New Research Study – Post-breast cancer weight management

jjohnstonkay

Permission to conduct this research study has been granted from the Breastcancer.org moderators and participation is strictly voluntary.

Subject: New Research Study – Post-breast cancer weight management

Breast cancer survivors face many challenges as they transition from the acute phase of treatment to survivorship, and one of those challenges is dealing with weight management during and after a diagnosis of breast cancer.

What is the study about?

The proposed study seeks to understand from the perspective of the breast cancer survivor with hormone sensitive tumors their experiences with weight management. This research study is about understanding the essence of the lived experiences of breast cancer survivors who have struggled with their weight after cancer treatment and the meaning ascribed to the experience.

The study will ask you to describe how you feel about your weight gain, how it has affected your life and relationships, your weight management efforts, impact on your life, and the meaning of your experiences.

Please read on to discover what you can do to participate in this exciting opportunity. If this study is not a good fit, I hope you will let someone else know that may qualify.

Who can participate?

You can participate in this study if you match ALL of the following criteria:

 English speaking

 U.S. Citizen

 Female

 Over the age of 18

 Have hormone sensitive tumors

 Have struggled with weight gain after your cancer treatment.

 Have been diagnosed with breast cancer within the past seven years.

How to volunteer to participate?

To volunteer for this study all participants will need to send a private email message to the researcher and sign a consent form and Health Insurance Portability and Accountability Act (HIPAA) authorization form. Once the researcher receives an email of interest in this study she will email potential participants the consent form and HIPAA authorization form. Please download both forms, read them carefully, annotate either yes or no, sign, or either scan the document back, or mail to the address provided at the bottom of this message. The researcher's email and telephone number is provided at the bottom.

What's involved with the study?

Once you volunteer to participate in the study you will be contacted by the researcher. You will be asked to sign a consent form and HIPAA authorization form before being allowed to participate in the study.

This research study is about understanding the essence of the lived experiences of breast cancer survivors who have struggled with their weight after cancer treatment and the meaning ascribed to the experience. I am going to ask you to describe your experiences with weight gain after your breast cancer treatments and how this has made you feel and the meaning of the experience.

There will be three telephonic interviews that should take approximately one-hour each of your time. The first interview focuses on your life history related to the research topic and will help put your experience in context. The second interview focuses on the concrete details of your experience with the topic under investigation. And in the third interview you will be asked to reflect on the meaning of your experience. The interview questions will consist of open-ended questions that will allow you to freely express yourself. All interviews will be recorded.

Where is the study being conducted?

The study is being conducted through the University of the Rockies online doctorate program.

Who is conducting the study?

Julie K. Johnston, PsyD. Candidate

IRB #16-045-O

Researchers Contact Information

Julie K. Johnston

Julie.Johnston@my.rockies.edu or jjohnstonkay@gmail.com

Dissertation Chair: Mark A. Arcuri, PhD

mark.arcuri@faculty.rockies.edu

UoR Chairperson of the Institutional Review

IRB@rockies.edu.

renzkay55

I would be interested in knowing more about this study and participating in this study. I don't think there is enough information about this subject, and it sure is not one my oncologist discusses!

Lily55

i think you need to send an email to the researchers renzkay

renzkay55

Lily55

I did! I sent a message to the researcher and she seems to be very nice. The surprise was that she is also a breast cancer survivor and dealing with her own weight management issues. Are you going to participate in the study? The researcher Ms. Julie Johnston is looking for more participants and asked me if I knew of anyone else that would like to participate. I think it would be a good thing and way for our voices to be heard. I am glad I signed up.

Kat

jjohnstonkay

Message to Recruit Participants'

Permission to conduct this research study has been granted from the Breastcancer.org moderators and participation is strictly voluntary.

Subject: New Research Study – Post-breast cancer weight management

I have received many private emails from Breastcancer.org members that are concerned about their weight but are hesitant to participate in this study because they believe it will make them feel worse about their weight and efforts to lose. I want to assure you that am not here to judge, and I do not want anyone to feel worse about their weight status. I know this is a sensitive subject, because I am there with you. I too am a breast cancer survivor who has struggled with weight management after my cancer treatment, and it is that struggle that prompted me to study the problem. So with that said, and in an effort to be transparent, I have listed below the questions that will be the focus of my interviews. I will be asking you questions about your experiences with weight gain after your cancer treatments and how that has made you feel, impact on your life, impact on your relationships, efforts to lose weight, and any meaning you have attributed to those experiences.

Interview Questions

1. Opening question: "Could you tell me as much as possible about your life history?"

• Can you describe your breast cancer experience?
• Can you describe how your breast cancer experience changed your body?

2. Opening question: "Could you tell me as much as possible about your experience with weight gain after your breast cancer treatments?"

