Symptoms and General Pathology

All Conditions

Death

Questionnaire completed by the parents Interview with the parents and the psychologist (University Rennes 2)

Questionnaire and interview

Guillaume Robert

Cancer is the second cause of over-one-year-old children mortality after accident. Survival rate is more than 70%, but in some cases, curative treatments are not sufficient and palliative support is implemented for those children in end of life.

Pediatric guidelines about the place of end-of-life care are varied. On European scale, home is recommended (IMPaCCT study, 2007). In France, the 2008-2012 palliative care development program recommended home or initial hospital care unit. This program also supports implementation of mobile team rather than specific hospital units.

In Brittany, a pattern of regional palliative care resource team has been implemented since 2005. In oncology, further to the guidelines, end-of-life place of care is often discussed several times for each case. Sometimes occur a lot of returns between home and hospital, psychological difficulties, and difficulties to offer adapted care conditions. Finally, less than 30% of children in palliative care decease at home.

The primary objective is to identify main determinants of the place of palliative care in pediatric oncology.

The secondary objective is to clarify the factors of change comparing to the initial planned place.

Intervention :

Questionnaire completed by the parents Interview with the parents and the psychologist (University Rennes 2)

Number of subjects is : Parents of 68 to 93 children who died from cancer after a palliative phase, that means 136 to 186 parents.

Expected results and perspectives :

Using both quantitative and qualitative methods, expected results are the followings:

* Identification of the objective and subjective factors, which influenced the decision of the place of care.
* Determination of the factors of change comparing to the initial planned place.

Once identified, main factors could be the ones to pay attention to in order to help for initial decision, better anticipation of change of place and better guidance of palliative care organization wherever, at home or in hospital.

Results would be new information for research on palliative care for children but also for adults.

Finally, this work is part of an improving approach of palliative care, related to the development of open-care hospital networks. We can expect some public health impacts with new arguments to help for complementary recommendations.

Eligibility criteria :

Inclusion criteria are :

Parents of a deceased child

* From cancer, after palliative phase
* Age of death under 18 years old.
* Death occurred in Brittany
* Death between 2005 and 2010

Exclusion criterium is :

Parents of child who deceased after 2010 (respecting a bereavement delay)

Outcomes measures :

Primary study endpoint : Consideration or not by parents that they and/or their child had the choice of the end-of-life place of care.

Secondary study endpoints :

* objective factors : grade, occupational categories, marital status of parents, siblings, home conditions, access to the hospital, meeting with a professional of palliative care network, helpful general practitioner, volunteers, psychological support but also unexpected symptoms, needed nursing care which can explain a return from home to hospital for instance.
* subjective factors such as family or religious values, needs of intimacy, communication, support, sense of security, anxiety, fear, doubts about the next events.

Determinants of End-of-life Place of Care for Children Suffering From Cancer.

DELI-DEVI : Determinants of End-of-life Place of Care for Children Suffering From Cancer.

Consideration or not by parents that they and/or their child had the choice of the end-of-life place of care.

Objective factors : grade, occupational categories, marital status of parents, siblings, home conditions, access to the hospital, meeting with a professional of palliative care network, helpful general practitioner, volunteers, psychological support but also unexpected symptoms, needed nursing care which can explain a return from home to hospital for instance

Subjective factors such as family or religious values, needs of intimacy, communication, support, sense of security, anxiety, fear, doubts about the next events.

University of Rennes 2

Rennes University Hospital

Analgesics

Central Nervous System Depressants

All Drugs and Chemicals

Morphine

Control group participants will be recruited from the cancer patients in need of palliative care at Tata Medical Center (TMC), Kolkata, India. Participants will be recruited and consented by TMC researchers. There will be random allocation to the "control" or "Pal-Care" group. The control group (n=45) will receive "usual care" palliative services in which the patient or caregiver (by proxy) must visit the Tata Medical Center (TMC) cancer center for care. TMC services include consultation with a multi-disciplinary team (oncologist, nurse, psychologist), a 21-day morphine supply at reduced cost (as morphine is regulated in use),basic training on medication usage, catheter and wound care, other topics as relevant,and psychological counseling. Patients (or their proxy) must return to the cancer center as needed for follow up care and they are provided a 24/7 hotline to call in case of emergency.

