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NCT Number: NCT03403075

Therapeutic Education in Physical Activity (ETAF)

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.

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Key information

Conditions

Hematologic Neoplasms Behavior Fatigue Hematologic Diseases Hemic and Lymphatic Diseases Motor Activity Neoplasms Neoplasms by Site Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Local Health Authority - IRCCS of Reggio Emilia

Reggio Emilia, RE, 42123, Italy

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.)

Treatment and study plan

ETAF

Behavioral

Therapeutic education and Physical activity

Usual Care

Behavioral

Usual care

Primary outcomes

  1. Rate of adherence to ETAF

    Time frame: 18 months (on average) - through study completion

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

Secondary outcomes

  1. Effect size on Fatigue

    Time frame: 6 months

    The size of the effect of ETAF, compared to the usual care, will be estimated on cancer-related fatigue (FACIT Fatigue Scale);

  2. Effect size on QoL

    Time frame: 6 months

    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);

  3. Effect size Psychological distress

    Time frame: 6 months

    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);

  4. Effect size on Physical function

    Time frame: 6 months

    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)

Other outcomes

  1. Effect of patient education - adherence

    Time frame: 6 months

    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).

  2. Effect of patient education - satisfaction

    Time frame: 6 months

    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).

Sponsors and collaborators

Lead sponsor

Azienda USL Reggio Emilia - IRCCS

Other Gov

Collaborators

  • GRADE Onlus
  • University of Modena and Reggio Emilia

Registry information

Official study title

Physical Therapy as "Drug, Non-drug"

Acronym: ETAF

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Jan 18, 2018
Registry last updated
Jun 11, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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