Advocate Clinical Trial Accrual and Retention Project (CTARP): A Model Peggy Devine¹, Judy Allen¹, Gayle Becker¹, Nora Carbine¹, Robin Hutchison¹, Linda Katz¹, Jo Ellen Lezotte¹, Laura Esserman², Meredith Buxton², Nola Hylton², Kathy Hwang², Deborah Collyar³.

CALGB 1500017 / CALGB 150012/ACRIN 6657 Advocates¹, UCSF Breast SPORE², CALGB Advocate Chair, BSAC PI³.

ABSTRACT

Advocate Clinical Trial Accrual and Retention Project (CTARP): A Model

Peggy Devine¹, Judy Allen¹, Gayle Becker¹, Nora Carbine¹, Robin Hutchison¹, Linda Katz¹, Jo Ellen Lezotte¹, Laura Esserman², Nola Hylton², Kathy Hwang², Deborah Collyer³. CALGB 1500017 / CALGB 150012/ACRIN 6657 Advocates¹, UCSF Breast SPORE², CALGB Advocate Chair³.

The MRI/ Correlative Science clinical trial sponsored by CALGB, ACRIN and the NCI, is an innovative trial designed to test biomarkers in combination with MRI imaging throughout a persons neoadjuvant chemotherapy treatment. It will analyze whether predictive markers can be identified and imaged to show the biological response to therapy. Since this trial asks women to take additional steps that are not related to their treatment, an advocate component was introduced as a way to help the trial succeed through the approval, accrual, and retention phases. The trial PI’s requested that advocates be placed at each of six participating trial sites. They also requested that various materials be developed to assist patients with all aspects of the trial.

HYPOTHESIS: Patient advocate involvement in large National clinical trials will improve: • The ability to obtain CHR approval • Patient satisfaction and compliance• Patient recruitment, accrual and retention SPECIFICATIONS: Develop methods to integrate advocates into the clinical trial process in a way that will add value to both patients and clinicians. A Few Examples (not inclusive) • Assistance with the IRB process: Consent form language Cover letter to the IRB about advocate assistance and support for the study • Development of educational materials for eligible trial participants:  Woman to Woman Note (WWN) Trial brochure explaining core biopsies and MRIs A flowchart to help patients understand their time and procedure commitment MRI tip sheet•  Peer support throughout length of the trial: Each trial participant will receive procedure reminder and support calls DATA ANALYSIS: Compare data elements at all sites to facilitate analyses and impact of advocate involvement (analyses will be stratified by sites with/without advocate assistance ) • Percentage of eligible patients that enroll and complete the study: Comparisons will be made against historical data • IRB/CHR Approval Comparisons will be made against historical data • Questionnaire will be completed by each trial participant to grade response to advocate materials and calls • Determine which aspects of the project where successful and how to further improve it. •  Develop a plan so that successful strategies can be applied to other Cooperative Group clinical trialsCONCLUSIONS: Data will be available to document if advocate involvement in all areas of the clinical trial process, increases accrual and retention in the trial.

As the CALGB 150007 / ACRIN 6657 moved through the design phase, Deborah Collyar, CALGB advocate chair and the University of California at San Francisco (UCSF) breast SPORE advocate core, (BSAC) principal investigator (PI), met with the study PIs Laura Esserman, MD, MBA and Nola Hylton, PhD. She suggested that advocates may be able to play an important educational and support role for women who enroll in the trial. Since this trial asked newly diagnosed women to come in for 2 to 3 non-treatment MRIs and 1 to 2 biopsy cores, the study PI’s decided that advocates may be an asset to both the PI’s and the trial participants. The project was brought to BSAC to develop. BSAC has been assisting the UCSF Breast SPORE for over 9 years. This new level of advocate involvement will deepen the advocate/researcher relationship and expand it to include other sites.

Advocate involvement in all stages of a large national clinical Trial, can be an asset to both the study PI’s and the patients enrolled, resulting in:

·  Assistance with the IRB process · Increased patient recruitment, accrual and retention

·   Patient satisfaction and compliance 

I. Assistance with the IRB process: A. Consent forms: Modified the consent form by changing the format of required procedures from

paragraph format, to bulleted format – instantly clarifying the requirements. Cancer patients are in shock when they are asked to read consent forms. Short bulleted statements are more readily understood than long statements in paragraph form.

B. Advocate letter to the IRB: A letter was written stating that advocates supported the trial, had a role in wording the consent form, and would be available to patients enrolled to offer support.

