ICD Justif Memo_Email and Education Materials

Date: March 27, 2012

To: Office of Management and Budget (OMB)

Through: Keith Tucker, Report Clearance Officer, DHHS

Seleda Perryman, Project Clearance Officer, NIH

Vivian Horovitch-Kelley, PRA OMB Project Clearance Liaison, NCI

From: Holly A. Massett, Behavioral Scientist Analyst

Nina Goodman, Project Officer

Office of Market Research and Evaluation

Office of Communications and Education (OCE),

National Cancer Institute (NCI/NIH)

Subject: Generic Sub-study, Formative Evaluation of Concise Informed Consent Document (ICD) under “Formative Research, Pretesting, and Customer Satisfaction of NCI’s Office of Communications and Education,” (OMB No. 0925-0046-20, Expiry Date 02/28/2013).

Background/Need and Use of Information

This information collection request described in this memo supports the National Cancer Institute (NCI) Clinical Investigations Branch of the Cancer Therapy and Evaluation Program (CTEP) in the Division of Cancer Treatment and Diagnosis (DCTD) and is a collaborative effort between CTEP and the NCI Office of Communications and Education (OCE).

Volunteers recruited for clinical trials must be informed of the risks and benefits of participation, as well as the requirements for participation, so that they may make an informed decision about joining. The Agency for Healthcare Research and Quality recommends shorter, easier-to-read forms to relieve study participant burden.¹ However, studies show that the reading level of many consent forms is quite high, even higher than standards set by Internal Review Boards.² Besides improving comprehension, shorter and simpler consent forms may also be more preferred by study participants, according to previous research.

In 1997, the NCI developed a lay language Informed Consent Template for use in its cancer clinical trials. This Informed Consent Template complies with regulatory requirements in a low-literacy format and provides a structure and guidance on how to use lay language to create informed consent documents (ICDs) for NCI-sponsored trials. Overtime, however, use of the template has resulted in the creation of trial-specific consent documents that are generally too long and burdensome to patients. As a result, NCI’s CTEP, working with experts from the field, has recently developed a more concise template that it hopes will produce shorter, less burdensome ICDs.

NCI is planning to conduct a formative evaluation to determine whether the revised “concise” template makes it easier to understand and better meet the needs of people considering cancer clinical trial participation. As part of this formative evaluation, CTEP will develop an ICD for an existing trial using the concise template (an ICD would already exist for that trial using the original 1997 template). CTEP is planning to assess patient satisfaction and knowledge gained using the new concise ICD compared to the original ICD. Published literature also suggests that adding patient-friendly material about the trial (in addition to an ICD) increases patient satisfaction and knowledge gained. To determine if additional patient materials are helpful, CTEP will add a third group to the study that also receives two patient-friendly documents. Overall, CTEP will survey 150 colorectal cancer survivors randomly assigning each into three groups: 1) those who read the ICD using the original 1997 template; 2) those who read an ICD based upon the new, concise template; and 3) those who read an ICD based on the new, concise template and also receiving two patient-friendly educational materials. Participants will be identified through national research panels, and the survey will be administered confidentially online.

The request put forth in this memo is to determine if NCI should adopt the concise template that was developed by the experts, if changes are needed before implementing, and whether or not it is worthwhile to include additional patient-friendly materials with each ICD (these materials require resources to develop and NCI wants to learn if they are worth the investment).

Participants

For this formative research, NCI proposes conducting a web-based panel survey with adult colorectal cancer survivors. The decision to enlist participants who are colorectal cancer survivors is based on its diagnostic prevalence and a major priority to be addressed by both NCI and other organizations such as American Cancer Society (ACS). Additionally, using colorectal cancer as the subject for this study increases the likelihood of identifying survivors and completing the study without a gender bias, as breast or prostate might introduce. In order to minimize anxiety to participants who might be undergoing treatment, the proposed criteria for this study are:

• Colorectal cancer survivors who have completed treatment within the past 10 years

• 18 years of age or older (most will be 50 or older)

• Speak and read English

• Have Internet access at home.

The overall sample will be drawn to achieve a balanced distribution for gender, geographic location, and education level. We will over-recruit for race/ethnicity to obtain adequate numbers of African American participants.

