AzTrials
AzTrials

CancerNCT02158637

Validation Study of the Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)

An observational study of Cancer, run by Mayo Clinic at 9 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

This study is being done to try out questions from a large set of questions called the Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE). The PRO-CTCAE is a set of questions which asks patients about their symptoms. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Cancer
How many people
1,100 participants
Where
9 sitesUnited States
Study dates
Aug 2010to 13 Mar 2017
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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Adult patients initiating or receiving chemotherapy, radiation therapy, or both at nine U.S.-based cancer centers and community oncology practices were approached in clinical waiting areas and invited to participate in this questionnaire-based study.

Who may be able to join

  • Age greater than or equal to 18 years
  • Disease and treatment matching 1 of 7 following cohorts: breast cancer receiving chemotherapy or initiating chemotherapy in the next 7 days; lymphoma/myeloma receiving chemotherapy or initiating chemotherapy in the next 7 days; metastatic prostate or bladder cancer receiving chemotherapy or initiating chemotherapy in the next 7 days; metastatic or locally advanced lung cancer receiving chemotherapy or initiating chemotherapy in the next 7 days or receiving radiation therapy for greater than or equal to 21 more days; metastatic colorectal cancer receiving chemotherapy or initiating chemotherapy in the next 7 days; head, neck, or gastroesophageal cancer receiving radiation therapy for greater than or equal to 21 more days; any cancer enrolled through an National Cancer Institute Community Cancer Centers Program site
  • Willing to return to registering institution in 1-6 weeks (subset only)
  • Eastern Cooperative Oncology Group Performance Status 0-4
  • Ability to understand English and read questions on a computer screen
  • Ability to hear and respond to questions in English using a telephone keypad (subset only)
Show all 10Show fewer
  • Ability to complete questionnaire(s) by themselves or with assistance
  • Provide informed written consent
  • Willing to be reached at a single telephone number (without extension or operator involvement) for the next 21 to 28 days (subset only)
  • Ability to participate in the study visit lasting 45-60 minutes total, including the informed consent process, being shown by study staff how to use each mode of administration (computer, automated telephone, and paper), and completing questionnaires (subset only)

Who cannot join

  • Clinically significant cognitive or memory impairment in the opinion of clinical or research staff

Trial locations and contacts

9 sites in 1 country.

9 sites in 1 country

United States9 sites

  • The Cancer Program of Our Lady of the Lake and Mary Bird Perkins

    Baton Rouge, Louisiana, 70809

  • Dana-Farber Cancer Institute

    Boston, Massachusetts, 02215

  • Hartford Hospital

    Hartford, Connecticut, 06102

  • MD Anderson Cancer Center

    Houston, Texas, 77030

  • Memorial Sloan-Kettering Cancer

    New York, New York, 10065

  • St. Joseph Hospital of Orange

    Orange, California, 92868

  • Mayo Clinic

    Rochester, Minnesota, 55905

  • Gibbs Cancer Center

    Spartanburg, South Carolina, 29303

  • Christiana Care Health Services

    Wilmington, Delaware, 19899

Other trials in United States

About this study

This study is being done to try out questions from a large set of questions called the Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE). The PRO-CTCAE is a set of questions which asks patients about their symptoms. This study will look at properties of these questions and will provide information about how these questions can be improved for research studies. PRO-CTCAE questions were developed under a contract from the National Cancer Institute (NCI) to allow patients to self-report symptoms in future cancer clinical trials. Patients with cancer receiving treatment will complete a web-based questionnaire containing PRO-CTCAE questions and a paper booklet containing a commonly used questionnaire for assessing quality of life, functioning, and symptoms at two visits one to six weeks apart. Some patients will additionally complete web-based questionnaires containing PRO-CTCAE questions weekly for four to five weeks, while completing a daily questionnaire containing PRO-CTCAE questions using an automated telephone system. Lastly, a small number of patients will complete only a single visit in which a web-based, telephone-based, and paper-based questionnaire containing PRO-CTCAE items is completed in addition to a paper booklet containing a commonly used questionnaire for assessing quality of life, functioning, and symptoms. The primary hypothesis is that scores for PRO-CTCAE questions will differ between patients with high versus low general well-being as measured by your doctor using a scale called the Eastern Cooperative Oncology Group Performance Score.

