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

This study is ongoing, but not recruiting participants.
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Mayo Clinic Identifier:
First received: February 3, 2009
Last updated: April 19, 2016
Last verified: April 2016

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.

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

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Assessing the Clinical Significance of Real-time Quality of Life Data in Cancer Patients Treated With Radiation Therapy

Resource links provided by NLM:

Further study details as provided by Mayo Clinic:

Primary Outcome Measures:
  • Overall quality of life (QOL) scores at baseline, weeks 1, 3, 5, and end of treatment as assessed by LASA [ Time Frame: 7 Weeks ]

Secondary Outcome Measures:
  • 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 [ Time Frame: 7 Weeks ]
  • Frequency and severity of toxicity as assessed by NCI CTCAE at baseline, weeks 1, 3, 5, and of treatment [ Time Frame: 7 Weeks ]
  • Scores from the IPPRS, satisfaction with the physician scale score, and global question assessment [ Time Frame: 7 Weeks ]
  • Quantitative assessments from the post-treatment questionnaires and the qualitative data gleaned from the post-treatment interviews [ Time Frame: 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 ... [ Time Frame: One month post study ]
  • Average physician rating of the patient-physician relationships for the two treatment groups [ Time Frame: 7 Weeks ]
  • Average duration of the weekly on treatment visit for the two treatment groups [ Time Frame: 7 Weeks ]
  • Percentage of patients for which physician reports indicate that availability [ Time Frame: 7 Weeks ]

Estimated Enrollment: 132
Study Start Date: January 2009
Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Patient's QOL assessments data is not shared with the physician, nurse, and/or nurse practitioner and the patient
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.

Detailed Description:


  • 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.

Ages Eligible for Study:   18 Years to 120 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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


  • 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


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


  • See Disease Characteristics
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00836992

United States, Arizona
Mayo Clinic in Arizona
Scottsdale, Arizona, United States, 85259-5499
Sponsors and Collaborators
Mayo Clinic
National Cancer Institute (NCI)
Principal Investigator: Michele Yvette Halyard, M.D. Mayo Clinic
  More Information

Responsible Party: Mayo Clinic Identifier: NCT00836992     History of Changes
Other Study ID Numbers: 08-005566
P30CA015083 ( US NIH Grant/Contract Award Number )
CDR0000629594 ( Registry Identifier: NCI )
08-005566 ( Other Identifier: Mayo Clinic IRB )
MCS1065 ( Other Identifier: Mayo Clinic Cancer Center )
Study First Received: February 3, 2009
Last Updated: April 19, 2016

Keywords provided by Mayo Clinic:
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

Additional relevant MeSH terms:
Lung Neoplasms
Colorectal Neoplasms
Stomach Neoplasms
Head and Neck Neoplasms
Pancreatic Neoplasms
Esophageal Neoplasms
Liver Neoplasms
Anus Neoplasms
Gallbladder Neoplasms
Bile Duct Neoplasms
Intestinal Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Gastrointestinal Neoplasms
Digestive System Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Stomach Diseases
Endocrine Gland Neoplasms
Pancreatic Diseases
Endocrine System Diseases
Esophageal Diseases
Liver Diseases processed this record on April 26, 2017