Therapeutic Education and Physical Activity to Support Self-management of Cancer-related Fatigue in Hematologic Cancer Patients: Protocol of a Feasibility Randomized Controlled Trial
| Autor: | Stefania Costi, Monica Denti, Monia Allisen Accogli, Stefania Fugazzaro |
|---|---|
| Jazyk: | angličtina |
| Rok vydání: | 2020 |
| Předmět: |
Adult
medicine.medical_specialty patients with cancer self-management medicine.medical_treatment Physical activity physical activity nonpharmacological treatments Therapeutic education lcsh:RC254-282 law.invention rehabilitation 03 medical and health sciences Study Protocol 0302 clinical medicine Randomized controlled trial law Internal medicine medicine Humans physical therapy 030212 general & internal medicine cancer-related fatigue hematologic malignancies therapeutic education Cancer-related fatigue Exercise Fatigue Randomized Controlled Trials as Topic Protocol (science) Self-management Rehabilitation business.industry Cancer medicine.disease lcsh:Neoplasms. Tumors. Oncology. Including cancer and carcinogens Observational Studies as Topic Complementary and alternative medicine Oncology 030220 oncology & carcinogenesis Exercise and Cancer Treatment Hematologic Neoplasms Quality of Life Feasibility Studies medicine.symptom business |
| Zdroj: | Integrative Cancer Therapies Integrative Cancer Therapies, Vol 19 (2020) |
| ISSN: | 1552-695X 1534-7354 |
| Popis: | Introduction Hematologic 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. Methods TEPA 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 |
| Databáze: | OpenAIRE |
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