Conditions
Cancer
Keywords
PRO-CTCAE, Patient-Reported Outcomes, Common Terminology Criteria for Adverse Events, Questionnaire, Adverse Events, Symptoms
Medical subject headings
Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT02158637
Study groupRoleWhat they receive
Cancer patients receiving treatmentPatients receiving active treatment for cancer or initiating treatment for cancer in the next 7 days

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Difference in PRO-CTCAE item scores between patients with good and poor performance status at the first visit (study day 1)

    Measured: 1 day

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Jun 2014 (estimated)
  2. Study startAug 2010
  3. Primary completionMar 2012
  4. Study completion13 Mar 2017

Resources

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 only
Time perspective
Prospective
Enrolment
1,100 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02158637
Sponsor's protocol ID
10-002504 / MC1091
Other IDs
MC1091
Status last verified
May 2017
First submitted
4 Jun 2014
Last updated
24 May 2017
Results posted
No
Data monitoring committee
No

Publications

  • Lee MK, Mitchell SA, Basch E, Deal AM, Langlais BT, Thanarajasingam G, Ginos BF, Rogak L, Mendoza TR, Bennett AV, Noble BN, Mazza GL, Dueck AC. Psychometric Properties and Interpretability of PRO-CTCAE(R) Average Composite Scores as a Summary Metric of Symptomatic Adverse Event Burden. Cancers (Basel). 2025 Oct 28;17(21):3459. doi: 10.3390/cancers17213459.

    PubMed 41228252

  • Lee MK, Mitchell SA, Basch E, Mazza GL, Langlais BT, Thanarajasingam G, Ginos BF, Rogak L, Meek EA, Jansen J, Deal AM, Carr P, Blinder VS, Jonsson M, Mody GN, Mendoza TR, Bennett AV, Schrag D, Dueck AC. Identification of meaningful individual-level change thresholds for worsening on the patient-reported outcomes version of the common terminology criteria for adverse events (PRO-CTCAE(R)). Qual Life Res. 2025 Feb;34(2):495-507. doi: 10.1007/s11136-024-03819-5. Epub 2024 Nov 6.

    PubMed 39503942

  • Mead-Harvey C, Basch E, Rogak LJ, Langlais BT, Thanarajasingam G, Ginos BF, Lee MK, Yee C, Mitchell SA, Minasian LM, Mendoza TR, Bennett AV, Schrag D, Dueck AC, Mazza GL. Statistical properties of items and summary scores from the Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE(R)) in a diverse cancer sample. Clin Trials. 2025 Apr;22(2):161-169. doi: 10.1177/17407745241286065. Epub 2024 Oct 23.

    PubMed 39440720

  • Bennett AV, Dueck AC, Mitchell SA, Mendoza TR, Reeve BB, Atkinson TM, Castro KM, Denicoff A, Rogak LJ, Harness JK, Bearden JD, Bryant D, Siegel RD, Schrag D, Basch E; National Cancer Institute PRO-CTCAE Study Group. Mode equivalence and acceptability of tablet computer-, interactive voice response system-, and paper-based administration of the U.S. National Cancer Institute's Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE). Health Qual Life Outcomes. 2016 Feb 19;14:24. doi: 10.1186/s12955-016-0426-6.

    PubMed 26892667

Questions about this trial

What is this clinical trial studying?

An observational study of Cancer, run by Mayo Clinic at 9 sites 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?

The sponsor lists 10 inclusion and 1 exclusion criteria. 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 9 sites 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?

Difference in PRO-CTCAE item scores between patients with good and poor performance status at the first visit (study day 1) (time frame: 1 day). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02158637, which also lists 4 linked publications.

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.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in