Lise Laclautre

Frank PIZON, MCF HDR

Laurent GERBAUD, PU PH

Model and map, from a qualitative multi-phased protocol, the conceptions and systems of conceptions of the determinants of health and cancer expressed and perceived by schoolchildren aged 6 to 11 years. The secondary objectives are to analyze the ability to question the conceptions of children's health regardless of their age and to link conceptions and determinants to contextual factors. The informative value and complementarity of the collection tools (photo expression, QC, photo-narration) and the relevance of a mixed analysis methodology (qualitative and quantitative) in order to highlight the different determinants of health will also be studied.

Qualitative observational study of human and social sciences (SHS), multicenter, conducted with schoolchildren.

The qualitative methodology used combines the use of photographs, open questionnaires and focus groups, over very large panels, aiming at both diversity and representativeness.

* Photo expression: to identify the determinants perceived as having a positive or negative influence on one's health;
* CQR : Certainty/Question/Rumour on how to take care of one's health (health promotion input following on from school policies, i.e. PES: Politique d'Etablissements Scolaires);
* Photo narration: to identify argumentative frameworks in health and alternatives perceived as being positive or negative for one's health,
* Focus groups: to improve understanding of the rationalities built by adolescents in relation to that which determines their health.

This choice is justified by the need to explore and understand the actions from the participants' point of view.

The diversity of schools and pupils (5 classes in 4 schools in the AURA region, i.e. 320 pupils) will make it possible to obtain the data saturation required in qualitative research.

This makes it possible to consider a mixed analysis strategy, both qualitative and quantitative.

This project aims to better understand the rationalities elaborated by children and the way in which their concepts on the determinants of cancer interlink, as well as to describe the declared impact these concepts have on the decision-making regarding their health.

Determinants of Health and Cancer: Investigating the Conceptions of Children From 6 to 11 Years Old

The analysis of the content will be carried out according to the ascending / descending method by categorization, described by Laurence Bardin. According to L. Bardin (2013), categorization is an operation of classification of elements constituting a set by differentiation then grouping by genre (analogy) according to previously defined criteria.

The informative value and complementarity of the collection tools (photo The informative value are measured with collection tools (photo expression, photo-narration) and a mixed analysis methodology (qualitative and quantitative) is used in order to highlight the different determinants of health.

The informative value are measured with collection tools (photo expression, photo-narration) and a mixed analysis methodology (qualitative and quantitative) is used in order to highlight the different determinants of health.

Identify child profiles / classes / school based :• Socio-demographic data (class / age, sex, class size, number of male and female, school enrollment, class number, geographical location, priority education, team stability, health project, type of project, impression of researchers)

• Domains or designs: Individual \& collective Domains created during the qualitative analysis

Université d'Auvergne

University Hospital, Clermont-Ferrand

Symptoms and General Pathology

All Conditions

Digestive System Diseases

Syndrome

Intestinal Diseases

Low Anterior Resection Syndrome

Colonic Diseases

Gastrointestinal Diseases

Rectal Diseases

Postoperative Complications

Patients with lived-experience of anterior resection surgery, who may or may not have subsequently developed bowel dysfunction symptoms, will be invited to take part in a focus group. They will discuss a new questionnaire and the phrasing of the questions, ensuring clarity and reducing the potential variability in interpretation of each question.

Julie Cornish

The purpose of this study is to develop a new severity scoring tool for Low Anterior Resection Syndrome (LARS) drawing on the international consensus criteria for LARS as well as opinions of patients with lived-experience of LARS.

Six out of ten patients have significant bowel problems in the first 12 months after surgery to remove their rectum (last bit of bowel), with as many as 4 out of 10 having longer term issues. This is an operation which is most commonly performed to treat bowel cancer. Bowel problems can include having to rush to the toilet, having accidents or leakage into the underwear or difficulty fully emptying the bowels. This condition is called Low Anterior Resection Syndrome, or 'LARS' for short. The definition of Low Anterior Resection Syndrome was developed in 2020 with patient involvement throughout the process so it accurately captures the real-world experience of LARS. This definition is to be used to create a new scoring system to measure the severity of LARS.