B. Trial brochure: Explains core biopsies and MRIs. Pictures of each procedure are included to ease women’s fears of the unknown.

BACKGROUND

INTERVENTIONS

Woman to Woman: MRI & Marker Study Information Dear Patient,

 

There is no way to prepare for the shocking news “ You have breast cancer.” You are probably asking yourself “what do I do now?” As breast cancer survivors, we have experienced the same shock and asked the same question. We understand how many decisions must be made and how overwhelming it feels.

Unfortunately, as you explore your options, you will quickly find out that there is no “answer book.” One of your choices may include a “clinical trial.” While this may sound a bit intimidating, it is simply a study that carefully tests new ways to prevent, diagnose, treat or research diseases like breast cancer. We understand that you have been given information on the MRI and Marker study. This letter is written with the hope that it will help you understand the study better.

What is the MRI & Marker Study about?

UCSF has opened an important research study with other Cancer Centers for women, who with their physician, have decided to get chemotherapy before surgery (this is called neoadjuvant). The purpose of this study is to carefully monitor (or track) how your tumor will respond to the chemotherapy you are getting. This is actually important because at the present time your Doctor cannot tell you whether your tumor responds to chemotherapy. Your treatment and care are not affected in any way because there is no treatment in this particular study. Women who participate will help make a difference for future women by providing new facts about how a tumor responds to chemotherapy.

There are two different ways that patients are followed in the MRI & Marker studyThe first way is with MRI scans to monitor the change in tumor growth. MRIs create different (and sometimes better) images of tissue in a breast than mammography. Information from these images will be reviewed to see if MRI can consistently and accurately find out who will respond to chemotherapy, even very early on in treatment. The information learned from this research may help future women who are not responding to their treatment. These women could then stop chemotherapy and move to another form of treatment. This will save time and spare women from possible side effects of a treatment that is not helping.

 The second way, the marker study, is tracking actual changes in tissue. This tissue will be obtained from your breast with a core biopsy (you will have three biopsies). This portion of the study may provide clues on how individual tumors respond to treatment. Currently almost everyone receives chemotherapy because it is not known who needs it. With new markers, the hope is that only women who will benefit from chemotherapy will receive it.

You are not AloneYou have made a good decision in coming to this Breast Care Center. For additional information about this clinical trial, please call ……….

To talk to a breast cancer survivor call: …………..

 

Wishing you the best,

Peggy Devine

Deborah Collyar; H.L. Ittner; Linda Vincent; Judi Allen; Seri Gomberg; Carolene Marks; Chira Chen; Louise Hyneman; Bambi Schwartz

 

 

II. Development of educational materials for eligible trial participants continued

C. Trial procedure flowchart: A color-coded flowchart was developed to help patients understand their time and procedure commitment.

Understanding

Your

MRI and Biomarker Study

For more Information Call:

Advocate:

MRI CRA:

Trial CRA:

HYPOTHESIS

II. Development of educational materials for eligible trial participants: Cancer patients are in a state of shock after receiving their diagnosis. Despite this, they are asked to make treatment choices, tissue donation choices and participation in clinical trial choices. It is our contention that if people have a clear understanding of the clinical trial, they are more likely to enroll. The following educational materials were developed to aid potential study participants in understanding the study and were distributed by the clinical research associates (CRAs) during recruitment: a letter explaining the trial, a brochure that explains the study procedures, a Magnetic Resonance Imaging (MRI) tip sheet and a sheet with helpful hints for spouses. We have also developed a study flowchart that assists the Doctor and/or CRA, as they explain the study to the patient. To further explain the requirements of this study, we have developed a standard vs. study procedure chart.

A. Woman-to-Woman Note (WWN): A letter that explains the trial in lay language was drafted by Peggy Devine and and finalized by the entire advocate core (Judi Allen, Chira Chen, Deborah Collyar, Seri Gomberg, Louise Hyneman, H.L. Ittner, Carolene Marks, Susan Samson and Bambi Schwartz.).

INTERVENTIONS Cont.

A method has been developed to integrate advocates into large national trials. We plan to evaluate the positive and negative impact of the advocates on this trial and to use this information for equipping future studies with advocates.

FUTURE PLANS

Your MRI

MRI is similar to a CT scan but uses magnetism instead of X-rays to build up cross-sectional pictures of your body. Since there is no radiation, you do not need to be concerned about having several MRI scans.

