Recipe for Success for Quality of Life Questionnaire Study Compliance

February 11 2021

Article by Joyce Neading, Quality Assurance Specialist, Seidman Cancer Center at University Hospitals of Cleveland, Case Comprehensive Cancer Center, Cleveland, Ohio

This article describes a practice used to capture completed Quality of Life (QOL) questionnaires from study participants to comply with study requirements in protocols that use paper questionnaire forms. This practice can increase capture of QOL time-points in the study that do not always coincide with clinic visits.

Ingredients:Colored highlighter pen

Forms Due Calendar with required dates for QOL Submission highlighted

IRB-approved instruction page (contents described below*)

QOL questionnaires

3-hole paper punch

½ inch three-ring binder with pockets

Colored paper to use as dividers

Self-addressed postage-paid envelopes

CRA/CTN Outlook calendar

Process:

Construct the binder to give to the study participant at the first visit after registration/randomization.Using the highlighted Forms Due Calendar, print the date of required QOL completion for the entire study on each colored paper divider. Put a copy of the QOL questionnaire behind the dated colored paper divider. Highlight the participant’s signature and date lines on the last page of the QOL questionnaire. Punch pages with holes and put into ½-inch three-ring binder. Put the self-addressed postage-paid envelopes in the binder’s pockets.

*The instruction page directs the study participant about how to complete and return the QOL questionnaire to the CRA/CTN in the self-addressed postage-paid envelopes provided. Emphasize the importance of answering all of the questions as well as signing and dating the last page of the questionnaire. Include the CRA/CTN phone number so the study participant can contact you with any questions related to the QOL questionnaire completion. Punch holes in the page of instructions and place it as the first page in the binder. Review the instruction page and the binder contents with the study participant to confirm that the study participant understands the process and the importance of completing QOL questionnaire.

Using the CRA/CTN’s calendar, enter a note on the date two weeks prior to date that QOL questionnaire should be completed to prompt yourself to call the study participant to remind them to complete and return the QOL questionnaire.

Upon receipt of the completed QOL questionnaire from the study participant, review it for completeness. If incomplete, contact study participant to discuss incomplete section(s) of the questionnaire. Once the questionnaire is completed, populate the QOL Cover Sheet with study participant’s identifiers. Photocopy the cover sheet and QOL questionnaire and attach the post-marked return envelope for filing in the study participant’s research chart. Submit the original forms to NRG Oncology. Note the date of submission to NRG Oncology on the research chart copy.

Yield: Use of this practice can insure study compliance and provide important data for QOL endpoints of the study.

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