Prehabilitering hos gynekologiska cancerpatienter (PHOCUS)
Prehabilitering hos patienter med gynekologisk cancer planerad för uppskjuten kirurgisk behandling: en prospektiv randomiserad studie.
Prehabilitation refers to interventions aiming to improve patients' resilience and functional capacity before a known stressful event, e.g., scheduled surgery. These interventions usually consist of physical activity and psychological and nutritional support. There is substantial evidence of the positive effect of multimodal prehabilitation among patients treated surgically for non-gynaecological cancers; however, no prospective data are available in gynaecological cancer patients.
PHOCUS trial is a prospective randomised trial aiming to evaluate the role of multimodal prehabilitation in patients with gynaecological cancer. Sixty-four patients will be randomised in single institution within 36 months with a 1:1 ratio into ARM A: control arm which will be provided with a basic information and standard of care support; ARM B: active arm undergoing multimodal prehabilitation composed of physical activity and psychological and nutritional support. All patients will be assessed at standard intervals (three times during the trial) by a spectrum of non-invasive tests, evaluating physical functional capacity, postoperative morbidity, nutritional status, level of stress and anxiety, and quality of life.
Studieöversikt
Status
Betingelser
Intervention / Behandling
Detaljerad beskrivning
The objective of the trial is to evaluate the impact of intensive multimodal prehabilitation protocol on pre-operative functional capacity, postoperative morbidity, and quality of life in patients undergoing surgical treatment for gynaecological cancer.
Two groups of patients scheduled for postponed surgical treatment will be eligible for the trial: i) advanced ovarian cancer patients referred for neoadjuvant chemotherapy and interval debulking surgery; ii) stage I-II endometrial cancer patients classifying as frail (according to the validated modified Frailty Index), who will be treated by hormonal therapy for three months, followed by surgical treatment.
Studietyp
Inskrivning (Beräknad)
Fas
- Fas 3
Kontakter och platser
Studiekontakt
- Namn: Jana Stribrna
- Telefonnummer: +420 224 967 432
- E-post: jana.stribrna@vfn.cz
Studera Kontakt Backup
- Namn: Stefan Lednicky, MD.
- E-post: stefan.lednicky@vfn.cz
Studieorter
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Prague, Tjeckien, 12000
- Rekrytering
- Gynecologic Oncology Center in Prague
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Kontakt:
- David Cibula, M.D.
- Telefonnummer: +420603547055
- E-post: dc@davidcibula.cz
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Kontakt:
- Jana Stribrna
- Telefonnummer: +420224967432
- E-post: jana.stribrna@vfn.cz
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Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
Inclusion criteria
Two groups of patients will be eligible for the trial:
i) Epithelial ovarian cancer patients referred for NACT: a) FIGO stage III or IV disease; b) Patient is not a candidate for primary debulking surgery; c) Patient is a suitable candidate for standard of care combined chemotherapy; d) Patient is a candidate for interval.debulking surgery
ii) Stage I or II endometrial cancer patients classifying as frail according to the validated modified Frailty Index: a) FIGO stage I or II; b) Patient is classified as frail; c) Patient is suitable candidate for hormonal therapy.
Exclusion criteria
- Second malignant tumour (under the treatment)
- Patient is not suitable for any surgery delay
- Patient is not physically able to meet the prehabilitation intervention plan or is unable to walk
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Stödjande vård
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
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Inget ingripande: A
Patients will be provided with a basic information and standard of care support. |
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Experimentell: B
Active prehabilitation will be provided, composed of i) three physical activity-related interventions provided by a physical and rehabilitation medicine (PRM) specialist; iii) three 30 min consultations regarding nutritional status with physician or nutrition specialist; ii) three sessions with psychologist. |
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Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
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Functional capacity changes
Tidsram: 9-12weeks
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Six-minute walking test (6MWT) |
9-12weeks
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Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
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Längd på postoperativ sjukhusvistelse (dagar)
Tidsram: 9-12 veckor
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9-12 veckor
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Effekter av näringsstödsprogram på kroppssammansättning (fettvikt och mager kroppsmassa i kg)
Tidsram: 9-12 veckor
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9-12 veckor
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Effekter av näringsstödsprogram på vilande energiförbrukning (mätt i kcal/kg).
Tidsram: 9-12 veckor
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9-12 veckor
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Effekter av näringsstödsprogram på fettsyrors sammansättning av plasma- och erytrocytfosfolipider (mätt i mol%).
