Supplementary Information
Participant information sheet and informed consent form
(for adult subjects and interventional studies)
Title of study: Perioperative Oral Nutrition Supplementation in Malnourished Surgical
Cancer Patients- A Randomised Controlled Trial
1.
Name of investigator and institution:
i.
Professor Dr. Winnie Chee Siew Swee
-Department of Nutrition & Dietetics, International Medical University, Bukit Jalil
ii.
Dato’ Dr. Kandasami Palayan
-Department of Surgery, International Medical University, Seremban
iii.
Dr. Zarina Bt Ahmed
-Department of Surgery, Hospital Tuanku Ja’afar, Seremban
iv.
Dr Syed Ali Ibrahim Bin Syed Akbar Ali
-Department of Surgery, Hospital Tuanku Ja’afar, Seremban
v.
Ms. Lydianis Binti Bahari
-Department of Dietetics and Food, Hospital Tuanku Ja’afar, Seremban
vi.
Dr. Subhathira A/P M. Manohkaran
-Department of Surgery, Hospital Tuanku Ampuan Najihah, Kuala Pilah
vii.
Dr Mohd Razali Ibrahim
-Department of General Surgery, Hospital Kuala Lumpur, Wilayah Persekutuan
viii.
Dr Khairul Hazim bin Hamdan
-Department of General Surgery, Hospital Kuala Lumpur, Wilayah Persekutuan
ix.
Dr Nur Syazrina Erma Binti Abdullah Thani
-Department of General Surgery, Hospital Kuala Lumpur, Wilayah Persekutuan
x.
Ms. Koh Bi Qi
-Dietetic and Food Service Department, Hospital Kuala Lumpur, Wilayah Persekutuan
xi.
Dr. Chen Seong Ting
-Department of Nutrition & Dietetics, International Medical University, Bukit Jalil
xii.
Dr. Ong Shu Hwa
-Department of Nutrition & Dietetics, International Medical University, Bukit Jalil
xiii.
Dr. Sangeetha Shyam
-Department of Nutrition & Dietetics, International Medical University, Bukit Jalil
Sites of study: Hospital Tuanku Ja’afar (Seremban), Hospital Tuanku Ampuan Najihah (Kuala Pilah), Hospital Kuala Lumpur (Wilayah Persekutuan)
2.
Name of sponsor: Kotra Pharma (M) Sdn Bhd
Introduction:
You are invited to participate in a research study because you are malnourished cancer patient who will be undergoing elective surgery that requires nutrition intervention. The details of the research trial are described in this document. It is important that you understand why the research is being done and what it will involve. Please take your time to read through and consider this information carefully before you decide if you are willing to participate. Ask the study staff if anything is unclear or if you would like more information. After you are properly satisfied that you understand this study, and that you wish to participate, you must sign this informed consent form. To participate in this study, you may be required to provide your doctor with information on your health history; you may harm yourself if you are not truthful with the information provided.
Your participation in this study is voluntary. You do not have to be in this study if you do not want to. You may also refuse to answer any questions you do not want to answer. If you volunteer to be in this study, you may withdraw from it at any time. If you withdraw, any data collected from you up to your withdrawal will still be used for the study. Your refusal to participate or withdrawal will not affect any medical or health benefits to which you are otherwise entitled.
This study has been approved by the Medical Research and Ethics Committee, Ministry of Health Malaysia.
What is the purpose of the study?
The purpose of this study is to evaluate the effectiveness of perioperative oral nutrition supplementation on nutritional status in malnourished cancer patients undergoing elective surgery. This research is necessary because it provides a better understanding on the benefits and optimal duration for perioperative oral nutrition supplement (ONS) feeding to improve nutrition care for malnourished cancer patients who are undergoing elective surgery. Currently, the most common practice for elective surgery cancer patients in hospitals is malnourished patients receive dietary counselling by dietitians to improve nutrition condition before surgery and after surgery, they are given ONS while in the hospital until the day they are discharged from hospital.
A total of 108 subjects like you will be participating in this study. The whole study will last about two (2) years and your participation will be about four (4) months.
What kind of study products [or procedures] will I receive?
