COOLVAS: Exploring the Feasibility and Impact of Cooling Mats on Vasomotor Symptoms in Patients Receiving Endocrine Treatment: A Pilot Study
Phase: NA
Conditions: Hot Flashes, Sleep, Hormonal, Cancer
Sponsor: Sligo General Hospital

COOLVAS PROTOCOL V1.0 16 July 2025 
 
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CLINICAL RESEARCH PROTOCOL 
 
______________________________________________________________________________________ 
 
 
 
 
Study Title: 
COOLVAS Study 
Exploring the Feasibility and Impact of Cooling Mats on Vasomotor Symptoms in 
Patients Receiving Endocrine Treatment: A Pilot Study 
 
 
Protocol Number:  Version 1 
Date: 16th July 2025 
 
 
 
Protocol Author: 
Breege Farrelly and Moira Maxwell  
 
 
_______________________________________________________________________________________ 
Principal Investigators:  
Breege Farrelly, Advanced Nurse Practitioner Oncology, Sligo University Hospital, Ireland 
 
 
 
 
 
 

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INVESTIGATOR PROTOCOL AGREEMENT PAGE 
 
I, the undersigned, am responsible for the conduct of the trial at this site and agree to the following: 
- 
I understand and will conduct the trial according to the protocol, any approved protocol 
amendments, ICH GCP and all applicable regulatory authority requirements and national laws. 
- 
I will not deviate from the protocol without prior written approval from the Institutional Review 
Board or Independent Ethics Committee, except where necessary to prevent any immediate 
danger to the subject. 
- 
I have sufficient time to properly conduct and complete the trial within the agreed trial period, 
and I have available an adequate number of qualified staff and adequate facilities for the foreseen 
duration of the trial to conduct the trial properly and safely. 
- 
I will ensure that any staff at my site(s) who are involved in the trial conduct are adequately 
trained regarding the protocol and their responsibilities.   
 
 
 
Signed  
 
 
 
 
 
     Date 
____________________________                                     _________________ 
 
Breege Farrelly, Principal Investigator, Sligo University Hospital 
 
 
 
 
 
 
 
 
 
 
 

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CO-INVESTIGATORS 
 
Moira Maxwell, CNM2, Cancer Research Department, Sligo University Hospital. 
Mary O’Brien Staff Nurse, Cancer Services, Sligo University Hospital. 
Oliva Grady, Oncology CNS, Sligo University Hospital. 
Dr Lore Komanyae, Consultant Medical Oncologist, Sligo University Hospital. 
Dr. Michael Martin, Consultant Medical Oncologist, Sligo University Hospital. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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CONTENTS 
1. 
SYNOPSIS .................................................................................................................................................................. 6 
Primary Endpoint.......................................................................................................................................................... 6 
Secondary Endpoint ..................................................................................................................................................... 7 
2.  INTRODUCTION ........................................................................................................................................................... 8 
2.1 Background Information ........................................................................................................................................ 8 
3.  STUDY RATIONALE ....................................................................................................................................................... 9 
4.  STUDY AIM ................................................................................................................................................................... 9 
5. STUDY OBJECTIVES ....................................................................................................................................................... 9 
6. STUDY ENDPOINTS ..................................................................................................................................................... 10 
6.1 Primary Endpoint.................................................................................................................................................. 10 
6.2 Secondary Endpoint ............................................................................................................................................. 10 
7. STUDY DESIGN ............................................................................................................................................................ 10 
8. STUDY POPULATION ................................................................................................................................................... 10 
8.1 Participant Selection and Recruitment ................................................................................................................ 10 
8.2 Study Inclusion Criteria ........................................................................................................................................ 10 
8.3 Exclusion Criteria .................................................................................................................................................. 11 
9. WITHDRAWL FROM STUDY ........................................................................................................................................ 11 
10. INFORMED CONSENT ............................................................................................................................................... 11 
11. METHODOLOGY ........................................................................................................................................................ 12 
Table 1 Schedule of assessments ............................................................................................................................... 13 
12. INTERVENTION ......................................................................................................................................................... 14 
13. ASSESSMENTS AND PROCEDURES ........................................................................................................................... 14 
13.1 Demographics ..................................................................................................................................................... 14 
13.2 Medical History .................................................................................................................................................. 14 
13.3 Social History ...................................................................................................................................................... 15 
13.4 Vasomotor Symptom Assessment ..................................................................................................................... 15 
14. STATISTICAL METHODS ............................................................................................................................................ 17 
14.1 Statistical Analysis .............................................................................................................................................. 17 
14.2 Proposed Sample Size and Calculation .............................................................................................................. 17 
15. STUDY RISKS ............................................................................................................................................................. 18 
16. STUDY BENEFITS ....................................................................................................................................................... 18 
17. ADVERSE EVENT REPORTING ................................................................................................................................... 18 
17.1 Monitoring and Detection ................................................................................................................................. 18 
17.2 Documentation of Adverse Events .................................................................................................................... 19 
17.3 Reporting of Adverse Events .............................................................................................................................. 19 
17.4 AE/SAE Follow-up and Management ................................................................................................................ 19 

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18. ETHICS AND REGULATORY CONSIDERATIONS ......................................................................................................... 20 
19. DATA PROTECTION ................................................................................................................................................... 20 
20. DATA HANDLING ...................................................................................................................................................... 20 
20.1 Data Storage ....................................................................................................................................................... 20 
20.2 Data Processing .................................................................................................................................................. 20 
20.3 Data Confidentiality ........................................................................................................................................... 21 
21. PUBLICATION OF STUDY FINDINGS AND USE OF INFORMATION ........................................................................... 21 
22. INDEMNITY ............................................................................................................................................................... 21 
APPENDIX I: PATIENT INFORMATION LEFLEAT AND INFORMED CONSENT FORM ...................................................... 22 
APPENDIX II: INSTRUCTIONS FOR CARE AND USE OF RESTORE BY SILENTNIGHT COOLING PADS ............................. 29 
(as per manufacturer’s instructions) ............................................................................................................................. 29 
APPENDIX III:  
ELIGIBILITY AND ENROLLMENT FORM ............................................................................................... 31 
APPENDIX IV: BASELINE ASSESSMENT FORM ............................................................................................................... 32 
APPENDIX V:    Hot flash-Related Daily Interference Scale (HFRDIS) ........................................................................... 35 
APPENDIX VI:    HOT FLASH DIARY AND COOL PAD USAGE .......................................................................................... 36 
APPENDIX VII:  END OF INTERVENTION ASSESSMENT .................................................................................................. 37 
APPENDIX VIII Adverse Event Log .................................................................................................................................. 41 
REFERENCES .................................................................................................................................................................... 42 
 
 
 
 
 
 
 
 
 
 
 
 
 

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1. SYNOPSIS 
 
Study Title 
Exploring the Feasibility and Impact of Cooling Mats on Vasomotor Symptoms in 
Patients Receiving Endocrine Treatment: A Pilot Study. COOLVAS 
Background 
Hot flashes and other vasomotor symptoms (VMS) are common and distressing, 
affecting up to 75% of women during peri- and post-menopause. These symptoms 
significantly impair quality of life and increase risks for depression, anxiety, and 
cardiovascular disease. Management is especially challenging in cancer patients, where 
hormone replacement therapy is contraindicated. Women undergoing endocrine 
therapy for breast cancer and men receiving androgen deprivation therapy for prostate 
cancer often report VMS and rely on non-pharmacological interventions. 
Rationale 
VMS are highly prevalent among cancer patients on endocrine therapy and are 
associated with poor treatment adherence, impaired sleep, and psychological stress. 
Cooling gel pads may offer a safe and effective symptom management strategy, but 
evidence supporting their use, particularly in Ireland, is limited. 
Study Aim 
1. Assess the severity of vasomotor symptoms in patients undergoing endocrine 
therapy following a breast or prostate cancer diagnosis. 
2. Evaluate the feasibility and effectiveness of a non-pharmaceutical intervention, 
which uses thermoregulation materials, designed to keep body temperature in a 
comfortable range by reducing heat, through a cooling mat, for managing these 
symptoms. 
Objectives 
1. To identify the prevalence and severity of vasomotor symptoms in patients 
receiving endocrine therapy. 
2. To determine patient tolerance and satisfaction with the use of a cooling pad, as a 
non-pharma logical intervention for symptom management. 
3. To explore any changes in the frequency and severity of vasomotor symptoms 
when using a cooling pad. 
4. To assess the feasibility of incorporating a cooling pad as a routine non-
pharmacological intervention in clinical practice.  
Endpoints 
Primary Endpoint  
To reduce the severity and frequency of vasomotor symptoms. 

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Secondary Endpoint 
1. To evaluate patient satisfaction and tolerability 
2. Assess feasibility of cooling pad use 
3. Assess change in sleep quality 
4. Assess impact on quality of life 
Study Design 
Prospective, single-arm pilot study with 30–40 adult patients with hormone-sensitive 
breast or prostate cancer receiving endocrine therapy. Recruitment at Sligo University 
Hospital Oncology Service. 
Inclusion 
Criteria 
 Adult aged ≥ 18 years 
 Diagnosed with breast or prostate cancer 
 Receiving endocrine therapy cancer treatment 
 Experiencing vasomotor symptoms, such as hot flushes or night sweats. 
Exclusion 
Criteria 
 Prior use of cooling mats for vasomotor symptoms 
 Allergy to Polyvinyl chloride (PVC) 
 Patients who are unable to co-operate with the study protocol 
 Patients who are unable to give informed consent 
Intervention & 
Procedures 
Participants receive two Silentnight® cooling gel pads (pillow and mattress) for 8 
weeks.  
Baseline demographic, medical, and social data will be collected. VMS assessment 
tools include: 
• Hot Flash-Related Daily Interference Scale (HFRDIS) 
• NCI CTCAE v5 
• PRO-CTCAE® Symptom Terms 
• 3-Category Daily Hot Flash Diary 
• Daily cooling pad usage and satisfaction log 
Data Collection 
& Analysis 
Descriptive statistics for demographics and VMS characteristics. Pre-/post-intervention 
comparisons using paired t-tests or Wilcoxon signed-rank tests. Correlation analyses 
(Pearson’s or Spearman’s). IBM SPSS v31 for analysis. 
Risks & Benefits 
Risks: Minimal, potential mild skin irritation or discomfort. 
Benefits: Identification of a safe, non-drug VMS intervention; potential improvement 
in therapy adherence and patient well-being. 

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Ethical 
Considerations 
Ethical approval from Sligo University Hospital. Compliance with GCP and HSE data 
policies. Participants can withdraw anytime. Adverse events monitored and serious 
events reported. 
Data Protection 
& Dissemination 
Data pseudonymised and stored securely for five years. Results may be published or 
presented, with confidentiality maintained. 
 
2.  INTRODUCTION 
2.1 Background Information 
Hot flashes are a common and distressing symptom during perimenopause and post-menopause, affecting 
up to 75% of women. These symptoms, including sudden heat, sweating, and flushing, can last for years and 
significantly impact quality of life by disrupting sleep and mood, and increasing risks of depression, anxiety, 
and cardiovascular disease. 
For women with a history of breast cancer, managing hot flashes is particularly challenging as hormone 
replacement therapy is often contraindicated. Non-pharmacological interventions, such as lifestyle 
modifications, cognitive behavioural therapy, relaxation techniques, mindfulness, physical activity, and 
acupuncture, are crucial alternatives. Men undergoing endocrine therapy for prostate cancer also 
experience hot flashes and rely on similar non-pharmacological strategies for relief. 
This study aims to identify if another non-pharmacological intervention, a cooling mat, can assist individuals 
in managing their hot flash symptoms as a consequence of cancer treatment and thus improve their quality 
of life. This investigation seeks to address a critical gap in the existing evidence base by evaluating a novel 
and emerging supportive care intervention. The findings from this study are intended to contribute to the 
development of evidence-based, patient-centred interventions that are practical, accessible, and suitable 
for integration into routine oncology practice. 
In summary, hot flashes remain a significant unmet need in supportive cancer care for both women and men 
affected by hormonal changes due to cancer therapies. Non-pharmacological interventions, including the 
potential use of cooling mats, are essential, especially when hormonal treatments are not an option, and 
should be tailored to individual needs and preferences. This study addresses a key gap in current research 
by guiding the development of evidence-based, patient-centred supportive care strategies to enhance 
supportive care in oncology practice. 
 

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3.  STUDY RATIONALE 
Patients undergoing endocrine therapy for hormone-sensitive cancers, such as breast and prostate cancer, 
frequently experience vasomotor symptoms (VMS), including hot flushes and night sweats. These symptoms 
are often induced by treatment-related menopause or hormonal suppression and can be distressing, leading 
to: 
 
Reduced quality of life 
 
Disrupted sleep 
 
Decreased medication adherence 
 
Increased psychological burden 
Pharmacologic options for managing these symptoms (e.g., hormone replacement therapy) are often 
contraindicated in this population due to the hormone-sensitive nature of their cancer. Cooling gel pads 
offer a simple, low-risk, and potentially effective non-pharmaceutical approach to manage vasomotor 
symptoms by maintaining thermoregulation during rest or sleep. Preliminary evidence suggests cooling 
surfaces can reduce the intensity and frequency of hot flushes, but there is limited data specific to cancer 
populations, especially in Ireland.  This research seeks to fill a critical gap in the current evidence base and 
inform the development of supportive care interventions that are safe, patient-centred, and practical for 
implementation in real-world oncology settings. 
 
4.  STUDY AIM  
1. Assess the severity of vasomotor symptoms in patients undergoing endocrine therapy following a 
breast or prostate cancer diagnosis. 
2. Evaluate the feasibility and effectiveness of a non-pharmaceutical intervention, which uses 
thermoregulation materials, designed to keep body temperature in a comfortable range by 
reducing heat, through a cooling mat, for managing these symptoms. 
 
5. STUDY OBJECTIVES 
1. To identify the prevalence and severity of vasomotor symptoms in patients receiving endocrine 
therapy. 
2. To determine patient tolerance and satisfaction with the use of a cooling pad, as a non-pharma 
logical intervention for symptom management. 

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3. To explore any changes in the frequency and severity of vasomotor symptoms when using a cooling 
pad. 
4. To assess the feasibility of incorporating a cooling pad as a routine non-pharmacological 
intervention in clinical practice.  
 
6. STUDY ENDPOINTS 
6.1 Primary Endpoint  
To reduce the severity and frequency of vasomotor symptoms. 
6.2 Secondary Endpoint 
1. To evaluate patient satisfaction and tolerability 
2. Assess feasibility of cooling pad use 
3. Assess change in sleep quality 
4. Assess impact on quality of life 
   
7. STUDY DESIGN 
This is a prospective single arm pilot study to assess the feasibility and effectiveness of cooling mats in 
reducing the frequency and severity of vasomotor symptoms. 
 
8. STUDY POPULATION 
Adult patients diagnosed with hormone sensitive breast or prostate cancer receiving endocrine therapy 
and experiencing vasomotor symptoms. 
8.1 Participant Selection and Recruitment 
Purposeful sampling method will be utilised to select patients that meet the eligibility criteria and 
attend the Oncology Service.  Patients will be provided with information about the study and will be 
enrolled following written informed consent. 
 8.2 Study Inclusion Criteria 
 Adult aged ≥ 18 years 
 Diagnosed with breast or prostate cancer 

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 Receiving endocrine therapy cancer treatment 
 Experiencing vasomotor symptoms, such as hot flushes or night sweats. 
8.3 Exclusion Criteria 
 Prior use of cooling mats for vasomotor symptoms 
 Allergy to Polyvinyl chloride (PVC) 
 Patients who are unable to co-operate with the study protocol 
 Patients who are unable to give informed consent 
 
9. WITHDRAWL FROM STUDY 
Participants will be informed of their right to refuse to participate and their right to withdraw from this 
research study 
 
10. INFORMED CONSENT 
Informed consent to take part in the research will be obtained.  Patients will be consented by a member of 
the study team.  This will occur in person when they attend their clinic visit.  Information about the study 
may be provided remotely as follows: 
 Potential participates identified at the hospital clinic will be provided a hard copy of the Patient 
Information Leaflet and Informed Consent Form (PIL/ICF). 
 Potential participants identified from a virtual clinic will receive a hard copy of the PIL/ICF in the 
post. 
 If the patient is willing to consent to the study they will be asked to attend the hospital clinic to sign 
the consent form with the research team member who will also sign the consent form. 
 The completed ICF (signed by the both the participant and the research team member) will be filed 
in the study file which is kept securely in the cancer research office.  One copy will be placed in the 
patient’s medical notes and one copy will be given to the participant for their own records. 
 Participants will be given the opportunity to take their time between receiving the PIL and agreeing 
to participate in the study, this may mean attending to provide consent at a subsequent clinic. 

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11. METHODOLOGY 
All participants will be assessed with regards to their vasomotor symptoms at baseline along with 
demographic data collection.  They will then be provided with two Silentnight© cooling gel pads: 
1. Restore by Silentnight Cooling Gel Pillow Pad. 
2. Restore by Silentnight Body Cooling Gel Mattress Pad. 
Participants will receive written instructions on their use and maintenance, Appendix II.  Participants will use 
the intervention for eight weeks and complete a daily hot flash and cooling pad utilisation diary. At the end 
of the intervention phase, vasomotor symptoms, adherence and satisfaction will be assessed. 
 
 
Schedule of Assessments next page. 
 
 
 
 
 
 
 
 
 
 
 

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Table 1 Schedule of assessments 
 
Time Point 
Baseline 
8 week 
Intervention 
phase 
End of 
Intervention 
(Virtual Visit) 
Procedures 
 
 
 
Screening/Eligibility  
 Informed Consent 
 Screening/Eligibility 
 Enrolment Form 
X 
 
 
Demographics 
 Sex 
 Age 
 Ethnicity 
X 
 
 
Medical History 
 Cancer Diagnosis 
 Menopausal Status 
 Endocrine Therapy 
 BMI 
X 
 
 
Social History 
 Employment Status 
 Smoking Status 
 Alcohol Intake 
 Caffeine Intake 
 Exercise Levels 
 
X 
 
X 
Vasomotor symptom 
management Strategies History 
X 
 
X 
Vasomotor Assessments 
 Hot Flash-Related Daily 
Interference Scale 
(HFRDIS) 
 NCI CTCAE v5  
Hot Flashes  
 NCI CTCAE PROM 
X 
 
X 
Daily Hot Flash Diary 
 
X 
 
Cooling Pad Usage 
 
X 
 
Satisfaction with Cooling Pad 
 
 
X 
Adverse Events 
X 
X 
X 

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12. INTERVENTION 
The intervention being evaluated comprises of Silentnight Restore Cooling Gel Mattress Pad and Silentnight 
Restore Cooling Gel Pillow Pad, a non-pharmacological, non-invasive commercially available cooling aid 
designed to provide localized body cooling and thermal comfort, particularly during sleep. It is intended for 
individuals who experience overheating or night sweats, including those with vasomotor symptoms. 
The mattress pad measures 60 x 90 cm, approximately the width of a standard pillow and long enough to 
cover the upper body area where night sweats typically occur. It is composed of 100% PVC outer material 
with a 100% gel inner core, divided into three gel compartments to help prevent heat dispersion across the 
mattress and maintain localized cooling. The pad has a depth of 5 mm and features a soft and flexible 
structure.  The pillow pad measures 60 x 40cm and is composed the same material as the mattress pad, 
divided into two gel compartments.  
Participants will be instructed to use the cooling pad daily for a period of 8 weeks, placing it either directly 
under their body, on top of the mattress, or beneath the fitted sheet or pillow case, based on personal 
comfort. The pad functions passively by absorbing excess body heat to reduce skin temperature. For 
enhanced cooling on particularly hot nights, participants may optionally place the pad in the refrigerator 
prior to use, although refrigeration is not required for efficacy. 
The pads are wipe-clean only and must not be bleached, tumble dried, or ironed. They can be folded neatly 
for travel or storage and must be kept away from fire. While its primary use is during sleep, participants may 
also use the pad while sitting or reclining, such as on a sofa or during travel. Participants will be provided 
verbal and written instructions of use, as detailed in appendix II.  
 
13. ASSESSMENTS AND PROCEDURES 
13.1 Demographics 
At baseline participants will be asked their sex, age and ethnicity. 
13.2 Medical History 
At baseline, participants will provide information on their cancer diagnosis, menopausal status (for 
females), endocrine treatment history, height, and weight (for BMI calculation). 

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13.3 Social History 
Participants social history, including employment status, smoking, alcohol and caffeine intake, and 
exercise levels, will be collected at baseline and at the end of the intervention phase. 
13.4 Vasomotor Symptom Assessment 
Multiple tools will be used to assess vasomotor symptoms:  
 Hot flash-Related Daily Interference Scale (HFRDIS) 
The Hot Flash-Related Daily Interference Scale (HFRDIS) is a validated, self-report questionnaire used 
to measure how much hot flashes interfere with various aspects of daily life, particularly those 
experiencing menopause or undergoing treatments that cause vasomotor symptoms. It consists of 
10 items that assess the impact of hot flashes on areas such as work, social and leisure activities, 
sleep, mood, concentration, sexuality, and overall quality of life. Each item is rated on a scale from 0 
(not at all interfering) to 10 (extremely interfering), with higher scores indicating greater disruption. 
The total score provides a summary measure of overall interference. The HFRDIS is widely used in 
clinical and research settings to evaluate the burden of hot flashes and assess the effectiveness of 
interventions aimed at alleviating them. The HFRDIS demonstrates strong psychometric properties, 
including high internal consistency (Cronbach’s alpha > 0.90) and established construct and 
convergent validity with other measures of quality of life and symptom burden. It can be completed 
in approximately five minutes.  Permission was sought from Dr Janet S. Carpenter, author of the 
HFRDIS and a leading expert on menopause symptoms, and granted on 24th September 2024 for use 
in this study. 
 NCI CTCAE v5 Hot Flashes  
The NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 includes a 
standardized grading system for assessing hot flashes as an adverse event in clinical trials. This tool, 
developed by the National Cancer Institute, is used to classify the severity of hot flashes based on 
their impact on daily functioning. 
In CTCAE v5.0, hot flashes are defined as sudden, transient episodes of flushing, typically associated 
with perspiration. The grading is as follows: 
o Grade 1 represents mild symptoms that do not interfere with function. 
o Grade 2 indicates moderate symptoms that limit instrumental activities of daily living (e.g., 
preparing meals or using the telephone). 

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o Grade 3 reflects severe symptoms that limit self-care activities of daily living (e.g., bathing or 
dressing). 
This standardized grading system allows for consistent reporting and monitoring of treatment-
related hot flashes across studies and supports the evaluation of intervention safety and tolerability. 
 PRO-CTCAE® Symptom terms: Hot flashes and Insomnia  
The Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events 
(PRO-CTCAE®) includes symptom terms such as insomnia and hot flashes, allowing patients to directly 
report the frequency, severity, and interference of these symptoms in clinical trials. For insomnia, 
patients typically rate how often they experienced difficulty sleeping, how severe it was, and how 
much it interfered with daily activities. For hot flashes, patients report on the frequency and severity 
of episodes, as well as their impact on daily life. This tool complements clinician-reported CTCAE by 
capturing the patient’s subjective experience, enhancing the accuracy and sensitivity of symptom 
monitoring in cancer and symptom management research. 
 
 3-Category Daily Hot Flash Dairy adapted from Guttuso et al. (2012) 
The three-category hot flash diary is a standardized patient-reported tool designed to capture the 
frequency and severity of hot flashes over time. As reviewed by Guttuso et al. (2012), this diary 
categorizes hot flashes into mild, moderate, or severe episodes, allowing participants to record the 
number and intensity of occurrences throughout the day. 
o Mild hot flashes are those that are noticeable but do not cause discomfort or disruption. 
o Moderate hot flashes may cause discomfort and possibly some interference with activities. 
o Severe hot flashes are intensely uncomfortable and significantly disrupt daily activities or 
sleep. 
Participants will be asked to complete the diary daily, making it a useful tool for tracking symptom 
patterns and evaluating the effectiveness of therapeutic interventions. The three-category diary is 
valued for its simplicity, feasibility, and sensitivity in clinical trials and observational studies involving 
vasomotor symptom management. It helps quantify symptom burden over time, offering objective 
data to complement subjective quality-of-life measures. 
 Vasomotor symptom management Strategies History 
Participants will be asked about history what vasomotor symptoms management strategies they 
have used in the past. 
 

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 Cooling Pad Utilization and Satisfaction 
Participants will record daily cooling pad usage, and satisfaction data will be collected at the end of 
the intervention phase. 
 
14. STATISTICAL METHODS 
14.1 Statistical Analysis 
Data analysis will include descriptive statistics will be used to characterise the sample through 
measurement of central tendency, variability and frequency distribution.  Comparative analysis (paired 
t-test or Wilcoxon signed-rank test depending on distribution of data) will compare the pre/post 
intervention differences on the dependent variables.  Correlation analysis will be used to assess 
relationship between the variables (Pearson’s correlation or Spearman’s rank correlation depending on 
distribution of data). 
Data analysis will be done by the research team using IBM SPSS version 31.  
14.2 Proposed Sample Size and Calculation 
The study team aims to prospectively enrol approximately 40 patients to this study. 
Based on last year’s combined data for breast and prostate cancer patients at the hospital, 130 
individuals were diagnosed and referred for treatment, with approximately 65% of breast cancer patients 
and all prostate cancer patients receiving endocrine therapy. As a result, the target population size is 95, 
requiring a representative sample of 77 patients (95% confidence level, 5% confidence interval). 
However, due to constraints in human resources, time, and financial securement to allow the purchase 
of the necessary cooling mats, a pilot study is proposed. No previous Irish study available to guide sample 
size. 
A literature review indicates that pilot studies typically require 10–30 participants per group, with at least 
30 recommended for estimating effect sizes. Therefore, a sample size of 30–40 participants has been 
selected for this single-arm pilot study, considering the inclusion of two distinct populations (breast and 
prostate cancer patients). As this is a pilot study, it is not intended to be representative. 
 

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15. STUDY RISKS 
The cooling mat is a non-pharmacological, passive strategy. Therefore, risks, if any are expected to be 
minimal. No serious adverse events are expected from the use of the cooling mat based on its intended 
design and current evidence. 
 However potential anticipated adverse events may include and are not limited to: 
 
Mild skin irritation or rash 
 
Discomfort during sleep or difficulty adjusting to the device 
 
Allergic reaction to materials (rare) 
 
16. STUDY BENEFITS 
The potential identification of a non-pharmaceutical intervention for vasomotor symptoms in patients 
receiving endocrine therapy. 
 
17. ADVERSE EVENT REPORTING 
An Adverse Event (AE) is any untoward medical occurrence in a participant that arises during the course of 
the study, regardless of whether it is considered related to the study intervention (cooling pad). 
A Serious Adverse Event (SAE) is defined as any AE that: 
 
Results in death 
 
Is life-threatening 
 
Requires inpatient hospitalisation or prolongation of existing hospitalisation 
 
Results in persistent or significant disability or incapacity 
 
Is a congenital anomaly/birth defect 
 
Is deemed medically significant by the investigator Adverse Events (AE) refers to any untoward 
event or medical occurrence that may not have a causal relationship with the treatment.  
 
17.1 Monitoring and Detection 
Participants will be provided with contact information for the study team and instructed to report any 
symptoms or concerns. Study staff will proactively inquire about potential adverse effects during 

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scheduled check-ins.  Participants will be monitored through routine clinical care and follow-up 
appointments. 
17.2 Documentation of Adverse Events 
All adverse events must be documented in the patient’s medical records and recorded in the study 
Adverse Events Log, Appendix VIII, to include:  
 
Date and time of event onset 
 
Description of the event 
 
Severity (mild, moderate, severe) 
 
Assessment of relatedness to the study intervention (definitely, probably, possibly, unlikely, or 
unrelated) 
 
Action taken (e.g., discontinuation of mat, medical treatment) 
 
Outcome and resolution date 
17.3 Reporting of Adverse Events 
 
Non-serious AEs: 
 
Logged in patient medical records and AE logs 
 
Reviewed during regular team meetings 
 
Reported in study summary at conclusion 
 
Serious Adverse Events 
 
Must be reported to the Principal Investigator and patients medical consultant within 24 hours of 
awareness. 
 
Principal Investigator reports to the Research Ethics Committee (REC) within 7 calendar days of 
awareness (for unexpected and related SAEs) 
 
Documentation medical records and AE log. 
 
17.4 AE/SAE Follow-up and Management 
All AEs will be followed until: 
 
The event resolves 

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 
The participant returns to baseline health status 
 
A final outcome is established 
If any participant discontinues use of the cooling mat due to an AE, the reason and outcomes must be 
fully documented. 
 
18. ETHICS AND REGULATORY CONSIDERATIONS 
Ethics approval has been obtained for this study from the ethics committee governing Sligo University 
Hospital.  All study procedures will be conducted in line with Good Clinical Practice Guidelines. 
 
19. DATA PROTECTION 
Explicit consent will be sought from participants for the processing of their data.  
Sligo University Hospital, HSE is both the data controller and data processor for this study.  
 
20. DATA HANDLING 
20.1 Data Storage 
Data will be retained for a period up to 5 years post completion of study and destroyed as per HSE 
policy. 
20.2 Data Processing 
All data collected is for the purpose of achieving the objective of this research study.  The data will not 
be processed in any way that will cause damage or distress to the participant. 
Once explicit consent has been obtained from participants their data will be pseudonymised by 
assigning a unique identifier to their data.  Only members of the research team will have access to the 
identifier key which will be locked in restricted office within Sligo University Hospital. 
All study documents and participant data will be stored in a locked and restricted office within Sligo 
University Hospital.  Only study team members will have access to the data.  Data analysis will be 
completed on a HSE computer that is password protected, encrypted and cyber secure per the HSE IT 
security policy.  

COOLVAS PROTOCOL V1.0 16 July 2025 
 
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20.3 Data Confidentiality 
All information regarding the study data or results supplied to the investigator is privileged and 
confidential information.  All research team members who have access to the data are bound to 
maintain confidentiality in line with their employment contract and professional conduct per their 
regulatory body. 
 
21. PUBLICATION OF STUDY FINDINGS AND USE OF INFORMATION  
Data associated with this study may be used in the context of scientific research and publications or 
educational material.  No participant will be identifiable from the data presented. 
 
22. INDEMNITY 
This study is registered with the Clinical Research Development Office and CIS cover obtained where applicable. 
  
 
 
 
 
 
 
 
 
 
 
 
 

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APPENDIX I: PATIENT INFORMATION LEFLEAT AND INFORMED CONSENT FORM 
 
Patient Information Leaflet 
 
 
Study title: Exploring the Feasibility and Impact of Cooling Mats on Vasomotor Symptoms in 
Patients Receiving Endocrine Treatment: A Pilot Study 
 
 
Principal investigator’s name:   Breege Farrelly 
 
Principal investigator’s title:                                         Advanced Nurse Practitioner Oncology                                            
Telephone number of principal investigator:  
0877918160 
 
 
Co-investigator’s name: 
Moira Maxwell 
 
Co-investigator’s title: Research Clinical Nurse Manager II  
 
Co--investigator’s name: 
Olivia Grady 
 
Co-investigator’s title: Clinical Nurse Specialist  
 
Co--investigator’s name: 
Mary O’Brien 
 
Co-investigator’s title: Staff Nurse  
 
Data Controller’s/joint Controller’s Identity: Breege Farrelly 
Data Controller’s/joint Controller’s Contact Details: 0877918160 
Data Protection Officer’s Identity:  Liam Quirke 
Data Protection Officer’s Contact Details: 
Email: ddpo.west@hse.ie 

COOLVAS PROTOCOL V1.0 16 July 2025 
 
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Introduction 
You are being invited to take part in a research study to be carried out at Sligo University Hospital by Principal 
Investigator Breege Farrelly and nurse colleagues in oncology department, with the full endorsement of both 
medical oncology consultants, Dr Michael Martin and Dr Lore Komanyane. 
Before you decide whether or not you wish to take part, you should read the information provided below 
carefully and, if you wish, discuss it with your family, friends or doctor.  Take time to ask questions – don’t 
feel rushed and don’t feel under pressure to make a quick decision. 
You should clearly understand the risks and benefits of taking part in this study so that you can make a 
decision that is right for you. This process is known as ‘Informed Consent’.  
You don't have to take part in this study. If you decide not to take part it won’t affect your future medical 
care. 
You can change your mind about taking part in the study any time you like.  Even if the study has started, 
you can still opt out.  You don't have to give us a reason.  If you do opt out, rest assured it won't affect the 
quality of treatment you get in the future. 
 
Why is this study being done? 
This research study will investigate whether using a non-drug option, like a cooling mat, made of 
temperature-regulating materials, can help relieve the discomfort of hot flushes and/or night sweats for 
people receiving hormone treatment following a cancer diagnosis.  
Cooling mats are made from specialised material designed to keep body temperature in a comfortable range 
by reducing heat.  Previous research has shown these materials can be helpful for managing hot flushes 
during menopause, and we are investigating if the same benefits apply to cancer patients. 
Ultimately we hope this information will offer an alternative, non-drug option for managing these symptoms, 
providing cancer patients with additional approach to improve their quality of life. 
 
Who is organising and funding this study? 
The study is being run by nurses in the oncology department, who are employed at Sligo University Hospital. 
The pharmaceutical company Novartis is providing some funding for this study.  The majority of the funds 
will be allocated to purchasing cooling mats, while the remaining funds will be used for a statistical analysis 
package, posters, and other necessary materials. 
There is no financial gain for any of the research team.  This is solely being done to improve symptom 
management for patients. 
 
Why am I being asked to take part? 
You are invited to participate in this study because you have are experiencing hot flushes and/or night sweats 
and are prescribed endocrine treatment after a cancer diagnosis. 

COOLVAS PROTOCOL V1.0 16 July 2025 
 
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How will the study be carried out? 
We plan to commence the study in early 2025 at Sligo University Hospital for a 3-6 month a period. We aim 
to recruit 40 patients with a breast or prostate cancer diagnosis who report hot flushes interfering with their 
quality of life.  
We will provide the cooling mat, to help manage your hot flushes and you will also be asked to complete 
questionnaires and a hot flush diary. 
 
What will happen to me if I agree to take part? 
Following your consent, you will be asked to complete a daily questionnaire/scale for a short period to 
ascertain the impact of the hot flushes on your quality of life prior to an intervention. This should take no 
longer than 5 minutes each day. Once this information is completed, a cooling mat will be provided to you, 
with instructions on its use and care. You will be asked to complete a daily questionnaire which again should 
take no longer than 5 minutes daily. On completion of 8 weeks of use of the cooling mat, you will be asked 
to reassess if a benefit has been experienced as a result of the intervention. 
 
What are the benefits? 
As part of this study, you will be provided with a cooling mat to use. We hope that its use will help reduce 
the severity of your hot flushes. The results of this study may benefit other cancer patients who experience 
hot flushes related to cancer treatments. 
 
What are the risks? 
We envisage your participation in this study carrying minimal risk. No serious adverse events are expected 
from the use of the cooling mat based on its intended design and current evidence. 
 
However potential adverse events may include and are not limited to: 
 
Mild skin irritation or rash  
 
Discomfort during sleep or difficulty adjusting to the device 
 
Allergic reaction to materials (rare) 
 Your oncology team and study team are available to discuss any concerns. 
 
What if something goes wrong when I’m taking part in this study? 
If any issue arises during the course of your participation or if you wish to make a complaint, please contact 
your oncology team or a member of the study team. 
If you wish to make a formal complaint please contact: 

COOLVAS PROTOCOL V1.0 16 July 2025 
 
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Patient Advice Liaison Services (PALS) Co-Ordinator 
Saolta University Healthcare Group  
Sligo University Hospital 
Email: pals.suh@hse.ie 
 
Will it cost me anything to take part? 
No. It will not cost you anything to take part in this study.  The cooling mat will be provided to you for the 
study. 
 
Is the study confidential? 
Yes.  The information collected as part of the study will remain confidential. A unique study ID number will 
be assigned to each participant.  This number is linked to the patient identifying information (a process called 
pseudo anonymization).  The information collected for the study will be stored in a secure location in the 
Hospital by the Principle Investigator. 
Research team members who have access to the data are bound to maintain confidentiality in line with their 
employment contract and will have undertaken GDPR training. Study data will be maintained confidentially 
in a dedicated database in a secure location within the hospital for 5 years. It will then be destroyed in line 
with HSE practice. 
The findings will be published in a nurse journal and displayed at local and national professional conferences. 
No identifiable information will be published. 
 
Data Protection 
We will be using your personal information in our research to help us gain a greater understanding of a non-
drug intervention to manage hot flushes related to cancer treatments for legitimate interests and for 
scientific research purposes.  Researchers involved in this study will have access to the data.  All research 
staff are bound to maintain confidentiality in line with their employment contract and will have undertaken 
training in data protection law and practice. If any data breach occurs during this study, appropriate 
measures will be taken.  You will be informed and further processes to mitigate the risk of data breach will 
be reviewed and implemented. 
You have the right to withdraw consent to your participation and to your data being used in this study.  
Please inform your oncology nurse or the principal investigator.  This will not affect your care or treatment 
plan. 
Under data protection legislation, it is important to know that as a participant in the study, you have a right 
to lodge a complaint with the Data Protection Commissioner. 
You have the right to request access to your data and receive a copy of it. 
You have the right to restrict of object to processing. 

COOLVAS PROTOCOL V1.0 16 July 2025 
 
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You have the right to have any inaccurate information about you corrected or deleted, unless your request 
would make it impossible or make it very difficult to conduct the research. 
You have the right to have your personal data deleted, unless the timing of the deletion would be impossible 
i.e. just before publication. 
You have the right to data portability, meaning you have a right to move your data from one controller to 
another in a readable format. 
Please be assured there is no automated decision making or patient profiling in this study.  Data will be used 
for the reasons stated above. 
All study data will remain in Ireland at Sligo University Hospital. 
If you have any questions about data privacy and data protection, please contact the Data Protection 
Officer for the hospital by phone: 091 524222, or email: ddpo.west@hse.ie  
 
Consent to Future Uses 
We would like to retain the data for up to five years for the possible future research by the current researcher 
or colleagues.  Any such research will remain in keeping with recognised ethical standards for scientific 
research. 
 
Where can I get further information? 
If you have any further questions about the study or if you want to opt out of the study, you can rest assure 
it won't affect the quality of treatment you get in the future.   
If you need any further information now or at any time in the future, please contact:  
Name: Breege Farrelly, ANP Oncology 
Address Sligo University Hospital, Rathquarter, F91 H684  
Phone No 0877918160 
 
Name: Moira Maxwell, Research Clinical Nurse Manager II 
Address Sligo University Hospital, Rathquarter, F91 H684  
Phone No 0874526654 
 
 
 
 
 

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PATIENT CONSENT FORM 
 
Study title: Exploring the Feasibility and Impact of Cooling Mats on Vasomotor Symptoms in 
Patients Receiving Endocrine Treatment: A Pilot Study 
 
I have read and understood the Information Leaflet about this research 
project.  The information has been fully explained to me and I have been 
able to ask questions, all of which have been answered to my satisfaction. 
Yes  
No  
I understand that I don’t have to take part in this study and that I can opt 
out at any time.  I understand that I don’t have to give a reason for opting 
out and I understand that opting out won’t affect my future medical care. 
Yes  
No  
I am aware of the potential risks, benefits and alternatives of this research 
study. 
Yes  
No  
I give permission for researchers to look at my medical records to get 
information.  I have been assured that information about me will be kept 
private and confidential. 
Yes  
No  
I have been given a copy of the Information Leaflet and this completed 
consent form for my records. 
Yes  
No  
I consent to take part in this research study having been fully informed of 
the risks, benefits and alternatives. 
Yes  
No  
I give informed explicit consent to have my data processed as part of this 
research study.  
Yes  
No  
I consent to be contacted by researchers as part of this research study. 
Yes  
No  
 
 
FUTURE CONTACT  [please choose one or more as you see fit] 
 
 
I consent to be re-contacted by researchers about possible future research 
related to the current study for which I may be eligible. 
Yes  
No  
 
STORAGE AND FUTURE USE OF INFORMATION    
RETENTION OF RESEARCH MATERIAL IN THE FUTURE  
I give permission for material/data to be stored for possible future research 
related to the current study without further consent being required but only if 
the research is approved by a Research Ethics Committee. 
Yes  
No  

COOLVAS PROTOCOL V1.0 16 July 2025 
 
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I give permission for material/data to be stored for possible future research 
unrelated to the current study without further consent being required but only if 
the research is approved by a Research Ethics Committee. 
Yes  
No  
 
 
Patient Name (Block Capitals) 
 
Patient Signature 
 
 
Date 
 
--------------------------------------------                  ------------------------------------                 -------- 
 
Translator Name (Block Capitals)                   Translator Signature                             Date 
 
---------------------------------------------        
--------------------------------------     
-------- 
 
Legal Representative/Guardian Name   
Legal Representative/Guardian Signature 
 
Date 
 
---------------------------------------------------         --------------------------------------------------------      
-------- 
 
 
To be completed by the Principal Investigator or nominee.  
 
I, the undersigned, have taken the time to fully explain to the above patient the nature and purpose of this 
study in a way that they could understand. I have explained the risks involved as well as the possible 
benefits. I have invited them to ask questions on any aspect of the study that concerned them. 
 
Name  (Block Capitals) 
|  Qualifications 
| Signature 
| Date 
 
 
3 copies to be made: 1 for patient, 1 for PI and 1 for hospital records. 
 
 

COOLVAS PROTOCOL V1.0 16 July 2025 
 
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APPENDIX II: INSTRUCTIONS FOR CARE AND USE OF RESTORE BY SILENTNIGHT COOLING PADS 
(as per manufacturer’s instructions) 
 
As part of this study, you will be using the Silentnight Cooling Gel Mattress Pad and Silentnight Restore 
Cooling Gel Pillow Pad at home each night to help manage symptoms such as hot flashes and night sweats. 
Please follow the instructions below to ensure safe and consistent use of the cooling pad throughout the 
study period. 
Cooling Pads Composition Materials: 
o Cover: 100% PVC 
o Filling: 100% Gel 
How to Use the Cooling Pad: 
1. Placement Mattress Pad: 
o Place the cooling pad on your mattress in the area where your upper body typically rests. 
o You can use the pad on top of your fitted sheet or underneath it, depending on what feels 
most comfortable to you. 
o Ensure the pad lies flat and does not bunch or fold while in use. 
Placement Pillow Pad: 
o Fits across a standard pillow 
o Insert the pad inside your pillowcase, on top of your usual pillow, or place it directly on top. 
2. Nightly Use: 
o Use the cooling pad during your normal sleep schedule. 
o If you wake up during the night and need to reposition the pad, do so to maintain comfort. 
o If desired, you may chill the pad in the refrigerator for extra cooling, especially on warmer 
nights. Do not place the pad in a freezer. 
 
3. Other Settings (Optional): 
o You may also use the pad while sitting or resting during the day (e.g., on a sofa). 
Care Instructions: 
 
The pad is wipe-clean only. Use a damp cloth and mild soap if needed. 
 
Do not machine wash, tumble dry, or iron the pad. 
 
Store the pad flat or loosely folded in a cool, dry place when not in use. 
 
Keep away from fire. 
 
Check the pad daily for any damage or leaks. 
 
During the Study Period: 
 
Complete symptom diary daily to track your experience, including whether you used the pad. 

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If You Experience Any Problems: 
 
If the pad causes discomfort, skin irritation, or disrupts your sleep, stop using it and inform the 
research team immediately. 
 
If the pad is damaged, discontinue use and notify the research team for a replacement. 
Research Team Contact Numbers: 
📞  0877918160 or 0874526654 (office hours only) 
Clinical Nurse Specialist Contact Numbers: 
 📞 Breast Care Nurse: 0873331729 or Oncology CNS: 0877589022 (office hours only)  
Out of Office hours Contact Number: 
📞0719174399 (haematology/oncology inpatient ward) 
In an emergency, please attend your local emergency department or GP. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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APPENDIX III:  ELIGIBILITY AND ENROLLMENT FORM 
COOLVAS STUDY PARTIICIPANT ELIGIBILITY AND ENROLLMENT FORM 
 
Section 1.  Eligibility 
 
 
 
Inclusion Criteria 
 
Yes 
 
No 
 
Adult aged ≥ 18 years 
 
 
 
Diagnosed with breast or prostate Cancer 
 
 
 
Receiving endocrine therapy cancer treatment 
 
 
 
Experiencing vasomotor symptoms, such as hot flushes or night sweats. 
 
 
 
 
Exclusion Criteria 
 
 
Yes 
 
No 
Prior use of cooling mats for vasomotor symptoms 
 
 
Patients who are unable to co-operate with the study protocol 
 
 
Patients who are unable to give informed consent 
 
 
Allergy to Polyvinyl chloride (PVC) 
 
 
Section 2. Enrolment 
 
 
Date of Informed Consent (mm/dd/yyyy) 
 
 
 
___ /___ / ______ 
Participant Enrolment Number 
 
 
 
____ ____ ____ 
 
 
Completed by: 
 
____________________________                 __________________                        _______________ 
Print Name 
 
 
 
        Sign 
 
 
 
 Date  
 

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APPENDIX IV: BASELINE ASSESSMENT FORM 
COOLVAS STUDY 
BASELINE ASSESSMENT QUESTIONNAIRE Version 1 
Study Number:___________  
 
 
 
      
 
 
 
 
Date:____________ 
Section 1. Demographics 
Please tick your answer in the box or write in 
the space provided 
1. What is your gender? 
 
