NCT00836992

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
144

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2009

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2009

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

February 3, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 4, 2009

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 15, 2011

Completed
3.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 27, 2015

Completed
Last Updated

May 24, 2017

Status Verified

May 1, 2017

Enrollment Period

2.7 years

First QC Date

February 3, 2009

Last Update Submit

May 23, 2017

Conditions

Anal CancerColorectal CancerEsophageal CancerExtrahepatic Bile Duct CancerGallbladder CancerGastric CancerHead and Neck CancerLiver CancerLung CancerPancreatic CancerSmall Intestine Cancer

Keywords

anal cancercolon cancerrectal canceresophageal cancerextrahepatic bile duct cancergallbladder cancergastric canceradult primary liver cancerpancreatic cancersmall intestine cancernon-small cell lung cancersmall cell lung cancerhead and neck cancer

Outcome Measures

Primary Outcomes (1)

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

    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

    7 Weeks

  • Frequency and severity of toxicity as assessed by NCI CTCAE at baseline, weeks 1, 3, 5, and of treatment

    7 Weeks

  • Scores from the IPPRS, satisfaction with the physician scale score, and global question assessment

    7 Weeks

  • Quantitative assessments from the post-treatment questionnaires and the qualitative data gleaned from the post-treatment interviews

    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 ...

    One month post study

  • +3 more secondary outcomes

Study Arms (2)

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.

Eligibility Criteria

Age18 Years - 120 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

Mayo Clinic in Arizona

Scottsdale, Arizona, 85259-5499, United States

Location

MeSH Terms

Conditions

Anus NeoplasmsColorectal NeoplasmsEsophageal NeoplasmsBile Duct NeoplasmsGallbladder NeoplasmsStomach NeoplasmsHead and Neck NeoplasmsLiver NeoplasmsLung NeoplasmsPancreatic NeoplasmsColonic NeoplasmsRectal NeoplasmsCarcinoma, HepatocellularCarcinoma, Non-Small-Cell LungSmall Cell Lung Carcinoma

Condition Hierarchy (Ancestors)

Intestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesIntestinal DiseasesAnus DiseasesRectal DiseasesColonic DiseasesEsophageal DiseasesBiliary Tract NeoplasmsBile Duct DiseasesBiliary Tract DiseasesGallbladder DiseasesStomach DiseasesLiver DiseasesRespiratory Tract NeoplasmsThoracic NeoplasmsLung DiseasesRespiratory Tract DiseasesEndocrine Gland NeoplasmsPancreatic DiseasesEndocrine System DiseasesAdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeCarcinoma, BronchogenicBronchial Neoplasms

Study Officials

  • Michele Yvette Halyard, M.D.

    Mayo Clinic

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 3, 2009

First Posted

February 4, 2009

Study Start

January 1, 2009

Primary Completion

September 15, 2011

Study Completion

July 27, 2015

Last Updated

May 24, 2017

Record last verified: 2017-05

Locations

US(1)