Psychotropic Drugs

All Drugs and Chemicals

Fluoxetine

Participants will receive CONTINUUM intervention visit with a nurse practitioner within three business days of hospital discharge and complete questionnaires about their cancer and care.

Participants will receive standard oncology care following hospital discharge with follow-up appointments scheduled per primary team and participant preferences. Participants will complete questionnaires about their cancer and care.

The intervention, CONTINUUM (CONTINUity of care Under Management by video visits), consists of a video visit conducted by an oncology nurse practitioner within three business days of hospital discharge, to: (1) reconcile medications, (2) manage symptoms, (3) review the post-hospital care plan for hospitalization-specific issues, and (4) schedule follow-up with the outpatient oncology team.

CONTINUUM Intervention

Patients assigned to the usual care group will have their post-discharge follow-up scheduled per hospital, outpatient oncology team, and patient preference.

Usual Care

Jennifer S Temel, MD

This study is examining whether a care transition intervention, CONTINUUM (CONTINUity of care Under Management by video visits), consisting of a supportive care-focused video visit with an oncology nurse practitioner (NP) within three business days of hospital discharge, may improve post-discharge transitions of care for recently hospitalized patients with advanced cancer.

To address the rising incidence and burden of hospital readmissions for patients with advanced cancer, the investigators developed a population-specific care transition intervention based upon the scholarly literature and our qualitative study. The intervention, CONTINUUM (CONTINUity of care Under Management by video visits), consists of a video visit conducted by an oncology NP within three business days of hospital discharge, to: (1) reconcile medications, (2) manage symptoms, (3) review the post-hospital care plan for hospitalization-specific issues, and (4) schedule follow-up with the outpatient oncology team.

From 01/07/21 to 05/28/21, the investigators conducted a pilot trial of CONTINUUM in 48 patients with advanced cancer recently discharged from the Massachusetts General Hospital Cancer Center (NCT04640714). The investigators found that the intervention was feasible and acceptable in our population.

The investigators are now conducting a randomized controlled trial of the CONTINUUM intervention versus standard of care, to study whether CONTINUUM improves patients' confidence in managing their health condition, as measured by the Patient Activation Measure-13. The investigators will also assess the efficacy of CONTINUUM for improving patient satisfaction with clinician communication, and physical and psychological symptom burden. Lastly, the investigators will explore the effect of the intervention on hospital readmissions within 30-days.

Study procedures include random assignment to either the CONTINUUM intervention or standard oncology care following hospital discharge, questionnaires and medical record data collection.

Participants are expected to be on the study for up to 40 days after hospital discharge.

It is anticipated that about 286 people will take part in this research study.

Care Transition Intervention for Hospitalized Patients With Advanced Cancer

Randomized Trial of a Care Transition Intervention for Hospitalized Patients With Advanced Cancer

The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to: \[contact information for Sponsor Investigator or designee\]. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.

Compare hospital readmissions within 30 days of discharge between study groups.

Compare change in the PAM-13 from baseline to 10-15 days post-discharge between study groups. The PAM-13 is scored 0-100 with higher scores indicating greater confidence in managing one's health condition.

Compare differences in CAHPS-Communication at up to 10-15 days post-discharge between study groups. CAHPS-Communication has a composite score (score range 0-20) with higher scores indicating better satisfaction. As recommended by CAHPS, we will also analyze specific differences in CAHPS-Communication individual items, which relate to patients' assessment of whether clinicians discussed 1) illness course expectations, 2) what is most important to the patient, and 3) how the treatment plan should match what is most important to the patient. These items are scored as "Yes" vs. "No" responses.

Compare change in the Edmonton Symptom Assessment System-Revised (ESAS-r) total score and physical sub-scale between baseline and 10-15 days of discharge between study groups. Scores on the ESAS-r range from 0-100 with higher scores indicating worse symptom burden. Scores on the ESAS-Physical sub-scale range from 0-70 with higher scores indicating worse symptom burden.

Compare change in the Patient Health Questionnaire-4 (PHQ-4) between baseline and 10-15 days of discharge between study groups. The PHQ-4 is a 4-item tool that contains two 2-item subscales assessing depression and anxiety symptoms. Both subscales and the composite PHQ-4 score can also be evaluated continuously, with higher scores indicating worse psychological distress. Scores on each subscale range from 0 to 6.

Conquer Cancer Foundation

Massachusetts General Hospital

Principal Investigator

The patient will complete a questionnaire of 10 questions before leaving hospital. This questionnaire concerns the care pathway for hospitalized patients.

medical questionnaire

HENRY ALINE

The Purpose of MGPEC_ONCO is to see if patient consult their general practitioner during the management of their cancer, especially before hospitalization. The study concerns not planned hospitalizations in medicine service.

