CALGB 70501

KCCOP Protocol Summary

The summary below serves as a brief review of the treatment plan and eligibility for the protocol.
This summary is not intended to be used in place of the full protocol.
Members may follow the "Full Protocol" link or contact KCCOP for complete protocol information.

Full Protocol

(members only)

Consent Form

HIPAA

CALGB 70501 - "Collection of Patient-Reported Symptoms and Performance Status Via the Internet"

NOTES:

1) Prior to enrolling 1st pt, the facility must be trained by a KCCOP staff member.

2) A specific CRA at the facility must be designated & be responsible for this study.

3) A dedicated Internet-enabled tablet laptop computer (w/stylus) will be provided (contact KCCOP). No home or outside access to the program will be permitted.

Treatment Plan (Supplied Drug: N/A)

REGISTRATION (Up to & including 2nd scheduled visit [Cycle 2] on therapy)

CRA completes Background Info Form

Pt completes Baseline Questionnaire

2nd SCHEDULED VISIT DAY

AFTER seeing clinician:

1) Pt is registered by CRA into Symptom Tracking & Reporting for Pts (STAR) database & obtains password

2) Computer/STAR pt training by CRA

3) 1st pt STAR session AFTER seeing clinician (Baseline Self-Report)

4) CRA fills out 70501 AE Form

SCHEDULED VISITS CYCLES 3, 4, 5, 6

BEFORE seeing clinician:

1) CRA reminds pt to login / complete online STAR questionnaire BEFORE seeing clinician

2) CRA prints report & adds report to clinician visit materials

3) Clinician reviews report

4) CRA administers Pt Feedback Questionnaire & Clinician Feedback Email Survey (SCHEDULED VISIT 4 ONLY)

Eligibility

Must be enrolled or concurrently enrolling on CALGB 30607, 30704, 40502, 40503, 40601, 40603, 70604, 80405, or 90401. May be enrolled on any day following enrollment on the tx trial, up until & including the day of 2nd scheduled clinic visit/cycle of the tx trial (i.e., approx Day 15 for CALGB 80405, approx Day 22 for CALGB 30607, & approx Day 29 for CALGB 40502 & CALGB 70604).
Able to read & understand English & be able to see a computer screen (no visual impairments), or be accompanied on visits by someone who can read the screen to the pt.
Signed informed consent.