NCI will use a vendor, Salter>Mitchell, with whom it has an established relationship in order to ensure efficiencies and high quality data collection. Salter>Mitchell will use a multi-faceted approach to recruit study participants. They will predominantly rely on a professionally-managed, web-based survey panel, InspiredOpinions: Healthcare, that focuses on healthcare audiences.  Panel members have experience conducting online surveys, have already indicated an expressed interest in completing web-based surveys, and have explicitly agreed to participate in surveys presented to them about issues both unrelated and related to health.

Panel members are incentivized where each participant receives a small monetary award which is determined by survey length, interest, complexity and the topical expertise) per survey (anticipated at $25/person for this study given the additional requirement to first read a 6-12 page document). InspiredOpinions: Healthcare, is a double opt-in, online community of individuals developed and maintained by Schlesinger Associates. Schlesinger, a global market research provider with a 40+ year history, employs numerous traditional and innovative resources to build extensive, stringently verified members panels. These multi-mode approaches to recruiting patients include a combination of telephone, e-mail, direct mail, physician referrals, and in-person “intercept” interviews. If needed, Schlesinger will supplement their panel via targeted recruitment efforts aimed at channels where our target audience may be more concentrated, such as colorectal cancer survivor support web sites or related medical professional referrals. The advantage of incorporating “active” recruitment methods along with drawing on a relatively more static database of respondents is it allows for greater latitude in controlling for demographic variables such as gender or geographic location.

Methodology and Research Instrument

Web-based surveys represent a standard state-of-the-art formative testing methodology, adapted from marketing and communications research. For this formative research, a self-administered web-based survey will be used, as it is a methodology frequently used to pretest drafts of concepts and materials that is both reliable and efficient. This survey will be accessed on-line at a designated and secure Internet location.

Panel members eligible to participate in the current survey will be contacted through an e-mail invitation from the panel managers which will include a secure, non-identifiable link to the web-based screener (Attachment 20A). Recruitment will continue until the target sample size for completed surveys is reached. Participants who agree to be in the study will be mailed hard copy versions of a sample ICD based a closed clinical trial for colorectal cancer treatment. Participants will be randomized into one of the three groups (original ICD; revised, new ICD; revised, new ICD with two patient-friendly supplements about the trial).

Participants will be asked to answer a preliminary set of baseline questions to assess attitudes toward clinical trials (See Attachment 20B for copy of the screener). Upon submitting their responses, they will then be randomized into one of the groups and mailed their group’s respective ICD. One of the groups will also be sent supplemental patient educational materials (See and Attachment 20D for copies of two educational materials). It was decided to not have participants download their materials as each group will have a different number of pages to download, which introduces the potential for error in both the process and mechanically.

After receiving and reading their respective documents, participants will be asked to return to the online link and complete the remaining questions. Specific measures on the survey will include the following (Attachment 20C):

1. Comprehension of specific component of informed consent

   1. trial procedures, benefits to self and others, privacy, rights, side effects, and financial issues

2. Satisfaction with and perceptions of the sample ICD

3. Attitudes and perceptions toward clinical trials and participation in clinical trials

4. Attitudes and reactions to the patient-friendly educational materials

5. Demographic questions.

Other Considerations

• A request for Office of Human Subjects Research exemption was submitted on February 7, 2012 and we are awaiting approval.

• No PII will be collected from respondents who complete the surveys. Furthermore, no email addresses will be collected or stored. There will be a database behind each survey web-link, but this database is not designed to allow NCI staff, or others connected to the project, the ability to access or search, and it will not have any information stored that identifies the people in any way what so ever.

Burden

A total of 190 screening surveys and 150 formative evaluation surveys will be administered over a 6-week timeframe (total = 150 completed surveys). Each screener should take each of the participants approximately 10 minutes (0.17 hours) to complete. Review of materials and ICD and completion of the survey should take approximately 60 minutes (1.0 hour). We therefore expect the total respondent burden for this proposed effort to be 182 hours. The “Category of Respondents” is individuals.

There have been 19 previous approved sub-studies under Generic submission OMB No. 0925-0046, totaling 2,706 burden hours approved to date. Approval by OMB of this sub-study would bring the total burden hour requested to date to 2,888, which is 41% of the total burden hours allowed (7050). Estimated cost to the Federal Government is $40,000 (contract submitted by vendor to recruit participants, conduct online survey, submit and analyze dataset).

