared to interactions where quality of life data are
not utilized.

- To obtain preliminary estimates of whether the real-time use of QOL data in a radiation
oncology practice significantly increases the duration of the weekly on treatment
visit.

OUTLINE: Patients are randomized to 1 of 2 groups.

- Group 1 (control): Patients complete QOL assessments (e.g., the Linear Analog Self
Assessment [LASA]) at weeks 1, 3, and 5 during treatment and the last week of
treatment. They also complete the Interpersonal Patient-Provider Relationship Scale
(IPPRS) and Was it Worth It (WIW) questionnaires on the final day of treatment. Data is
not shared with the physician, the patient, or any other clinical assistant that may be
supporting the physician (e.g. nurse, or nurse practitioner).

- Group 2 (active): Patients complete QOL assessments (e.g., LASA) and the IPPRS and WIW
questionnaires as in group 1. Information from the questionnaires is shared with the
physician, nurse, and/or nurse practitioner and the patient immediately prior to the
on-treatment visit.