The aim of this study is to transform this new definition into a scoring tool which can be used to assess the severity of Low Anterior Resection Syndrome and investigate how well various treatments work for LARS. It is vital to have patients involved throughout this work to ensure that the new score gives an accurate picture of the severity of these symptoms.

Translation of the International Consensus Definition of LARS Into a Bowl Dysfunction Severity Scoring Tool (New LARS Score)

A Qualitative Research Study Using Patient Focus Groups to Translate International Consensus Definition of Low Anterior Resection Syndrome (LARS) Into a Bowel Dysfunction Severity Scoring Tool.

Qualitative research methods will be used develop the new tool. A patient focus group will be conducted to review the draft questionnaire and refine question and response wordings.

Focus groups will be asked to rank proposed tool names from 'least favoured' to 'most favoured'. This will be considered along with clinical opinion to derive final tool name.

Participants will be asked to complete the new LARS score tool, along with existing LARS tool to test proposed question set and administration method as well as comparability to existing tool.

University of Auckland, New Zealand

University of Aarhus

Cambridge University Hospitals NHS Foundation Trust

Cardiff and Vale University Health Board

Behaviors and Mental Disorders

Fatigue

Quality of Life

A single-faceted patient-directed (PD) strategy that will embed the change at patient level.

A multi-faceted (MF) strategy that will embed the change at the patient, professional and organizational levels.

The patient-directed strategy will be designed to embed the success of implementation of PCRPs by influencing the patients.

The patient-directed (PD) strategy

The multi-faceted strategy will be designed to embed the success by not only influencing the patients, but also professionals and organizational aspects.

The multi-faceted (MF) strategy

C. IJsbrandy, MD

R.P.M.G. Hermens, PhD

C. IJsbrandy, drs.

The aim of this study is to develop and identify the most effective strategy to implement PCRPs into daily care. We want to assess the added value of a multi-faceted strategy compared with a single-faceted patient-directed strategy.

The aim of this study is to develop and identify the most effective strategy to implement PCRPs into daily care. We want to assess the added value of a multi-faceted strategy compared with a single-faceted patient-directed strategy.

We will conduct a clustered controlled before and after study (CBA) in the Netherlands that compares two strategies to implement PCRPs. The patient-directed (PD) strategy (five hospitals) will focus on change at the patient level. The multi-faceted (MF) strategy (five hospitals) will focus on change at the patient, professional and organizational levels. Eligibility criteria are as follows: (A) patients: adults; preferably (history of) cancer in the gastro-intestinal, reproductive and/or urological system; successful primary treatment; and without recurrence/metastases. (B) Healthcare professionals: involved in cancer care.

A stepwise approach will be followed:

Step 1: Analysis of the current implementation of PCRPs and the examination of barriers and facilitators for implementation, via a qualitative study with patients (four focus groups n = 10-12) and their healthcare workers (four focus groups n = 10-12 and individual interviews n = 30-40) and collecting data on adherence to quality indicators (n = 500 patients, 50 per hospital).

Step 2: Selection and development of interventions to create a PD and MF strategy during expert's roundtable discussions, using the knowledge gained in step 1 and a literature search of the effect of strategies for implementing PCRPs.

Step 3: Test and compare both strategies with a clustered CBA (effectiveness, process evaluation and costs), by data extraction from existing registration systems, questionnaires and interviews. For the effectiveness and cost-effectiveness, n = 500 patients, 50 per hospital. For the process evaluation, n=50 patients, 5 per hospital, and n = 40 healthcare professionals, 4 per hospital.

Implementation of Physical Cancer Rehabilitation Programmes in a European Healthcare System.

An Evaluation of a Patient-directed Strategy Compared With a Multi-faceted Strategy to Implement Physical Cancer Rehabilitation Programmes; a Controlled Before and After Study.

The experiences and exposure of patients and professionals with the PD- and MF strategy will be evaluated by interviews.

incremental costs and incremental cost-effectiveness ratios (ICERs)

A pre- and post measurement of 'the percentage of screened patients with the screening tool recommended by the Dutch guideline 'Cancer Rehabilitation'' will be done. The differences between the pre- and post measurement will be measured.