• Can you describe how you feel about your weight gain?
• Can you describe how your weight gain has affected your life?
• Can you describe how your weight gain has affected your relationships?
• What kind of impact has your weight gain had on your life?
• Can you describe your efforts to lose weight after your cancer treatments?

3. Opening question: "As you reflected on the meaning of your experiences with weight management, could you tell me as much as possible about what meaning you have ascribed to your experiences?

If you feel more comfortable responding to the questions by email that is perfectly ok. I would just ask that you sign the consent and HIPAA forms that I will email you prior to your participation in the study. Your input is very much valued. If you have any questions please feel free to contact me.

Researcher: Julie Johnston

(865)274-9519

Julie.Johnston@my.rockies.edu

ksusan

I've just completed Julie's interview and found her warm and responsive. If you're thinking about participating in this study, I want to encourage you to look at the questions and contact her. This research may help with a pretty big gap in information and survivorship resources.

Hopeful82014

After reading all of the above I still remain concerned about the need for the HIPPA release. Perhaps I'll email her directly to get more insight into that.

I agree with Ksusan about the major gap in information on this issue - it makes the Grand Canyon look small! The worst of it is that it seems to have been resolved in the minds of most MOs and researchers as a minor (read "trivial") side effect that can be controlled with diet and exercise - they don't see how resistant this weight can be and how the lack of estrogen can stymie most efforts to lose. Surprisingly, it never seems to cross their minds that it might contribute to the depression so many of us experience.

renzkay55

Hopeful8201

I was interviewed last week and it was not painful at all. Actually it was nice being able to express myself with someone who has been where I have been and understands it. Once you email the researcher about your interest in the study she will send you the HIPAA Authorization Form and the consent form. The HIPAA form is not a release form by law the researcher needs to include it if any personally identifiable information (PII) such as your name, email address, user ID, street address, and telephone number obtained while corresponding and recording interviews. The researcher will give each participant a letter and number combo for the study to protect their identify. The HIPAA and consent form are used to protect our identify. I would really encourage you to participate. This is one way for our voice to be heard.

Kat

jjohnstonkay

I just wanted to say that I appreciate everyone who has commented on this study, and I want to let you know that your privacy will be protected. I tried to attach a copy of the HIPAA Authorization From and the Informed Consent form that will need to be signed before participating in this study but there is not a way to attach a document so I have cut and pasted these documents so that you will know what the documents contain because some of you have expressed concerns about these documents. Also, please feel free to contact me with any questions or concerns you may have.

Julie

jjohnstonkay

Informed Consent

Informed Consent Form for Phenomenological Investigation of Post-Breast Cancer Weight Management

1.Please read the following informed consent and select YES to indicate agreement and sign or NO to indicate you would not like to participate.

2. Purpose of the study: Ms. Julie K. Johnston, doctoral candidate at the University of the Rockies, is conducting this study to understand breast cancer survivor's struggles with weight management after breast cancer treatment and the meaning of the experience. This research may help healthcare providers better understand the struggles breast cancer survivors have with post-breast cancer weight management and the interventions that best support the needs of breast cancer survivors as they transition from acute cancer care to survivorship care. This study could aid healthcare providers with better communication strategies on weight management discussions during and after breast cancer therapy. Your responses in the interview are confidential and only available to the researchers.

3.Description of the procedures to be followed and approximate duration of the study. Participants in the research will participate in answering questions, which will focus on your struggles with weight management after breast cancer treatment. You will be asked to describe in detail how you feel about your weight gain, how it has affected your life and relationships, your weight management efforts, impact on your life, and the meaning of your experiences. This process will consist of three interviews that should take approximately one-hour each of your time. The first interview focuses on your life history related to the research topic and will help put your experience in context. The second interview focuses on the concrete details of your experience with the topic under investigation. And in the third interview you will be asked to reflect on the meaning of your experience.

4.Description of the discomforts, inconveniences, and risks that can be reasonably expected as a result of participation in this study. Discussing your weight management struggles after cancer treatment may be uncomfortable and you may want to seek mental health counseling or support from a local breast cancer support group in your local community. Many city/county/state mental health services are advertised in your local telephone book or have a website detailing their services. If you need assistance please do not hesitate to contact me.

5. Description of how confidentiality will be assured and the limits to these assurances, if any. Individual participant data will not be divulged, discussed, or presented by the researcher. Only the researcher will have access to your information. Data collected, transcribed, and filed from interview sessions and recordings will be assigned a numeric code that will help protect your identity. If you decide not to complete the study all data obtained will be disposed of at the conclusion of the study. Files from interview sessions and recordings will be destroyed by shredding hardcopy notes and deleting any digital recordings.

