Symptoms and General Pathology

All Conditions

Neoplasms

Skin and Connective Tissue Diseases

Pain

Polyps

Myoma

Leiomyoma

Myofibroma

Neoplasms, Connective and Soft Tissue

Neoplasms by Histologic Type

Neoplasms, Connective Tissue

Connective Tissue Diseases

Central Nervous System Depressants

All Drugs and Chemicals

Anesthetics

Bupivacaine

Anesthetics, Local

10cc Bupivacaine 1% at 0.5-1 cm depth of the cervicovaginal junction at 5 and 7 o'clock positions (20cc in total).

10cc Bupivacaine 1% through the endocervix using an 17-gauge epidural catheter

evaluation of pain by using two different types of local anesthesia

Bupivacaine Injection

Janey Fang, MD

Chantal Rivard, MD

Paz Garcia, MD

Mélissa Roy, MD

Émilie Hudon, MD

Émilie Gorak, MD

Mik Gangal, MD

Hysteroscopy is a minimally invasive, diagnostic and therapeutic gynecological surgical technique and the gold standard in the study of the uterine cavity. Thanks to the decrease in the diameter of hysteroscopes and to the vaginoscopic approach, anesthesia is no longer necessary in diagnostic hysteroscopy. Nevertheless, in operative hysteroscopy, given the instrumentalization and the need of cervical dilation, the use of local anesthesia, with or without sedation, is recommended. The different alternatives described in the literature are the following:

1. Cervical/ intracervical block: injection of local anesthetic into the four quadrants of the cervix.
2. Paracervical block: injection of local anesthetic in the cervicovaginal junction at 5 and 7 o'clock positions.
3. Transcervical (uterine) anesthesia: instillation of a local anesthetic agent via catheter through the cervix and into the uterine cavity.
4. Topical cervical anesthesia: application of local anesthetic in gel or spray to the cervix.

To assess the best anesthetic pathway to decrease pain during outpatient hysteroscopy, the investigators will perform a prospective multicentric study that compare two types of local anesthesia in outpatient procedural hysteroscopy: paracervical block, that is the actual gold-standard, and transcervical instillation.

To assess the best anesthetic pathway to decrease pain during outpatient hysteroscopy, the investigators will perform a multicentric prospective randomized trial, single-blinded, that compares two types of local anesthesia in outpatient procedural hysteroscopy: paracervical block, that is the actual gold-standard, and transcervical instillation.

The population studied will consist in adult women with indication of an outpatient surgical hysteroscopy (myomectomy or polypectomy). Every one of them will be invited to participate the day of their procedure. In the outpatient hysteroscopy clinic, the investigators will verify inclusion and exclusion criteria, explain the objectives of the study, collect data and obtain the patient's consent.

The sample size is 242 patients (121 in each group). The study will be performed in two different centers:

* Integrated University Health Center and Social Services of the East of the Island of Montreal
* Integrated University Health Center and social services of the South Center of the Island of Montreal

Right before each procedure the patients will be randomized through anonymous and alternized enveloppes that will be distributed in each center, to either receive paracervical or transcervical anesthesia before hysteroscopy.

Each patient will receive a pre-established dose of sedative before the procedure, according to their weight: Fentanyl 0,5 mcg/kg IV and Midazolam 0,02 mg/kg. The subsequent doses will be noted.

Under sedation, with the patient in lithotomy position, a medium size speculum will be inserted. The vagina will be disinfected with chlorhexidine and the anterior lip of the cervix will be gripped with a Pozzi forceps.

According to previous randomization, each patient will receive one of the following alternatives of local anesthesia:

* Group A: Paracervical 10cc Bupivacaine 1%, without epinephrine, at 0.5-1 cm depth of the cervicovaginal junction at 5 and 7 o'clock positions (20cc in total).
* Group B: Transcervical (uterine) 10cc Bupivacaine 1% through the endocervix using an 17-Gauge epidural catheter

During the procedure (T1), the nurse will be in charge to fill the scale (to avoid bias). The patients will be given a Visual Analogue Scale (VAS) to fill 15 minutes after the procedure (before discharge), to assess pain.

For each group the investigators will calculate the average rate of pain according to the Visual Analogue Scale during and immediately after the procedure (15 minutes). The investigators will subdivide each group into pre and postmenopausal women and into nulliparous and parous women and compare their Visual Analogue Scale as well.

Statistical analysis will be performed to compare results.