Intervention group participants will be recruited from cancer patients in need of palliative care at Tata Medical Center (TMC), Kolkata, India. Pal-Care will be delivered over a 6-month period. At baseline visit, the patient and their caregiver will meet with their community health worker (CHW) and clinical team and an individualized care plan will be created. Patients will be assigned to the CHW living nearest to their home. The CHW will make home visits to patients 1+ times weekly, depending on patient need. At each visit, the CHW will use resources from the WHO Palliative Care Toolkit to: 1)monitor patient condition, 2) provide basic palliative care (medication administration, wound care, catheter care), 3) deliver prescribed morphine, 4) teach caregivers to deliver care,5) monitor pain and symptom control, and 6) assist patients to access their oncologists and other resources. Timely communication between CHW and clinical team will be maintained using a tele-health platform.

Semi-structured interviews of stakeholder groups will be conducted by MUSC researchers who are well-trained and speak the local language, to evaluate the Pal-Care intervention. We will conduct 20 key informant interviews/KIIs (or until saturation is reached), representing Pal-Care clinical team members, CHWs and patients/caregivers, who participated in the intervention at TMC, India. Clinicians will include social workers, oncology nurses, cancer center administrators, counselors, and palliative care oncologists. Patients/ caregivers will be purposefully selected to represent experiences across different cancers, clinical problems and assigned CHWs. Interviews will be performed in-person or over a telehealth platform, as needed. Interviews will query barriers, facilitators, optimal strategies, experiences, needs and expectations for palliative care delivery. Interviews will be digitally recorded, transcribed and analyzed.

Pal-Care intervention participants will receive a 6-month intervention based upon the WHO toolkit and it will be delivered by the community health workers (CHWs). The goal of this pragmatic clinical trial is to test and evaluate a home-based palliative care intervention for utilizing community health workers to facilitate the delivery of palliative care to cancer patients in rural India. More details provided in the "intervention" arms section. After the intervention, clinicians, CHWs and a purposefully selected set of patients/caregivers, who were involved in the Pal-Care will be interviewed to understand their experiences, needs, expectations, barriers, facilitators and strategies.

Pal-Care

The control group will receive "usual care" palliative services in which the patient or caregiver (by proxy) must visit the Tata Medical Center (TMC) cancer center for care. TMC services include consultation with a multi-disciplinary team (oncologist, nurse, psychologist), a 21-day morphine supply at reduced cost (as morphine is regulated in use),basic training on medication usage, catheter and wound care, other topics as relevant,and psychological counseling. Patients (or their proxy) must return to the cancer center as needed for follow up care and they are provided a 24/7 hotline to call in case of emergency.

Control-Usual Care

Melissa Butcher, MPH

Gaurav Kumar, MD

Suparna Qanungo, PhD

The goal of this pragmatic clinical trial is to test and evaluate a home-based palliative care intervention for utilizing community health workers to facilitate the delivery of palliative care to cancer patients in rural India. The study builds upon use of the World Health Organization-endorsed "Palliative Care Toolkit," which provides a comprehensive suite of evidence-based materials for delivering palliative care in limited resource settings. For the intervention, two specific aims will be addressed to evaluate: 1) implementation of the intervention within the context of the RE-AIM Framework and 2) outcomes of this intervention to determine its relative effects compared to a standard control group on patients' palliative care needs, symptom burden, quality of life (QOL) and experience with care.

This pragmatic clinical trial is a collaboration between the Medical University of South Carolina (MUSC)and Tata Medical Center (TMC), a cancer center in Kolkata, India. The study has two parts: a) Implementation of a Pal-Care intervention as compared to control/no intervention b) Qualitative post-intervention evaluation.

The part a) of the study is conducted at Tata Medical Center (TMC) in Kolkata, India, under the supervision of the site PI, Dr. Gaurav Kumar. All participants will be recruited from among the TMC patients who are referred to cancer palliative care and will be grouped to the "Control" or "Pal-Care" intervention groups. This part of the study will compare an intervention group of patients who will receive home-based palliative services (Pal-Care)from community health workers (CHWs) vs. a control group of patients who will receive cancer-center based palliative services. This intervention implementation part of the study is approved by TMC Ethics Board and Indian Council of Medical Research (ICMR), approval letter on file with MUSC IRB. MUSC relies on TMC IRB for this part and the ICF document is approved by the TMC Ethics Board in India.

The part b) of the study (under purview of MUSC IRB) involves post-intervention qualitative interviews. MUSC research team will evaluate the implementation and effect of the Pal-Care intervention to deliver CHW navigated home-based palliative care for rural cancer patients in India. The participants of this part of the study will also be from India and include stakeholders, representing all Pal-Care clinical team members and CHWs and patients/caregivers who participated in the Pal-Care intervention. This part has a waiver of signed consent.

The RE-AIM framework guides our evaluation plan to measure the reach, effectiveness, adoption, implementation and maintenance of the Pal-Care intervention. Diverse data sources will be used to evaluate the intervention within the REAIM Framework.

R21 India Pal-Care Evaluation

Implementation of Home-Based Palliative Care in Limited Resource Settings

MUSC researchers have access to ONLY de-identified data. All source documents and identifiers are with Dr. Gaurav Kumar, Site PI at TATA Medical Centre, Rajarhat, Kolkata, India

Quality of Life will be will be assessed with the 26-item WHO QOL-BREFF Scale that addresses 4 QOL domains (physical, psychological, social relationships and environment. Items are rated on a 5-point Likert scale (low score of 1 to high score of 5; higher score indicating higher QOL).

Multidimensional palliative care outcomes will be measured with Palliative Care Outcomes (POS) Scale that that measures physical and psychological symptoms; spiritual, practical and emotional concerns; and psychosocial needs of patient/family on a 5-point likert scale (0-4, with a higher score indicating higher symptom burden or concern).

National Cancer Institute (NCI)

Tata Medical Center, Kolkata, India

Medical University of South Carolina

Associate Professor

Neoplasms

Skin and Connective Tissue Diseases

Digestive System Diseases

Gland and Hormone Related Diseases

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Nervous System Diseases

Rare Diseases

Breast Neoplasms

Triple Negative Breast Neoplasms

Pancreatic Neoplasms

Ovarian Neoplasms

Carcinoma, Ovarian Epithelial

Brain Neoplasms

Pancreatic Cancer

Ovarian Cancer

Ovarian Epithelial Cancer

Anti-Inflammatory Agents

Antirheumatic Agents

Hypoglycemic Agents

Anti-Infective Agents

Antineoplastic Agents

Lipid Regulating Agents

Herbal and Botanical

Ibuprofen

Metformin

Doxycycline

Mebendazole

Atorvastatin

Hydroxymethylglutaryl-CoA Reductase Inhibitors

Anticholesteremic Agents

Hypolipidemic Agents

Antimetabolites

Enzyme Inhibitors

Anti-Bacterial Agents

Antimalarials

Antiprotozoal Agents

Antiparasitic Agents

Anthelmintics

Tubulin Modulators

Antimitotic Agents

Cola

Subjects will take the following treatments and have their data collected from their medical records every 3 months.

* Oral atorvastatin up to 80mg uid, for study duration.
* Oral metformin up to 1000mg uid, increased to bid if tolerated after 2 weeks, for study duration.
* Oral doxycycline 100mg uid, for study duration.
* Oral Mebendazole 100mg uid, for study duration.

While subjects are being treated with the four metabolic drugs, every 3 months they will bring in their medical records and data will be collected to determine the effect of the intervention

Metabolic treatment

Samir Agrawal, MRCP FRCPath

The purpose of this study is to determine the effectiveness of a regimen of selected metabolic treatments for patients with cancer in a real world setting and to conduct exploratory analysis on the relationship between the degree of response and changes in biochemical markers (such as glucose and lipid levels).

\*This study has been designed to collect data prospectively and to retrospectively analyse data on the metabolic treatments within the cancer clinic. The retrospective study is ongoing, while the prospective study has not yet started.\*

This is a real world study since this gives the best opportunity to properly examine the effect of multi-drug regimens in representative populations. Including a standard of care arm is inappropriate, in a population in which that standard of care has already been shown to be ineffective or intolerable.

Patients will be sent to the study clinic directly by their Health Care Professionals ("HCP's") .

The study will consist of a pre-screening visit to determine eligibility for inclusion into the study, an initiation visit and then a follow up visit every three months thereafter. If required, unscheduled visits may take place. Day 0 (baseline) for each patient will be the initiation visit when study treatment is started.