6. Anticipated benefits resulting from this study. Although there are no direct benefits to the participants, potential benefits to you from participating in the study are to help the researchers better understand the weight management issues facing breast cancer survivors after cancer treatment. The potential benefits to the scientific and medical community that may result from this study are to provide evidence to give healthcare providers the opportunity to better understand the weight management struggles of breast cancer survivors and interventions that best support their needs as they transition from acute cancer care to survivorship care. In addition, this study may provide medical care providers with the information to develop better communication strategies on weight management discussions during and after cancer therapy that benefit all breast cancer survivors.

7.Alternative procedures. There are no alternative procedures to participation in the interview.

8.Contact Information. If you have any questions about this study, you can contact the person(s) below:

Researcher: Julie Johnston

(865) 274-9519

Julie.Johnston@my.rockies.edu

Dissertation Chair: Mark A. Arcuri, PhD

(505) 629-1631

mark.arcuri@faculty.rockies.edu

UoR Chairperson of the Institutional Review

IRB@rockies.edu.

This study has been reviewed and approved by the University of the Rockies Institutional Review Board (IRB). The IRB has determined that this study meets the ethical obligations required by federal law and University policies. If you have questions or concerns regarding this study please contact the Investigator or Dissertation Chair. If you have any questions regarding your rights as a research subject, please contact the IRB Chair at IRB@rockies.edu.

9. Your rights as a volunteer. Your participation in this study is completely voluntary, and you may choose not to participate. You are free to withdraw from this study at any time with no penalty to you. Your responses will be confidential. If the results of this study were to be written for publication, no identifying information will be used. If you change your mind later and do not want your information collected (or shared), you can verbally tell the researcher in person or send a letter to the researcher telling her that you have changed your mind and do not want her to collect (or share) your information. Once the researcher receives your request, you will be removed from the study and all collected information will be destroyed.

STATEMENT BY PERSON AGREEING TO PARTICIPATE IN THIS PROJECT

I have read this consent form, and all of my questions have been answered. I freely and voluntarily choose to participate in the research interview, and I understand that I can receive a signed copy of this form upon request. The information contained in this consent form has been adequately explained to me.

All my questions have been answered?______YES _______NO

A copy of this consent form will be provided to you.

10. Statement by individual agreeing to participate in this research study:

I understand the above information and voluntarily consent to participate in the research

______Yes ______ No

I authorize the researcher to document all interviews that I participate in via electronic means or written notes.

______Yes ______ No

I further attest that I am a female.

______Yes ______ No

I further attest that I am at least 18 years of age.

______Yes ______ No

I further attest that I am a United States citizen.

______Yes ______ No

Signature of Participant:________________________Date: __________________________

IRB Approval Number: __16-045-O_______________ IRB Expiration Date:October, 31, 2017

jjohnstonkay

Informed Consent

Informed Consent Form for Phenomenological Investigation of Post-Breast Cancer Weight Management

1.Please read the following informed consent and select YES to indicate agreement and sign or NO to indicate you would not like to participate.

2. Purpose of the study: Ms. Julie K. Johnston, doctoral candidate at the University of the Rockies, is conducting this study to understand breast cancer survivor's struggles with weight management after breast cancer treatment and the meaning of the experience. This research may help healthcare providers better understand the struggles breast cancer survivors have with post-breast cancer weight management and the interventions that best support the needs of breast cancer survivors as they transition from acute cancer care to survivorship care. This study could aid healthcare providers with better communication strategies on weight management discussions during and after breast cancer therapy. Your responses in the interview are confidential and only available to the researchers.

3.Description of the procedures to be followed and approximate duration of the study. Participants in the research will participate in answering questions, which will focus on your struggles with weight management after breast cancer treatment. You will be asked to describe in detail how you feel about your weight gain, how it has affected your life and relationships, your weight management efforts, impact on your life, and the meaning of your experiences. This process will consist of three interviews that should take approximately one-hour each of your time. The first interview focuses on your life history related to the research topic and will help put your experience in context. The second interview focuses on the concrete details of your experience with the topic under investigation. And in the third interview you will be asked to reflect on the meaning of your experience.

4.Description of the discomforts, inconveniences, and risks that can be reasonably expected as a result of participation in this study. Discussing your weight management struggles after cancer treatment may be uncomfortable and you may want to seek mental health counseling or support from a local breast cancer support group in your local community. Many city/county/state mental health services are advertised in your local telephone book or have a website detailing their services. If you need assistance please do not hesitate to contact me.

5. Description of how confidentiality will be assured and the limits to these assurances, if any. Individual participant data will not be divulged, discussed, or presented by the researcher. Only the researcher will have access to your information. Data collected, transcribed, and filed from interview sessions and recordings will be assigned a numeric code that will help protect your identity. If you decide not to complete the study all data obtained will be disposed of at the conclusion of the study. Files from interview sessions and recordings will be destroyed by shredding hardcopy notes and deleting any digital recordings.