If you agree to participate in the study, the doctor may need to perform some tests and examinations to determine if you are suitable for the study. If you are deemed suitable, you will be randomly (by chance, like flipping a coin) assigned to one of the study groups below. You have equal chance of being assigned to each of the groups.
The study product contains bovine or milk protein from cow’s milk.
Group 1: You will receive an oral nutrition supplement in the form of milk powder drink (Product name: Appeton Wellness Recovery) for 14 days before operation date and after operation while in the hospital until the day you are discharged to go home.
Group 2: You will receive an oral nutrition supplement in the form of milk powder drink (Product name: Appeton Wellness Recovery) for 14 days before operation date and after operation while in the hospital and continue up to 3 months at home.
Group 3: You will receive nutrition counselling and a meal plan by a dietitian 14 days before operation date. After operation you will receive oral nutrition supplement in the form of milk powder drink (Product name: Appeton Wellness Recovery) until the day you are discharged to go home.
The Appeton Wellness Recovery product is certified HALAL by JAKIM and the Halal Certification can be made available upon request.
What will happen if I decide to take part?
You will be required to attend the screening session and another
FIVE (5) visits to the Surgical Outpatient Department, Hospital Tuanku Ja’afar, Seremban
ii.
First visit: Two weeks before operation
iii.
Second visit: The day before operation
iv.
Third visit: The day before you discharge from hospital
v.
Fourth visit: One month after operation
vi.
Fifth visit: Three months after operation
Procedure/ measurements during screening:
-The study staff will interview you on your personal information, social history, medical history, dietary habits.
-The study staff will ask you on your food intake, weight changes; examine fat loss at eye, arms and ribs areas, muscle loss at temples, clavicles, shoulders, hands, scapula, thigh and calf; check fluid accumulation and strength of your hand-grip. This examination is for screening of malnutrition status.
Procedures/measurements during the other FIVE (5) visits:
The study staffs will conduct the following measurements each time when you come to the hospital clinic, for the five visits mentioned above.
-Measure your weight, height, your arm circumference with a tape, the skinfold at your triceps using a caliper.
-Measure the strength of your hand-grip using a hand dynamometer.
-A qualified nurse or phlebotomist will draw 8 mls of blood (approximately 1 ½ teaspoons) from your arm to measure serum proteins (pre-albumin, albumin, transferrin), haemoglobin and inflammatory markers (hs-CRP and IL-6).
-Take 1-2 mls of your saliva (approximately ½ teaspoon) to measure your cortisol stress level. You will be requested to rinse your mouth with water before you provide your saliva.
-Make phone calls to ask about the type and quantity of food on three different days for first, fourth and fifth visits. For the second and third visits while you are in hospital, they will ask you to recall the food that you eat on the day before.
-Interview you using a questionnaire on how well is your sleep.
You are required to fill in a form on how many times and how many scoops of the oral nutrition supplement you drink every day.
You do not need to fast before coming for blood taking.
You can continue to take the medication that is prescribed by your doctor.
The blood and saliva specimens collected from you are not used for genetics research.
When will I receive the trial product and how should it be kept?
You will be given the study product at each study visit throughout the treatment period of the study. You must not give the product to anyone else. The study staff will instruct you on how the product must be handled and stored. Please ensure that you keep your used and partly used study products after you have finished with them. For all visits you will need to bring back all study products (partly used, unused and empty cans) to your study site.
What are my responsibilities when taking part in this study?
It is important that you answer all of the questions asked by the study staff honestly and completely. If your condition or circumstances change during the study, you must tell the study doctor. You must inform your study doctor immediately if you make any changes to any of your current treatments, even those which you have been taking for a long time.
It is very important that your study doctor be informed very rapidly of any eventual changes to your health during your participation in the study. For your own security, it is important that you follow your study doctor’s instructions throughout the entire duration of the study.
What kind of treatment will I receive after my participation in the trial?
No study product will be given to you at the end of your participation in the study. Whether you complete the study or withdraw early, your doctor will discuss the best alternatives for your future treatment with you.
What are the potential risks and side effects of being in this study?