Before leaving hospital, the patient completes the survey, other data are taken in patient record

Place of General Medical During Oncology Care Management

Percentage of patients in unscheduled hospitalization who have seen their general practitioner

Institut de Cancérologie de Lorraine

All subjects eligible for inclusion in this study will receive usual care physiotherapy treatment. The number of treatment sessions and content of physiotherapy treatment sessions will depend on the diagnosis and needs of the individual patient. This study will not interfere with the content of the usual care physiotherapy treatment. Usual care physiotherapy sessions wil take approximately 20-30 minutes per session. They receive no additional intervention and will not use Hospital Fit as part of their physiotherapy treatment. The patients in the control group will receive an activity monitor to collect data about their physical activity levels. However, patients and their healthcare professionals will not receive feedback on patients' physical activity levels.

Patients in the intervention group will receive usual care physiotherapy and us Hospital Fit additionally. At the end of the last physiotherapy treatment session before discharge, or after a maximum of nine days of study inclusion (whichever comes first), the physiotherapist will remove the activity monitor and data collection will end.

Hospital Fit consists of a smartphone app combined to the MOX accelerometer. Hospital Fit provides patients and physiotherapists direct feedback on patients' physical activity behavior. Individual goals regarding the number of minutes per day spent walking can be set by the therapist. Hospital Fit also gives patients insight into their own recovery process. During every treament, the physiotherapist will evaluate the extent of functional recovery. In addition, Hospital Fit will give physiotherapists the option of creating a patient-specific exercise program supported by videos. During every treatment session, the patient and physiotherapist will evaluate (and if necessary adapt) the amount of activity performed since the previous treatment, the extent of functional recovery and the exercise program.

Hospital Fit 2.0, HFITAPP0, release 05, Maastricht Instruments B.V., the Netherlands

Antoine F Lenssen, Prof, PhD

The primary objective of this study is to investigate the effectiveness of using Hospital Fit as part of the physiotherapy treatment on average time spent walking per day in patients hospitalised at the Medical Oncology or Cardiology Departments of the Maastricht University Medical Center (MUMC+) and Radboud University Medical Center (Radboudumc) compared to patients who received physiotherapy before implementation of Hospital Fit. Secondary: to investigate the effectiveness of using Hospital Fit as part of the physiotherapy treatment on average time spent standing per day, average time spent lying/sitting per day, average number of transitions per day and the Modified Iowa Level of Assistance scale (mILAS) scores in hospitalised patients. Besides, the reach, efficacy, adoption, and implementation of using Hospital Fit as part of the physiotherapy treatment will be investigated from the perspective of both patients and healthcare professionals.

Rationale: Physical inactivity is a major, underrecognised problem in patients during their hospital stay. Patients spend between 87 and 100% of their time lying or sitting. This physical inactivity has been associated with adverse outcomes such as functional decline, increased length of hospital stay and mortality. Digital health tools could be valuable to prevent negative effects of inactivity. Hospital Fit is a promising app-based intervention to stimulate physical activity by 1) continuous physical activity monitoring, 2) personalised goalsetting, 3) providing patients insight in their functional recovery, 4) providing patients tailored exercise programs, 5) informing patients about benefits of physical activity, and 6) reminding patients to use Hospital Fit 7) linking the data to the electronic medical record, making it available for other healthcare professionals.

Objectives: Primary: to investigate the effectiveness of using Hospital Fit as part of the physiotherapy treatment on average time spent walking per day in patients hospitalised at the Medical Oncology or Cardiology Departments of the Maastricht University Medical Center (MUMC+) and Radboud University Medical Center (Radboudumc) compared to patients who received physiotherapy before implementation of Hospital Fit. Secondary: 1) to investigate the effectiveness of using Hospital Fit as part of the physiotherapy treatment on average time spent standing per day, average time spent lying/sitting per day, average number of transitions per day and the Modified Iowa Level of Assistance scale (mILAS) scores in hospitalised patients; and 2) to investigate the reach, efficacy, adoption, and implementation of using Hospital Fit as part of the physiotherapy treatment from the perspective of both patients and healthcare professionals.

Study design: A prospective, multi-centre, stepped-wedge cluster randomised trial will be performed to investigate the effectiveness of Hospital Fit. Additionally a process evaluation will be performed using questionnaires and semi-structured interviews in patients and focus-group interviews in healthcare professionals.

