Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

All Conditions

Prostatic Neoplasms

Genital Neoplasms, Male

Urogenital Neoplasms

Genital Diseases

Genital Diseases, Male

Urogenital Diseases

Prostatic Diseases

Male Urogenital Diseases

All Drugs and Chemicals

Androgens

patients attend three sessions of therapeutic education

therapeutic education program

Jean-Etienne Terrier, MD

The purpose of the study is to build and assess the feasibility of a therapeutic education program, constructed in collaboration with the urologists of the University Hospital of Saint Etienne. The aim of this therapeutic education program is to delay the onset or to reduce the amplitude of the development of insulin resistance and side effects of androgen deprivation therapy in patients treated with androgen deprivation in the context of an evolutive prostate cancer.

Feasibility Study of an Intervention Therapeutic Education for Patients Treated With Androgen Deprivation

Institut de Cancérologie de la Loire

Central Nervous System Depressants

Other Dietary Supplements

Benzocaine

Tannic Acid

The oral semi-structured interview uses the principles of motivational interviewing (partnership with the patient, no judgment, altruism, evocation) and follow the content of the booklet used in the control group.

The information booklet was designed by the physiotherapists at Cliniques universitaires Saint-Luc and is specifically dedicated to raise patient's awareness about the benefits of physical activity (PA) in the context of cancer.

The physiotherapist discusses and goes through each page of the booklet and involves the patient as much as possible. He demonstrates the exercises proposed in the booklet and then ask the patient to perform them in front of him. The physiotherapist tries to identify the patient's needs and suggests different ways to ensure that the patient has different opportunities to maintain the best possible level of PA

Therapeutic patient education : oral semi-structured interview

The booklet (11 pages): explains why it is important to maintain a good level of PA as part of cancer treatment and reviews the most common side effects of cancer therapy and the relative importance of PA in combating these effects (pages 2-3) ; defines PA, its modalities and possible security precautions (pages 4-5), suggests exercises to be performed oneself and a target intensity to be reached (pages 6-8), provides a roadmap to be completed oneself (pages 9-10), and outlines procedures for joining an exercise medicine group (page 11).

Therapeutic patient education : booklet (passive)

Despite significant evolution of cancer therapies from the early 20th century, these therapies are still associated with toxic effects that negatively impact the patient's performance status, quality of life and survival. The role of physical activity to counteract these side effects is acknowledged. However, cancer patients are often misinformed about the potential benefits of physical therapy during cancer therapy. In this context, the role of therapeutic patient education seems essential.

Because of lack of time, therapeutic patient education (TPE) is often provided via an information booklet. However, the investigators assume that a face-to-face interview results in a greater impact on patient's behavior change (the level of physical activity during cancer therapy, in our case). This research project is designed to challenge this hypothesis. The investigators hypothesize that a brief oral educational session of 30 minutes provided at the very beginning of cancer therapy will enhance the physical activity level of our patients for at least 6 months, i.e. during their cancer therapy.

The investigators aim to compare the effects of two forms of TPE on the patient's PA level. In one of the two forms, TPE is delivered using an information booklet accompanied with a semi-structured oral interview (intervention group), whereas in the other form TPE is only delivered via the booklet (control group). The investigators hypothesize that the brief oral educational session of 30 minutes provided at the very beginning of cancer therapy will enhance the PA level of our patients for at least 6 months, i.e. during their cancer therapy.

The study is designed as a double-blind randomized controlled trial. The primary outcome is the evolution in each group of the PA level (via the international physical activity questionnaire (IPAQ) - long form) between the start of cancer therapy and 6-month follow-up.

Eligible patients will be randomly assigned either to the intervention group (TPE includes the information booklet + the semi-structured oral intervention provided by a physiotherapist) or to the control group (TPE will consist only in the information booklet). Patients and assessors will be blinded.

The relative efficacy of these 2 treatment arms will be evaluated at baseline, after 3 months at a visit for a follow-up medical consultation set by the oncologist, and after 6 months at a second follow-up consultation.

Effect of an Oral Therapeutic Patient Education Session on Physical Activity in Patients With Cancer

Effect of a Brief Therapeutic Patient Education Session on Physical Activity in Patients at the Onset of Cancer Therapy: A Randomized Controlled Trial

The PA level will be estimated in MET/h/week via the International Physical Activity Questionnaire (long form) validated in French in subjects aged 18-84 years.

The questionnaire classifies the subject according to 3 activity levels: inactive, moderate, high

Body mass index (BMI) is measured as weight (kg) divided by height is meters squared (m²)

Fatigue is measured via the Functional Assessment of Chronic Illness Therapy - Fatigue scale (FACIT-F).

The scale is a 40-item measure that assesses self-reported fatigue and its impact upon daily activities and function.

The total score range from 0 to 160. The lower the score, the higher the fatigue.

