Therapeutic Education in Physical Activity (ETAF)

Hematologic Neoplasms Clinical Trial

— ETAF  

Official title:

Physical Therapy as "Drug, Non-drug"

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03403075
• Other study ID #: ETAF2017
• Status: Completed
• Phase: N/A
• Start date: January 1, 2018
• Est. completion date: December 3, 2019

Study information

• Verified date: January 2020
• Source: Arcispedale Santa Maria Nuova-IRCCS
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 46
• Est. completion date: December 3, 2019
• Est. primary completion date: August 31, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.)

Related Conditions & MeSH terms

• Hematologic Neoplasms

Intervention

Behavioral:
• ETAF
Therapeutic education and Physical activity
• Usual care
Usual care

Locations

Country	Name	City	State
Italy	Local Health Authority - IRCCS of Reggio Emilia	Reggio Emilia	RE

Sponsors (3)

Lead Sponsor	Collaborator
Arcispedale Santa Maria Nuova-IRCCS	GRADE Onlus, University of Modena and Reggio Emilia

Country where clinical trial is conducted

Italy, 

References & Publications (2)

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. Review. Update in: Cochrane Database Syst Rev. 2019 Jan 31;1:CD009075. — View Citation

Kirkpatrick, DL. Great ideas revisited: revisiting Kirkpatrick's four-level model. Training and Development. 1996; 50:54-58.

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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