Study population: In total 180 patients hospitalised at the Medical Oncology Department or Cardiology Departments at the MUMC+ or Radboudumc will be included to study the effectiveness. The process evaluation will be performed in the intervention group using a questionnaire in all 90 patients, semi-structured interviews in 24 purposefully selected patients (or less if data saturation is reached), and focus group interviews in 24 healthcare professionals (i.e., physiotherapists, nurses, and physicians (assistants).

Intervention: Physical activity will be measured in all patients with an accelerometer until discharge with a maximum of nine days. The control group will receive usual care physiotherapy (n=90), while the intervention group will use Hospital Fit additionally (n=90).

Main study parameters/endpoints: Primary outcome parameter: average time spent walking per day (min). Secondary outcome parameters: average time spent standing and lying/sitting per day (min.), average number of transitions from lying/sitting to standing/walking per day, and mILAS score per day. Outcome parameters process evaluation: participation; representation; perceived efficacy; use of app; use of different functionalities; barriers and facilitators to Hospital Fit use; and expected maintenance.

Nature and extent of the burden and risks associated with participation, benefit and group relatedness: The burden and risks on patients are minimal. The control group will receive usual care physiotherapy and will wear an accelerometer. The intervention group will use Hospital Fit additionally. Wearing a small accelerometer and using Hospital Fit should not be a burden to patients. The only burden is the time it takes to prepare subjects (install app, explain study). No invasive interventions will take place. Anticipated benefits of Hospital Fit use include improved physical activity, therewith reducing the negative effects associated with low physical activity.

A prospective, multi-center, stepped-wedge cluster-randomised trial will be performed to investigate the effectiveness of Hospital Fit. Additionally, a process evaluation will be performed using semi-structured interviews and questionnaires in patients and focus-group interviews in healthcare professionals.

Effectiveness of Hospital Fit on Physical Activity of Hospitalised Patients

Effectiveness of Hospital Fit on Physical Activity of Hospitalised Patients: a Stepped-wedge Cluster-randomised Clinical Trial and Process Evaluation

We do not intent to make IPD available to other researchers.

The 'total number of users' (included patients allocated to the intervention group that used Hospital Fit) divided by the 'total number of included subjects' (all included patients allocated to the intervention group). A 'user' is defined included subject who has indicated that she/he used Hospital Fit at least once.

Patient characteristics (i.e., age, gender, clinical diagnosis) of patients in the intervention group shown separate for users and non-users. A 'user' is defined included subject who has indicated that she/he used Hospital Fit at least once. A 'non-user' is an included subject who has indicated in the questionnaire that she/he did not use Hospital Fit.

Data on perceived efficacy will be collected using individual, semi-structured, face-to-face interviews with 24 patients included in the intervention group and 4 focus group interviews with in total 6 healthcare professionals (physiotherapists, nurses, and physician(s) assistant(s)) per focus group. The following topics will be discussed: What is the impact of Hospital Fit use on physical activity of patients during their hospital stay according to patients? How do healthcare professionals determine if Hospital Fit use has been effective for patients? What were perceived positive and negative outcomes? How likely is it that Hospital Fit improved patients' physical activity?

Patients included in the intervention roup will score how many times per day she/he has used Hospital Fit on a daily questionnaire.

Patients included in the intervention group will score how many times per day the different functionalities of Hospital Fit were used on a daily questionnaire.

Barriers and facilitators to Hospital Fit use according to patients allocated to the intervention group and healthcare professionals. This will be explored using individual, semi-structured, face-to-face interviews with 24 patients included in the intervention group and 4 focus group interviews with in total 6 healthcare professionals (physiotherapists, nurses, and physician(s) assistant(s)) per focus group.

Expected maintenance will be explored using individual, semi-structured, face-to-face interviews with 24 patients included in the intervention group and 4 focus group interviews with in total 6 healthcare professionals (physiotherapists, nurses, and physician(s) assistant(s)) per focus group. The following topics will be discussed: What might be the long-lasting effects of Hospital Fit on physical activity of patients? How will Hospital Fit be maintained at the hospital ward?

Total number of minutes walking divided by the total number of valid measurement days in the period between inclusion and discharge, with a maximum of nine days.

Total number of minutes standing divided by the total number of valid measurement days in the period between inclusion and discharge, with a maximum of nine days.

Total number of minutes lying/sitting divided by the total number of valid measurement days in the period between inclusion and discharge, with a maximum of nine days.

Total number of transitions divided by the total number of valid measurement days in the period between inclusion and discharge, with a maximum of nine days.

The 5-item Modified Lowa Level of Assistance Scale (mILAS) assesses the ability of patients to perform 5 activities of daily living and rates the amount of assistance and type of walking aid needed. Each item has a 7-point rating scale (0-6 points), resulting in total scores ranging between 0-30 points. Higher scores indicate that a patient needs more assistance.