Quality of life is measured via the European Organization for Research and Treatment of Cancer quality of life questionnaire (EORTC QLQ-C30).

The QLQ-C30 is composed of both multi-item scales and single-item measures. There are 30 items. These include five functional scales, three symptom scales, a global health status / QoL scale, and six single items. All single-item measures range in score from 0 to 100.

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, A high score for a symptom scale / item represents a high level of symptomatology / problems.

Exercise capacity is measured via the 1-minute sit-to-stand test

Handgrip strength test is measured via the JAMAR dynamometer

The number of steps taken weekly via an application (ITO) downloaded on the patient's phone

The proportion of patient who started a program of exercise medicine will be calculated in each group

Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Principal Investigator

Skin and Connective Tissue Diseases

Breast Neoplasms

Breast Diseases

Skin Diseases

Patients follow the classic support prescription of hormonotherapy

Patients follow the 4 sessions of PEP hormonotherapy. The therapeutic education prgram is led by a trained educational team, inside a prevention center : Hygée centre.

Aurélie Bourmaud, MD

The purpose of this study is to evaluate the feasibility and the effectiveness of a patient education program on patients' adherence to adjuvant hormone therapy (anti-estrogen or aromatase inhibitors) for breast cancer, in collaboration with teams of sociologists, patient education and medical oncologists.

Therapeutic Education Intervention in Breast Cancer: PEPs Hormonotherapy

Development and Evaluation of a Therapeutic Education Intervention Focused on the Accession of Patients Treated With Hormonal Therapy in the Management of Breast Cancer: PEPs Hormonotherapy

compliance measure with prescription refillment and questionnaire. At the inclusion and at the end of the study

measure of the patients' competence with a specific questionnaire of scenarii

Measuring the level of knowledge of patients with a specific quizz

Measuring the level of patient anxiety with HAD scale

Measuring the level of confidence with a visual analogic scale

quality of life evaluated with the EQ-5D questionnaire

Symptoms and General Pathology

Fatigue

Patients receive tailored program of physical exercises and nutritional counseling during the course of adjuvant treatments (CT followed by RT, 27 weeks).

Tailored program of PA and nutritional counseling

Cancer-related fatigue is by far the most common symptom affecting cancer patients. Combining regular dietary counseling and tailored physical activity is associated with reduced cancer-related fatigue and can improve quality of life and body weight control. We propose to conduct a randomized controlled trial which purpose is to evaluate the effect of an intervention combining physical exercise and nutritional therapeutic education on cancer-related fatigue. To gain behavioral change towards PA and nutrition habits, interventions will take place within hospitals, on the same days of adjuvant treatments.

Effect of a Tailored Program of Physical Activity and Nutritional Counseling on Fatigue Reduction in Breast Cancer Patients Receiving an Adjuvant Treatment

A Randomized Controlled Trial to Evaluate the Effect of a Tailored Program of Physical Activity and Nutritional Counseling on Fatigue Reduction in Breast Cancer Patients Receiving Adjuvant Treatment.

Subjective fatigue is measured using the Multidimensional Fatigue Inventory (MFI-20) questionnaire

Quality of life is measured by the EORTC QLC-C30 questionnaire

Anxiety/depressive symptoms is measured by the HADS questionnaire

Physical activity level is measured by the GPAQ questionnaire

Attention fatigue is measured usingt the TAP 2.2 software

Body Mass Index is calculated using bodyweight and length measurements

Body composition (fat mass/fat-free mass ratio) is assessed by dual-energy X-ray absorptiometry (DEXA)

Institut du Cancer de Montpellier - Val d'Aurelle

Pain

Daily 15-min yoga sessions at home during 12 weeks. One 90-min yoga-therapeutic education session/week (during 6 weeks).

Daily 15-min yoga sessions at home with the "Le guide du yoga" and the audio-guide, during 12 weeks.

One 90-min yoga-therapeutic education session/week (during 6 weeks) given by a physical therapist trained to postural yoga.

educational yoga program

Kerstin FARAVEL

As much as 45 to 60% of patients treated with hormonotherapy (HT) for breast cancer (BC) suffer from osteoarticular pain during treatment. Secondary effects have become a real issue because of their consequences on the patients' quality of life, but also on treatment efficacy and survival when they induce dose reduction or premature withdrawal of treatment.

Additional medicines (acupuncture, hypnosis, yoga) have become more and more popular these last years. 48 to 80% of patients with BC eventually choose them. A review comparing efficacy of various therapies to decrease osteoarticular pain concludes to a highest efficacy of anti-inflammatory treatments, paracetamol and yoga.

With this project, the investigators will assess the feasibility of a therapeutic yoga program with home practice for patients with breast cancer treated with hormonotherapy. The investigators will measure adhesion of the patients to perform yoga postures in an autonomous manner. Our study will also allow collection of data on the effect of such a program on quality of life, in view of setting-up an intervention study.

Numerous initiatives have started in France, often associative. It is essential to evaluate in a rigorous manner, these therapies before making them part of the patient's care pathway.

Yoga has shown a real benefit in terms of pain reduction in patients with BC treated with HT. These osteoarticular pains are the secondary effect on which a physical therapeutic care can have a real benefit.

It thus appears innovative to complete this care with a therapeutic education program (TEP) in postural yoga which will enable patients to practice yoga postures at home by themselves. Yoga allows a large adaptation to pains expressed by each patient. It will favor the development of the feeling of control that they have in particular on their pain. participants will so improve the self-efficacy, the quality of life, and will reduce their fatigue and their pain. The patients involved have already lived major body transformations because of the disease and treatments. Yoga will help them put their lives together again, both physically and psychologically, and reclaim their body.

Studies have shown the short-term effects of yoga practice on anxiety, stress, pain and quality of life. Few rare studies have suggested that patients could add yoga practice at home to the supervised sessions, but these studies lacked therapeutic patient education. To date, to our knowledge, no data on the effect of the realization of yoga postures at home on increase of the patients' self-competency feeling are available in France. Also, the long-term effects of such programs need to be assessed.

The Montpellier Cancer Institute (ICM) has set-up 8 years ago yoga sessions for women with breast cancer, together with an association located in Montpellier.

With this study, the investigators will assess the feasibility of an educational yoga program given by a trained physical therapist in patients with beast cancer treated with hormonotherapy.

Feasibility Study: Yoga Educational Project

Feasibility Study of the "SKYPE" Educational Project in Patients With Breast Cancer Treated With Hormonotherapy

Compliance will be posittive if 70% of daily sessions at home and 4 sessions out of the 6 therapeutic educational (TEP) sessions delivered in the center by a physical therapist are realised

Satisfaction will be measured using the Likert scale (0 no satisfy to 10: strongly satisfy)

self-competency feeling induced will be assessed using the GSES (General Self Efficacy-Schwarzer) questionnaire (10 questions - scale 1- not at all true to 4-totally true)

Quality of life will be measured by EORTC QLQ-C30 (Quality of Life Questionnaire)

Quality of life will be measured by EORTC QLQ-Br23 (Quality of Life Questionnaire specify for Breast Cancer)

Fatigue and stress will be assessed using a Visual Analogous Scale (VAS) (0: no fatigue or no stress to 10 - maximum fatigue or stress)

Anxiety and depression will be assessed by HADS (Hospital Anxiety and Depression Scale) questionnaire (7 questions about Anxiety and 7 questions about Depression)

osteoarticular pain will be assessed using a Visual Analogous scale (0: no pain to 10: maximum pain)

Forward-flexion flexibility is defined by the distance between the fingertips and the floor. It will be measured with a ruler.

Respiratory capacity will be measured with a spirometer

Taking hormonotherapy treatments will be reported in a log-book by the patients.

The patient enrolment rate will be estimated (i.e. the proportion of patients giving their consent to participate in the study among eligible screened patients).

The reason of non-participation to the study (difficulty of coming, not concerning by the project, not interesting by the project, fatigue, other) will be reported by the patient to the doctor.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Feasibility Study of an Intervention Therapeutic Education for Patients Treated With Androgen Deprivation	NCT02460549	Prostate Cancer	therapeutic edu...	18 Years -	Institut de Cancérologie de la Loire
Feasibility Study of an Intervention Therapeutic Education for Patients Treated With Androgen Deprivation	NCT02460549	Prostate Cancer	therapeutic edu...	18 Years -	Institut de Cancérologie de la Loire
Effect of an Oral Therapeutic Patient Education Session on Physical Activity in Patients With Cancer	NCT04665973	Cancer	Therapeutic pat... Therapeutic pat...	18 Years - 84 Years	Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Therapeutic Education Intervention in Breast Cancer: PEPs Hormonotherapy	NCT02300675	Breast Cancer	therapeutic edu...	18 Years -	Institut de Cancérologie de la Loire
Effect of an Oral Therapeutic Patient Education Session on Physical Activity in Patients With Cancer	NCT04665973	Cancer	Therapeutic pat... Therapeutic pat...	18 Years - 84 Years	Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Effect of a Tailored Program of Physical Activity and Nutritional Counseling on Fatigue Reduction in Breast Cancer Patients Receiving an Adjuvant Treatment	NCT01495650	Breast Cancer	Tailored progra...	18 Years - 76 Years	Institut du Cancer de Montpellier - Val d'Aurelle
Feasibility Study: Yoga Educational Project	NCT04001751	Breast Cancer	educational yog...	18 Years -	Institut du Cancer de Montpellier - Val d'Aurelle
Therapeutic Education Intervention in Breast Cancer: PEPs Hormonotherapy	NCT02300675	Breast Cancer	therapeutic edu...	18 Years -	Institut de Cancérologie de la Loire

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