Development of a Measurement Strategy for Bladder Cancer

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Project Code / Site ID / Subject ID

Subject Clinical Screener

The following information is for the clinician or his/her representative to complete in its entirety.
The clinician must sign.
Clinician’s printed name:
Clinician’s signature:
Clinician’s specialty:
Name and title of person completing this form:
Practice name:
Address:
Telephone no: |___|___|___|-|___|___|___|-|___|___|___|___|
Date: |___|___|/|___|___|/|___|___|
MonthDayYear

Inclusion Criteria

The following information is for the clinician or his/her representative to complete.

Please check all appropriate boxes. / YES / NO
Has the patient completed a written Informed Consent Form and Health Insurance Portability and Accountability Act (HIPAA) Authorization? / 1 / 0
Is the patient at least 18 years of age?
Patient’s date of birth: ______
Gender:______/ 1 / 0
Does the patient have a clinical diagnosis of Stage IV (defined as ≥T4b, any N; or any T, N2-N3; or M1 for bladder) bladder cancer currently or within the past 6 months prior to screening? / 1 / 0
Does the patient have a life expectancy of ≥12 weeks (in the opinion of the clinician)? / 1 / 0
Is the patient fluent in US English (i.e., able to speak, read, write, and comprehend)? / 1 / 0
Is the patient willing and able to participate in a one-hour, face-to-face or telephone interview? / 1 / 0
  • Please STOP if “NO” is checked for any of the questions above. This patient is ineligible.
  • Please CONTINUE to the next table if “YES” is checked for all of the questions above.

EXCLUSION CRITERIA

The following information is for the clinician or his/her representative to complete.

Please check all appropriate boxes. / YES / NO
Does the patient have any of the following active or prior documented disorders within the past 3 years?
  • Autoimmune or inflammatory disorders; or
  • Diverticulitis [with the exception of diverticulosis]; or
  • Any serious gastrointestinal chronic conditions associated with diarrhea
The following are exceptions to this criterion:
  • Patients with vitiligo or alopecia
  • Patients with hypothyroidism
/ 1 / 0
Does the patient have a history of any other invasive malignancy within the past 5 years?
Patients with noninvasive malignancies such as cervical carcinoma in situ or non-melanomatous carcinoma of the skin may be included. Cancer patients with incidental histologic findings of prostate cancer (tumor/node/metastasis [TNM] stage of T1a or T1b or prostate specific antigen <10) who have not received hormonal treatment may be included. / 1 / 0
Does the patient have a history of leptomeningeal carcinomatosis
? / 1 / 0
Does the patient have brain metastases or spinal cord compression? / 1 / 0
Is the patient currently enrolled in an investigational drug or device study or participating in such a study within 30 days of entry into this study? / 1 / 0
Does the patient have any condition or situation that would put the patient at significant risk, may confound the study results, or may interfere significantly with the patient’s involvement in the study? / 1 / 0
  • If “NO” is checked for all of the questions above, the patient is eligible to participate in this study.
  • If “YES” is checked for any of the questions above, the patient is ineligible to participate in this study.

When completed, this form must be faxed immediately from your office to the attention of
Nate Cahill at Adelphi Values; fax number: (617) 412-3122. Thank you for completing this form.

AZ7269A SCS v4_0 track changesPage 1 of 4 05 Jan 16