A pre- and post measurement of 'The percentage of referrals to PCRPs where needed, according to the Dutch guideline 'Cancer Rehabilitation'' will be done. The differences between the pre- and post measurement will be measured.

A pre- and post measurement of 'QoL' will be done. The differences between the pre- and post measurement will be measured.

A pre- and post measurement of 'patientempowerment' will be done. The differences between the pre- and post measurement will be measured.

A pre- and post measurement of ' the Remaining quality indicators of the Dutch guideline 'Cancer Rehabilitation'' will be done. The differences between the pre- and post measurement will be measured.

Radboud University Medical Center

Neoplasms

Carcinoma

Carcinoma, Squamous Cell

Head and Neck Neoplasms

Squamous Cell Carcinoma of Head and Neck

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Martina Schmocker, MSc

The goal of this qualitative study is to explore influencing factors for physical activity participation in people affected by an advanced head and neck cancer from the perspective of people affected and their significant others.

Individual interviews will be conducted with people affected by head and neck cancer and focus group interviews will be held with significant others of people being affected to answer the following research questions:

* What capabilities and opportunities for physical activity participation do people with advanced head and neck cancer experience?
* What motivates people with advanced head and neck cancer to be physically active?
* How do significant others view capabilities, opportunities, and motivation for physical activity participation in people with head and neck cancer?

The interviews will be transcribed verbatim and analysed with a structuring content analysis approach.

Influencing Factors for Physical Activity in People With Head and Neck Cancer

Exploring Influencing Factors for Physical Activity Participation in People With Advanced Head and Neck Cancer - a Qualitative Study

individual interviews and focus group interviews will be transcribed verbatim to be analyzed

characteristics of interview and focus group participants will be collected to be able to describe the study participants, including age, education level, cancer stage, treatment received, activity levels

Eastern Switzerland University of Applied Sciences

University of Applied Sciences of Western Switzerland

UMC Utrecht

University of Lausanne

Zurich University of Applied Sciences

Kantonsspital Winterthur KSW

Patients will be interviewed by open-ended questions face to face concerning their past experiences. The recorded interview will be transcribed and analyzed by psychodynamic and semio-pragmatic approach.

Semi-structured face to face interviews.

MARCHAL FREDERIC, MD

Systematic screening for cervical cancer stops in France at 65 years old. The incidence of certain types of gynecological neoplasia increases with age (endometrium, vulva). Diagnosis delay of 8 months has been described for uterine cancer and longer delays for vulvar cancer.

The aim of our study is to understand help-seeking behavior and its delay for this type of cancer among patients older than 65.

Our study assess the reasons for which the patient took time to go to the doctor despite of their symptoms. We use a qualitative methodology. Our study categorizes lived experiences, recorded in semistructured interview transcripts. We use psychodynamic and semiopragmatic analyses of the discourse to obtain hypotheses about possible reasons of the delay in the help-seeking process."

Understanding Low Gynecological Cancer Delay and Help-seeking Behavior in Older Patients.

Understanding Low Gynecological Cancer Delay and Help-seeking Behavior in Older Patients. Qualitative Approach

Qualitative interview performed at one occasion where the patient describes the experience of the help seeking period she has passed through.

qualitative methodology using verbal data analysis of semi-structured interview.

Institut de Cancérologie de Lorraine

Catherine Ward, BSc, MBBS, FRCA, PGCME

Charlotte Hitchins, BMedSci, BMBS, MRCS

Failures in non-technical skills (NTS) contribute to adverse events in healthcare. Previous research has explored the assessment and training of these skills, and yet there is a lack of evidence for their impact on clinical outcomes. Gastrointestinal endoscopy is a high-pressure specialty, but to date there is little on the role of NTS in this area, or a method for their assessment.

This MD project aims to measure NTS in endoscopy, explore their relationship with clinical outcomes, and identify those specific to this area of healthcare.

Methods An observational study of endoscopy teams in real time, using the Oxford NOTECHS II assessment tool. Comparison of NTS performance with procedure outcomes and patient satisfaction.

A qualitative interview study with staff members to establish the NTS specifically relevant to working in gastrointestinal endoscopy.

Ten to fifteen percent of patients will experience some kind of adverse event during their hospital stay. A significant proportion of these occur in surgery. The causes of such adverse events often stem not from deficiencies in clinical or technical skills but from the non-technical aspects of human and team performance).

Much of the early research in this field comes from the aviation industry where "non-technical skills" are defined as "the cognitive and social skills of flight crew members in the cockpit". Failures in teamwork in cockpit crews have been linked to half of adverse events in aviation and further work within surgery has shown a significant reduction in adverse events when teams perform well.

Behavioural ratings systems have been used in aviation and other high risk industries for many years to facilitate assessment and training. "NOTECHS" was designed in the 1990s by a collaboration of European aviation experts as a system to assess the non-technical skills of individual pilots. Over recent years similar such tools or taxonomies have been developed in healthcare. Within surgery some taxonomies assess individual team members such as 'Non-Technical Skills for Surgeons' (NOTSS), 'Anaesthetists' Non-Technical Skills' (ANTS) and 'Scrub Practitioners List of Intra-operative Non-Technical Skills' (SPLINTS), whilst others aim to assess the whole team: 'revised NOTECHS', 'Oxford NOTECHS (II)' and 'Observational Teamwork Assessment for Surgery' (OTAS). 'NOTSS', 'ANTS' and 'SPLINTS' were developed by a group at the University of Aberdeen. Each provides a rating scale to assess the non-technical skills of an individual practitioner within a surgical team. They can be used as an observational assessment or a self-evaluation tool for reflection and professional development. The "revised NOTECHS" scale developed by a team at Imperial College, adapted the "NOTECHS" system to assess the non-technical skills of theatre teams. The "Oxford NOTECHS" was similarly adapted from "NOTECHS" to assess theatre teams but with an additional subdivision into three "sub-teams" (surgical, anaesthetic and nursing). The "Oxford NOTECHS" has further been revised to the "Oxford NOTECHS II" scale to improve the discrimination between levels of performance. "OTAS" combines a task checklist and a team behaviour assessment in the pre- operative, operative and post-operative phases of a procedure.

Two studies using the Oxford NOTECHS system have shown an improvement in scores after a training intervention. Mishra et al observed 65 laparoscopic cholecystectomies before and after a Crew Resource Management (CRM) style training intervention applied to all staff members (29 laparoscopic cholecystectomies before, 39 after). Oxford NOTECHS scores improved significantly after the training intervention. Scores negatively correlated with technical error rates and positively (but not significantly) with staff safety attitudes. Another study observing laparoscopic cholecystectomy and carotid endarterectomy showed similar improvement in Oxford NOTECHS scores after a training intervention (all staff trained). This was associated with a concurrent decrease in technical errors, procedural errors and an increase in Safety Attitude Questionnaire scores, but no significant change in clinical outcomes. These findings are consistent with a number of other studies investigating the effect of human factors team training within healthcare. Outcome measures vary between studies: learning assessment questionnaires, observed teamwork behaviour, participant perception of teamwork and staff attitudes have all been used as markers of performance and have all shown to improve after team training interventions. Unfortunately only a few studies have linked training interventions to clinical outcome improvements. The Veterans Health Administration Medical Team Training (MTT) program was a multi-center quality improvement program in the USA. This study showed a significant reduction in surgical morbidity after the introduction of team training. This along with the Oxford NOTECHS studies demonstrates that improving non-technical skills may improve clinical outcomes. Thus though there is a range of data on the effect of training on reduction of non-technical error, and some data which demonstrates a direct link between non-technical skills and successful outcomes, there is still much work to be done in clarifying the three-way links between non-technical skills, successful outcomes and the role of training.