Prior to conducting any study-related procedures, subjects will provide written informed consent, eligibility will be assessed, a medical history and past medical records will be taken and vital signs will be measured. These records will include the stage of their disease, response to previous cancer therapy, their prior and current medications and any specific regimen they are currently on for their cancer. If prior medical records do not contain sufficient information to determine a baseline for the patient, additional blood tests and scans will be undertaken as appropriate.

Patients will be monitored quarterly thereafter when blood tests (e.g. safety parameters, glucose, cholesterol, immune response and cancer markers where applicable) and scans (where applicable) will be taken.

All patients will be on the same drug regimen (see below) at the same doses throughout the study. All patients will be followed up until they choose to leave the study, or death.

Data from all patients recruited to the study will be analysed using an Intention-to-treat (ITT) philosophy, so data will be included in the primary analysis irrespective of whether the dose regimen was followed throughout the study. If appropriate, and numbers allow, analysis will also be conducted on the Per Protocol population, comprising those patients who adhere to the regimen as prescribed.

Survival analysis methods will be used to estimate the Overall survival associated with the study regimen for each type of cancer. These estimates will be interpreted in the light of data obtained from the literature, and from eliciting expert opinion. Bayesian methods may be used where appropriate.

Tumour response, where applicable, will be summarised in tables and graphs. Estimates of response rates will be presented for each cancer type with confidence intervals.

The relationship between changes in biochemistry values (glucose, lipids) and efficacy outcomes (Progression Free Survival (PFS), Overall Survival (OS) and HRQoL) will be investigated graphically, or using other methods as appropriate.

Further exploratory analysis to investigate the effects of other factors such as age , ethnic backgrounds , cancer stage, and response to prior therapy, will also be conducted in order to try and characterise the profile of patients most likely to benefit from the study regimen.

The characteristics of patients on the regimen and those who do not stay on the regimen, for whatever reason, will be summarised to see whether there is any observed bias. If appropriate, methods will be used to adjust for any observed bias, for example using propensity scores. OS can then be assessed adjusted for this to try and mitigate for any possible risk of bias which can occur in uncontrolled studies. Furthermore, by enrolling all eligible patients over a specified time frame, it is hoped that the risk of bias should be further reduced. In addition, a large number of patients are expected to participate in the study.

Study of the Safety, Tolerability and Efficacy of Metabolic Combination Treatments on Cancer

A Non Randomised, Non Blinded Real World Trial of the Safety, Tolerability and Effectiveness of Metabolic Medicines for the Treatment of Cancer Compared Against Matched Controls

Adverse events reported by the subject or their HCP.

• Quarterly assessment of routine laboratory tests

Overall survival for all cancer types and for each cancer type (years and months)

Tumour size for all cancer types and for each cancer type. Units of size vary depending on cancer type.

Tumour spread (metastasized) to other tissues/organs, for all cancer types and for each cancer type. This is measured as either 0 for no spread or 1 for confirmed spread.

Tumour number for all cancer types and for each cancer type

Cancer biomarkers for all cancer types and for each cancer type. Units of measurement vary depending on the cancer type. When biomarkers, either alone or in combination with other biomarkers, are raised above normal they are seen as predictive of cancer of progression. If returned to normal are indicative of treatment response.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Determinants of End-of-life Place of Care for Children Suffering From Cancer.	NCT02060578	Cancer	Questionnaire a...	18 Years -	Rennes University Hospital
R21 India Pal-Care Evaluation	NCT04972630	Cancer Palliati...	Pal-Care Control-Usual C...	18 Years - 85 Years	Medical University of South Carolina
Study of the Safety, Tolerability and Efficacy of Metabolic Combination Treatments on Cancer	NCT02201381	Cancer Overall Surviva...	Metabolic treat...	18 Years - 85 Years	Health Clinics Limited
R21 India Pal-Care Evaluation	NCT04972630	Cancer Palliati...	Pal-Care Control-Usual C...	18 Years - 85 Years	Medical University of South Carolina
Study of the Safety, Tolerability and Efficacy of Metabolic Combination Treatments on Cancer	NCT02201381	Cancer Overall Surviva...	Metabolic treat...	18 Years - 85 Years	Health Clinics Limited
Study of the Safety, Tolerability and Efficacy of Metabolic Combination Treatments on Cancer	NCT02201381	Cancer Overall Surviva...	Metabolic treat...	18 Years - 85 Years	Health Clinics Limited

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