Initiative for Cancer-Survivorship Approached Naturally (I-CAN)
Summary for Prospective Research Participants
Who is conducting the study, why you have been asked to participate, how you were selected, and what is the approximate number of participants in the study?
The Initiative for Cancer-Survivorship Approached Naturally (I-CAN) research study is a partnership with The Chopra Foundation and biomedical scientists from The University of California, San Diego (UCSD) and Sanford Burnham Medical Research Institute (SBMRI). The study is being conducted so we can learn more about the biochemical, physiological, and psychosocial effects of the Perfect Health (PH) course offered at the Chopra Center for Wellbeing located at Omni La Costa Resort and Spa in Carlsbad, CA. We are looking for approximately 30 female breast cancer survivors, 18 years of age or older.
To ensure you qualify for participation in this study, please review the main eligibility criteria page.
Why is this study being done?
It is becoming increasingly recognized that ancient practices for wellbeing, including meditation, yoga, and specific herbs, can improve health and promote longevity. While studies have documented such effects for a variety of individual practices for wellbeing, few studies have taken a more systems biology approach that is simultaneously inclusive of numerous practices. The purpose of this study is to find out more about the health and psychological effects of breast cancer survivors in participation of the Perfect Health course.
What will happen to you in this study?
If you are interested in taking the Perfect Health course, and are also interested in participating in the Initiative for Cancer-Survivorship Approached Naturally, you will be assigned to the Perfect Health study group, should you qualify, after having completed an eligibility criteria form. Placement in this study is on a first come first serve basis. If you are eligible and are placed into the study group, you will attend the week-long Perfect Health course at the Omni La Costa Resort and Spa in Carlsbad, CA. Resort accommodations and meals during the Perfect Health course, in addition to the Perfect Health program will be provided for you.
The Procedures to take part in the study will include:
- Electronic Consent Form: After reading this document, receiving a detailed overview of the study from our research coordinator via telephone and/or in person, and asking the study coordinator any questions you may have, you may sign the electronic consent form by typing your name at the end of the document. The electronic consent form will be provided to you via email after approval from a study coordinator.
- Baseline Questionnaires: After completing the electronic consent form, questionnaires will be available online for you to complete up to one month prior to your scheduled arrival at Omni La Costa Resort and Spa in Carlsbad, CA for your 6-night stay. To understand how participating in an intensive wellness program may affect wellbeing, we need a sense of what breast cancer survivor’s daily lives, mood, and health are like when they are in their natural environment (not a resort). These questionnaires will cover a range of questions about your mental and physical wellbeing, including depression, mood, stress levels, ways of dealing with feelings, energy level, and health behaviors. Please note the online survey will take less than one hour to complete. You will complete these questionnaires again, day of arrival and end of the program week, in addition to 1 month and 3 months post program.
- Heart Rate Variability Assessment: The study coordinator will provide you with a special heart rate monitor, called amiigo, which consists of a wristband sensor to record upper body activity. You will wear this on your wrist for approximately 2 continuous days at the beginning of the program week and 2 continuous days at the end of the program week. Detailed instructions regarding placement and use will be discussed in the on-site study orientation, as well as described in hand out form. This device allows the researchers to examine your heart rate variability, rate and depth of your breathing, physical activity, and position while you are at the resort. After having worn the device for two days and syncing the amiigo to your smart phone via the app, you will return the device to the study coordinator to charge the device before wearing it for the last two remaining days of the program.
- Salivary Collection: The study coordinator will provide you with a set of small plastic tubes each containing a cotton insert, along with detailed instructions for the collection and storage of your saliva so that we may examine markers of stress in your saliva at the beginning of the Perfect Health week and at the end of the Perfect Health week. The first saliva kit will be given to you during your Study Orientation on TBD, 2016 and will be collected throughout the day on TBD, 2016. Your second saliva kit will be given to you on TBD, 2016 and collected throughout the day on TBD, 2016.
- Home Preparation Week: The study coordinator will send you detailed instructions regarding activities you will perform at home related to diet and mind-body exercises via e-mail. Instructions will be sent approximately one week prior to your stay at Omni La Costa Resort and Spa in Carlsbad, CA. The home preparation week will require additional time to read the instructions, prepare special meals, and self-reflect. We estimate the additional time required for the home preparation week will total approximately 3 hours.
- Microbiome Assessment: The study coordinator will also provide you with a special collection kit so you can provide a small stool sample for which we will use to measure the microbiome of your gastrointestinal system. The microbiome refers to the aggregate of microorganisms such as bacteria and fungi that reside on and within the body. Microbiome assessments can provide insight into human health and wellbeing. You will return the stool samples to the study coordinator on site.
- Photojournaling: Photojournaling is an innovative approach to using visual data in qualitative health research. This method enables participants to use photography and journaling to convey personal views and relay lived experiences that may involve sensitive and deeply felt issues. The photojournaling exercise is meant to encourage breast cancer survivors to capture visual images that reflect self-identification, enhance exchange of information between participants, and explore individual changes in perceived self-growth and self-efficacy throughout the program.
- Biophoton Assessment: Biophoton emission is the spontaneous emission of ultraweak light emanating from all living systems, including man. The purpose is to examine biophoton emission in breast cancer survivors, and the potential effects of integrative modalities on this emission. During each of the two in person laboratory assessments, biophoton emission assessments will be taken. Participants will wear light-tight gloves to dark-adapt hands for at least 20 min in a poorly lit room before measurements are performed. Then participants will be comfortably seated while putting both hands under a photon multiplier, which measures (without the gloves) their photon emission non-invasively.
