Anti-Infective Agents

Central Nervous System Depressants

All Drugs and Chemicals

Ethanol

Adult cancer survivors (until 74 years old) who have completed their heavy treatments (chemotherapy, radio-chemotherapy, ...) and that are taking part in the "JUMP post-cancer day" which is a multidisciplinary evaluation carried out at the end of treatments.

They must not have cognitive disorders that limit their ability to understand and complete the questionnaire. Also, they have to speak, read and write French language.

The study will be presented to the patient who can refuse to participate. The digital version of the questionnaire will be handed out, if the patient does not object after a period of thinking, when he or she comes to the day hospital for his or her JUMP Day. The study will therefore take place at a single point in time, and no pre-inclusion or follow-up visits are planned as part of this protocol.

Completing the questionnaire takes about 15 to 20 minutes. All questions are designed to meet the stated objectives. No personally identifiable data is collected.

The study will be presented to the patient who can refuse to participate. The digital version of the questionnaire will be handed out, if the patient does not object after a period of thinking, when he or she comes to the day hospital for his or her JUMP Day. The study will therefore take place at a single point in time, and no pre-inclusion or follow-up visits are planned as part of this protocol.

Completing the questionnaire takes about 15 to 20 minutes. All questions are designed to meet the stated objectives. No personally identifiable data is collected.

Adult cancer survivors who have completed their heavy treatments

Justine STOLTZ

* Cancer is now becoming a chronic condition though it was, until a short time ago, a fatal illness. Thus, according to the French national cancer institute, nearly 4 million French people have been diagnosed with cancer in their lifetime.
* Screening is used to detect the presence of a pathology at an early, infra-clinical stage, or the presence of a risk factor in people who are supposedly healthy.
* There are three organized screening programs in France (breast cancer, colorectal cancer, cervical cancer), as well as many others recommended by learned societies such as the National Authority for Health . However, they are underused, far from European recommendations and government targets.
* According to DREES (research, studies, evaluation and statistic department), public health and primary prevention interventions could have prevented 143 deaths per 100.000 inhabitants, and healthcare interventions could have spared 59 deaths per 100.000 inhabitants, for a total of 202 avoidable deaths per 100.000 inhabitants in France in 2020.
* As for cancers, French national cancer institute estimates the rate of avoidable cancers in France in 2023 at 40%. Breast cancer, for example, is the most common cancer that can be associated with alcohol consumption and estimations suggest that nearly 20.000 breast cancers could be prevented each year (a third of new cancer cases in 2018).
* In France, prevention accounts for 5.5% of healthcare expenses in 2021, with 46% for individual primary prevention, 41% for individual secondary prevention and 12% for collective prevention and prevention programs. These healthcare expenses must be set against the social cost of each risk factor, to see how important they are.
* Relative burden of cancer and noncancer mortality among long-term survivors of breast, prostate, and colorectal cancer in the US has been demonstrated. It shows that "patients with low oncologic risk at the time of diagnosis had at least 3-fold higher risk of noncancer death compared with death from the index cancer".
* In France, medical desertification is a reality. Now, according to the VICAN-5 study, nearly a third of cancer patients are not followed up by general practitioners. Though primary prevention is one of GP's prerogatives and a governmental priority.
* There is a high interest in screening and preventive action to limit the risk of other avoidable pathologies, whether cancerous or not.

The research hypothesis is that a customized screening will enable the implementation of comprehensive preventive action to limit the onset of avoidable diseases (second cancer or other pathology) for cancer survivors.

Study of Health-risk Behaviours (Tobacco, Alcohol or Drug Consumption ; Nutrition ; Sedentary Lifestyle ; Sexual Practices) Among Cancer Survivors

Modifiable health risk behaviors are: tobacco, alcohol or drug consumption ; nutrition ; sedentary lifestyle ; sexual practices.

Hospices Civils de Lyon

Symptoms and General Pathology

All Conditions

Fatigue

Individuals in the BfitBwell Cancer Exercise Program complete a FACIT-Fatigue questionnaire at their baseline assessment. This will be screened for all incoming BfitBwell participants and those meeting the inclusion criteria of a score of 48 or less will be approached for interest in participating. The primary research activities beyond recruitment, screening, and informed consent are the collection of EMA fatigue assessments via smartphone application and PA assessment via actigraphy.

Jared Scorsone

Ryan Marker, PhD, PT

This is an investigation of possible relationships between daily physical activity (PA) and different measurements of fatigue in cancer survivors participating in a cancer exercise program.

This is an investigation of possible relationships between daily physical activity (PA) and different measurements of fatigue in cancer survivors participating in a cancer exercise program. Results will inform exercise prescription and timing to best reduce fatigue, as well as methodology for measuring fatigue. Participants will answer several daily questions on fatigue using a smartphone application during the 3 month exercise program and wear a PA monitor for 10 days during the first month and last month of the program.

Relationships Between Physical Activity and Different Measures of Fatigue in Cancer Survivors

Measures of fatigue are collected electronically. Tools utilized to collect these outcomes: REDCap and the LifeData smartphone application.

* REDCap: REDCap is a secure, university supported and approved data collection tool. Links to complete the standardized questionnaires of fatigue (FACIT-Fatigue and MFI) will be emailed to participants with regular reminder emails sent daily until completed.
* LifeData: LifeData is a secure research platform used by previous research studies involving EMA (https://www.lifedatacorp.com/customer-publications/). The application will send a smartphone notification to collect data at random timepoints in predefined windows, and allow participants to self-initiate data entry. Participants will not enter any identifying information and will instead be assigned a de-identified research IDd. Linking documentation of participant to this ID will be stored solely on university servers. LifeData will be utilized to collect the EMA assessments of fatigue.

Severity of fatigue experienced over the course of the day, ranked 0-10. How would you rate your fatigue, over the last day, on a scale of 0-10, with 0 being no fatigue and 10 being the worst possible fatigue?

PA will be monitored using commonly used, non-invasive Actigraph devices (Actigraph GT3XP). Data will be collected utilizing methodology similar to that of the National Health and Nutrition Examination Survey (NHANES), in cancer survivors. The collected accelerometry data will be downloaded and analyzed in ActiLife software, calculation the average time spent in moderate-to-vigorous (MVPA) at each assessment period using standard algorithms and cut-points.

As all participants are recruited from active members of BfitBwell Cancer Exercise Program, additional data will be extracted from program documents which are regularly administered and collected by the BfitBwell Program. Administration/collection will not change for study participants. Physical assessment measures are obtained from a physical assessment and electronic questionnaire.

National Cancer Institute (NCI)

University of Colorado, Denver

Behaviors and Mental Disorders

Quality of Life

Children in cancer remission sent to ordinary schools: primary (3rd, 4th, 5th grade) and middle (6th, 7th grade) schools.

Children (not in cancer remission) sent to ordinary schools (age and sex matched): primary (3rd, 4th, 5th grade) and middle (6th, 7th grade) schools.

SPP questionnaire (Self Perception Profile for Children), Systemic inventory of life quality for children (ISQV-E), Anxiety questionnaire (STAI-C), Depression questionnaire (CDI)

Questionnaires

Pascal Chastagner, Pr

Fabienne Lemétayer

Few data about the evaluation of consequences of past life with cancer on life quality of children in school reintegration are available in literature. Nevertheless, some of these studies show that the reintegration impairs life quality of these children (school difficulties, conflictual relations with peers...). The hypothesis is that children with past life with cancer have more chances to have school integration difficulties with a consequent life quality degradation compared to healthy children.

The main objective of this project is to study the relation between the satisfaction of school reintegration of children in cancer remission and the evolution of life quality in the medium term (after getting back to school). More exactly, it is the question if the satisfaction of school reintegration influences life goals and priorities of these children.

The secondary objective is to study the role of psychological status of these children (anxiety, depressive symptoms) on satisfaction-life quality relation.

A group of children with cancer history sent to ordinary school is compared to a control group of children sent to school in the same conditions (sex and age matched). Data are collected with questionnaires some months to several years after school reintegration and same questionnaires 1 year later.

If the study hypothesis is confirmed, this study will show the necessity of a long term follow up of children in cancer remission and not only medical care, but also psychological and social care, in order to support a better school reintegration.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Study of Health-risk Behaviours (Tobacco, Alcohol or Drug Consumption ; Nutrition ; Sedentary Lifestyle ; Sexual Practices) Among Cancer Survivors	NCT06215365	Cancer Remissio...	Adult cancer su...	74 Years - 100 Years	Hospices Civils de Lyon
Relationships Between Physical Activity and Different Measures of Fatigue in Cancer Survivors	NCT05073848	Cancer Remissio...		18 Years -	University of Colorado, Denver
Life Quality of Children in Cancer Remission During School Reintegration	NCT03240029	Cancer Remissio...	Questionnaires	8 Years - 12 Years	Central Hospital, Nancy, France
Life Quality of Children in Cancer Remission During School Reintegration	NCT03240029	Cancer Remissio...	Questionnaires	8 Years - 12 Years	Central Hospital, Nancy, France
Study of Health-risk Behaviours (Tobacco, Alcohol or Drug Consumption ; Nutrition ; Sedentary Lifestyle ; Sexual Practices) Among Cancer Survivors	NCT06215365	Cancer Remissio...	Adult cancer su...	74 Years - 100 Years	Hospices Civils de Lyon

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