Multicentric, prospective, randomized trial, single-blinded, where eligible patients will be randomized to either receive paracervical or transcervical anesthesia before outpatient surgical hysteroscopy

Paracervical Block Versus Transcervical Block in Outpatient Procedural Hysteroscopy

A Prospective Randomized Study Comparing Different Types of Local Anesthesia in Outpatient Procedural Hysteroscopy

There is not a plan to make IPD available

comparing 10 point visual analogue scale (from 0 to 10 points) between two groups of patients recieving Bupivacaine administrated through a paracervical block versus a transcervical block

Compare the pain experience based on the 10 point visual analogue scale (from 0 to 10 points) between pre and post-menopausal patients

Compare the pain experience based on the 10 point visual analogue scale (from 0 to 10 points) between nulliparous and parous patients

Number of patients who demand an extra dose of sedative during hysteroscopy

Centre integre universitaire de sante et de services sociaux du Centre-Sud-de-l'Île-de-Montréal

Ciusss de L'Est de l'Île de Montréal

Blood and Lymph Conditions

Anemia

Patients will receive a transfusion under standard care

Patients will not receive an otherwise-indicated red blood cell transfusion

No-Transfuse

Daryl J Kor

Do ambulatory RBC transfusions improve home functional status?

Background: Red blood cell (RBC) transfusion is frequently employed in both ambulatory and hospital environments with the aim of improving patient functional status. The efficacy of this 10.5 billion dollar per year practice however has been increasingly called into question. The Investigators propose to directly measure the impact of outpatient RBC transfusions on at-home functional status by recording several physiological parameters and quantifiable physical activity metrics, e.g. daily energy expenditure and daily total step count, using the ActiGraph wGT3X-BT. This device is an accelerometer-based wearable similar in size to a small watch and is worn at the waist. Study participants will wear the device during the course of their daily activities giving the investigators quantifiable insight into activity levels in the home environment.

Methods/Design: This will be a randomized crossover pilot clinical trial with participant study duration of 28 days. The crossover nature allows each patient to serve as his/her own control. Details of the study design are provided in the text. Briefly, patients presenting at Mayo Clinic Scottsdale's Ambulatory Infusion Center (AIC) will be randomized to one of two arms: 1) receive an RBC transfusion as scheduled (transfuse), or 2) abstain from the scheduled transfusion (no-transfuse). After an appropriate washout period, patients will cross from the transfuse arm to the no-transfuse arm or vice-versa. Activity levels will be recorded continuously throughout the study with no need for intervention by the patient. In addition to device data, survey data will be collected via a weekly telephone interview. The primary outcome measures will include both technical performance metrics such as daily energy expenditure as well as practical performance metrics such as changes in step count. A variety of secondary outcome measures include daily sedentary time and PROMIS Global 10 scores.

Discussion: This trial will directly assess the impact of red blood cell transfusion on patient functional status in the location most important - the home. Patient recruitment will begin in August 2016 and is due to be completed in August 2017.

Red Blood Cell Transfusion in the Ambulatory Setting: Impact on Home Functional Status

Arizona State University

Mayo Clinic

Prinicipal Investigator

Digestive System Diseases

Colorectal Neoplasms

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Colonic Diseases

Intestinal Diseases

Rectal Diseases

Patients who are identified by the IPHR as study participants will see an attractive link. In the Prefs arm, via question prompt lists, patients will first identify their CRCS preference using previously developed elicitation strategies.

Tailoring will be used to increase salience of information, motivation, communication, and action plans. We envision the Prefs+ arm in its entirety will be 5-7 minutes, but will depend on Phase I formative work. If the patient remains non-adherent, they will receive an e-mail reminder generated by the IPHR (specific text and frequency determined in Phase I). The Prefs content is identical to the preference portion of the Prefs+Barriers arm, which will allow us to assess the incremental benefit of addressing preferences only and the incremental benefit of addressing preferences and barriers.

Patients who are identified by the IPHR as study participants will see an attractive link. In the Prefs+Barriers arm, via question prompt lists, patients will first identify their CRCS preference using previously developed elicitation strategies, and subsequently based on their test preference determine their top 3 test-specific barriers/concerns in "real time".

Tailoring will be used to increase salience of information, motivation, communication, and action plans. We envision the Prefs+Barriers arm in its entirety will be 15-25 minutes, but will depend on Phase I formative work. If the patient remains non-adherent, they will receive an e-mail reminder generated by the IPHR (specific text and frequency determined in Phase I). The Prefs content is identical to the preference portion of the Prefs+Barriers arm, which will allow us to assess the incremental benefit of addressing preferences only and the incremental benefit of addressing preferences and barriers

The IPHR will be programmed so that where the IPHR-CRCS would normally present patients, who based on their demographics and health conditions, with content advising them to seek CRCS and links to third-party sites, they would instead be randomized to receive the usual care (IPHR-CRCS).