Endoscopy units are akin to day-case theatre complexes. Endoscopic procedures vary in their length and complexity. Diagnostic gastroscopy and colonoscopy with or without biopsy (removal of tissue) are the commonest procedures performed. However, there are a wide range of therapeutic procedures also undertaken including stenting, endoscopic resection of tumours, endoscopic retrograde cholangio-pancreatography and feeding gastrostomy insertion. Patients consent to undergo these procedures having been fully informed of the risks involved. They are either awake, under sedation (56.4% of sedation in the Peninsula region occurs in Endoscopy units), or under general anaesthetic depending on the complexity of the procedure and their preference. The PHNT endoscopy unit performs more than 12,000 procedures per year in a contained unit of 5 rooms, operating Monday to Saturday. Additional procedures requiring x-ray screening occur within the radiology department supplemented by Endoscopists and Nursing staff from the unit.

There are clear auditable outcome standards for technical performance and training in Endoscopy provided by the British Society of Gastroenterology (BSG) and the Joint Advisory Group on GI Endoscopy (JAG). These include markers of completion of procedures such as Caecal Intubation Rate and Adenoma Detection Rate in Colonoscopy. Challand et al showed that good clinical performance in Colonoscopy was associated with increased efficiency. They also found that there was no negative effect of training on either of these outcomes.

Although adverse events are rare in Endoscopy, advances in technology and techniques have led to an increase in risk. As therapeutic procedures become more advanced the more "surgical" the specialty becomes. The National Confidential Enquiry into patient Outcomes and Death Report 2004 investigated the death of 1818 patients within 30 days of therapeutic endoscopy during April 2002 to March 2003. They found a wide variety of practice in different units across the UK, particularly in areas such as sedation administration, patient monitoring and planning of procedures: the non-technical aspects of endoscopy.

The Endoscopist, whether a Surgeon, Physician or Advanced Nurse Practitioner, is equivalent to the operating surgeon and nursing staff perform very similar roles to theatre nurses/practitioners. An anaesthetist is present only for those procedures performed under general anaesthetic. Despite a similar team and technical set up to an operation room there is a clear deficit in the literature with regards to non-technical skills and team performance within Endoscopy. It is likely that there will be a three-way relationship between non-technical skills, successful outcomes and training as there are for other surgical areas.

Endoscopy units share many characteristics with theatre complexes and are pioneering increasingly complex procedures and yet there is little literature relating to the assessment or training of team performance in this area; even within other areas of healthcare there is little correlation with clinical outcomes. Taxonomies for team performance and non-technical skills assessment in surgery are now well established and yet there still is no published evidence of their use in or adaptation for Endoscopy. There is therefore scope for:

1. The evaluation and development of a non-technical skills assessment tool within Endoscopy (based on Oxford NOTECHS II - a well-established taxonomy with good reliability and validity). Correlation of non-technical skills with clinical and other outcomes. Our endoscopy unit has a large throughput of similar cases per annum (\>12,000). This means the face, construct and concurrent validity of the non-technical skills assessment tool can be tested reliably with greater power. Scores could be correlated easily with standardized quality and safety outcomes.
2. Development of a Human Factors Simulation team training intervention based on the knowledge gained from. Training has yet to take place within the Endoscopy unit in our Hospital.

The aims of the project are as follows:

To develop the measurement of non-technical skills in endoscopy (using the Oxford NOTECHS II taxonomy); to delineate the relationship between successful clinical (and other) outcomes and non-technical skills as measured by the tool.

Endoscopy units share many characteristics with theatre complexes and are pioneering increasingly complex procedures and yet there is little literature relating to the assessment or training of team performance in this area; even within other areas of healthcare there is little correlation with clinical outcomes. Taxonomies for team performance and non-technical skills assessment in surgery are now well established and yet there still is little evidence of their use in or adaptation for Endoscopy. This project seeks to provide a firm basis for future work by establishing the measurement of non-technical skills in endoscopy, relating those skills to clinical outcomes, and identifying those features of non-technical skills training likely to be of greatest importance in terms of successful clinical outcomes.

Do Good Non-Technical Skills Correlate With Good Clinical Outcomes in Endoscopy?

