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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.
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

February 3, 2009
February 18, 2014
January 2009
September 2011   (final data collection date for primary outcome measure)
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 ]
  • Overall quality of life (QOL) scores at baseline, weeks 1, 3, 5, and end of treatment as assessed by LASA [ Designated as safety issue: No ]
  • Percentage of patients for which physician reports indicate that availability of the real-time QOL data improved the care provided to the patient [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00836992 on ClinicalTrials.gov Archive Site
  • 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 ]
  • Component QOL domains reported on the five numerical analogue items (physical, intellectual, emotional, spiritual, and social QOL), Cleeland's Brief Pain Inventory, and LASA [ Designated as safety issue: No ]
  • Frequency and severity of toxicity as assessed by NCI CTCAE at baseline, weeks 1, 3, 5, and of treatment [ Designated as safety issue: Yes ]
  • Scores from the IPPRS, satisfaction with the physician scale score, and global question assessment [ Designated as safety issue: No ]
  • Quantitative assessments from the post-treatment questionnaires and the qualitative data gleaned from the post-treatment interviews [ 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 ... [ Designated as safety issue: No ]
  • Average physician rating of the patient-physician relationships for the two treatment groups [ Designated as safety issue: No ]
  • Average duration of the weekly on treatment visit for the two treatment groups [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Quality of Life in Patients Undergoing Radiation Therapy for Primary Lung Cancer, Head and Neck Cancer, or Gastrointestinal Cancer
Assessing the Clinical Significance of Real-time Quality of Life Data in Cancer Patients Treated With Radiation Therapy

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.

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.
Observational
Observational Model: Case Control
Time Perspective: Prospective
Not Provided
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Non-Probability Sample

Patients with head and neck tumors, lung tumors, and gastrointestinal tumors receiving radiation therapy at Mayo Clinic Arizona

  • 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
Not Provided
  • 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.
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
132
Not Provided
September 2011   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00836992
08-005566, P30CA015083, CDR0000629594, 08-005566, MCS1065
Yes
Mayo Clinic
Mayo Clinic
National Cancer Institute (NCI)
Principal Investigator: Michele Yvette Halyard, M.D. Mayo Clinic
Mayo Clinic
February 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP