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

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.

Sex

All

Minimum age

18 Years

Maximum age

100 Years

* INCLUSION CRITERIA:

Note: Patients meeting the below inclusion criteria who are registered to the study should be assigned by the individual enrolling/registering institution to one of the three Patient Groups as defined in Section 5.1.

* 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).
* Ability to hear and respond to questions in English using a telephone keypad.

NOTE: Required for patients enrolling in Groups A and B only; not required for Group C.

* 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. NOTE: Required for patients enrolling in Groups A and B only; not required for Group C.

EXCLUSION CRITERIA:

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

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• DERIVEDAtkinson 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
• DERIVEDSchoen 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