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.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Mayo Clinic
ClinicalTrials.gov Identifier:
NCT00836992
First received: February 3, 2009
Last updated: February 18, 2014
Last verified: February 2014
  Purpose

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.


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

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 ] [ Designated as safety issue: No ]

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 ] [ Designated as safety issue: No ]
  • Frequency and severity of toxicity as assessed by NCI CTCAE at baseline, weeks 1, 3, 5, and of treatment [ Time Frame: 7 Weeks ] [ Designated as safety issue: Yes ]
  • Scores from the IPPRS, satisfaction with the physician scale score, and global question assessment [ Time Frame: 7 Weeks ] [ Designated as safety issue: No ]
  • Quantitative assessments from the post-treatment questionnaires and the qualitative data gleaned from the post-treatment interviews [ Time Frame: One month post study ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Average physician rating of the patient-physician relationships for the two treatment groups [ Time Frame: 7 Weeks ] [ Designated as safety issue: No ]
  • Average duration of the weekly on treatment visit for the two treatment groups [ Time Frame: 7 Weeks ] [ Designated as safety issue: No ]
  • Percentage of patients for which physician reports indicate that availability [ Time Frame: 7 Weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 132
Study Start Date: January 2009
Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts
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.

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.
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00836992

Locations
United States, Arizona
Mayo Clinic in Arizona
Scottsdale, Arizona, United States, 85259-5499
Sponsors and Collaborators
Mayo Clinic
Investigators
Principal Investigator: Michele Yvette Halyard, M.D. Mayo Clinic
  More Information

Additional Information:
No publications provided

Responsible Party: Mayo Clinic
ClinicalTrials.gov Identifier: NCT00836992     History of Changes
Other Study ID Numbers: 08-005566, P30CA015083, CDR0000629594, 08-005566, MCS1065
Study First Received: February 3, 2009
Last Updated: February 18, 2014
Health Authority: United States: Federal Government

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:
Anus Neoplasms
Colorectal Neoplasms
Esophageal Neoplasms
Head and Neck Neoplasms
Liver Neoplasms
Lung Neoplasms
Stomach Neoplasms
Pancreatic Neoplasms
Duodenal Neoplasms
Ileal Neoplasms
Jejunal Neoplasms
Gallbladder Neoplasms
Bile Duct Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Rectal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Anus Diseases
Rectal Diseases
Colonic Diseases
Esophageal Diseases
Liver Diseases
Respiratory Tract Neoplasms
Thoracic Neoplasms
Lung Diseases

ClinicalTrials.gov processed this record on April 16, 2014