Refinement of the Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) Via Cognitive Interviewing and Usability Testing

NCT01031641 | Completed

• 2 other identifiers: 99991002610-C-N026
• Study Type: observational
• Target: 1,448
• Locations: 1 country
• Sites: 2

Brief Summary

Background:

• Currently, National Cancer Institute treatment trials use clinical staff reporting to monitor adverse side effects. The clinical staff reports draw on items from the Common Terminology Criteria for Adverse Events (CTCAE).
• Several of the items in the CTCAE can be adapted for use in patient self-reporting of side effects. Researchers are interested in developing a patient-reported outcome (PRO) approach to the CTCAE. Objectives:
• To develop questions that can be used to create a patient-reported outcome version of the CTCAE (PRO-CTCAE).
• To evaluate patient comprehension of and test the usefulness of the PRO-CTCAE questions among diverse groups of patients. Eligibility:
• Individuals 18 years of age and older who are receiving chemotherapy or radiotherapy as cancer treatment.
• Participants must be able to speak and understand English. Design:
• Researchers will conduct up to three rounds of interviews with patients currently receiving chemotherapy or radiation therapy treatments for cancer.
• Participants will be recruited independently from four different clinical treatment sites. At least 25 percent of patients will have an educational attainment of high school or less.
• Each patient will complete a two-part protocol, including a set of PROs that will be followed by a series of questions to evaluate patient comprehension, memory, perceived clarity, and judgment of the PROs.
• The research will be completed in approximately 1 hour, and participants will receive a small amount of compensation for their time and participation.

Conditions

Lymphomas; Leukemias; Multiple Cancers

Keywords

Patient-Reported Outcomes; Symptoms; Instrument Development; Adverse Events; Questionnaire; Patient Reported Outcomes

Outcome Measures

Primary Outcomes (2)

• Evaluate patients understanding of measurement tool items

  Patient report of symptom experience

  Study completion

• Evaluate the usability of the technology interface for collecting the PRO data of the PRO-CTCAE system

  Patient report of technology usability

  Study completion

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Cancer patients receiving chemotherapy or radiation treatment.@@@

You may qualify if:

• Age greater than or equal to18 years.
• Disease and treatment matching 1 of the 6 following cohorts:
• Cohort Breast: Breast cancer patients initiiating chemotherapy within the next 7 days or currently receiving chemotherapy.
• Cohort Lymphoma/Myeloma: Lymphoma/myeloma cancer patients initiating chemotherapy within the next 7 days or currently receiving chemotherapy.
• Cohort Prostate/Bladder: Metastatic prostate or bladder cancer patients initiating chemotherapy within the next 7 days or currently receiving chemotherapy.
• Cohort Lung: Metastatic or locally advanced lung cancer patients EITHER:
• initiating chemotherapy within the next 7 days or currently receiving chemotherapy; OR
• receiving daily radiation therapy for greater than or equal to 21 more days (concurrent chemotherapy allowed).
• Cohort Colorectal: Metastatic colorectal cancer patients initiating chemotherapy within the next 7 days or currently receiving chemotherapy.
• Cohort Head/Neck/Gastroesophageal: Head/neck/gastroesophageal cancer patients receiving daily radiation therapy for greater thanor equal to 21 more days (concurrent chemotherapy allowed).
• Cohort NCCCP: Cancer patients with cancer type NOT matching one of the previous six cohorts listed above and enrolled through an NCCCP site. Patient must be initiating active anti-cancer treatment (chemotherapy, targeted agents/biologics, and/or radiation therapy; hormonal therapy alone is not allowed) within the next 7 days or currently receiving active anti-cancer treatment (chemotherapy, targeted agents/biologics, and/or radiation therapy; hormonal therapy alone is not allowed).
• NOTE: A patient registered through an NCCCP site matching one of the previous six cohorts should be registered through that cohort. Only NCCCP patients NOT matching one of the previous six cohorts should be registered through this cohort.
• Willing to return to registering institution in 1-6 weeks.
• ECOG Performance Status (PS):0-4.
• Ability to understand English and read questions on a computer screen (or listen to questions via headphones and then select responses on a screen).

You may not qualify if:

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

Sponsors & Collaborators

• National Cancer Institute (NCI): lead

Study Sites (2)

Memorial Sloan Kettering Cancer Center

New York, New York, 10021, United States

Location

MD Anderson Cancer Center

Houston, Texas, 77030-4096, United States

Location

Related Publications (5)

• Clark MA, Armstrong G, Bonacore L. Measuring sexual orientation and gender expression among middle-aged and older women in a cancer screening study. J Cancer Educ. 2005 Summer;20(2):108-12. doi: 10.1207/s15430154jce2002_12.

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• Diefenbach MA, Weinstein ND, O'Reilly J. Scales for assessing perceptions of health hazard susceptibility. Health Educ Res. 1993 Jun;8(2):181-92. doi: 10.1093/her/8.2.181.

  PMID: 10148827 BACKGROUND

• Friedenreich CM, Courneya KS, Bryant HE. Relation between intensity of physical activity and breast cancer risk reduction. Med Sci Sports Exerc. 2001 Sep;33(9):1538-45. doi: 10.1097/00005768-200109000-00018.

  PMID: 11528344 BACKGROUND

• Atkinson TM, Reeve BB, Dueck AC, Bennett AV, Mendoza TR, Rogak LJ, Basch E, Li Y. Application of a Bayesian graded response model to characterize areas of disagreement between clinician and patient grading of symptomatic adverse events. J Patient Rep Outcomes. 2018 Dec 4;2(1):56. doi: 10.1186/s41687-018-0086-x.

  PMID: 30515599 DERIVED

• Schoen MW, Basch E, Hudson LL, Chung AE, Mendoza TR, Mitchell SA, St Germain D, Baumgartner P, Sit L, Rogak LJ, Shouery M, Shalley E, Reeve BB, Fawzy MR, Bhavsar NA, Cleeland C, Schrag D, Dueck AC, Abernethy AP. Software for Administering the National Cancer Institute's Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events: Usability Study. JMIR Hum Factors. 2018 Jul 16;5(3):e10070. doi: 10.2196/10070.

  PMID: 30012546 DERIVED

MeSH Terms

Conditions

Lymphoma; Leukemia

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Hematologic Diseases

Study Officials

• Kathleen Castro, R.N.

  National Cancer Institute (NCI)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 11, 2009
• First Posted: December 14, 2009
• Study Start: November 19, 2009
• Primary Completion: June 1, 2012
• Study Completion: July 16, 2020
• Last Updated: July 17, 2020

Record last verified: 2020-07

Locations

US (2)