Caregiver Education in CIPN: Phase I Project Application

CONSENT FORM TO PARTICIPATE IN A RESEARCH STUDY

TITLE:  mHealth app for caregiver instruction in manual therapy for chemotherapy-induced peripheral neuropathy

PROTOCOL NO.: R43CA268678, WCG IRB Protocol #20224018

SPONSOR: National Cancer Institute, NIH

AGENCY RESPONSIBLE FOR THE PROJECT: Collinge and Associates, Inc., Eugene, Oregon

INVESTIGATOR: William Collinge, PhD, MPH, 3480 Kincaid Street, Eugene, Oregon 97405, United States

STUDY-RELATED PHONE NUMBER(S): 541-632-3502

You are being asked to participate in a research study to develop an educational mobile app for caregivers. The goal of the app is to teach caregivers some simple massage techniques to help reduce symptoms of chemotherapy-induced peripheral neuropathy (CIPN) in a cancer survivor at home. The purpose of this Phase I project is to obtain input from cancer survivors and caregivers to help inform the design of the app.

In order to decide whether you want to be part of this project, you should understand enough about the activities and responsibilities involved, and any risks and benefits of participation, so that you can make an informed choice. This is known as “informed consent.” Please take your time to make your decision.

Why is this project being conducted?

CIPN is a common treatment side effect that affects quality of life for millions of cancer survivors. Experts in the field of oncology massage have developed specific techniques found helpful in dealing with CIPN symptoms. If a mobile app can deliver effective instruction in these methods to caregivers at home, this could improve quality of life for sufferers and reduce the overall burden of cancer treatment on survivors, caregivers, and possibly other family members.

This Phase I project will produce a prototype or “mock-up” of a mobile app designed with input from both cancer survivors and caregivers about what is needed for it to be acceptable and useful. The focus in this phase is on only the design of the app prototype. No actual intervention or use of the app will take place in this phase. A future study may be conducted to complete development and evaluate its impact in a sample of cancer survivors and caregiver

How many people will take part in the study, and who is being recruited?

55 adult caregivers (family member, partner or friend) and 15 adult cancer survivors with CIPN will participate via Zoom meetings.

Who is eligible to participate?

Cancer survivors must (1) attest to having been diagnosed with CIPN by a physician, (2) be age 18 or over, (3) speak and read English, and (4) have internet access.

Caregivers must (1) attest to being currently in a caregiving relationship with a cancer survivor  (spouse, intimate partner, adult child, sibling, other relative, or friend) who has been diagnosed by a physician as having CIPN, (2) be age 18 or over, (3) speak and read English, (4) have internet access, and (5) have a mobile device with an iOS (ver. 10 or higher) or Android (ver. 8 or higher) operating system.

Caregivers are NOT eligible if they have received training or instruction in manual therapy for CIPN.

What is involved in being in the study?

1.   Complete the online Application Form that is attached at the end of this Consent Form.

2.   Applicants will be selected based on the needs of the study for gender, age and ethnic diversity. Candidates for acceptance will have a phone interview by a research assistant to go over this Consent Form to confirm informed consent.

3.   Cancer survivors participate for one hour in an online focus group over Zoom, with five survivors per group. The researchers will describe the plans for caregiver instruction in the app. Cancer survivors will be asked to share their opinions and feedback about the proposed instruction, including any recommendations they may have.

4.   Caregivers participate in ONE of TWO activities:

(a)  Attend a one-hour focus group meeting with 4 other caregivers over Zoom, to view and give feedback on proposed features and content of the proposed app.

(b) Attend a 90-minute one-on-one Zoom session with the researchers to view the prototype of the mobile app and give feedback on its features and content.

At this time, the only activities are evaluation of the proposed app and you will not be trained on massage therapy techniques.

What information is collected?

1.   Contact information (phone, address, email)

2.   Demographic information (age, gender, race/ethnicity, education, employment status, marital status)

3.   Cancer survivors: Confirmation of having been diagnosed with CIPN by a physician.

4.   Caregivers: Type of relationship with a cancer survivor (spouse, partner, adult child, etc.); how long in the caregiver role, and confirmation that the care recipient has been diagnosed with CIPN by a physician.

5.   All participants will have their verbal feedback and comments recorded in the meetings to be transcribed and studied to aid in development of the mobile app content and features. In addition, caregivers in the one-on-one sessions exploring the app will provide ratings of different aspects of the app prototype such as ease of use and understanding, relevance, completeness, usefulness, confidence in it, and how likely they would be to use and recommend it.

