NCT03403075

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
46

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2018

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 8, 2017

Completed
2 months until next milestone

Study Start

First participant enrolled

January 1, 2018

Completed
17 days until next milestone

First Posted

Study publicly available on registry

January 18, 2018

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2019

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 3, 2019

Completed
Last Updated

June 11, 2025

Status Verified

January 1, 2020

Enrollment Period

1.7 years

First QC Date

November 8, 2017

Last Update Submit

June 6, 2025

Conditions

Hematologic Neoplasms

Keywords

blood cancerexercisetherapeutic educationfatiguefeasibility

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (4)

  • Effect size on Fatigue

    6 months

  • Effect size on QoL

    6 months

  • Effect size Psychological distress

    6 months

  • Effect size on Physical function

    6 months

Other Outcomes (2)

  • Effect of patient education - adherence

    6 months

  • Effect of patient education - satisfaction

    6 months

Study Arms (2)

Usual Care

ACTIVE COMPARATOR

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

ETAF: Therapeutic Education Physical Activity

EXPERIMENTAL

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

Interventions

ETAFBEHAVIORAL

Therapeutic education and Physical activity

ETAF: Therapeutic Education Physical Activity
Usual careBEHAVIORAL

Usual care

Usual Care

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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.)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Local Health Authority - IRCCS of Reggio Emilia

Reggio Emilia, RE, 42123, Italy

Location

Related Publications (4)

  • 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.

    PMID: 25386666BACKGROUND

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

    BACKGROUND

  • 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.

    PMID: 36534365DERIVED

  • 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.

    PMID: 33243016DERIVED

MeSH Terms

Conditions

Hematologic NeoplasmsMotor ActivityFatigue

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsHematologic DiseasesHemic and Lymphatic DiseasesBehaviorSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Stefania Fugazzaro, MD

    AUSL - IRCCS of Reggio Emilia

    PRINCIPAL INVESTIGATOR

  • Stefania Costi, PT

    AUSL - IRCCS of Reggio Emilia and University of Modena and Reggio Emilia

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 8, 2017

First Posted

January 18, 2018

Study Start

January 1, 2018

Primary Completion

August 31, 2019

Study Completion

December 3, 2019

Last Updated

June 11, 2025

Record last verified: 2020-01

Data Sharing

IPD Sharing
Will not share

Locations

IT(1)