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

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

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.

Study Overview

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

• Study Type: Observational
• Enrollment (Actual): 144

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Scottsdale, Arizona, United States, 85259-5499
      • Mayo Clinic in Arizona

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 120 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Control; Patient's QOL assessments data is not shared with the physician, nurse, and/or nurse practitioner and the patient
Active; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Overall quality of life (QOL) scores at baseline, weeks 1, 3, 5, and end of treatment as assessed by LASA	7 Weeks

Secondary Outcome Measures

Outcome Measure	Time Frame
Component QOL domains reported on the five numerical analogue items (physical, intellectual, emotional, spiritual, and social QOL), average pain item and fatigue reported in the LASA	7 Weeks
Frequency and severity of toxicity as assessed by NCI CTCAE at baseline, weeks 1, 3, 5, and of treatment	7 Weeks
Scores from the IPPRS, satisfaction with the physician scale score, and global question assessment	7 Weeks
Quantitative assessments from the post-treatment questionnaires and the qualitative data gleaned from the post-treatment interviews	One month post study
Proportion of cases for which the clinical team indicates that the clinical pathways contributed positively to patient management, the number of cases which the clinicians report referrals were generated, and the qualitative data derived from the pos ...	One month post study
Average physician rating of the patient-physician relationships for the two treatment groups	7 Weeks
Average duration of the weekly on treatment visit for the two treatment groups	7 Weeks
Percentage of patients for which physician reports indicate that availability	7 Weeks

Collaborators and Investigators

• Sponsor: Mayo Clinic
• Collaborators: National Cancer Institute (NCI)
• Investigators: Principal Investigator: Michele Yvette Halyard, M.D., Mayo Clinic

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2009
• Primary Completion (Actual): September 15, 2011
• Study Completion (Actual): July 27, 2015

Study Registration Dates

• First Submitted: February 3, 2009
• First Submitted That Met QC Criteria: February 3, 2009
• First Posted (Estimate): February 4, 2009

Study Record Updates

• Last Update Posted (Actual): May 24, 2017
• Last Update Submitted That Met QC Criteria: May 23, 2017
• Last Verified: May 1, 2017

More Information

Terms related to this study

• Keywords: non-small cell lung cancer; rectal cancer; colon cancer; esophageal cancer; gastric cancer; pancreatic cancer; head and neck cancer; small cell lung cancer; anal cancer; adult primary liver cancer; gallbladder cancer; small intestine cancer; extrahepatic bile duct cancer
• Additional Relevant MeSH Terms: Digestive System Diseases; Respiratory Tract Diseases; Neoplasms by Histologic Type; Neoplasms; Lung Diseases; Neoplasms by Site; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Endocrine System Diseases; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Stomach Diseases; Endocrine Gland Neoplasms; Liver Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms; Intestinal Diseases; Rectal Diseases; Esophageal Diseases; Colorectal Neoplasms; Gallbladder Diseases; Biliary Tract Diseases; Pancreatic Diseases; Bile Duct Diseases; Rectal Neoplasms; Anus Diseases; Biliary Tract Neoplasms; Stomach Neoplasms; Head and Neck Neoplasms; Lung Neoplasms; Pancreatic Neoplasms; Cholangiocarcinoma; Liver Neoplasms; Esophageal Neoplasms; Intestinal Neoplasms; Anus Neoplasms; Gallbladder Neoplasms; Bile Duct Neoplasms
• Other Study ID Numbers: 08-005566 (Other Identifier: Mayo Clinic IRB); P30CA015083 (U.S. NIH Grant/Contract); CDR0000629594 (Registry Identifier: NCI); MCS1065 (Other Identifier: Mayo Clinic Cancer Center)