Radboud University Medical Center

Maastricht University Medical Center

Behaviors and Mental Disorders

All Conditions

Quality of Life

* Patient and caregiver participants will have access to Laguna Health coaching and the Laguna Health mobile platform for 12 weeks after discharge from the hospital to a home environment.
* Patient participants will receive usual post-discharge care as arranged by their inpatient and outpatient oncology teams.
* Patient participants will complete study questionnaires to assess their quality of life, symptoms, and psychological outcomes.
* Caregiver participants will complete study questionnaires to assess their quality of life and caregiving burden.
* 10-20 participants will complete exit interviews to ascertain more feedback on the Laguna Health intervention.

* Participants will receive usual post-hospital discharge care as arranged by their inpatient and outpatient oncology care teams.
* Patient participants will complete study questionnaires to assess their quality of life, symptoms, and psychological outcomes.
* Caregiver participants will complete study questionnaires to assess their quality of life and caregiving burden.

Laguna Health is a novel behavioral coaching intervention (Laguna Health) that provides supportive care to patients with cancer who are discharged from the hospital and their caregivers. The intervention includes four components: 1) behavioral coaching with a Laguna Health recovery coach; 2) digital psycho-educational content tailored to the needs of patients with cancer; 3) summary of post-discharge care tasks; and 4) behavioral strategies to promote self-efficacy.

Laguna Health

Tejaswini Dhawale, MD

The overall goal of this study is to examine the feasibility, acceptability, and preliminary efficacy of using a behavioral coaching intervention (Laguna Health) for optimizing post-hospital discharge care in patients with cancer. Patients will be randomly assigned into one of the study groups: the behavioral coaching intervention (Laguna Health) + usual care versus usual care alone.

The Laguna Health intervention has several components:

1. Post-Discharge Recovery Coaching with a Laguna Health recovery coach to help patients identify barriers to post-discharge recovery
2. Digital psycho-educational content tailored to the needs of patients with cancer
3. Personal healthcare summaries
4. Digital content and coaching on behavioral strategies to promote self-efficacy

This is a single-center, randomized, controlled research study to test the feasibility, acceptability and preliminary efficacy of Laguna Health for improving post-hospital discharge care in patients with cancer.

Laguna Health is behavioral coaching intervention wherein patients and their caregivers are paired with a Laguna Health recovery coach to promote post-discharge recovery. Additionally, Laguna Health offers patients and their caregivers access to a mobile platform containing psycho-educational content, healthcare summaries, and interactive features such as journaling and task lists.

Participants will be randomized in 1:1 fashion to one of the two study groups: Laguna Health + usual care versus usual care alone, stratified by cancer type and therapy intent (curable solid tumor vs. incurable GI cancer vs. incurable other solid tumor vs hematologic malignancy).

Participants randomly assigned to the Laguna Health group will receive access to the Laguna Health recovery coach and mobile platform for 12 weeks after they are discharged from the hospital.

Participants randomly assigned to the usual care group will receive usual post-hospital discharge care as arranged by their inpatient oncology team. They will not be given access to the Laguna Health intervention.

In both groups, participants are asked to complete questionnaires at baseline, weeks 6, weeks 12 and weeks 24 after enrolling in the study.

It is expected that 80 patients and at most 80 caregivers will take part in this study.

Laguna Health, Inc. is supporting this research study by providing funding.

Behavioral Coaching Intervention (Laguna Health) for Patients With Cancer

Pilot Randomized Controlled Trial of an Artificial Intelligence (AI)-Powered Behavioral Coaching Intervention (Laguna Health) to Promote Post-Hospital Discharge Recovery for Patients With Cancer

The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to: Tejaswini Dhawale, MD. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.

Compare patient self-efficacy, as assessed through the Cancer Self-Efficacy Scale (CASE) between the study groups. The CASE is a commonly utilized measure to assess patients' confidence in managing the impact of their illness. This is a 17-item questionnaire with higher scores (range = 0-170) indicating higher levels of self-efficacy.

Compare caregiver QOL as assessed through the Caregiver Oncology Quality of Life Questionnaire (CarGOQoL) between the study groups. The CARGOQOL is a validated measure of caregiver QOL. The CARGOQOL ranges from 0-100 with higher scores indicating better QOL.

Compare caregiving burden as assessed through the Caregiver Reaction Assessment (CRA) between the two study groups. The CRA ranges from 24-120 with higher scores indicating greater caregiving burden.

Electronic Health Records (EHR) will be used to assess patient health care utilization including days alive and out of hospital, unplanned readmissions, post-discharge appointment attendance, and emergency department visits during the first 12 and 24 weeks after discharge.

