Quality of Life in Patients Undergoing Radiation Therapy for Primary Lung Cancer, Head and Neck Cancer, or Gastrointestinal Cancer

Mayo Clinic

Status: Completed

Conditions: Gallbladder Cancer; Anal Cancer; Gastric Cancer; Esophageal Cancer; Extrahepatic Bile Duct Cancer; Lung Cancer; Head and Neck Cancer; Liver Cancer; Small Intestine Cancer; Pancreatic Cancer; Colorectal Cancer

Study type: Observational

Funder types: Other; NIH

Identifiers

NCT00836992

P30CA015083 (U.S. NIH Grant/Contract)

MCS1065 (Other Identifier)

CDR0000629594 (Registry Identifier)

08-005566 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 144 patients

Sex: All

Ages: 18 to 120 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

DISEASE CHARACTERISTICS:

• Diagnosis of 1 of the following:

  • Primary lung cancer
  • Head and neck cancer
  • Gastrointestinal cancer

• No evidence of distant metastasis

• Receiving ≥ 5 weeks of definitive or adjuvant radiotherapy at Mayo Clinic Arizona

PATIENT CHARACTERISTICS:

• Able to complete computer based questionnaires
• Able to complete quality of life questionnaires in English
• Willing and able to comprehend and provide informed consent

PRIOR CONCURRENT THERAPY:

• See Disease Characteristics

Trial design

144 participants in 2 patient groups

Control

Description:

Patient's QOL assessments data is not shared with the physician, nurse, and/or nurse practitioner and the patient

Active

Description:

Patient's QOL assessments data is shared with the physician, nurse, and/or nurse practitioner and the patient immediately prior to the on-treatment visit.