You will be given an injection of dye into a vein in the arm to improve the image. During the test you will be asked to lie very still on a bed inside a long chamber for up to an hour.

This can be a little frightening if you don't like enclosed spaces; if so, it may help to mention this to the radiographer.

The MRI scanning process is also noisy, but you will be given earplugs.

Try to relax!

Your Core Biopsy

In a core needle biopsy, the physician makes a small skin incision through which a needle is inserted into the lesion to obtain sample tissue. This procedure is done under local anesthesia in a doctor's office or outpatient facility.

A small amount of tissue is collected with a special spring-loaded device placed over the site of the tumor.

A small bandage covers the biopsy site for several days.

You may experience some bruising and discomfort for a short period of time.

INTERVENTIONS Cont.

Compare data elements at all sites: To look at the impact of advocate involvement, we will compare results from sites that have advocates with sites that do not. We understand that there are limitations to comparing across sites in this study, so we will also compare our findings against historical data

A. IRB Assistance: We understand the limitations of comparing such factors as time to IRB approval, number of revisions, ect. across sites. Therefore, to assess the effectiveness of advocate material on IRB approval, we plan to interview PIs at each site and ask about the IRB process for this study. We will ask them to compare this study to previous experiences with other complicated study protocols.

B. Percentage of eligible patients that enroll and complete the study: Comparisons will be made against historical data

C.  Patient Questionnaire: A self administered questionnaire will be used to look at the impact of advocate involvement. Specific questions asking patients to rank the usefulness of the various interventions will be asked.

D. MRI tip sheet: A tip sheet that explains the experience of undergoing an MRI was developed.

III. Peer support throughout length of the trial: Each trail participant is partnered with a volunteer The peer volunteer makes procedure reminder and support calls, hopefully assisting both the patient and the study by keeping retention in the trial high.

IV. Patient Questionnaire: A patient satisfaction questionnaire was developed and will be completed by each trial participant to grade response to advocate materials and calls.

1/2/03

Neoadjuvant MRI Correlative Science TrialProcedure Time Line

Patient________________

Date

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Mammogram MRI #3MRI #1

SURGERYDate

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Start TAXANEsee page 2

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Mammogram MRI #2 Core Biopsy #1Core Biopsy #2

End AC

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Cycle 2

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Cycle 3 Cycle 4

AC Chemo dates

2 weeks after AC starts

O.R. Tissue Specimens

48 hrs after AC starts

(24-96 hrs)

Advocate Call

1 2 3 4 5Cycle 1Start AC

6A

Serum sample

Date

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PROPOSED ANALYSIS

AIMS

The aims of this project are to ease the institutional review board (IRB) approval phase and to develop various educational and support interventions. These that will be available to assist patients who are eligible to participate in this trial.. We will test the interventions through a patient questionnaire and will use various methods in an attempt to measure if the materials and support strategies had value. RESULTS TO DATE

Of the six open for accrual, five have incorporated advocates into the study. Two sites submitted advocate materials with the original IRB and were able to incorporate them as soon as patients enrolled. Three sites submitted materials at differing points after the original submission. We will try to document that once advocate materials where available, accrual and retention rates increased. Of the 58 patients screened, 37 enrolled, 1 was later determined to be ineligible, 2 decided to go to surgery before completing neoadjuvant chemo, zero dropped from the study.

ACKNOWLEDGMENTSThe advocate component of this study would not be successful without the support and cooperation of the study PIs, the project manager, the advocates, the research nurses and CRAs at each site. We would therefore like to acknowledge the following people: the lead study PIs - Laura Esserman and Nola Hylton, the lead site PIs - Lisa Carey, Angie DeMichele, Helen Krontira, Minetta Liu and Leslie Montgomery. The project manager - Meredith Buxton, originally Kathy Hwang. The advocates - Robin Hutchison, Linda Katz, Nora Carbine, Gayle Becker, Peggy Devine, Jo Ellen Lezotte and Judy Allen. The study nurses and CRAs – Lorna Beccaria, Jessie Gibbs, Nneka Emenyonu, Hillary Robbins, Lauren Sherman, Rachael Sherron, Tara Holiday, Amanda Tweed, Lynn Werner, Valerie Kracke, Tori Amos, Jane Fey, Carolina Montalvo, Cathleen Cooper, Jen Torres,Jenny Crawford, Ann Gallagher and Anita Sarcone.