MyCRCS+Prefs

Patients who are identified by the IPHR as study participants will see an attractive link. In the Prefs+Barriers arm, via question prompt lists, patients will first identify their CRCS preference using previously developed elicitation strategies, and subsequently based on their test preference determine their top 3-5 test-specific barriers/concerns in "real time".

Tailoring will be used to increase salience of information, motivation, communication, and action plans. We envision the Prefs+Barriers arm in its entirety will be 15-25 minutes, but will depend on Phase I formative work. If the patient remains non-adherent, they will receive an e-mail reminder generated by the IPHR (specific text and frequency determined in Phase I). The Prefs content is identical to the preference portion of the Prefs+Barriers arm, which will allow us to assess the incremental benefit of addressing preferences only and the incremental benefit of addressing preferences and barriers.

MyCRCS+Prefs+Barriers

Resa M Jones, MPH, PhD

This study involves 3 phases that modifies current Interactive Preventative Health Record-Colorectal Cancer Screening (IPHR-CRCS) modules to address each patient's individual colorectal cancer screening (CRCS) knowledge, attitudes, preferences, and test-specific barriers. The study will engage patients, ages 50-75 years who are non-adherent to CRCS, to assess their CRCS test preferences and corresponding test-specific barriers in "real time". Based on patient characteristics (e.g. age, personal and family history, physician CRCS recommendation, CRCS test preferences, top test-specific barriers), tailored messages/videos will appear in the pop-up screens to address/reduce the top patient-reported, test-specific CRCS barriers while incorporating an action plan for CRCS adherence. The investigators hypothesize that modifying the IPHR-CRCS module to address each patient's individual CRCS knowledge, attitudes, preferences, and test-specific barriers will further increase CRCS.

An Interactive Preventive Health Record to Increase Colorectal Cancer Screening

Develop and pretest MyCRCS+, which focuses on integrating patient CRCS preferences and test-specific barriers in an interactive web-based intervention. Answer the question: What intervention content and reminder content, packaging and frequency are acceptable to patients?

Having had ≥1 test (i.e., fecal occult blood test, sigmoidoscopy, colonoscopy and barium enema) within the time frame specified for each procedure will count as adherent CRCS.

The four NCI-recommended CRCS history questions will be included on the self-report surveys. Respondents will identify the last time they had each test (i.e., fecal occult blood test, sigmoidoscopy, colonoscopy and barium enema). Having had ≥1 test within the time frame specified for each procedure will count as adherent CRCS.

We will track participants' use of the intervention and usual care arms to capture number of log-ins, pages viewed, length of view, links clicked. In addition to elucidating patients' uptake of intervention components, these data can indicate engagement for dose-response analyses or be examined as potential mediators. For Phase II, this data will allow us to assess the timing of intervention reminders to make a decision about what frequency is most appropriate so that we can modify before we begin the feasibility study (phase III).

Scales (e.g. Decisional conflict, intentions , self-efficacy, perceived susceptibility, worry, etc.) are included in the patient questionnaire, which have good psychometric properties.

A previously validated modality-specific colorectal cancer screening barrier instrument will be used. The FOBT-specific scale includes 19 questions relating to barriers for fecal occult blood test, and the colonoscopy-specific scale includes 21 questions relating barriers to colonoscopy. All items are measured on a 5-point Likert-type scale, with 5 representing greater barrier endorsement. Items are summated to create continuous scale scores (range: FOBT=19-95; colonoscopy=21-105).

Phase III is a feasibility study to determine among other things, implementation in the "real world" setting. The outcomes we propose to measure are defined by the RE-AIM model. Specifically, we selected four essential elements pertaining to the feasibility of fielding MyCRCS+: Reach, Effectiveness, Implementation, and Maintenance.

The patient survey will include key questions related to intervention reach and potential future implementation adaptations addressing patient awareness and perception of the practices' MyCRCS+ integration strategies.Surveys will assess: patients' awareness of MyCRCS+, how they learned about it, what they liked or disliked about how practices promoted and used MyCRCS+; to what extent they used the MyCRCS+, the factors that influenced use, facilitators and barriers to both using and acting on MyCRCS+ recommendations; anxiety and worry; and quality of life (QOL).

