Clinical trial NCT03403075: Therapeutic Education in Physical Activity (ETAF)
Official title: Physical Therapy as "Drug, Non-drug"
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hematologic Neoplasms
Keywords: blood cancer
exercise
therapeutic education
fatigue
feasibility
Lead sponsor: Azienda USL Reggio Emilia - IRCCS
Sponsor class: OTHER_GOV
Collaborators: name: GRADE Onlus
name: University of Modena and Reggio Emilia
First posted: 2018-01-18
Enrollment: 46
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: 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.)

Primary outcomes:
measure: Rate of adherence to ETAF
timeFrame: 18 months (on average) - through study completion
Secondary outcomes:
measure: Effect size on Fatigue
timeFrame: 6 months
measure: Effect size on QoL
timeFrame: 6 months
measure: Effect size Psychological distress
timeFrame: 6 months
measure: Effect size on Physical function
timeFrame: 6 months
Other outcomes:
measure: Effect of patient education - adherence
timeFrame: 6 months
measure: Effect of patient education - satisfaction
timeFrame: 6 months
Locations:
city: Reggio Emilia
country: Italy
facility: Local Health Authority - IRCCS of Reggio Emilia
state: RE
Study officials:
affiliation: AUSL - IRCCS of Reggio Emilia
name: Stefania Fugazzaro, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: AUSL - IRCCS of Reggio Emilia and University of Modena and Reggio Emilia
name: Stefania Costi, PT
role: STUDY_CHAIR
References:
citation: 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.
citation: Kirkpatrick, DL. Great ideas revisited: revisiting Kirkpatrick's four-level model. Training and Development. 1996; 50:54-58.
citation: 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.