A Modified Theatre Team Non-Technical Skills Scoring System

Torbay and South Devon NHS Foundation Trust

Plymouth University Peninsula Schools of Medicine & Dentistry

University Hospital Plymouth NHS Trust

Heart and Blood Diseases

Blood and Lymph Conditions

Immune System Diseases

Rare Diseases

Multiple Myeloma

Neoplasms, Plasma Cell

Hemostatic Disorders

Blood Coagulation Disorders

Vascular Diseases

Paraproteinemias

Blood Protein Disorders

Hematologic Diseases

Hemorrhagic Disorders

Lymphoproliferative Disorders

Immunoproliferative Disorders

All study participants will be enrolled in a 3-month digital health coaching program. They will also receive a Fitbit device to be worn daily for the capture of physical activity data.

Participants have the option to participate in a one time interview about their treatment experience.

consisting of weekly calls and delivery of evidence-based content across health and wellness domains (e.g. nutrition, exercise, physical, emotional and financial health) up to 4 times weekly via text, email or mobile application.

Digital Health Coaching Program

A wrist-worn activity tracker allowing for the capture of physical activity, including but not limited to step-count and minutes of activity, to be captured daily.

Fitbit

Kelly J Brassil, PhD

Jennifer Loftis, DNP

Jasper Olsem

Melody R Becnel, MD

Trenton Grossfeld, BS

Rahul Banerjee, MD

This descriptive study aims to evaluate the experience of adults with relapsed or refractory multiple myeloma receiving standard of care isatuximab-irfc through collection of quantitative, qualitative and wearable data. Fifty adults with relapsed or refractory multiple myeloma receiving standard of care isatuximab-irfc will be enrolled across 2 sites, The University of California San Francisco and The University of Texas MD Anderson Cancer Center. Consented participants will be enrolled in a 3-month digital health coaching program through which electronic patient reported outcomes and wearable activity data will be collected. Outcomes include treatment experience, quality of life, financial toxicity, treatment adherence, symptom burden and health self-efficacy. These will be captured by patient reported outcome measures including the Patient's Qualitative Assessment of Treatment- Real World (PQAT-RW), Patient Global Impression of Change/Severity (PGIC/S), European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-C30), Quality of Life Questionnaire Multiple Myeloma (QLQ-MY20), and the European QoL-5 Dimensions (EQ5D), Cancer Behavior Inventory-Brief Form (CBI-B), Center for Adherence Support Evaluation (CASE) Medication Adherence Index, Comprehensive Score for Financial Toxicity (COST) Instrument.

Clinical data, including treatment history, healthcare utilization, and co-morbidities, as well as demographic data will be collected via the electronic health record from each clinical site. This data will be complemented by qualitative data from a selected cohort of study participants with a focus on treatment experience ranging from infusion burden, toxicity management, to overall quality of life. Evaluation of this data in combination will be used to better understand the treatment experience of individuals on standard of care isatuximab-irfc specifically, and with relapsed or refractory multiple myeloma generally, contributing to an existing gap in the literature regarding patient reported outcomes from diverse data sources. Outcomes will be analyzed with attention to the relationship between social determinants of health, including race, ethnicity, and geographic location, and treatment experience as reflected in both the qualitative and quantitative data.

A single cohort of 50 individuals with relapsed/refractory multiple myeloma will be enrolled in the study, all of which will be enrolled in a digital health coaching program and receive a Fitbit device for activity tracking. Individuals from both study sites will be enrolled to this single cohort.

Real World Insights During Treatment for Relapsed/Refractory Multiple Myeloma With Isatuximab

Clinical and Patient Reported Outcomes for Individuals With Relapsed/Refractory Multiple Myeloma Treated With Isatuximab: Real-World Insights From Patient Reported, Wearable, and Qualitative Data in the Context of Digital Health Coaching

Physical activity, including step count and minutes of physical activity will be collected via Fitbits provided to study participants

Frequency, types and duration of engagement with the digital health coaching platform

A 6-item survey assessing experience of a drug during clinical trial. The instrument consists of 3-free text and 3 scaled responses assessing the perceived benefits and disadvantages of received treatment and willingness to continue on drug after the study.