National Cancer Institute (NCI)

Virginia Commonwealth University

Temple University

Control Group participants were exposed to the normal hosting conditions of the hospital when receiving the usual chemotherapy treatment in ambulatory hospital setting.

Experimental Group participants were exposed to the Hospital Clowns intervention plus the normal hosting conditions of the hospital when receiving the usual chemotherapy treatment in ambulatory hospital setting.

Hosting conditions care

the patients are welcome by the nurse, whom talk and give the comfort needed by the patients before starting the treatments.

Hosting conditions

The HCs "Palhaços D'Opital (PdO)" have a program aiming to bring joy, affection and good mood to adults and elders in hospital environment. They work in pairs, dressed in colorful costumes and they prepared sketches in advance. Their performances recreate day-to-day situations (e.g., clowns trying to install a new TV screen; planning a wedding between the clowns and asking the public for their ideas), ending with specific closure, in order to indicate to the audience that the session had finished and to promote a positive environment after their departure. Each intervention lasted around 15 minutes.

Hospital Clowns

Manuela Grazina

The goal of this interventional study is to evaluate the impact of Hospital Clowns (HCs) intervention, besides to hospital hosting conditions, in the well-being of adult female patients during ambulatory chemotherapy.

The main question\[s\] it aims to answer are:

* Do the short-term HCs interventions during ambulatory chemotherapy may increase well-being of adult cancer patients in comparison to the hospital hosting conditions?
* Do the short-term HCs interventions, besides the hospital hosting conditions, have effects on well-being biomarkers in association with psychological outcomes?

Participants self-collect a sample of saliva followed by psychological assessment, at a first time-point (basal) and at a final time-point (\~after 90 minutes of basal) (pre- and post-test), during the chemotherapy treatment session.

Researchers have compared an HCs intervention plus hosting conditions - experimental group, EG, and hosting conditions only - control group, CG, by the repeated measures of pre- and post-test of biomarkers in saliva and the psychological functioning evaluations, to see the degree of the impact of HCs intervention in the well-being of the patients in comparison with normal hosting conditions. Each HCs intervention lasts around 15 minutes, and it is performed in the middle of the procedure between pre- and post-test.

The recruitment of participants was carried out by a nursing professional in the Portuguese Institute of Oncology of Coimbra, according to the appointments of patients whom would be receiving the usual chemotherapy treatment in ambulatory hospital setting, on the days defined for data and samples collection. Participants were told that they would participate in a study to better understand the variations in the relationships between saliva biomarkers' properties and psychological emotional and attentional states across morning time and those who agree to participate were provided with written informed consent at arrival to ambulatory hospital.

Data were obtained after participants signing informed consent, according to Law no.12/2005, DL no.131/2014 and the Norm 015/2013 of the Directorate-General of Health (DGS), following the Tenets of the Helsinki Declaration. Samples were anonymized following the European Union General Data Protection Regulation (GDPR - EU 2016/679) and the Portuguese Law (Law no.58/2019).

Sociodemographic data, including age, educational level, marital status and profession were obtained by filling in the questionnaire that included the psychological assessment provided by the psychology team members.

This is the first study assessing changes in biomarkers and psychological symptoms in adults with cancer, in particular related to clown performances in treatment rooms. This is a pilot study, in which 64 women were analyzed: experimental group (EG; n=36; HCs intervention plus hosting conditions) versus control group (CG; n=28; hosting conditions). It is important to stress out the novelty of this work, in which a set of well-being biomarkers is implemented, in correlation with psychological evaluation including cognitive function, besides emotional states, all evaluated by cluster analysis.

The psychological assessment protocol covered affective, cognitive and satisfaction aspects of the intervention, in the form of both quantitative and qualitative data. The affective dimension was assessed in both groups using the Emotional States Perception Scale (PESS, with lower values corresponding to a better emotional state), the Positive Affectivity and Negative Affectivity Scale (PANAS, with higher and lower values, respectively, better affectivity), the Cognitive and Affective Mindfulness Scale-Revised (CAMS-R, a measure of attention, tolerance and acceptance of the present moment, with higher values corresponding to better results in these aspects). The cognitive dimension was assessed using the Clock-Drawing Test (CDT, with higher values corresponding to better cognitive functioning). The CDT, as a neuropsychological measure, assesses visuospatial, visuoconstructive and visuomotor abilities. It also involves other cognitive functions, including language/comprehension, memory, attention and executive functions (planning, organization, simultaneous processing, self-monitoring). It is also used as a brief cognitive screening test.