Drawing of blood may cause slight pain, infection or bruising. Precautions will be taken to minimise these risk by engaging a trained phlebotomist and using sterile technique
There are no serious side effects known to be caused by the study product. The study procedures are all routine procedures for the condition studied and has no other alternative procedures. There are thus minimal risks for you.
Please ask your study doctor if you need more information on risks and side effects. The study staff will inform you in a timely manner about any new findings or changes about the study product which may affect your health or willingness to continue in this study. Where necessary, you may be asked to reconsent to participate.
The collection of your blood and saliva specimens will not be used for future testing or research.
What are the benefits of being in this study?
There may or may not directly benefit you. Information obtained from this study will help improve the nutrition management of other participants with the same disease or condition. The findings will be shared with all participants at the end of the study.
What if I am injured during this study?
If you are injured as a result of being in this study, you should contact your study doctor. In the event of a bodily injury or illness directly resulting from the study product or a medical procedure required for this study, the sponsor will pay for reasonable and necessary treatment. The sponsor is not responsible for medical expenses due to pre-existing medical conditions, any underlying diseases, any ongoing treatment process, your negligence or willful misconduct, the negligence or willful misconduct of your study doctor or the study site or any third parties. You do not lose any of your legal rights to seek compensation by signing this form.
What are my alternatives if I do not participate in this study?
You do not have to participate in this study to get treatment for your disease or condition.
Who is funding the research?
This study is sponsored by Kotra Pharma (M) Sdn Bhd who will pay for all study products and procedures. All other drugs and procedures that are not required by the study but are part of your routine medical care will have to be paid by you or your insurance. The sponsor will financially compensate the time spent by the study staff, use of facilities, etc., for including you in the study. You will be reimbursed RM50.00 as your travel expenses for each study visits. There will be no other payment for participating in this study.
Can the research or my participation be terminated early?
The study doctor or the sponsor may due to concerns for your safety, stop the study or your participation at any time. If the study is stopped early for any reason you will be informed and arrangements made for your future care.
Will my medical information be kept private?
All your information obtained in this study will be kept and handled in a confidential manner, in accordance with applicable laws and/or regulations. When publishing or presenting the study results in scientific journals, no names and individual data will be revealed. You will not be identified. Your data will be entered using a unique participant ID only, e.g. 1001, 2001, 3001.
Individuals involved in this study and in your medical care, qualified monitors and auditors, the sponsor or its affiliates and governmental or regulatory authorities may inspect and copy your medical records, where appropriate and necessary.
Who should I call if I have questions?
If you have any questions about the study or if you think you have a study related injury and you want information about treatment, please contact the study doctor, Professor Dr Winnie Chee Siew Swee, Tel:+603 2731 7305 (Ext. 2284) .
If you have any questions about your rights as a participant in this study, please contact: The Secretary, Medical Research & Ethics Committee, Ministry of Health Malaysia, at telephone number 03-2287 4032.
Informed consent form
Title of Study: Perioperative Oral Nutrition Supplementation in Malnourished Surgical
Cancer Patients- A Randomised Controlled Trial
By signing below I confirm the following:
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I have been given oral and written information for the above study and have read and understood the information given.
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I have had sufficient time to consider participation in the study and have had the opportunity to ask questions and all my questions have been answered satisfactorily.
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I understand that my participation is voluntary and I can at anytime free withdraw from the study without giving a reason and this will in no way affect my future treatment. I am not taking part in any other research study at this time. I understand the risks and benefits, and I freely give my informed consent to participate under the conditions stated. I understand that I must follow the study doctor’s (investigator’s) instructions related to my participation in the study.
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I understand that study staff, qualified monitors and auditors, the sponsor or its affiliates, and governmental or regulatory authorities, have direct access to my medical record in order to make sure that the study is conducted correctly and the data are recorded correctly. All personal details will be treated as STRICTLY CONFIDENTIAL.
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I will receive a copy of this subject information/informed consent form signed and dated to bring home.
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I agree/disagree* for my family doctor to be informed of my participation in this study. (*delete which is not applicable)
Investigator conducting informed consent:
Impartial witness:
(Required if the participant is illiterate and contents of participant information sheet is orally communicated to the participant)