Estimates of Burden Hours
Types of Respondents	Instrument	Number of Respondents	Frequency of Response	Average Time Per Response (Hours)	Total Hour Burden
Patients with Colorectal Cancer	Screening Survey (Attachment 20B)	190	1	10/60 (0.17)	32
	Formative Research Survey (Attachment 20C)	150	1	60/60 (1.00)	150
Total					182

List of Attachments

20A: Email invitation (attached below)

20B. Screener (separate file)

20C: Formative Evaluation Survey Screenshots (separate file)

20D: Patient-friendly educational materials (attached below)

Attachment 20A: Email invitation

Subject Line:

Get Rewarded for Your Time – Health Study

e-Mail Copy:

Dear <%First%>,

The National Cancer Institute is currently looking for people living with and beyond colorectal cancer to participate in research to help evaluate documents explaining an upcoming clinical trial.

The purpose of the research is to make sure that NCI is as clear as possible when putting together materials to help people decide whether or not to participate in the clinical trial.

The research project will include people who have had a diagnosis of colorectal cancer within the past 10 years and are not currently receiving treatment. We need participants from all age groups, backgrounds, and areas of the country to ensure a wide representation of colorectal cancer survivors.

Participation will involve reading a clinical trials informed consent form and answering some questions about it in an online survey.

Please click the link below to take part. It takes just a few minutes. Your information will be kept secure to the extent possible by law and you will receive $25 for your time.

Thank you in advance for your participation. Together, we are helping to improve care for people with colorectal cancer.

More background:

The clinical trials conducted by the Center for Cancer Research (CCR) on the NIH campus represent the core of the NCI’s intramural research program in Bethesda, Maryland. At the CCR, basic and clinical science are seamlessly integrated with a mission to reduce the burden of cancer through exploration, discovery, and the translation of novel approaches into compassionate and effective care for all cancer patients. Our clinical trials are aimed at answering critical questions about a particular disease or disease process and at identifying promising new therapeutic interventions that can then be confirmed in larger trials carried out across the country at cancer centers participating in NCI-supported research.

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Attachments 20D:

Patient-Friendly Educational Materials

What are Phase III Treatment Trials Fact Sheet

Cancer Trial Patient Handout Template

Taking Part in Phase III
Cancer Treatment Trials

What are cancer treatment trials?

Clinical trials are studies that test how well new medical treatments work and answer questions to find better ways to treat cancer. Treatment trials are designed to answer specific questions about:

• A new treatment

• A new way of using standard care, or

• How well a treatment works on a cancer.

Only people who already have cancer can join treatment trials.

What are Phase III trials?

Some treatment trials are called “phase III (three)” trials. This name shows that the drug or treatment has already been tested in a small group of people, so doctors know it’s safe to use. Phase III trials compare a new drug or treatment with the standard treatment. One group of people gets the standard treatment, and the other gets the new treatment. Then researchers compare the results from the two groups.

What are some of the benefits and drawbacks of a clinical trial?

Joining a clinical trial has several possible benefits:

• You may get promising new treatments that are not otherwise available.

• The new treatment studied may work better than standard care.

• Results from the study may help other cancer patients in the future.

• You will have the chance to help scientists better understand and fight cancer.

These are the possible drawbacks of a clinical trial:

• The new treatment may not work better than the standard one, or may have side effects.

• Even if the new treatment has benefits, it may not work for you. Even standard treatments do not help everyone.

• Your health insurance company may not cover all the costs of the study.

• You may be asked to make more clinic visits than you would otherwise make.

W ill I get a placebo in a Phase III trial?

Placebos are very rarely used in cancer treatment trials. Most treatment trials are designed to compare a new treatment with standard care. Some people in the study get the new treatment, and others get standard care, but no one goes without any treatment.

What does it mean to be eligible for a trial?

Each study has a list of characteristics about who can or cannot join the study, such as age, medical history, cancer type, and cancer stage. Asking people with similar characteristics to join a study helps to make sure that the results are due to the treatment and not other reasons. After you agree to join a study, you may be asked to have some additional tests to check your health to make sure you are eligible to join the trial.

How will my safety be protected?

Two groups of experts review, approve and watch over each trial to make sure it is safe. These committees review the study’s plan to make sure the study is conducted fairly, that people are not likely to be harmed, and that the risks are as few as possible. These committees also look at trial information, and stop a study if there are safety concerns.

Talk with your doctor about your options.

Read NCI’s

“Taking Part in Cancer Treatment Research Studies” at:

www.cancer.gov/clinicaltrials/Taking-Part-in-Cancer-Treatment-Research-Studies.pdf

YOUR LOGO

[A simple patient fact sheet about your trial can give patients and their family the key facts about a trial, to help them decide to join and to refer to while in the trial. Below is a template for Phase III cancer treatment trials adapted from a handout reviewed by clinical research staff.]