In the post-test, the EG was also assessed in terms of the importance and satisfaction attributed to the HCs intervention, as well as free-explanation testimonies, based on an open question, which finalized the assessment protocol in this group.

Concerning statistical analysis, primarily the qualitative data were described by its absolute and relative frequency while mean ± standard deviation and median \[Quartile 1; Quartile3\] were presented for quantitative data.

A factorial repeated measures ANOVA was applied in order to evaluate either the effect of evaluation moments and group interaction, and the main effect of the repeated measure (although some variables have presented normality deviations on their residuals, that fact did not have a significant impact on lowering power on those analysis). Moreover, bivariate comparisons between evaluations in each group were performed either using a Student's t-test for paired samples or a Wilcoxon test, according to sample distribution, and between groups for each time point using an independent samples t-test or a Mann-Whitney U-test using the same criteria. Pearson and Spearman rank order correlations between pre-test and post-test difference in biomarkers and psychological characteristics were also obtained for each group, and they were evaluated according to each data distribution. Furthermore, the differences of the changes in time of the variables were evaluated in function of the age and educational level of the patients between the two groups using a repeated measures ANOVA considering those as factors in a full factorial model.

These analyses were performed in IBM SPSS, version 25, and were analyzed at a 5% significance level (at a 10% significance level concerning Pearson and Spearman rank order correlations).

In order to assess association between biomarkers and psychological characteristics, cluster analyses using a Manhattan distance with single linkage were performed in Orange version 3.28.0 and the dendrograms obtained were presented.

Only women were included in order to avoid gender based bias, concerning well being biomarkers.

Participant eligibility is based on self-representation of gender identity.

Well-being Biomarkers (BIOSMILE) & Psychology Analyses in Women With Cancer After Hospital Clowns and Hosting Effects

Well-being Biomarkers and Psychological Functioning of Adult Patients During Chemotherapy Treatment: the Effects of Hospital Clowns and Hosting Conditions

Saliva collection for the biomarkers analysis was followed by psychological assessment, both at baseline (pre-test) and after \~90 minutes (post-test).

The procedure was similar for all participants, considering the HCs intervention duration of 15 minutes performed between the baseline (pre-test) and after \~90 minutes (post-test) in the EG.

Saliva collections were performed by the participants themselves, following instructions and using Saliva Collection Aid Salimetrics (5016.02-SAL), and stored at 4°C.

The evaluation of oxytocin levels was performed by using the colorimetric competitive enzyme immunoassay ELISA kit ADI-900-153A (Enzo Life Sciences). Oxytocin extraction was required prior to ELISA, using SPE columns, acetonitrile and trifluoroacetic acid, according to manufacturers' instructions. All the samples were analyzed in duplicate, the saliva oxytocin content was expressed in pg/mL, determined by plotting the optical density of each sample against the standard curve.

Saliva collection for the biomarkers analysis was followed by psychological assessment, both at baseline (pre-test) and after \~90 minutes (post-test).

The procedure was similar for all participants, considering the HCs intervention duration of 15 minutes performed between the baseline (pre-test) and after \~90 minutes (post-test) in the EG.

Saliva collections were performed by the participants themselves, following instructions and using Saliva Collection Aid Salimetrics (5016.02-SAL). The samples were collected according to the schedule as described above and stored at 4°C.

The evaluation of cortisol levels was performed by using the colorimetric competitive enzyme immunoassay ELISA kit ADI-900-071 (Enzo Life Sciences). The samples were thawed and centrifuged for immediate immunoassay processing in duplicate. A standard curve was used to estimate the cortisol content (pg/mL).

Saliva collection for the biomarkers analysis was followed by psychological assessment, both at baseline (pre-test) and after \~90 minutes (post-test).

The procedure was similar for all participants, considering the HCs intervention duration of 15 minutes performed between the baseline (pre-test) and after \~90 minutes (post-test) in the EG.

Saliva collections were performed by the participants themselves, following instructions and using Saliva Collection Aid Salimetrics (5016.02-SAL) and stored at 4°C.

In the serotonin determination, samples were concentrated by lyophilization. The samples were frozen in liquid nitrogen and then processed in a freeze dryer. The serotonin ELISA assay was performed using a colorimetric competitive enzyme immunoassay (ADI-900-175 (Enzo Life Sciences)) kit, following to manufacturers' directions. The optical density (OD) was red at λ=405nm and the serotonin content (ng/mL) was determined by plotting OD of each sample against the standard curve.

