Evidence map›Paper›PMID 33243016›Full record

ArticleIntegrative cancer therapies

Therapeutic Education and Physical Activity to Support Self-management of Cancer-related Fatigue in Hematologic Cancer Patients: Protocol of a Feasibility Randomized Controlled Trial.

Monica Denti, Monia Allisen Accogli, Stefania Costi, Stefania Fugazzaro

Registry-linked trialOpen access · goldAbstract readClinical Trial Protocol
In one paragraph

Article in Integrative cancer therapies. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03403075 (Physical Therapy as "Drug, Non-drug"), which is not on this map. Cited by 1 paper, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed, 1 pooled it
0.1field-weighted citation impact, top 52% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT03403075 nacompletednot on this map

Physical Therapy as "Drug, Non-drug"

TypeinterventionalSponsorAzienda USL Reggio Emilia - IRCCSRan2018 to 2019Enrolled46ConditionsHematologic NeoplasmsArmsETAF, Usual care
3 · Its place in the literature

Who cites it

1 citing paper in PubMed, 1 synthesis or guideline pooled it, 3 citations in OpenAlex.

  1. Pooled it
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

4 authors at 2 institutions in 1 country.

Monica DentiPhysical Medicine and Rehabilitation Unit, Azienda Unità Sanitaria Locale-IRCCS di Reggio Emilia, Reggio Emilia, Italy.ORCID 0000-0001-6541-2696
Monia Allisen AccogliPhysical Medicine and Rehabilitation Unit, Azienda Unità Sanitaria Locale-IRCCS di Reggio Emilia, Reggio Emilia, Italy.
Stefania CostiPhysical Medicine and Rehabilitation Unit, Azienda Unità Sanitaria Locale-IRCCS di Reggio Emilia, Reggio Emilia, Italy.
Stefania FugazzaroPhysical Medicine and Rehabilitation Unit, Azienda Unità Sanitaria Locale-IRCCS di Reggio Emilia, Reggio Emilia, Italy.
Azienda Sanitaria Unità Locale di Reggio Emilia · ITUniversity of Modena and Reggio Emilia · IT

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionHematologic malignancies account for nearly 8% of new cancer diagnosis in Italy. Cancer-related fatigue (CRF) is one of the most distressing symptoms reported by patients with cancer. As CRF has a multifactorial etiology, physical activity and therapeutic education may be beneficial for managing CRF, both during and after cancer treatment. However, there is a lack of evidence specific to hematologic malignancies. This paper describes the protocol of a feasibility study on Therapeutic Education and Physical Activity (TEPA) intervention to support self-management of CRF in patients with hematologic malignancies.

methodsTEPA was addressed to newly diagnosed adult individuals with hematologic malignancy able to take part in a rehabilitation programme at the AUSL-IRCCS of Reggio Emilia. The protocol was developed in 2 phases. Phase I was an observational cohort study involving a convenience sample of 10 participants with the aim to evaluate the feasibility of the assessment schedule and to register longitudinal clinical data regarding CRF (FACIT-F), psychologic distress (NCCN Distress Thermometer), QoL (EORTC QLQ-C30), physical performance (TUG and 6MWT) and habitual level of physical activity during first months after diagnosis. Phase II (underway) is a feasibility randomized controlled trial (TEPA) involving a convenience sample of 40 participants and comparing 2 parallel active interventions (Therapeutic Education versus Therapeutic Education and Physical Activity) on top of usual care. The primary aim is to estimate the feasibility of TEPA, measured by the adherence rate to the intervention. Secondary aims are: to estimate the effect size of TEPA in terms of changes in CRF, psychological distress, QoL, physical performance and habitual level of physical activity (measured as in Phase I); to collect patient satisfaction, perception of usefulness of the TEPA intervention and data on long-term adherence to an active lifestyle. Data are collected in both phases at the time of diagnosis and then at 1-, 3- (completion of intervention) and 7-month follow-up. DISCUSSION: Data on feasibility and effect size of TEPA will be analyzed upon completion of Phase II, allowing us to design a large, adequately powered RCT to verify the effectiveness of this intervention on CRF management in patients with hematologic cancer. Trial registration: clinicaltrials.gov; Trial registration number: NCT03403075.

Indexed as

Hematologic NeoplasmsSelf-ManagementAdultExerciseFatigueFeasibility StudiesHumansObservational Studies as TopicQuality of LifeRandomized Controlled Trials as Topiccancer-related fatiguehematologic malignanciesnonpharmacological treatmentspatients with cancerphysical activityphysical therapyrehabilitationself-managementtherapeutic education

Identifiers

PMID33243016
PMCPMC7705784
OpenAlexW3108572970

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.