A one time interview will be conducted to learn more about the experience of individuals related to their diagnosis, treatment, symptoms, side effects and overall care experience.

A 30-item measure of quality of life across 5 domains, including physical, emotional, social, role and cognitive), 8 symptoms, and items assessing global health and financial toxicity. Recall over the past week is scored primarily on a 4-point scale ranging from "not at all" to "very much". The instrument may be administered either on paper or electronically.

A 20-item measure of quality of life among individuals with multiple myeloma. It assesses a series of symptoms on a 4-point Likert scale ranging from 1 (Not at All) to 4 (Very Much).

A measure of quality of life across 5 dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression.

This 12-item instrument measures self-efficacy in coping with cancer across 7 domains. These include: Seeking and Understanding Medical Information, Emotion Regulation, Coping with Treatment Related Side Effects, Accepting Cancer/ Maintaining a Positive Attitude, Seeking Social Support, and Using Spiritual Coping. The instrument utilizes a 9-point response scale ranging from 1 "Not at all confident" to 9 "Confident".

A 1-item measure of severity of relapsed/refractory multiple myeloma symptoms since the last visit, which is scored a on a 5-response scale ranging from "none" to "very severe".

A 1-item measure of patient perception of change in relapsed/refractory multiple myeloma symptoms since starting a study. Responses are scored on a 7-point scale, ranging from "very much worse" to "very much better".

The Center for Adherence Support Evaluation (CASE) is a three-item questionnaire used to measure antiretroviral therapy adherence. This questionnaire was developed through the Special Projects of National Significance (SPNS) initiative called Assessing Existing Efforts to Increase Adherence to Medication. Patients take less than 5 minutes to answer the three unique questions, asking about their difficulty taking medications on time, average days per week with one dose missed, and the last time they missed a dose.

The Comprehensive Score for Financial Toxicity (COST) is an 11-item instrument used to measure the financial toxicity of cancer treatment, which has been demonstrated to be highly correlated with HRQoL (de Souza et al., 2017). This instrument was validated among individuals with advanced cancer and demonstrated high internal consistency (Cronbach's α \>.90) and highly correlated to HRQol (p=.05). The instrument consists of 11 items, utilizing a five-point ordinal scale ranging from (0- Not at all) to (4- Very much).

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Determinants of Health and Cancer: Investigating the Conceptions of Children From 6 to 11 Years Old	NCT04065542	Child Determinants of... Qualitative Res... Cancer		6 Years - 11 Years	University Hospital, Clermont-Ferrand
Translation of the International Consensus Definition of LARS Into a Bowl Dysfunction Severity Scoring Tool (New LARS Score)	NCT05605600	Low Anterior Re...		18 Years -	Cardiff and Vale University Health Board
Implementation of Physical Cancer Rehabilitation Programmes in a European Healthcare System.	NCT02205853	Cancer Fatigue	The patient-dir... The multi-facet...	18 Years -	Radboud University Medical Center
Influencing Factors for Physical Activity in People With Head and Neck Cancer	NCT06272513	Advanced Head a...		18 Years -	Kantonsspital Winterthur KSW
Understanding Low Gynecological Cancer Delay and Help-seeking Behavior in Older Patients.	NCT03336177	Gynecologic Can... Symptoms and Si... Aged	Semi-structured...	65 Years -	Institut de Cancérologie de Lorraine
Do Good Non-Technical Skills Correlate With Good Clinical Outcomes in Endoscopy?	NCT05110378	Bowel Cancer		18 Years -	University Hospital Plymouth NHS Trust
Real World Insights During Treatment for Relapsed/Refractory Multiple Myeloma With Isatuximab	NCT05053607	Multiple Myelom... Refractory Mult...	Digital Health ... Fitbit	18 Years -	Pack Health
Influencing Factors for Physical Activity in People With Head and Neck Cancer	NCT06272513	Advanced Head a...		18 Years -	Kantonsspital Winterthur KSW

Spots Global Cancer Trial Database for qualitative research