6. Anticipated benefits resulting from this study. Although there are no direct benefits to the participants, potential benefits to you from participating in the study are to help the researchers better understand the weight management issues facing breast cancer survivors after cancer treatment. The potential benefits to the scientific and medical community that may result from this study are to provide evidence to give healthcare providers the opportunity to better understand the weight management struggles of breast cancer survivors and interventions that best support their needs as they transition from acute cancer care to survivorship care. In addition, this study may provide medical care providers with the information to develop better communication strategies on weight management discussions during and after cancer therapy that benefit all breast cancer survivors.

7.Alternative procedures. There are no alternative procedures to participation in the interview.

8.Contact Information. If you have any questions about this study, you can contact the person(s) below:

Researcher: Julie Johnston

(865) 274-9519

Julie.Johnston@my.rockies.edu

Dissertation Chair: Mark A. Arcuri, PhD

(505) 629-1631

mark.arcuri@faculty.rockies.edu

UoR Chairperson of the Institutional Review

IRB@rockies.edu.

This study has been reviewed and approved by the University of the Rockies Institutional Review Board (IRB). The IRB has determined that this study meets the ethical obligations required by federal law and University policies. If you have questions or concerns regarding this study please contact the Investigator or Dissertation Chair. If you have any questions regarding your rights as a research subject, please contact the IRB Chair at IRB@rockies.edu.

9. Your rights as a volunteer. Your participation in this study is completely voluntary, and you may choose not to participate. You are free to withdraw from this study at any time with no penalty to you. Your responses will be confidential. If the results of this study were to be written for publication, no identifying information will be used. If you change your mind later and do not want your information collected (or shared), you can verbally tell the researcher in person or send a letter to the researcher telling her that you have changed your mind and do not want her to collect (or share) your information. Once the researcher receives your request, you will be removed from the study and all collected information will be destroyed.

STATEMENT BY PERSON AGREEING TO PARTICIPATE IN THIS PROJECT

I have read this consent form, and all of my questions have been answered. I freely and voluntarily choose to participate in the research interview, and I understand that I can receive a signed copy of this form upon request. The information contained in this consent form has been adequately explained to me.

All my questions have been answered?______YES _______NO

A copy of this consent form will be provided to you.

10. Statement by individual agreeing to participate in this research study:

I understand the above information and voluntarily consent to participate in the research

______Yes ______ No

I authorize the researcher to document all interviews that I participate in via electronic means or written notes.

______Yes ______ No

I further attest that I am a female.

______Yes ______ No

I further attest that I am at least 18 years of age.

______Yes ______ No

I further attest that I am a United States citizen.

______Yes ______ No

Signature of Participant:________________________Date: __________________________

IRB Approval Number: __16-045-O_______________ IRB Expiration Date:October, 31, 2017

Hopeful82014

Kat and Julie - I really appreciate the additional information, insights and encouragement to explore this further. Having the IC posted is quite helpful.

ksusan

Julie sent a transcript of the interview to me after we spoke. This gave me a chance to review what I had said, make corrections, and add any other thoughts that I had.

VickiRides

I just finished my interview with Julie. The interview was relaxed and totally non-judgmental. If you are thinking about participating, I would encourage you to do so. Weight gain seems to be part of survivorship for so many of us, and research like this can be very helpful.

KBeee

are you looking at just weight gain, or other Wright changes? I have lost weight

littleblueflowers

I just interviewed with Julie today. I think she is trying to fill in an important information gap. She seemed very kind.

jjohnstonkay

KBeee

I am primarily looking at weight gain; however, weight loss is not uncommon with initial cancer treatment.

Julie

jjohnstonkay

Although my post has received almost 300 views I have only had four people volunteer to participate (thank you!) in my study and I need at least 12. From the views this posting has received and comments from participants this subject matter is very important to all of us. Participating in this study and others allows our voices to be heard and the ability to collectively share our concerns.

I am only allowed to recruit participants under this forum but know that many of you post on different forums, and know of others who would meet the selection criteria for this study. If you know of others who would like to participate in a study like this please let hem know about it.

Thank you all for your support.

Julie K. Johnston

jjohnstonkay

Still looking for additional participants. If you know of any one who has gained weight after breast cancer please let them know about this study. Appreciate your support.

Julie

farmerlucy

Bump! I did an interview today and it was very cathartic. The researcher is very professional and courteous. She could use a few more volunteers. Just PM her for information.

jjohnstonkay

This study has ended. I will soon post the results. I want to thank everyone who participated or contacted me via email. I hope that the results of this study will shed light on this problem.

Julie K. Johnston, Psy.D.

ksusan

Thanks for the update, Julie.