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

Colorectal Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00836992
• Other study ID #: 08-005566
• Secondary ID: P30CA015083CDR00
• Status: Completed
• Phase: N/A
• First received: February 3, 2009
• Last updated: May 23, 2017
• Start date: January 2009
• Est. completion date: July 27, 2015

Study information

• Verified date: May 2017
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 144
• Est. completion date: July 27, 2015
• Est. primary completion date: September 15, 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 120 Years

Eligibility

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

Related Conditions & MeSH terms

• Anal Cancer
• Anus Neoplasms
• Bile Duct Neoplasms
• Colorectal Cancer
• Colorectal Neoplasms
• Esophageal Cancer
• Esophageal Neoplasms
• Extrahepatic Bile Duct Cancer
• Gallbladder Cancer
• Gallbladder Neoplasms
• Gastric Cancer
• Head and Neck Cancer
• Head and Neck Neoplasms
• Intestinal Neoplasms
• Liver Cancer
• Liver Neoplasms
• Lung Cancer
• Lung Neoplasms
• Pancreatic Cancer
• Pancreatic Neoplasms
• Small Intestine Cancer
• Stomach Neoplasms

Locations

Country	Name	City	State
United States	Mayo Clinic in Arizona	Scottsdale	Arizona

Sponsors (2)

Lead Sponsor	Collaborator
Mayo Clinic	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall quality of life (QOL) scores at baseline, weeks 1, 3, 5, and end of treatment as assessed by LASA		7 Weeks
Secondary	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
Secondary	Frequency and severity of toxicity as assessed by NCI CTCAE at baseline, weeks 1, 3, 5, and of treatment		7 Weeks
Secondary	Scores from the IPPRS, satisfaction with the physician scale score, and global question assessment		7 Weeks
Secondary	Quantitative assessments from the post-treatment questionnaires and the qualitative data gleaned from the post-treatment interviews		One month post study
Secondary	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
Secondary	Average physician rating of the patient-physician relationships for the two treatment groups		7 Weeks
Secondary	Average duration of the weekly on treatment visit for the two treatment groups		7 Weeks
Secondary	Percentage of patients for which physician reports indicate that availability		7 Weeks