Laguna Health will be deemed feasible if at least 60% of eligible patients are enrolled in the study, and of those patients enrolled and randomized to the intervention arm, 60% engage with the Laguna Health platform during at least 7 weeks of the 12-week post discharge intervention period.

Laguna health will be acceptable to patients, defined by at least 80% of patients reporting satisfaction (score \> 20, corresponding to scale midpoint) on the 8-item Client Satisfaction Questionnaire (CSQ-8). Total scores on the CSQ-8 range from 8 to 32 with the higher number indicating greater satisfaction.

Laguna health will be acceptable to caregivers, defined by at least 80% of caregivers receiving Laguna reporting satisfaction (score \> 20, corresponding to scale midpoint) on the 8-item Client Satisfaction Questionnaire (CSQ-8). Total scores on the CSQ-8 range from 8 to 32 with the higher number indicating greater satisfaction.

Compare patient QOL as assessed by the Functional Assessment of Cancer Therapy -General (FACT-G) between the two study groups longitudinally. The FACT-G is a 27-item QOL measure that assesses physical, social, emotional, and functional wellbeing during the prior seven days. Scores range from 0-108, with higher scores indicating better QOL.

Compare patient symptom burden, as assessed by the Edmonton Symptom Assessment Scale (ESAS-R) between the two study groups. The ESAS-R is a 10-item measure that assesses various symptoms relevant to patients with cancer. The ESAS-R score range 0-100 with higher scores indicating worse symptom burden.

Compare anxiety symptoms, as assessed by the self-reported Hospital Anxiety and Depression Scale (HADS), between the study groups. The HADS is a 14-item measure with subscales to evaluate symptoms of anxiety and depression. The HADS consists of two subscales assessing depression and anxiety symptoms, with scores ranging from 0 (no distress) to 21 (maximum distress) with higher scores indicating worse anxiety symptoms.

Compare depression symptoms, as assessed by the self-reported Hospital Anxiety and Depression Scale (HADS) between the study groups. The HADS is a 14-item measure with subscales to evaluate symptoms of anxiety and depression. The HADS consists of two subscales assessing depression and anxiety symptoms, with scores ranging from 0 (no distress) to 21 (maximum distress) with high scores indicating worse depression symptoms.

Compare post-traumatic stress symptoms as assessed through the Post-traumatic Stress Disorder Checklist-Civilian Version between the study groups. The PCL is a 17-item PTSD Checklist that evaluates severity of PTSD symptoms. Scores range from 17-85 with higher scores indicating worse PTSD symptoms

Laguna Health, Inc

Instructor in Medicine

An intervention (APA program) will be offered to patients hospitalized in the conventional hospitalization department of the medical oncology department.

At entry, after presenting the study and obtaining non-opposition from patients, an initial assessment will be carried out before the APA program.

At the end of the initial assessment, an APA program supervised (individually and in a room) by an APA teacher will be offered to patients. The sessions will be offered daily to patients (maximum 5 times/week). They will last on average 20 minutes each depending on the fatigue, pain and fitness of the patients. The objectives pursued are mainly an improvement in functional independence and mobility.

Content of the APA program:

* Strengthening of the lower limbs: Exercises alternating different regimes of muscular contractions (eccentric, concentric and isometric), with the use of elastics, balls or even body weight. These exercises will mainly work the quadriceps and hamstrings.
* Upper limb strengthening: Exercises focused on eccentric and concentric contraction regimes, in a global movement approach (as opposed to a segmental approach), with the use of elastics, dumbbells, weighted balls, etc. These exercises will work the muscles of the biceps, triceps, pectorals, deltoids and lats.
* Walking: In the room and/or in the corridor, with technical assistance (cane/walker, etc.) or human work
* Balance and proprioception: Balance work in a bi- and uni-pedal situation, statically and dynamically (eyes open and closed) will be offered with the use of proprioception boards and/or mats combining if possible work in dual task.

adapted physical activity program (APA Program)

Quentin JACQUINOT, Dr

This is a non-randomized, non-controlled feasibility study which will take place at the Besançon University Hospital in the conventional hospitalization department.

It will be carried out with patients hospitalized in the conventional hospitalization department of the medical oncology department of Besançon University Hospital.

At entry, after presenting the study and obtaining non-opposition from patients, an initial assessment will be carried out before the APA program. This assessment will include an evaluation of physical parameters (measurements of body composition, functional capacities, autonomy in activities of daily living and muscular strength), as well as an evaluation of quality of life relating to health and motivation to practice physical activity.