Tidsram: 9-12 veckor
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9-12 veckor
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Postoperative morbidity
Tidsram: 9-12weeks
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Intraoperative and early postoperative complications until the 30th postoperative day will be classified according to the Clavien-Dindo and the Comprehensive Complication Index. Adverse events occurring after 30th postoperative day will be assessed according to NCI Common Terminology Criteria for Adverse Events Version 5.0 |
9-12weeks
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Adherence to training program
Tidsram: 9-12weeks
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Daily step count and number of resistance exercises per week. |
9-12weeks
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Health-related quality of life
Tidsram: 9-12weeks
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The analysis of the QoL of both study ARMs will be made based on EORTC validated questionnaires: QLQ-C30 and OV28 (for ovarian cancer patients)/ EN24 (for endometrial cancer patients. QLQ-C30 was developed by the EORTC, this self-reported questionnaire assesses the health-related quality of life of cancer patients in clinical trials. The questionnaire includes five functional scales (physical, everyday activity, cognitive, emotional, and social), three symptom scales (fatigue, pain, nausea and vomiting), a health/quality of life overall scale, and a number of additional elements assessing common symptoms (including dyspnea, loss of appetite, insomnia, constipation, and diarrhea), as well as, the perceived financial impact of the disease. The EORTC QLQ-OV28/ EN24 is used in conjunction with the EORTC QLQ-C30 and provides information on an additional 25 items specifically related to ovarian/ endometrial cancer. |
9-12weeks
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Psychological health: DEPRESSION
Tidsram: 9-12weeks
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The Beck Depression Inventory: a 21-item, self-report rating inventory that measures characteristic attitudes and symptoms of depression. |
9-12weeks
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Psychological health: ANXIETY
Tidsram: 9-12weeks
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The State-Trait Anxiety Inventory: a psychological inventory consisting of 40 self-report items on a 4-point Likert scale. The STAI measures two types of anxiety - state anxiety and trait anxiety. |
9-12weeks
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Psychological health: NONSPECIFIC PERCEIVED STRESS
Tidsram: 9-12weeks
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Perceived stress scale: psychological instrument for measuring nonspecific perceived stress (stressfulness of situations, the effectiveness of stress-reducing interventions, and the extent to which there are associations between psychological stress and psychiatric and physical disorders). |
9-12weeks
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Psychological health: SPECIFIC PERCEIVED STRESS
Tidsram: 9-12weeks
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Stress profile: questionnaire assessing the severity of stress in nine areas of life: social habits, social relationships, life events, sexual problems, sleep, psychiatric symptoms, old age, menstrual stresses, and 'stress and the heart'. |
9-12weeks
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Samarbetspartners och utredare
Samarbetspartners
Utredare
- Huvudutredare: David Cibula, prof., Charles University, Czech Republic
Publikationer och användbara länkar
Allmänna publikationer
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- Minnella EM, Awasthi R, Loiselle SE, Agnihotram RV, Ferri LE, Carli F. Effect of Exercise and Nutrition Prehabilitation on Functional Capacity in Esophagogastric Cancer Surgery: A Randomized Clinical Trial. JAMA Surg. 2018 Dec 1;153(12):1081-1089. doi: 10.1001/jamasurg.2018.1645.
- Mayo NE, Feldman L, Scott S, Zavorsky G, Kim DJ, Charlebois P, Stein B, Carli F. Impact of preoperative change in physical function on postoperative recovery: argument supporting prehabilitation for colorectal surgery. Surgery. 2011 Sep;150(3):505-14. doi: 10.1016/j.surg.2011.07.045.
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- Cianci S, Tarascio M, Rosati A, Caruso S, Uccella S, Cosentino F, Scaletta G, Gueli Alletti S, Scambia G. Sexual function and quality of life of patients affected by ovarian cancer. Minerva Med. 2019 Aug;110(4):320-329. doi: 10.23736/S0026-4806.19.06080-4. Epub 2019 May 6.
- Cortes-Guiral D, Mohamed F, Glehen O, Passot G. Prehabilitation of patients undergoing cytoreductive surgery (CRS) and hyperthermic intraperitoneal chemotherapy (HIPEC) for peritoneal malignancy. Eur J Surg Oncol. 2021 Jan;47(1):60-64. doi: 10.1016/j.ejso.2020.01.032. Epub 2020 Jan 30.
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Studieavstämningsdatum
Studera stora datum
Studiestart (Faktisk)
Primärt slutförande (Faktisk)
Avslutad studie (Beräknad)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
- Urogenitala sjukdomar
- Genitala sjukdomar
- Sjukdomar i det endokrina systemet
- Patologiska processer
- Urogenitala neoplasmer
- Neoplasmer efter plats
- Neoplasmer
- Kvinnliga urogenitala sjukdomar
- Kvinnliga urogenitala sjukdomar och graviditetskomplikationer
- Livmodersjukdomar
- Genitala sjukdomar, kvinnor
- Neoplasmer i endokrina körtel
- Ovariella sjukdomar
- Adnexala sjukdomar
- Genitala neoplasmer, hona
- Gonadal sjukdomar
- Uterina neoplasmer
- Patologiska tillstånd, tecken och symtom
- Svaghet
- Ovariella neoplasmer
- Endometriella neoplasmer
- Psykoterapi
- Beteendediscipliner och aktiviteter
- Psykosocial intervention
Andra studie-ID-nummer
- PHOCUS_38/20
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