PHOCUS: Prehabilitation in Gynaecological Cancer Patients

Sponsor
Charles University, Czech Republic (Other)
Overall Status
Recruiting
CT.gov ID
NCT04789694
Collaborator
(none)
64
1
2
65.1
1

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Physiological intervention
  • Behavioral: Psychological intervention
  • Dietary Supplement: Nutritional intervention
Phase 3

Detailed Description

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
64 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Supportive Care
Official Title:
Prehabilitation in Patients With Gynaecological Cancer Planned for Postponed Surgical Management: A Prospective Randomised Trial.
Actual Study Start Date :
Jan 25, 2021
Anticipated Primary Completion Date :
Jun 30, 2025
Anticipated Study Completion Date :
Jun 30, 2026

Arms and Interventions

Arm Intervention/Treatment
No Intervention: A

Patients will be provided with a basic information and standard of care support.

Experimental: 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.

Other: Physiological intervention
Rehabilitation specialist consultation (3x) Individualized home-based exercise plan Functional capacity measuring

Behavioral: Psychological intervention
Clinical psychologist consultation (3x) Anxiety and depression scoring Psychological support

Dietary Supplement: Nutritional intervention
Nutritional specialist consultation (3x) Malnutrition scoring Dietary supplementation

Outcome Measures

Primary Outcome Measures

  1. Functional capacity changes [9-12weeks]

    Six-minute walking test (6MWT)

Secondary Outcome Measures

  1. Postoperative morbidity [9-12weeks]

    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

  2. Length of postoperative hospital stay (days) [9-12weeks]

  3. Adherence to training program [9-12weeks]

    Daily step count and number of resistance exercises per week.

  4. Effects of nutritional support program on body composition (weight of fat and lean body mass in kg) [9-12weeks]

  5. Effects of nutritional support program on resting energy expenditure (measured in kcal/kg). [9-12weeks]

  6. Effects of nutritional support program on Fatty acids composition of plasmatic and erythrocytes phospholipids (measured in mol%). [9-12weeks]

  7. Health-related quality of life [9-12weeks]

    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.

  8. Psychological health: DEPRESSION [9-12weeks]

    The Beck Depression Inventory: a 21-item, self-report rating inventory that measures characteristic attitudes and symptoms of depression.

  9. Psychological health: ANXIETY [9-12weeks]

    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.

  10. Psychological health: NONSPECIFIC PERCEIVED STRESS [9-12weeks]

    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).

  11. Psychological health: SPECIFIC PERCEIVED STRESS [9-12weeks]

    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'.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 85 Years
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
No

Inclusion criteria

Two groups of patients will be eligible for the trial:
  1. Epithelial ovarian cancer patients referred for NACT: a) FIGO stage III or IV disease;
  1. 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
  1. 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;
  1. Patient is suitable candidate for hormonal therapy.

Exclusion criteria

  1. Second malignant tumour (under the treatment)

  2. Patient is not suitable for any surgery delay

  3. Patient is not physically able to meet the prehabilitation intervention plan or is unable to walk

Contacts and Locations

Locations

Site City State Country Postal Code
1 Gynecologic Oncology Center in Prague Prague Czechia 12000

Sponsors and Collaborators

  • Charles University, Czech Republic

Investigators

  • Principal Investigator: David Cibula, prof., Charles University, Czech Republic

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
David Cibula, professor, Charles University, Czech Republic
ClinicalTrials.gov Identifier:
NCT04789694
Other Study ID Numbers:
  • PHOCUS_38/20
First Posted:
Mar 9, 2021
Last Update Posted:
Apr 1, 2022
Last Verified:
Mar 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by David Cibula, professor, Charles University, Czech Republic
Additional relevant MeSH terms:

Study Results

No Results Posted as of Apr 1, 2022