At the end of the initial assessment, an APA program supervised (individually and in a room) by an APA teacher will be offered to patients. The sessions will be offered daily to patients (maximum 5 times/week). They will last on average 20 minutes each depending on the fatigue, pain and fitness of the patients. The objectives pursued are mainly an improvement in functional independence and mobility.

Study Evaluating the Feasibility of an Adapted Physical Activity Program During the Hospitalization Phase in Cancer Patients Undergoing Treatment

The main objective of the study is to validate that the proportion of patients having completed, from inclusion (D0), at least three supervised APA sessions of a minimum duration of 15 minutes, during the first 7 consecutive days of his hospitalization (P) is beyond a threshold considered uninteresting of 50% (P0)

To test the following hypotheses:

H0: a compliant patient rate \<= 50% is uninteresting (P\<=P0) H1: a compliant patient rate \> 80% is expected (P\>P1) With an A'Hern type design, a one-sided alpha risk of 2.5% and a power of 90%, it is required to include 28 evaluable patients in the study to test H0 vs H1.

Considering a rate of unevaluable patients of 10% it will be necessary to include 32 patients.

Hypothesis H0 will be rejected if 20 (71.4%) or more than 20 patients out of the first 28 evaluable are compliant.

* fat-free mass index and muscle mass,
* body protein content,
* metabolic activity index

- Score of Short Physical Performance Battery Test (Score of 0 =Faible performance to 12= Haute performance)

IADL Questionnaire IADL score 0 to 4

* IADL score = 0: dependent
* IADL score = 4 autonomous

QLQ-C30 questionnaire All of the scales and single-item measures range in score from 0 to 100. A high scale score represents a higher response level. Thus a high score for a functional scale represents a high / healthy level of functioning, a high score for the global health status / QoL represents a high QoL, but a high score for a symptom scale / item represents a high level of symptomatology / problems.

Questionnaire BREQ-2 The BREQ-2 is a 19 item questionnaire that measures the stages of the self-determination continuum with respect to motivation to exercise with a 5 point Likert scale (0=not true for me, 4=very true for me)

Perception of effort with te Borg scale CR10.

Scale of 0 (No exertion at all) to 10 (representing an extreme intensity of activity)

Visual analog scale (0 = no pain and 10 = very severe pain)

Visual analog scale (0 = no fatigue and 10 = very severe fatigue)

Number of sessions carried out out of the number planned

Likert scale (0= unsatisfiedt o 5 =very satisfied)

Centre Hospitalier Universitaire de Besancon

Heart and Blood Diseases

Thrombosis

Thromboembolism

Venous Thromboembolism

Venous Thrombosis

Embolism

Embolism and Thrombosis

Vascular Diseases

Fibrinolytic Agents

Anticoagulants

Bone Density Conservation Agents

Anti-Infective Agents

Amino Acids

Heparin

Enoxaparin

Calcium heparin

Heparin, Low-Molecular-Weight

Tinzaparin

Dalteparin

PENTA

Fondaparinux

Enoxaparin sodium

Calcium

Calcium, Dietary

Factor Xa Inhibitors

Antithrombins

Antithrombin III

Protease Inhibitors

Serine Proteinase Inhibitors

HIV Protease Inhibitors

Enzyme Inhibitors

Serine

Healthcare claims records from patients aged 18 years or older with at least one primary inpatient discharge diagnosis of cancer and a cancer-related surgery during the hospitalization

An injectable anticoagulant medication for the prevention of VTE related to cancer surgery. Patients received dalteparin during one day prior to or two days after cancer-related surgery during the hospitalization.

dalteparin

An injectable anticoagulant medication for the prevention of VTE related to cancer surgery. Patients received enoxaparin during one day prior to or two days after cancer-related surgery during the hospitalization.

enoxaparin

An injectable anticoagulant medication for the prevention of VTE related to cancer surgery. Patients received fondaparinux during one day prior to or two days after cancer-related surgery during the hospitalization.

fondaparinux

An injectable anticoagulant medication for the prevention of VTE related to cancer surgery. Patients unfractionated heparin received during one day prior to or two days after cancer-related surgery during the hospitalization.

unfractionated heparin

GSK Clinical Trials

Venous thromboembolism (VTE), including deep vein thrombosis (DVT) and pulmonary embolism (PE), is a common post-operative complication. The effectiveness of fondaparinux compared with other injectable anticoagulants in VTE following major orthopedic and abdominal surgery has been evaluated in database studies; however, the effectiveness of injectable anticoagulant medications following cancer-related surgeries in the practice setting has not been as well documented.