Male □          
Female □ 
2. What is your age?     
                        
______ years 
3.  What is your ethnicity?  
 
 
Section 2. Medical History                                                                     Please tick your answer in the box or write in  
                                                                                                                     the space provided 
1. What is your cancer diagnosis? 
Breast □     
Prostate □ 
2. What is your menopausal status (female only question)? 
Pre-menopausal  □ 
Peri-menopausal  □ 
Post-menopausal  □ 
3. What endocrine/hormone therapy are you taking? 
 
 
4. How long have you been taking endocrine/hormone 
therapy? 
 
5. What is your weight in kg? 
6. What is your height in cm? 
_______ kg 
_______ cm 
 
BMI:   
Section 3. Social History 
Please tick your answer in the box or write in          
the space provided 
1. What is your employment status? 
 
Stay at home parent/carer ☐ 
Unemployed ☐ 
Self-Employed ☐ 
Full-time Employment ☐ 
Part-time Employment ☐  
2. Do you currently smoke tobacco products (e.g., cigarettes,  
cigars, pipe) or vape? 
 
 
 
3(a) If Yes to smoking tobacco products, how many cigarettes 
(or equivalents) do you have per day? 
 
 
3(b) If Yes to vaping, what is 
-the frequency of use  
-duration of use  
-time spent vaping per day   
-amount of e-liquid consumed 
Smoke:                           Vape: 
Yes ☐                         Yes ☐ 
No ☐                          No ☐ 
 Former smoker/vaper ☐  
 
1–10  ☐ 
11–20 ☐  
More than 21  ☐ 
 
Days per week/month ________________ 
Number of puffs per session _____________ 
Minutes/Hours ______________ 
Millilitres used per week/month _____________ 
4. Do you drink alcohol? 
Yes ☐            No ☐  

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5. If Yes, how often do you drink alcohol? 
 
 
 
 
6. On a typical drinking day, how many standard drinks do you 
consume? 
 
 
 
Rarely (less than once a month) ☐ 
Occasionally (1–4 times a month) ☐   
Weekly (1–3 times a week) ☐ 
Frequently (4 or more times a week) ☐   
 
1-2 ☐  
3-4 ☐   
5-6 ☐  
More than 6 ☐ 
 
7. Do you regularly consume caffeine (e.g., coffee, tea, soda,  
energy drinks)? 
 
8. On average, how many caffeinated beverages do you 
consume per day? 
 
 
 
 
 
9. What types of caffeinated products do you use? (Select all 
that apply) 
 
 
Yes ☐  
No ☐  
 
0 ☐  
1 ☐  
2 ☐  
3-4 ☐  
More than 4 ☐  
 
Coffee ☐ 
Tea ☐  
Energy drinks ☐ 
Cola or soft drinks ☐ 
Caffeine tablets/supplements ☐ 
Other: _______________ 
 
10. How often do you engage in physical activity (e.g., walking,  
cycling, gym, sports)? 
 
 
 
 
11. What type of physical activity do you usually perform? 
(Select all that apply) 
 
 
 
 
 
12. On average, how many minutes do you exercise per 
session? 
 
Rarely or never ☐ 
1–2 times per week ☐ 
3–4 times per week ☐ 
5 or more times per week ☐ 
 
Walking ☐ 
Jogging or running ☐ 
Strength training ☐ 
Yoga/Pilates ☐ 
Sports (e.g., tennis, football) ☐ 
Other: _______________ 
 
Less than 15 minutes ☐ 
15–30 minutes ☐  
31–60 minutes ☐ 
More than 60 minutes ☐ 
 
 
 
 
 
 
 

COOLVAS PROTOCOL V1.0 16 July 2025 
 
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Section 6. Vasomotor Assessment 
 
NCI CTCAE v5 symptom term: Hot Flash 
Definition: A disorder characterised by an uncomfortable and temporary sensation of intense body warmth, flushing, 
sometimes accompanied by sweating upon cooling 
 
◯ Grade 1 
Mild symptoms; intervention not 
indicated 
◯ Grade 2 
Moderate symptoms; limiting 
instrumental ADL 
◯ Grade 3 
Severe symptoms; limiting self-care 
ADL 
 
PRO-CTCAE® Symptom Term: Hot flashes 
 
a. In the last 7 days, how OFTEN did you have HOT FLASHES/FLUSHES? 
◯ Never 
◯ Rarely 
◯ Occasionally 
◯ Frequently 
◯ Almost constantly 
 
 
b. In the last 7 days, what was the SEVERITY of your HOT FLASHES/FLUSHES at their WORST? 
◯ None 
◯ Mild 
◯ Moderate 
◯ Severe 
◯ Very severe 
 
 
PRO-CTCAE® Symptom Term: Insomnia 
 
a. In the last 7 days, what was the SEVERITY of your INSOMNIA (INCLUDING DIFFICULTY FALLING ASLEEP, STAYING ASLEEP, OR 
WAKING UP EARLY) at its WORST? 
◯ Never 
◯ Mild 
◯ Moderate 
◯ Severe 
◯ Very Severe 
 
 
b. In the last 7 days, how much did INSOMNIA (INCLUDING DIFFICULTY FALLING ASLEEP, STAYING ASLEEP, OR WAKING UP 
EARLY) INTERFERE with your usual daily activities?? 
◯ Not at all 
◯ A little bit 
◯ Somewhat 
◯ Quite a bit 
◯ Very much 
 
 
Section 7. Vasomotor Management Strategies 
Have you used any treatment or therapys to help control your vasomotor symptoms strategies? 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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APPENDIX V:    Hot flash-Related Daily Interference Scale (HFRDIS) 
 
 
 
 
 
 
 
 
 

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APPENDIX VI:    HOT FLASH DIARY AND COOL PAD USAGE 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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APPENDIX VII:  END OF INTERVENTION ASSESSMENT 
COOLVAS STUDY 
END OF TREATMENT ASSESSMENT QUESTIONNAIRE version 1 
Study Number:___________  
 
 
 
      
 
 
 
 
Date:____________ 
Section 1. Social History 
Please tick your answer in the box or write in          
the space provided 
1. What is your employment status? 
 
Stay at home parent/carer ☐ 
Unemployed □ 
Self-Employed □ 
Full-time Employment □ 
Part-time Employment □ 
2. Do you currently smoke tobacco products (e.g., cigarettes,  
cigars, pipe) or vape? 
 
 
 
3(a) If Yes to smoking tobacco products, how many cigarettes 
(or equivalents) do you have per day? 
 
 
3(b) If Yes to vaping, what is 
-the frequency of use  
-duration of use  
-time spent vaping per day   
-amount of e-liquid consumed 
Smoke:                           Vape: 
Yes ☐                         Yes ☐ 
No ☐                          No ☐ 
 Former smoker/vaper ☐  
 
1–10  ☐ 
11–20 ☐  
More than 21  ☐ 
 
Days per week/month ________________ 
Number of puffs per session _____________ 
Minutes/Hours ______________ 
Millilitres used per week/month _____________ 
4. Do you drink alcohol? 
 
