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Hematologic NeoplasmsETAFNCT03403075

Therapeutic Education in Physical Activity (ETAF)

A study testing ETAF in people with Hematologic Neoplasms, run by Azienda USL Reggio Emilia - IRCCS at 1 site in Italy.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Hematologic Neoplasms
What is being tested?
ETAF
Could I receive a placebo?
No, everyone receives an active treatment
How many people
46 participants
Where
1 siteItaly
Study dates
1 Jan 2018to 3 Dec 2019
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • First diagnosis of blood cancer or early relapse of blood cancer

Who cannot join

  • 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.)

Trial locations and contacts

1 site in 1 country.

Italy1 site

  • Local Health Authority - IRCCS of Reggio Emilia

    Reggio Emilia, RE, 42123

Other trials in Italy

About this study

Official title: 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.

Read the 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.

Being tested
ETAF, Usual care
Keywords
blood cancer, exercise, therapeutic education, fatigue, feasibility
Medical subject headings
Hematologic Neoplasms, Motor Activity, Fatigue

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ETAFBehavioural

    Therapeutic education and Physical activity

  • Usual careBehavioural

    Usual care

Study groups in NCT03403075
Study groupRoleWhat they receive
Usual CareActive comparatorControl 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.
Receives: Behavioral: Usual care
ETAF: Therapeutic Education Physical ActivityExperimentalIntervention 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.
Receives: Behavioral: ETAF

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Rate of adherence to ETAF

    rate of adherence to experimental intervention: ratio between planned intervention and actual intervention (process indicator).

    Measured: 18 months (on average) - through study completion

Secondary outcomes (4)

  1. 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);

    Measured: 6 months

  2. 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);

    Measured: 6 months

  3. 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);

    Measured: 6 months

  4. 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)

    Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Jan 2018
  2. Study start1 Jan 2018
  3. Primary completion31 Aug 2019
  4. Study completion3 Dec 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
46 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03403075
Sponsor's protocol ID
ETAF2017
Acronym
ETAF
Status last verified
Jan 2020
First submitted
8 Nov 2017
Last updated
11 Jun 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

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.

    PubMed 25386666

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

  • Accogli MA, Denti M, Costi S, Fugazzaro S. Therapeutic education and physical activity are feasible and safe in hematologic cancer patients referred to chemotherapy: results of a randomized controlled trial. Support Care Cancer. 2022 Dec 19;31(1):61. doi: 10.1007/s00520-022-07530-4.

    PubMed 36534365

  • 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.

    PubMed 33243016

Questions about this trial

What is this clinical trial studying?

A study testing ETAF in people with Hematologic Neoplasms, run by Azienda USL Reggio Emilia - IRCCS at 1 site in Italy.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 11 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Rate of adherence to ETAF (time frame: 18 months (on average) - through study completion). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03403075, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jun 2025.

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