Following these initial procedures, if you are eligible to participate in the I-CAN study group, you will come to the Chopra Center for Wellbeing at Omni La Costa Resort and Spa in Carlsbad, CA and attend the Perfect Health course.
The day after your arrival (TBD, 2016) you will have heart rate and activity monitoring, a fasting blood sample taken, stool sample (for microbiome assessment), in addition to saliva sampling. Approximately one week later, on Saturday (TBD, 2016) before you return home, you will again have a fasting blood sample taken, another stool sample (for microbiome assessment), and will conclude with saliva sampling and a set of questionnaires to complete. Throughout the course of Perfect Health, you will be creating a photo journal comprised of photographs that are taken throughout the week on a daily basis. Directions for photo journaling will be provided in a live webinar, that will also be recorded should you be unable to attend, prior to attendance at the Chopra Center for Wellbeing’s Perfect Health program. All information pertaining to what is expected from participants will be provided in handout form, as well as, verbally described at the program’s study orientation on TBD, 2016.
Approximately one month later (TBD, 2016), you will return to the Chopra Center for Wellbeing at Omni La Costa Resort and Spa in Carlsbad, CA to attend a one month follow up event, where assessments will be completed and the opportunity to share a single photo chosen from your photo journaling exercise.
How much time will each study procedure take, what is your total time commitment, and how long will the study last?
The various assessments will take a total of several hours to complete.
What risks are associated with this study?
Questionnaires/Interview: Some of the questions are sensitive in nature. It may be difficult, uncomfortable, or boring to answer questions about your health history and wellbeing. You may skip any questions that cause you discomfort or that you do not wish to answer.
Heart Rate and Activity Monitor: The amiigo device is worn directly on your skin as a wristband. Although the amiigo wristband is much like wearing a watch or fitbit, if you are not used to wearing such devices, this may cause mild discomfort. In addition there is a small amount of time it will take to sync the amiigo to your smart phone via the app, for the 4 days in total you wear the device.
Photojournaling: Some of the photos you collect may be sensitive in nature. It may be difficult, uncomfortable, or boring to reflect on photos about your experience during the Perfect Health program. You do not have to share any information that causes you discomfort or you do not wish to reflect upon.
Loss of Confidentiality: There is risk of loss of confidentiality from collecting your data online. Care will be taken to minimize this risk and information collected will be stored at the University of California, San Diego using only a subject identifier and not your name.
If you are eligible to participate you may like or dislike the assignments during the home preparation week. For instance, you may find it uncomfortable or psychologically distressing to engage in the required self-reflection. Further you may not like the taste or consistency of the food, tea, or herbs. You may dislike the restrictions on the ingestion of animal products, recreational chemicals including alcohol, and frequency of food consumption. Because this is a research study, there may be some unknown risks that are currently unforeseeable. You will be informed of any significant new findings.
What are the alternatives to participating in this study?
The alternatives to participation in the Initiative for Cancer-Survivorship Approached Naturally research study, are to participate in the Perfect Health program without participating in the research study and/or stay at the Omni La Costa Resort and Spa in Carlsbad, CA without participating in the Perfect Health program.
What benefits can be reasonably expected?
There may or may not be any direct benefit to you from these procedures. The investigator(s), however, may learn more about the effect of participating in the Initiative for Cancer-Survivorship Approached Naturally study group on psychological and physical health. Personal results may be requested but not guaranteed. Dependent upon the personal results you receive, results may not be returned until 6-24 months after the study dates.
Can you choose to not participate or withdraw from the study without penalty or loss of benefits?
Participation in research is entirely voluntary. You may refuse to participate or withdraw at any time without penalty or loss of benefits to which you are entitled. If you decide that you no longer wish to continue in this study, you will be requested to contact the study coordinator, so that we may conduct a brief interview with you. This is to determine why you are no longer interested in participating, as well as arrange for the return of any study devices you may have in your possession.
You will be told if any important new information is found during the course of this study that may affect your wanting to continue.
Can you be withdrawn from the study without your consent?
You may be withdrawn from the study if Dr. Sheila Patel believes it is in your best medical interest. You may also be withdrawn from the study if you do not follow the instructions given to you by the study personnel.
Will you be compensated for participating in this study?
You will not receive any payment for your participation in this study.
Are there any costs associated with participating in this study?
Costs associated with this study are based on travel expenses to the Omni La Costa Resort and Spa in Carlsbad, CA from the Southern California county area in which you are traveling from, in addition to any added services (such as supplementary massages or ancillary services) and/or gratuities for services (such as massage). These additional services and/or gratuities will not be included in your funded Perfect Health program. A credit card on file is mandatory for any incidentals that may occur during your stay at Omni La Costa resort and Spa in Carlsbad, CA. Incidentals are at participants’ own expense. All other costs associated with the study such as: Hotel accommodations, Perfect Health Program, and food will be provided for you by the Chopra Foundation and donors/sponsors.
What about confidentiality?
Research records will be kept confidential to the extent allowed by law. A research file will be created containing data collected during these research procedures, and will be separated from all identifying information (such as your name and contact information). A participant ID will be used to manage all participant information, rather than your name or other identifying information. There is a potential loss of privacy due to participation in this project.
Who can you call if you have questions?
You can call the Chopra Foundation Research Team at (760) 494-1663 or send an email with the subject Line: Study Description at [email protected]