5. If Yes, how often do you drink alcohol? 
 
 
 
 
6. On a typical drinking day, how many standard drinks do you 
consume? 
 
 
Yes ☐    No ☐  
 
Rarely (less than once a month) ☐ 
Occasionally (1–4 times a month) ☐   
Weekly (1–3 times a week) ☐ 
Frequently (4 or more times a week) ☐   
 
1-2 ☐  
3-4 ☐  
5-6 ☐  
More than 6 ☐ 
 
7. Do you regularly consume caffeine (e.g., coffee, tea, soda,  
energy drinks)? 
 
8. On average, how many caffeinated beverages do you 
consume per day? 
 
 
 
 
 
Yes ☐  
No ☐  
 
0 ☐  
1 ☐  
2 ☐  
3-4 ☐  
More than 4 ☐  
 
Coffee ☐ 
Tea ☐  

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9. What types of caffeinated products do you use? (Select all 
that apply) 
 
 
Energy drinks ☐ 
Cola or soft drinks ☐ 
Caffeine tablets/supplements ☐ 
Other: _______________ 
 
10. How often do you engage in physical activity (e.g., walking,  
cycling, gym, sports)? 
 
 
 
11. What type of physical activity do you usually perform? 
(Select all that apply) 
 
 
 
 
 
 
12. On average, how many minutes do you exercise per 
session? 
 
Rarely or never ☐ 
1–2 times per week ☐ 
3–4 times per week ☐ 
5 or more times per week ☐ 
 
Walking ☐ 
Jogging or running ☐ 
Strength training ☐ 
Yoga/Pilates ☐ 
Sports (e.g., tennis, football) ☐ 
Other: _______________ 
 
Less than 15 minutes ☐ 
15–30 minutes ☐  
31–60 minutes ☐ 
More than 60 minutes ☐ 
 
Section 2. Vasomotor Assessment 
 
NCI CTCAE v5 symptom term: Hot Flash 
Definition: A disorder characterised by an uncomfortable and temporary sensation of intense body warmth, flushing, 
sometimes accompanied by sweating upon cooling 
 
◯ Grade 1 
Mild symptoms; intervention not 
indicated 
◯ Grade 2 
Moderate symptoms; limiting 
instrumental ADL 
◯ Grade 3 
Severe symptoms; limiting self-care 
ADL 
 
PRO-CTCAE® Symptom Term: Hot flashes 
 
a. In the last 7 days, how OFTEN did you have HOT FLASHES/FLUSHES? 
◯ Never 
◯ Rarely 
◯ Occasionally 
◯ Frequently 
◯ Almost constantly 
 
 
b. In the last 7 days, what was the SEVERITY of your HOT FLASHES/FLUSHES at their WORST? 
◯ None 
◯ Mild 
◯ Moderate 
◯ Severe 
◯ Very severe 
 
 
 
PRO-CTCAE® Symptom Term: Insomnia 
 
a. In the last 7 days, what was the SEVERITY of your INSOMNIA (INCLUDING DIFFICULTY FALLING ASLEEP, STAYING ASLEEP, OR 
WAKING UP EARLY) at its WORST? 
◯ Never 
◯ Mild 
◯ Moderate 
◯ Severe 
◯ Very Severe 
 
 
b. In the last 7 days, how much did INSOMNIA (INCLUDING DIFFICULTY FALLING ASLEEP, STAYING ASLEEP, OR WAKING UP 
EARLY) INTERFERE with your usual daily activities?? 
◯ Not at all 
◯ A little bit 
◯ Somewhat 
◯ Quite a bit 
◯ Very much 
 
 

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Section 3. Cooling Pad Experience  
Please tick your answer in the box or write in     
the space provided 
1. How long have you used the cooling pad? 
 
 
 
 
 
 
 
Less than 1 week ☐  
1–2 weeks ☐  
2–4 weeks ☐   
4-5 weeks ☐  
5-6 weeks ☐ 
6-7 weeks ☐   
8 weeks ☐ 
 
2. How easy was it to use the cooling pad? 
 
 
 
 
 
Very difficult ☐  
Difficult ☐ 
Neutral ☐ 
Easy ☐ 
Very easy ☐ 
 
3. Did you experience any discomfort while using the 
cooling pad? 
 
 
Yes ☐ (please describe): 
 
No ☐ 
 
4. How effective was the cooling pad in relieving your 
symptoms? 
 
 
 
 
Not effective ☐ 
Slightly effective ☐ 
Moderately effective ☐ 
Very effective ☐ 
Extremely effective ☐ 
 
5. How quickly did you notice symptom relief after using 
the pad? 
 
 
 
 
Immediately ☐ 
Within 15 minutes ☐ 
15–30 minutes ☐ 
More than 30 minutes ☐ 
No noticeable relief ☐ 
 
6. How often did you use the cooling pad? 
 
 
 
 
 
 
As needed ☐ 
Daily ☐ 
Several times per day ☐ 
Only at night ☐ 
Other: _______________ 
 
7. What is your overall satisfaction with the cooling pad? 
 
 
 
 
 
Very dissatisfied ☐ 
Dissatisfied ☐ 
Neutral ☐ 
Satisfied ☐ 
Very satisfied ☐ 
 

COOLVAS PROTOCOL V1.0 16 July 2025 
 
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8. Would you recommend the cooling pad to others with 
similar symptoms? 
 
 
Yes ☐ 
No ☐ 
Not sure ☐ 
 
9. What did you like most about the cooling pad? 
 
 
 
 
 
  
10. What did you dislike or find challenging about the cooling pad? 
 
 
 
 
 
 
11. Do you have any suggestions for improving the cooling pad or your experience? 
 
 
 
 
 
Section 4. Vasomotor Management Strategies 
Have you used any other treatment or therapys to help control your vasomotor symptoms? 
 
 
 
 
 
 
 
 

COOLVAS PROTOCOL V1.0 16 July 2025 
 
Page 41 of 42 
 
APPENDIX VIII Adverse Event Log  
 

COOLVAS PROTOCOL V1.0 16 July 2025 
 
Page 42 of 42 
 
REFERENCES 
 
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reduce vasomotor symptoms and improve sleep', Menopause, 29(8), pp. 973-978. 
2. Brook Hervik, J. and Stub, T. (2016) 'Adverse effects of non-hormonal pharmacological interventions in 
breast cancer survivors, suffering from hot flashes: A systematic review and meta-analysis', Breast 
Cancer Research and Treatment, 160, pp. 223-236. 
3. Carpenter, J.S. (2001) 'The Hot Flash Related Daily Interference Scale: A Tool for Assessing the Impact of 
Hot Flashes on Quality of Life Following Breast Cancer', Journal of Pain and Symptom Management, 
22(6), pp. 979-989. 
4. Gupta, A. (2018) 'Hormone Therapy–Related Hot Flashes and Their Management', JAMA Oncology, 
4(4), p. 595. 
5. Guttuso, T., DiGrazio, W.J. and Reddy, S.Y. (2012) 'Review of hot flash diaries', Maturitas, 71(3), pp. 
213-216. 
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Clemons, M. (2020) 'Comparing Interventions for Management of Hot Flashes in Patients With Breast 
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E86-E106. 
7. Rada, G., Capurro, D., Pantoja, T., Corbalán, J., Moreno, G., Letelier, L.M. and Vera, C. (2022) 'Non-
hormonal interventions for hot flushes in women with a history of breast cancer', Cochrane Database 
of Systematic Reviews, Issue 12. 
 
8. CTCAE (Common Terminology Criteria for Adverse Events): 
U.S. Department of Health and Human Services, 2017. Common Terminology Criteria for Adverse 
Events (CTCAE) Version 5.0. [pdf] Available at: https://dctd.cancer.gov/research/ctep-trials/for-
sites/adverse-events/ctcae-v5-5x7.pdf [Accessed 16 Jun. 2025]. 
 
9. PRO-CTCAE Symptom Terms (Hot Flashes and Insomnia):  
National Cancer Institute, n.d. PRO-CTCAE® English Language Questionnaire. [pdf] Available at: 
https://healthcaredelivery.cancer.gov/pro-ctcae/instruments/pro-ctcae/pro-ctcae_english.pdf 
[Accessed 16 Jun. 2025].