Saliva collection for the biomarkers analysis was followed by psychological assessment, both at baseline (pre-test) and after \~90 minutes (post-test).

The procedure was similar for all participants, considering the HCs intervention duration of 15 minutes made between the baseline (pre-test) and after \~90 minutes (post-test) in the EG.

Saliva collections were performed by the participants themselves, following instructions and using Saliva Collection Aid Salimetrics (5016.02-SAL), according to the schedule described and stored at 4°C.

The assessment of the saliva ATP levels was performed using a bioluminescent assay (ATP Bioluminescence Assay Kit HS II, Roche Diagnostics). This technique uses the ATP dependence on oxidation catalyzed by luciferase and allows the measurement of extremely low concentrations of ATP (up to 10-15 mol) in the saliva samples. The protein concentration was assayed by the Bradford method, and ATP levels were expressed normalized to that concentration.

Psychological assessment was performed after saliva collection, both at baseline (pre-test) and after \~90 minutes (post-test).

The procedure was similar for all participants, considering the HCs intervention duration of 15 minutes performed between the baseline (pre-test) and after \~90 minutes (post-test) in the EG.

Affectivity was assessed by the Positive and Negative Affect Schedule (PANAS). The PANAS has two independent subscales with five items each. Responses are in a Likert scale and can vary from 1 ("Nothing or very slightly") to 5 ("Extremely"). The PANAS can measure affective and mood states in the moment. Higher values in positive affect (PA) and lower values in negative affect (NA) correspond, respectively, to a better affectivity. The Portuguese adaptation showed good psychometric properties, internal consistency (Cronbach's alpha =0.86 for PA) and 0.89 for NA) and structural validity through Confirmatory Factor Analysis.

Psychological assessment was performed after saliva collection, both at baseline (pre-test) and after \~90 minutes (post-test).

The procedure was similar for all participants, considering the HCs intervention duration of 15 minutes performed between the baseline (pre-test) and after \~90 minutes (post-test) in the EG.

Emotional States were assessed by the Perception of Emotional States Scale (PESS), based on semantic differential scales and consisting of 8 pairs of opposite adjectives separated by 7 positions (e.g., calm/nervous; happy/sad). These pairs were selected because they represent emotional states, different from the affective states assessed by PANAS. Lower ratings correspond to a better emotional state.

Psychological assessment was performed after saliva collection, both at baseline (pre-test) and after \~90 minutes (post-test).

The procedure was similar for all participants, considering the HCs intervention duration of 15 minutes performed between the baseline (pre-test) and after \~90 minutes (post-test) in the EG.

Cognitive and Affective Mindfulness was measured by the Cognitive and Affective Mindfulness Scale-Revised (CAMS-R), having 9 items rated to a 4-point Likert scale, ranging from 1 (Not at all) to 4 (A lot) and measures mindfulness qualities of attention, tolerance and acceptance of the present moment, with higher values corresponding to better results. For the present study, only 6 items were considered, because of the need to make the psychological assessment as brief as possible so that a minimum interference with ambulatory sessions functioning would occur and respecting the patient's availability could be ensured.

Psychological assessment was performed after saliva collection, both at baseline (pre-test) and after \~90 minutes (post-test).

The procedure was similar for all participants, considering the HCs intervention duration of 15 minutes performed between the baseline (pre-test) and after \~90 minutes (post-test) in the EG.

Cognitive functioning was assessed by the Clock-Drawing Test (CDT, with higher values corresponding to better cognitive functioning). The CDT measures visuospatial, visuoconstructive and visuomotor capabilities. This test also evaluates other cognitive functions, including language/understanding, memory, attention and executive functions (planning, organization, simultaneous processing, self-monitoring). It is commonly used as a brief cognitive screening test. The Portuguese version of the 18-point quantitative scoring system was used.

Satisfaction with HCs' intervention was evaluated in EG through two single items: (1) "Do you think this type of interventions in the hospital is important?", answered on a 4-point Likert scale (ranging between "Very important" and "Nothing important"); and (2) "How satisfied are you with the intervention of the HCs that you just saw?" answered in a 5-point Likert scale (ranging between "Very Satisfied" and "Very Unsatisfied").

Portuguese Oncology Institute, Coimbra

University of Coimbra

Professor

Breast Neoplasms

Breast Diseases

Skin Diseases

total mastectomy

Elodie Demblocque, MD

Albine Mancaux, MD

Pierrick Theret, MD

Breast cancer is the first female cancer in France. Total mastectomy occurred in 30% of breast cancer patient population.

