Therapeutic Education in Physical Activity (ETAF) (ETAF)

Physical Therapy as "Drug, Non-drug"

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.

Study Overview

• Status: Completed
• Conditions: Hematologic Neoplasms
• Intervention / Treatment: Behavioral: Usual care; Behavioral: ETAF

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.

• Study Type: Interventional
• Enrollment (Actual): 46
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Italy
  • RE
    • Reggio Emilia, RE, Italy, 42123
      • Local Health Authority - IRCCS of Reggio Emilia

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.)

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Usual Care; 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; Usual care
Experimental: ETAF: Therapeutic Education Physical Activity; 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; Therapeutic education and Physical activity

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Effect of patient education - adherence	The effect of the educational intervention will be assessed through: - degree of patient's adherence to an active lifestyle (Kirkpatrick's taxonomy level 4) (Kirkpatrick, 1996).	6 months
Effect of patient education - satisfaction	The effect of the educational intervention will be assessed through: - degree of satisfaction of the patient involved in the study and perception of the utility of the treatment provided (Kirkpatrick's taxonomy level 1) (Kirkpatrick, 1996).	6 months

Collaborators and Investigators

• Sponsor: Azienda USL Reggio Emilia - IRCCS
• Collaborators: University of Modena and Reggio Emilia; GRADE Onlus
• Investigators: Principal Investigator: Stefania Fugazzaro, MD, AUSL - IRCCS of Reggio Emilia; Study Chair: Stefania Costi, PT, AUSL - IRCCS of Reggio Emilia and University of Modena and Reggio Emilia

Publications and helpful links

General Publications

• Bergenthal N, Will A, Streckmann F, Wolkewitz KD, Monsef I, Engert A, Elter T, Skoetz N. Aerobic physical exercise for adult patients with haematological malignancies. Cochrane Database Syst Rev. 2014 Nov 11;(11):CD009075. doi: 10.1002/14651858.CD009075.pub2.
• Kirkpatrick, DL. Great ideas revisited: revisiting Kirkpatrick's four-level model. Training and Development. 1996; 50:54-58.
• Denti M, Accogli MA, Costi S, Fugazzaro S. Therapeutic Education and Physical Activity to Support Self-management of Cancer-related Fatigue in Hematologic Cancer Patients: Protocol of a Feasibility Randomized Controlled Trial. Integr Cancer Ther. 2020 Jan-Dec;19:1534735420969830. doi: 10.1177/1534735420969830.

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2018
• Primary Completion (Actual): August 31, 2019
• Study Completion (Actual): December 3, 2019

Study Registration Dates

• First Submitted: November 8, 2017
• First Submitted That Met QC Criteria: January 10, 2018
• First Posted (Actual): January 18, 2018

Study Record Updates

• Last Update Posted (Actual): June 11, 2025
• Last Update Submitted That Met QC Criteria: June 6, 2025
• Last Verified: January 1, 2020

More Information

Terms related to this study

• Keywords: fatigue; exercise; feasibility; therapeutic education; blood cancer
• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Hematologic Diseases; Hematologic Neoplasms
• Other Study ID Numbers: ETAF2017

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No