The objective of this study is to analyze patient records from a national hospital database and compare the outcomes and costs between four types of injectable anticoagulant medications that were prescribed for the prevention of VTE following cancer-related surgery. This analysis will assess and quantify the outcomes, resource utilization, and cost of care for patients receiving fondaparinux, enoxaparin, dalteparin or unfractionated heparin. The outcomes of interest include the occurence of VTE, rates of major bleeds, medical resource utilization, and total costs (medical plus pharmacy).

The source of data for this study is the Premier Perspective Database™. This hospital claims database links de-identified inpatient medical, pharmacy, and billing data from more than 500 hospitals.

This study is a retrospective cohort study that uses propensity score matching to adjust for the differences between the numbers of patients treated with each medication.

Comparative Analysis of Injectable Anticoagulants for Thromboprophylaxis Post Cancer-related Surgery

VTE events were identified by International Classification of Disease-9 (ICD-9) codes for deep vein thrombosis (451.xx. 453.xx) and pulmonary embolism (415.xx) during the index hospitalization. Results will be calculated, reported as unadjusted, and adjusted to control for the effect of covariates on outcomes

Major bleeding events were identified according to ICD-9 codes for major bleed (568.81, 430.xx, 431.xx, 432.xx, or 998.11) or other bleeding accompanied by more than 2 units of blood transfused (246.3, 286.5, 287.3, 287.4, 287.5, 287.8, 287.9, 459.0, 530.82, 569.3, 578.x, 596.7, 599.7, 719.1, 784.7, 784.8, 786.3, 958.2, or 997.02) as recorded in the billing file during the index hospitalization plus 1 month post discharge. Results will be calculated, reported as unadjusted, and adjusted to control for the effect of covariates on outcomes.

Readmission rates were defined as a subsequent hospitalization for major bleeding or VTE that occurred within the follow-up period (discharge month plus 1 month).

Length of hospital stay was obtained from the discharge record and was defined as the number of days from patient admission to the hospital for cancer-related surgery until discharge from the hospital.

The mean total costs (medical plus pharmacy costs) from patient records in each antithrombotic cohort from the index hospitalization. Results will be calculated, reported as unadjusted, and adjusted to control for the effect of covariates on outcomes.

VTE events were identified according to ICD-9 codes for DVT and PE during the index hospitalization plus 1 month post discharge. Results will be calculated, reported as unadjusted, and adjusted to control for the effect of covariates on outcomes.

Major bleeding events were identified according to ICD-9 codes for hemoperitoneum bleed, intracranial hemorrhage/hemorrhagic stroke, hemorrhage complicating a procedure, or other bleeding accompanied by more than 2 units of blood transfused as recorded in the billing file during the index hospitalization plus 1 month post discharge. Results will be calculated, reported as unadjusted, and adjusted to control for the effect of covariates on outcomes.

The mean total costs (medical plus pharmacy costs) from patient records in each antithrombotic cohort from both the index hospitalization and the 1-month follow-up period. Results will be calculated, reported as unadjusted, and adjusted to control for the effect of covariates on outcomes

GlaxoSmithKline

Respiratory Tract (Lung and Bronchial) Diseases

Symptoms and General Pathology

Neoplasms

Digestive System Diseases

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Rare Diseases

Lung Diseases, Obstructive

Pulmonary Disease, Chronic Obstructive

Stomach Neoplasms

Lung Neoplasms

Lung Diseases

Urinary Bladder Neoplasms

Respiratory Tract Diseases

Chronic Disease

Disease Attributes

Respiratory Tract Neoplasms

Thoracic Neoplasms

Urologic Neoplasms

Urogenital Neoplasms

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Urinary Bladder Diseases

Urologic Diseases

Male Urogenital Diseases

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Stomach Diseases

Chronic Graft Versus Host Disease

Stomach Cancer

Nicotine

Smokers of e-cigarettes containing nicotine only (non smoking traditional cigarettes and inhaling at least 50 puffs per week since six or more months). This group will be further split in the secondary analyses: never or former smokers of traditional cigarettes

Smokers of traditional cigarettes only (smokers of at least one traditional cigarette per day since six or more months). This group will be further split in the secondary analyses: recent and older smokers.

Smokers of both electronic and traditional cigarettes (at least one per day since six or more months). This group will be further split in the secondary analyses: mixed smokers who quit and who did not quit traditional cigarette smoking during follow-up

Lamberto Manzoli, MD, MPH

The main aim of this multicentric 5-year follow-up study is to evaluate for the first time the long-term efficacy and safety (in terms of smoking-related serious diseases requiring hospitalization) of e-cigarette smoking, comparing its health effects with those of traditional cigarette smoking and mixed electronic and traditional cigarette smoking.

