Anal CancerNCT00836992
Quality of Life in Patients Undergoing Radiation Therapy for Primary Lung Cancer, Head and Neck Cancer, or Gastrointestinal Cancer
An observational study of Anal Cancer and Colorectal Cancer, run by Mayo Clinic at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 18 to 120 years
- Conditions the study is for
- Anal Cancer, Colorectal Cancer, Esophageal Cancer
- How many people
- 144 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2009to 27 Jul 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 120 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with head and neck tumors, lung tumors, and gastrointestinal tumors receiving radiation therapy at Mayo Clinic Arizona
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
Trial locations and contacts
1 site in 1 country.
United States1 site
Mayo Clinic in Arizona
Scottsdale, Arizona, 85259-5499
About this study
Official title: 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.
Read the 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.
- Conditions
- Anal Cancer, Colorectal Cancer, Esophageal Cancer, Extrahepatic Bile Duct Cancer, Gallbladder Cancer, Gastric 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
- Medical subject headings
- Anus Neoplasms, Colorectal Neoplasms, Esophageal Neoplasms, Bile Duct Neoplasms, Gallbladder Neoplasms, Stomach Neoplasms, Head and Neck Neoplasms, Liver Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall quality of life (QOL) scores at baseline, weeks 1, 3, 5, and end of treatment as assessed by LASA
Measured: 7 Weeks
Secondary outcomes (8)
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
Measured: 7 Weeks
Frequency and severity of toxicity as assessed by NCI CTCAE at baseline, weeks 1, 3, 5, and of treatment
Measured: 7 Weeks
Scores from the IPPRS, satisfaction with the physician scale score, and global question assessment
Measured: 7 Weeks
Quantitative assessments from the post-treatment questionnaires and the qualitative data gleaned from the post-treatment interviews
Measured: One month post study
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 ...
Measured: One month post study
Average physician rating of the patient-physician relationships for the two treatment groups
Measured: 7 Weeks
Average duration of the weekly on treatment visit for the two treatment groups
Measured: 7 Weeks
Percentage of patients for which physician reports indicate that availability
Measured: 7 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2009 (estimated)
- Study startJan 2009
- Primary completion15 Sep 2011
- Study completion27 Jul 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anal CancerStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 144 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Michele Yvette Halyard, M.D., Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00836992
- Sponsor's protocol ID
- 08-005566
- Other IDs
- P30CA015083, CDR0000629594, 08-005566, MCS1065
- Status last verified
- May 2017
- First submitted
- 3 Feb 2009
- Last updated
- 24 May 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 24 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing the Clinical Significance of Real-time Quality of Life Data in Cancer Patients Treated With Radiation Therapy
- ClinicalTrials.gov ID
- NCT00836992
- Acronym / sponsor ID
- 08-005566
- Conditions
- Anal Cancer, Colorectal Cancer, Esophageal Cancer, Extrahepatic Bile Duct Cancer, Gallbladder Cancer, Gastric Cancer
- Keywords
- anal cancer, colon cancer, rectal cancer, esophageal cancer, extrahepatic bile duct cancer, gallbladder cancer, gastric cancer, adult primary liver cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 144 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Jan 2009 (actual)
- Primary completion
- 15 Sep 2011 (actual)
- Study completion
- 27 Jul 2015 (actual)
- First posted
- 4 Feb 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 to 120 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with head and neck tumors, lung tumors, and gastrointestinal tumors receiving radiation therapy at Mayo Clinic Arizona
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Overall quality of life (QOL) scores at baseline, weeks 1, 3, 5, and end of treatment as assessed by LASA
Time frame: 7 Weeks
8 secondary outcomes
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
Frequency and severity of toxicity as assessed by NCI CTCAE at baseline, weeks 1, 3, 5, and of treatment
Time frame: 7 Weeks
Scores from the IPPRS, satisfaction with the physician scale score, and global question assessment
Time frame: 7 Weeks
Quantitative assessments from the post-treatment questionnaires and the qualitative data gleaned from the post-treatment interviews
Time frame: One month post study
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
Average physician rating of the patient-physician relationships for the two treatment groups
Time frame: 7 Weeks
Average duration of the weekly on treatment visit for the two treatment groups
Time frame: 7 Weeks
Percentage of patients for which physician reports indicate that availability
Time frame: 7 Weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 May 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michele Yvette Halyard, M.D. principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Anal Cancer and Colorectal Cancer, run by Mayo Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 May 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 May 2017.