The purpose of this study is to evaluate the feasibility of outpatient surgery for the total mastectomy.

In France, Ambulatory care is developed as part of the new national health plan.

Breast conserving surgery for tumorectomy or partial mastectomy is already done in outpatient vacation.

Total mastectomy is an extension of this surgery, and, as such, underpins the investigator's hypothesis that total mastectomy is feasible in outpatient care .

Feasibility of Total Mastectomy in Ambulatory Care

Post Anaesthetic Discharge Scoring System (PADSS), which considers six criteria: vital signs, ambulation, nausea/vomiting, pain, bleeding and voiding. Each criterion is given a score ranging from 0 to 2. Only patients who achieve a score of 9 or more are considered ready for discharge.

Centre Hospitalier de Beauvais

Centre Hospitalier de Saint-Quentin

Centre Hospitalier Universitaire, Amiens

Online remote monitoring tool during the care of patients over the age of 65 who are receiving medical treatment for cancer

Remote monitoring

Mathilde CABART, MD

Simone MATHOULIN-PELISSIER, MD, PhD

Monocentric, prospective cohort pilot study evaluating the feasibility of a online remote monitoring tool during the care of patients over 65 years of age being medically treated for cancer.

Each patient will have to answer the remote monitoring questionnaires on a mobile phone, tablet or computer via the Internet. Responses will be sent to the referring oncologist and team (Coordinating Nurse). For each question, predetermined response thresholds have been established, triggering "orange" (to watch) or "red" alerts (intervention by the healthcare team required).

In parallel, patient will continue standard follow-up with their referring oncologist and, if necessary (age ≥ 70 years and G8 score ≤ 14), will benefit from an onco-geriatric evaluation at inclusion then at 3 and 6 months.

At the end of 6 months of remote monitoring, the Coordinating Nurse will inform the patient of the end of study participation. Within one month of the end of the remote monitoring, the nurse will also remove the installation of the application and will organize the return of the equipment (tablet and/or 4G LTE key (4th Generation Long Term Evaluation)) if these were lent for the study.

Remote Monitoring for Ambulatory Care of Elderly Patients With Cancer

Remote Monitoring for Ambulatory Care of Elderly Patients With Cancer: The TS-PAC Study

Toxicities and symptoms will be assessed weekly using 20 questions selected and adapted from the French version of the CTCAE PRO (Basch et al., 2014; National Cancer Institute, 2017). For each question, predetermined response thresholds have been established, triggering "orange" (to watch) or "red" alerts (intervention by the healthcare team required). The number of red alerts will be collected for each patient.

Patient compliance with oral treatment will be assessed on a monthly basis during the treatment from the self-questionnaire MMAS-4 (Morisky et al., 1986) which has a range from 0 to 4. A high compliant score is defined by a score of 0, a medium compliance score (score=1 or 2) and a low compliance score (score=3 or 4).

The subjective evaluation of the perceived benefit of treatment will be evaluated at 3 and 6 months by a questionnaire developed specifically for this project. It comprises 3 items.The proportion of patients will be reported for each item of the questionnaire.

Patient satisfaction with the use of the remote monitoring tool will be evaluated at 3 and 6 months by a questionnaire developed specifically for this project. It comprises 2 items. The rate will be reported for each item.

Institut Bergonié

Age-eligible adults in the intervention communities will be exposed to the shared decision-making intervention when they are seen in the primary care clinics (N=all patients 50-75 years seen during the study period who are non-adherent to CRCS recommendation). Additionally, among patients with primary care visits scheduled one week or more before the visit, they will be randomized to receive either a mailed decision aid booklet or an informational flyer on shared decision making and CRCS prior to the visit. Patients with primary care visits scheduled less than one week prior to the visit will not be mailed materials in advance. The effect of the pre-visit materials on referral to SDM session and CRCS adherence between these groups will be compared. They will also be exposed to shared decision-making tools and resources available through the community-wide intervention activities.

Shared Decision Making for Colorectal Cancer Screening

The purpose of this study is to increase colorectal cancer screening by implementing a community-wide shared decision-making (SDM) intervention, which embeds shared decision making within clinical practice and also uses an extensive community engagement campaign. The investigators hypothesize that colorectal cancer screening adherence will be higher in the intervention group (participating communities) compared to the usual care control group (non-participating comparison communities).

Clinical practice: All patients 50-75 years seen in the participating primary care clinics during the study period who are non-adherent to CRCS recommendation. This sample is anticipated to be N\~50,000 patients.

Community engagement: Includes mailed questionnaires to age-eligible adults residing in intervention and comparison (control) communities (N=2150).