The study will also permit to evaluate, over a 5-year follow-up, the self-reported quality of life, and the reported adverse events according to current and past smoking habit.

Finally, the study will also explore the long-term adherence to e-cigarette smoking and its efficacy of e-cigarettes in reducing and/or quitting traditional cigarette smoking.

The Efficacy and Safety of Electronic Cigarettes: a 5-year Follow-up Study

Multicentric 5-year Follow-up Study to Assess the Efficacy of E-cigarettes as a Tool for Smoking Cessation and to Compare the Risk of Smoking-related Diseases Among Electronic and Traditional Cigarette Smokers, and Smokers of Both.

Percentage of subjects that were current (in TC and Mixed groups) or former (in EC group) smokers reporting sustained smoking abstinence from traditional cigarette smoking at 60 months. Smoking abstinence is defined as complete abstinence from tobacco smoking (not even a puff) for the 30 days period prior to the visit. This outcome will be self-reported and checked using CO analyzer after breath.

Change in the average self-reported number of traditional cigarette smoked per day.

Percentage of subjects who had a hospital admission for one of the followings: cardiovascular diseases, chronic obstructive pulmonary diseases, cancer of the lung, esophagus, larynx, oral cavity, bladder, pancreas, kidney, stomach, cervix, and myeloid leukemia. Repeated admissions of the same subject will be counted once.

Mean number of hospital admissions for one of the followings: cardiovascular diseases, chronic obstructive pulmonary diseases, cancer of the lung, esophagus, larynx, oral cavity, bladder, pancreas, kidney, stomach, cervix, and myeloid leukemia. Each admissions of the same subject will be counted.

Mean number of hospital admissions for cardiovascular diseases. Each admissions of the same subject will be counted.

Mean number of hospital admissions for cancer of the lung, esophagus, larynx, oral cavity, bladder, pancreas, kidney, stomach, cervix, and myeloid leukemia. Each admissions of the same subject will be counted.

Change in the average quality of life according to EuroQol EQ-D3.

Time to hospital admission for one of the followings: cardiovascular diseases, chronic obstructive pulmonary diseases, cancer of the lung, esophagus, larynx, oral cavity, bladder, pancreas, kidney, stomach, cervix, and myeloid leukemia. Repeated admissions of the same subject will be counted once and the subject will be censored at the date of the first admission.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Care Transition Intervention for Hospitalized Patients With Advanced Cancer	NCT05142345	Cancer Follow-Up Care Consultation, R... Advanced Cancer	CONTINUUM Inter... Usual Care	18 Years -	Massachusetts General Hospital
Place of General Medical During Oncology Care Management	NCT03416465	Oncologic Disor...	medical questio...	18 Years -	Institut de Cancérologie de Lorraine
Effectiveness of Hospital Fit on Physical Activity of Hospitalised Patients	NCT05378724	Cardiovascular ... Oncology Activation, Pat...	Hospital Fit 2....	18 Years -	Maastricht University Medical Center
Behavioral Coaching Intervention (Laguna Health) for Patients With Cancer	NCT06004141	Cancer	Laguna Health	18 Years -	Massachusetts General Hospital
Effectiveness of Hospital Fit on Physical Activity of Hospitalised Patients	NCT05378724	Cardiovascular ... Oncology Activation, Pat...	Hospital Fit 2....	18 Years -	Maastricht University Medical Center
Study Evaluating the Feasibility of an Adapted Physical Activity Program During the Hospitalization Phase in Cancer Patients Undergoing Treatment	NCT06321744	Cancer	adapted physica...	18 Years -	Centre Hospitalier Universitaire de Besancon
Comparative Analysis of Injectable Anticoagulants for Thromboprophylaxis Post Cancer-related Surgery	NCT01444612	Thrombosis, Ven...	dalteparin enoxaparin fondaparinux unfractionated ...	18 Years -	GlaxoSmithKline
Study Evaluating the Feasibility of an Adapted Physical Activity Program During the Hospitalization Phase in Cancer Patients Undergoing Treatment	NCT06321744	Cancer	adapted physica...	18 Years -	Centre Hospitalier Universitaire de Besancon
The Efficacy and Safety of Electronic Cigarettes: a 5-year Follow-up Study	NCT01785537	Cardiovascular ... Chronic Obstruc... Cancer of the L... Cancer of the B... Cancer of the S...		30 Years - 80 Years	Università degli Studi 'G. d'Annunzio' Chieti e Pescara
Finite Element Study of Biomechanical Changes After Unilateral Hemilamina and Facet Joint Resection of Cervical Spine	NCT04957056	Intraspinal Tum...	Hospitalization	18 Years - 35 Years	Peking University Third Hospital

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