Procedures that are considered experimental and are being tested in this study:

The participants in this study will provide guidance to the researchers in the design, content and features of a mobile app for caregivers. This guidance will be used to create a prototype of a mobile app that can later be used in an evaluation of its actual effects in cancer survivors with CIPN.

How long will you be in the study?

60 to 90 minutes depending on which activity is assigned.

What are the risks of the study?

Risks are minimal due to the way information is handled. To preserve confidentiality in Zoom meetings participants will be encouraged to use first names only or a pseudonym if they wish, and will be helped with this if they need help. Possible risks involve loss of confidentiality if the security of the server holding project data is breached.

What are the benefits of your participation?

You will be helping develop a caregiver education program that may be helpful to others in the future. There may be no direct personal benefit to your participation in this study.

Compensation:

You will receive an honorarium of $75 for attending a one-hour focus group or $100 for attending a one-on-one prototype evaluation meeting for 90 minutes.

What other options are there?

The alternative to participating in this study is not participating.

New Findings

Not applicable.

Withdrawal/Removal:

Your participation in this study is voluntary. Your refusal to participate or your withdrawal from the study will involve no penalty or loss of benefits to which you are entitled. You may stop your participation at any time. You will not receive the honorarium if you do not complete the assigned activity.

The investigator (Dr. Collinge) may end your participation in this study for any of the following reasons:

1.   If you begin the project but are unable to finish the project activities within their scheduled timeframe.

2.   If the study is canceled by the National Cancer Institute, WCG IRB, DHHS or by the FDA;

3.   For administrative reasons.

Who will see the personal information provided?

  1. The information on your application form will be seen by the Investigator (Dr. William Collinge) and a Research Assistant (to be named).
  2. No information about your identity will be included in any publications about the project.
  3. In order to assure that your rights and safety are protected, members of WCG IRB; or personnel of the National Cancer Institute, or the U.S. Food and Drug Administration (FDA), or the federal Office of Human Research Protections, may also see parts of the information you provide for this study and, therefore, may see your name and other personally identifiable information about you. The information collected is the property of Collinge and Associates, Inc., and you will not be able to get it back.

What about confidentiality?

Your records will be kept safely in the offices of Collinge and Associates, Inc. and IRIS Media, Inc., the mobile app development company that will be producing the app prototype and collecting feedback data. Efforts will be made to keep your personal information confidential. We cannot guarantee absolute confidentiality, as your personal information may be disclosed if required by law. Also see “Who will see this information?” section above. Any publication of findings will not include any way of identifying you.

Identifiers might be removed from the identifiable private information and after such removal, the information could be used for future research studies or distributed to another investigator for future research studies without additional informed consent from you.

What are the costs?

There is no cost to you for participating in this study.

What are your rights as a participant?

Taking part in this study is your choice. You may choose not to take part or may leave the study at any time. Leaving will not result in any penalty or loss of benefits to which you are entitled.

Who do you call if you have questions or problems?

For questions, concerns, or complaints about the study or if you think you have had a research-related injury contact Dr. Collinge at (541) 632-3502.

For questions about your rights as a research participant, contact the WCG IRB (which is a group of people who review the research to protect your rights) at 1-855-818-2289 or [email protected] if:

  • You have questions, concerns, or complaints that are not being answered by the research team.
  • You are not getting answers from the research team.
  • You cannot reach the research team.
  • You want to talk to someone else about the research.
  • You have questions about your rights as a research subjec

Remember

Your participation in this research is voluntary. If you decide to participate, you are free to withdraw at any time. You may print a copy of this form for your information and to keep for your records.

Statement of Consent

I have read the foregoing information and wish to apply to participate in this study. I understand that I may or may not be selected depending on the study’s requirements for diversity of participants. I understand I can contact the investigators for any questions I may have. By entering my name below and completing the application, I consent voluntarily to be a participant in this research if accepted.

Application

Please note: This application is part of the screening to determine your eligibility to participate. Not all eligible applicants will be selected to participate, based on the needs of the study for diverse representation. Questions marked with a red star are required.

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First name


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Last name


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Mailing address (street or PO box)


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City


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State


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Zip code


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Age


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Phone (for communication related to this project)


 
Text number (for communication related to this project) -- if none, leave blank


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Email (for communication related to this project)


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Gender

 Racial and ethnic categories (mark ALL that apply)

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Which of the following applies to you:

Continue ONLY when finished. You will be unable to return or change your answers.