Clinical trial NCT00836992: Quality of Life in Patients Undergoing Radiation Therapy for Primary Lung Cancer, Head and Neck Cancer, or Gastrointestinal Cancer
Official title: Assessing the Clinical Significance of Real-time Quality of Life Data in Cancer Patients Treated With Radiation Therapy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: 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
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
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2009-02-04
Enrollment: 144
Sex: ALL
Minimum age (years): 18
Maximum age (years): 120
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
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

Brief 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.

Eligibility 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

Primary outcomes:
measure: Overall quality of life (QOL) scores at baseline, weeks 1, 3, 5, and end of treatment as assessed by LASA
timeFrame: 7 Weeks
Secondary outcomes:
measure: 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
timeFrame: 7 Weeks
measure: Frequency and severity of toxicity as assessed by NCI CTCAE at baseline, weeks 1, 3, 5, and of treatment
timeFrame: 7 Weeks
measure: Scores from the IPPRS, satisfaction with the physician scale score, and global question assessment
timeFrame: 7 Weeks
measure: Quantitative assessments from the post-treatment questionnaires and the qualitative data gleaned from the post-treatment interviews
timeFrame: One month post study
measure: 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 ...
timeFrame: One month post study
measure: Average physician rating of the patient-physician relationships for the two treatment groups
timeFrame: 7 Weeks
measure: Average duration of the weekly on treatment visit for the two treatment groups
timeFrame: 7 Weeks
measure: Percentage of patients for which physician reports indicate that availability
timeFrame: 7 Weeks
Other outcomes:
Locations:
city: Scottsdale
country: United States
facility: Mayo Clinic in Arizona
state: Arizona
Study officials:
affiliation: Mayo Clinic
name: Michele Yvette Halyard, M.D.
role: PRINCIPAL_INVESTIGATOR
References: