NCT03403075

Therapeutic Education in Physical Activity (ETAF)

Physical Therapy as "Drug, Non-drug"

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 46 (actual)
• Sponsor: Azienda USL Reggio Emilia - IRCCS · Other Government
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

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.

Conditions

• Hematologic Neoplasms

Interventions

Type	Name	Description
BEHAVIORAL	ETAF	Therapeutic education and Physical activity
BEHAVIORAL	Usual care	Usual care

Timeline

• Start date: 2018-01-01
• Primary completion: 2019-08-31
• Completion: 2019-12-03
• First posted: 2018-01-18
• Last updated: 2025-06-11

Locations

1 site across 1 country: Italy