Quality of Life in Patients Undergoing Radiation Therapy for Primary Lung Cancer, Head and Neck Cancer, or Gastrointestinal Cancer
Condition: Anal Cancer; Colorectal Cancer; Esophageal Cancer; Extrahepatic Bile Duct Cancer; Gallbladder Cancer; Gastric Cancer; Head and Neck Cancer; Liver Cancer; Lung Cancer; Pancreatic Cancer; Small Intestine Cancer
MeSH terms: Lung Neoplasms; Pancreatic Neoplasms; Stomach Neoplasms; Head and Neck Neoplasms; Esophageal Neoplasms; Liver Neoplasms; Anus Neoplasms; Gallbladder Neoplasms; Bile Duct Neoplasms; Cholangiocarcinoma; Intestinal Neoplasms
Study type: Observational

Summary: 
      RATIONALE: Gathering information about patients' quality of life during radiation therapy for
      cancer may help doctors plan the best treatment.

      PURPOSE: This randomized clinical trial is studying quality of life in patients undergoing
      radiation therapy for primary lung cancer, head and neck cancer, or gastrointestinal cancer.
    

Detailed description: 
      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.
    

Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients with head and neck tumors, lung tumors, and gastrointestinal tumors receiving
        radiation therapy at Mayo Clinic Arizona
      
Keywords: anal cancer; colon cancer; rectal cancer; esophageal cancer; extrahepatic bile duct cancer; gallbladder cancer; gastric cancer; adult primary liver cancer; pancreatic cancer; small intestine cancer; non-small cell lung cancer; small cell lung cancer; head and neck cancer