Colorectal Cancer Screening With Improved Shared Decision Making

Colorectal Cancer Screening With Improved Shared Decision Making (CRCS-WISDM)

Colorectal cancer screening adherence will be defined as having screening according to the recommendations of the United States Preventive Services Task Force. Participants will be classified as screened per recommendations if they have had fecal occult blood testing in the last year, flexible sigmoidoscopy in the last five years, or colonoscopy in the last ten years. Participants will be classified as non-adherent if they have not had any of the modalities within the recommended timeframe.

A previously validated decisional conflict scale, will be used, which includes 16 items all measured on a 5-point Likert-type scale. (e.g. difficulty in decision making, certainty with a decision, demonstrated feeling of understanding about risks and benefits of a decision, and satisfaction with a decision). Responses will be coded so that higher responses represent greater decisional conflict.

A previously validated modality-specific colorectal cancer screening barrier instrument will be used. The FOBT-specific scale includes 19 questions relating to barriers for fecal occult blood test and the colonoscopy-specific scale includes 21 questions relating barriers to colonoscopy. All items are measured on a 5-point Likert-type scale, with 5 representing greater barrier endorsement.

Colorectal cancer-related confusion will be measured using 9 items which will be coded on a scale from 1 to 5 where 5 represents greater confusion endorsement.

Patients will answer multiple questions relating to their experience with the implementation of shared decision-making and their interactions with clinical staff. Items will be measured on Likert-like scales and will be coded so that higher scale numbers reflect more endorsement of positive opinions and experiences.

Providers and staff will answer multiple questions relating to their experience with the implementation of shared decision-making with their patients in clinical practice. Items will be measured on Likert-like scales and will be coded so that higher scale numbers reflect more endorsement of positive opinions and experiences.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Paracervical Block Versus Transcervical Block in Outpatient Procedural Hysteroscopy	NCT05967936	Myoma;Uterus Polyp Uterus	Bupivacaine Inj...	18 Years -	Ciusss de L'Est de l'Île de Montréal
Red Blood Cell Transfusion in the Ambulatory Setting: Impact on Home Functional Status	NCT02835937	Red Blood Cell ... Anemia Hematology Oncology Ambulatory Care	No-Transfuse	18 Years -	Mayo Clinic
An Interactive Preventive Health Record to Increase Colorectal Cancer Screening	NCT01885351	Colorectal Canc...	MyCRCS+Prefs MyCRCS+Prefs+Ba...	50 Years - 75 Years	Temple University
Well-being Biomarkers (BIOSMILE) & Psychology Analyses in Women With Cancer After Hospital Clowns and Hosting Effects	NCT06143189	Well-Being, Psy... Biomarkers Cancer Ambulatory Care Complementary T...	Hosting conditi... Hospital Clowns	18 Years -	University of Coimbra
Feasibility of Total Mastectomy in Ambulatory Care	NCT04270136	Breast Cancer Mastectomy Ambulatory Care	total mastectom...	18 Years -	Centre Hospitalier Universitaire, Amiens
An Interactive Preventive Health Record to Increase Colorectal Cancer Screening	NCT01885351	Colorectal Canc...	MyCRCS+Prefs MyCRCS+Prefs+Ba...	50 Years - 75 Years	Temple University
Well-being Biomarkers (BIOSMILE) & Psychology Analyses in Women With Cancer After Hospital Clowns and Hosting Effects	NCT06143189	Well-Being, Psy... Biomarkers Cancer Ambulatory Care Complementary T...	Hosting conditi... Hospital Clowns	18 Years -	University of Coimbra
Remote Monitoring for Ambulatory Care of Elderly Patients With Cancer	NCT04913259	Cancer	Remote monitori...	65 Years -	Institut Bergonié
Paracervical Block Versus Transcervical Block in Outpatient Procedural Hysteroscopy	NCT05967936	Myoma;Uterus Polyp Uterus	Bupivacaine Inj...	18 Years -	Ciusss de L'Est de l'Île de Montréal
Feasibility of Total Mastectomy in Ambulatory Care	NCT04270136	Breast Cancer Mastectomy Ambulatory Care	total mastectom...	18 Years -	Centre Hospitalier Universitaire, Amiens
Colorectal Cancer Screening With Improved Shared Decision Making	NCT01519999	Colorectal Canc... Shared Decision...	Shared Decision...	50 Years - 75 Years	Virginia Commonwealth University

Spots Global Cancer Trial Database for ambulatory care