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


N/A
18 Years
N/A
Open (Enrolling)
Both
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

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Trial Information

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


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.

Inclusion 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

Type of Study:

Observational

Study Design:

Observational Model: Case Control, Time Perspective: Prospective

Outcome Measure:

Overall quality of life (QOL) scores at baseline, weeks 1, 3, 5, and end of treatment as assessed by LASA

Outcome Time Frame:

7 Weeks

Safety Issue:

No

Principal Investigator

Michele Yvette Halyard, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

Mayo Clinic

Authority:

United States: Federal Government

Study ID:

08-005566

NCT ID:

NCT00836992

Start Date:

January 2009

Completion Date:

Related Keywords:

  • 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
  • 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
  • Anus Neoplasms
  • Colorectal Neoplasms
  • Esophageal Diseases
  • 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

Name

Location

Mayo Clinic in ArizonaScottsdale, Arizona  85259-5404