[study number]: Study of [describe in 3-5 simple words] for [type] cancer

The standard treatment (or standard care) for [type] cancer is [chemotherapy]. [Number of] drugs are used, called [name and [name]. Some people also get a drug called [name], if it is right for their cancer.

The [number] study looks at how another drug, [name], works with standard care to treat [type] cancer. [Drug name] currently is used to treat [type/other] cancer(s). This study will help see how useful [drug name] is as [a new/part of standard] treatment for [type] cancer.

Everyone on this study will get at least standard chemotherapy. Others will get standard chemotherapy plus [drug name]. Everyone on this study will get treated for their cancer.

A computer will put you into a study group. Neither you nor your doctor can choose the group you will be in. You have an [equal] chance of getting [study drug] or standard care. A description of each group is shown on the next page.

All people who receive treatment for [type] cancer may have side effects. People on this study will be watched carefully for any side effects. We don’t know all the side effects that may happen. Side effects may be mild or very serious. We may give you medicines to help lessen side effects. Many side effects go away soon after you stop the treatment. In some cases, side effects can be serious, long lasting, or may never go away. There is also a risk of death. We will explain the side effects to you.

If you do not want to be a part of the study for any reason, you can decide to stop at any time. We may also ask you to stop the study:

• If it is in your best interest,

• If you do not follow the study rules, or

• If the study is stopped.

A collaboration of the National Cancer Institute and [Cooperative Group name].

[study number]: Study groups

[Adapt this page to show patients the arms of the study.]

Groups	If you are in this group:
Group 1: Standard chemotherapy only	You will get standard care By IV (through your veins) Every X weeks It takes X hours to get all of the drugs. You will stop the study after X weeks.
Group 2: Standard chemotherapy plus [drug name]	You will get standard care, plus [drug name] By IV (through your veins) Every X weeks It takes about X hours to get all of the drugs. After X weeks, you will continue to get [drug name] every X weeks. We will ask you to take this drug as long as your cancer does not get worse and the side effects are not too bad.
Group 3: Standard chemotherapy plus [drug name] and [study drug name]	You will get standard care, plus [drug name] and [study drug name] By IV (through your veins) You will get [study drug] [X] times a week and the other drugs every X weeks Your first visit will take about X hours. The visits to get all of the drugs will take about X hours. After X weeks, you will stop standard care and continue to get [study drug and frequency] and [drug name and frequency]. We will ask you to take these drugs as long as your cancer does not get worse and the side effects are not too bad.
Group 4: Standard chemotherapy plus [study drug]	You will get standard care, plus [study drug] By IV (through your veins) You will get [study drug] once a week and the other drugs every X weeks The weekly visit for [study drug] will take about X hours. The visits to receive all the drugs will take about X hours. After X weeks, you will stop standard care and continue to get [study drug] alone [frequency]. We will ask you to take this drug as long as your cancer does not get worse and the side effects are not too bad.

Cancer drugs in this study

[Adapt this page with simple descriptions of each study drug. This page is optional.]

Name of the drug		What it does
[insert drug name] (standard care)	This drug works to xxx [e.g., inside the cancer cell to slow its growth and may even break it apart].
[insert drug name] (standard care)	This drug is xxx [e.g., made from extract of the Pacific yew tree. This drug stops cancer cells from multiplying. It can also help break apart cancer cells].
[insert drug name] (standard care for some cancers)	This drug xxx [e.g., stops the growth and workings of blood vessels that feed cancer tumors. This drug is not used to treat squamous cell carcinoma of the lung].
[insert drug name] (treatment)	This drug xxx [e.g., antibody sticks to a marker on the outside of the cancer cell. It then blocks the cell from getting messages to grow or multiply. This drug is used to treat colon cancer and head and neck cancer. It is being tested on other cancers.]

1 Agency for Healthcare Research and Quality. (2009, September). The AHRQ Informed Consent and Authorization Toolkit for Minimal Risk Research. AHRQ Publication No. 09-0089-EF. AHRQ: Rockville, MD. Available at www.ahrq.gov/fund/informedconsent/

2 Paasche-Orlow, M. K., and others. (2003). Readability standards for informed-consent forms as compared with actual readability. NEJM, 348(8):721-6.