Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Breast Neoplasms

Breast Diseases

Skin Diseases

patients treated and monitored for breast cancer under the APA programme

patients treated and monitored for breast cancer who have received recommendations for physical activity

Patients treated and monitored for their breast cancer following the 6-month APA program.

APA Program

Patients treated and monitored for their breast cancer who have received recommendations for physical activity as well as a 6-month activity schedule. To facilitate patient acceptance and participation in this study, patients who will be randomized to the control group will be offered to follow the APA program after one year of inclusion

Recommendations for physical activity

Marie-Eve Rougé-Bugat, MD

Marie-Eve Rougé Bugat

Adapted physical activity (APA) was recognized as a non-drug therapy by the French Health Authority (HAS) in 2011. Very few studies have examined the efficiency of APA programs during the active phase of treatment in cancer patients. The investigators assumed that non-drug therapy such as APA could improve the quality of life and reduces health costs. The main objective of this study is to assess the efficiency of a standardized APA program, as compared to conventional management including simple recommendations for the practice of physical activity in women in phase active breast cancer treatment.

Scientific rationale: The incidence of breast cancer in women is on the rise again over the period 2010-2018. The overall cost of cancer treatment is 16.8 billion euros, including 3.6 billion for drugs alone. The treatments are more and more prolonged, the proportion of anticancer drugs continues to increase with 10% of the amount reimbursed for drugs delivered in pharmacies in 2017.

Adapted physical activity (APA) was recognized as a non-drug therapy by the HAS in 2011. It reduces certain side effects of treatments, as well as certain symptoms linked to the catabolic activity of the disease such as: fat gain, loss of muscle mass, physical deconditioning, fatigue or pain. For breast cancer, a meta-analysis showed that APA following adjuvant therapy may have a beneficial effect on quality of life. The APA shows in particular for breast cancer, a reduction in all-cause mortality as well as specific mortality and a reduction in recurrence.The prescription of APA has been allowed since the 2016 health law but there is no coverage by the French national health insurance fund (CNAM) despite the benefits shown. APA is only accessible in a few centers in France that have chosen to offer it to patients, thus creating social inequalities in health.

Very few studies have examined the efficiency of APA programs during the active phase of treatment. They related to cohorts of 60 to 165 patients and uses different methods. The investigators decided to set up a study that can measure the efficiency of the standardized APA programs offered to patients diagnosed with breast cancer, assuming that non-drug therapy such as APA would improve the quality of life while reducing health costs.

Description of the procedures: The intervention consists of an initial consultation appointment with a medical check-up and physical tests, then inclusion in the standardized APA program for 6 months. The control group will be offered the same initial consultation appointment with medical check-up and physical tests and will receive recommendations for physical practice as well as a calendar of activities to be practiced independently for 6 months. Inclusion in the APA program will be offered one year after inclusion.

Follow-up: The data will be collected at T0, T + 3 months, T + 6 months, T + 9 months and T + 12 months in both arms. There will be 1 year of data analysis.

Health Economic Evaluation of an Adapted Physical Activity Program for Women With Breast Cancer

Health Economic Evaluation of an Adapted Physical Activity Program for Women With Breast Cancer During the Active Phase of Treatment: a Randomized Controlled Trial

Evaluation of the differential cost-utility ratio (cost / QALY), according to the perspective of the community over a 12-month period, of an adapted physical activity program (APA) in comparison to conventional care, including simple recommendations for physical activity for patients with breast cancer during the active phase of treatment.

Breast Cancer Specific Quality of Life Questionnaire (QLQ) (BR23-QLQ-C30) is a 52-item questionnaire. The choices range from 1 "not at all" to 4 "very much".

Progression-free survival measured for non-metastatic (relapse-free survival) and metastatic (progression-free survival) patients

BR23-QLQ-C30 questionnaire.

Breast Cancer Specific Quality of Life Questionnaire (BR23-QLQ-C30) is a 52-item questionnaire. The choices range from 1 "not at all" to 4 "very much".

Number of hours of informal help for basic and instrumental activities of daily life

Patient satisfaction questionnaire (EORTC-IN-PATSAT32) is a 32-item questionnaire. The choices range from 1 "bad" to 4 "excellent".

Traced by the reservation system for adapted physical activity (APA) sessions

Socioeconomic determinants (changes in income, socio-professional category, level of education and family environment)

Annual and 5-year net financial benefit of the systematic implementation of an adapted physical activity (APA) program

University Hospital, Toulouse

Digestive System Diseases

Gland and Hormone Related Diseases

Symptoms and General Pathology

Rare Diseases

Behaviors and Mental Disorders

Pancreatic Neoplasms

Fatigue

Gastrointestinal Neoplasms

Digestive System Neoplasms

Endocrine Gland Neoplasms

Gastrointestinal Diseases

Pancreatic Diseases

Endocrine System Diseases

Pancreatic Cancer

Quality of Life

The control arm corresponds to usual care (without APA), including :

* Weekday hospital chemotherapy (every 7 or 14 days, depending on chemotherapy protocol)
* Evaluation by the oncologist at the usual rate
* Assessment every 8 weeks (TAP scan + CA-19.9)
* Nutritional, psychological and pain management as recommended, according to the usual schedule.

The experimental arm corresponds to usual care, combined with a 16-week APA program.

The APA program consisted of personalized aerobic and resistance exercises, with a weekly remote supervision by an APA professional trainer, and unsupervised sessions with a family member or friend (APA partner).

without APA program

Experimental Arm : chemotherapy + APA program during 16 weeks (aerobic and muscular strength exercises)

APA program

Pascal Hammel, MD

Adapted Physical Activity (APA) program may provide an opportunity to improve symptoms for patients with unresectable pancreatic cancer.

Thereby, it is proposed to conduct an open trial to assess effects of the APA program in such population

The benefit of Adapted Physical Activity (APA) has been demonstrated after cancer diagnosis in term of symptomatic improvement: reducing fatigue, pain and improving the quality of life, psychological and emotional state, and adherence to treatment.

The aim of the study is to assess the effects of an APA program in pancreatic cancer population treated by usual chemotherapy.

200 randomized patients are required.

The program is organized in 16 weeks. During the trial, assessments include: aerobic exercises, muscular strength, six-minute walk test, body composition (bioimpedance, L3 CT-scan), level of physical activity - International Physical Activity Questionnaire - (IPAQ questionnaire), fatigue - Multidimensional Fatigue Inventory - (MFI-20 questionnaire), quality of life - EORTC Quality of Life questionnaire C-30 - (EORTC QLQ-30 questionnaire), depression symptom - Hospital Anxiety and depression scale - (HADS questionnaire), pain (Brief Pain Inventory Short form), and nutritional evaluation (BMI, ingests EVA).

Furthermore, relationships between insulin resistance, insulin secretion, Insulin like Growth Factor 1 (IGF-1) and pancreatic carcinogenesis exist. APA may improve the quality of life in decreasing insulin-resistance, insulin secretion and IGF-1.

Evaluation of an Adapted Physical Activity Program in Patients With Unresectable Pancreatic Cancer

Multicenter, Randomized Study, Evaluation of Adapted Physical Activity Program in Patients With Unresectable, Locally Advanced or Metastatic Pancreatic Cancer

HRQoL at week 16 according to the EORTC Core Quality of Life questionnaire (EORTC QLQ-C30) with three targeted dimensions: global health status, physical function and fatigue.

Nutritional Status will be measured by weigth, Body Mass Index, body composition, EVA ingests, caloric intake and protidic, albumin/prealbumin, inflammation markers (PNN and CRP)

Six minutes walk test, dyspnea scale, Borg scale, muscular pain, strength test with bands and compliance program

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Health Economic Evaluation of an Adapted Physical Activity Program for Women With Breast Cancer	NCT05949983	Breast Neoplasm	APA Program Recommendations...	18 Years -	University Hospital, Toulouse
Evaluation of an Adapted Physical Activity Program in Patients With Unresectable Pancreatic Cancer	NCT02184663	Unresectable Lo... Metastatic Panc...	without APA pro... APA program	18 Years -	GERCOR - Multidisciplinary Oncology Cooperative Group

Spots Global Cancer Trial Database for apa program

Every month we try and update this database with for apa program cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for apa program

Every month we try and update this database with for apa program cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for apa program cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.