Therapeutic Education in Physical Activity (ETAF)

Study Overview
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Brief Summary
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To date, studies published on multidimensional rehabilitation programs are addressed to patients with different types of cancer and, frequently, these studies only include a limited number of patients with blood neoplasms. So, there is no evidence of the effectiveness of multidimensional rehabilitation programs in this particular category of patients. A systematic review of the effectiveness of aerobic exercise alone, not associated with therapeutic education, has recently been conducted in adult individuals with hematological malignancies (reference 25386666). The review highlighted the effectiveness of physical activity on the quality of life of the target population. However, the medium and long term effects that physical exercise have on other clinically relevant endpoints, such as fatigue, psychological distress, and physical performance level, remain to be clarified. Thus, it is important to investigate the effectiveness of multidimensional interventions that integrate physical activity to therapeutic education targeted at the specific needs of individuals with blood neoplasm. The aim of this study is to evaluate, in blood cancer patients, the feasibility of a therapeutic education program associated with physical activity, and to verify its effect by a long-term follow-up.

Detailed Description
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This is a randomized controlled pilot study • Control Group will be offered usual care (UC), which includes two sessions of therapeutic education delivered in small groups. In these educational sessions, patients are provided with useful information on communication strategies, problem solving strategies, recognition and management of symptoms and the management of any aids/orthoses provided in everyday life, etc. In the meetings, it will be emphasized the importance of maintaining an active lifestyle as much as possible by encouraging involvement in physical activity even during the cancer treatment period. Written information material that summarizes the concepts addressed during group meetings will be provided. • Intervention group will be offered therapeutic education as described for the control group, plus 6 individual sessions of therapeutic education and physical activity (ETAF). The 6 individual session will be held by a physiotherapist dedicated to the study, on a weekly / bi-weekly basis, according to the objectives set and the needs of the patient. In these sessions, the topics already discussed in group will be deepened, personalizing them according to the patient's characteristics. Furthermore, personalized physical activity is planned, taking into account the context of execution, the clinical condition and the patient's preferences. Patients will be trained to build an action plan aimed at self-plan physical activities and a diary will be provided to monitor the physical activity carried out autonomously. Written information material that summarizes the concepts addressed during group and individual sessions will be provided.

Official Title
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Physical Therapy as Drug, Non-drug

Conditions
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Hematologic Neoplasms

Intervention / Treatment
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* Behavioral: ETAF
* Behavioral: Usual care


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: First diagnosis of blood cancer or early relapse of blood cancer Exclusion Criteria: Expected prognosis <12 months Clinical or anamnestic conditions preventing participation in the rehabilitation program (dementia, non-collaboration for major psychiatric disorders, blindness, deafness, any language barriers or communication deficits that prevent participation in the program, etc.)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Usual Care<br>Control Group will be offered usual care (UC), plus two sessions of therapeutic education delivered in small groups. In these educational sessions, patients are provided with useful information on communication strategies, problem solving strategies, recognition and management of symptoms and the management of any aids/orthoses provided in everyday life, etc. In the meetings, it will be emphasized the importance of maintaining an active lifestyle as much as possible by encouraging involvement in physical activity even during the cancer treatment period. Written information material that summarizes the concepts addressed during group meetings will be provided. | Behavioral: Usual care<br>* Usual care<br>|
| Experimental: ETAF: Therapeutic Education Physical Activity<br>Intervention group will perform UC, and the two sessions of therapeutic education delivered in small group, as for the Control Group. The Intervention group will also provided for 6 individual sessions of therapeutic education and physical activity held by physiotherapists dedicated to the study, according to the patients' needs and objectives. In these sessions, the topics discussed in group will be deepened, personalizing them according to the patient's characteristics. Furthermore, personalized physical activity is planned, taking into account the context of execution, the clinical condition and the patient's preferences. The patient will be trained to build an action plan aimed at self-plan physical activities and a diary will be provided to monitor the physical activity carried out autonomously. Written information material that summarizes the concepts addressed during group and individual sessions will be provided. | Behavioral: ETAF<br>* Therapeutic education and Physical activity<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of adherence to ETAF | rate of adherence to experimental intervention: ratio between planned intervention and actual intervention (process indicator). | 18 months (on average) - through study completion | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effect size on Fatigue | The size of the effect of ETAF, compared to the usual care, will be estimated on cancer-related fatigue (FACIT Fatigue Scale); | 6 months | 
| Effect size on QoL | The size of the effect of ETAF, compared to the usual care, will also be estimated on quality of life (EORTC Quality of life Questionnaire-C30); | 6 months | 
| Effect size Psychological distress | The size of the effect of ETAF, compared to the usual care, will also be estimated on psychological distress (NCCN Distress Thermometer and Problem list for patients); | 6 months | 
| Effect size on Physical function | The size of the effect of ETAF, compared to the usual care, will also be estimated on Physical function (Time up and go and 6MWT) | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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feasibility, blood cancer, exercise, therapeutic education, fatigue