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| ID | Type | Description | Link |
|---|---|---|---|
| 2024-A01991-46 | Other Identifier | ANSM |
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Bladder and kidney cancers are commonly diagnosed in older adults. Surgery remains the primary treatment modality for patients with kidney or bladder cancer. In older patients, common co-morbidities include fatigue, physical deconditioning characterized by reduced cardiorespiratory fitness and progressing sarcopenia, pain- whether disease- related or treatment-induced- and undernutrition. These factors increased the risk of post-operative complications and exacerbate patient frailty.
The investigators propose a personalized 6-month program both pre- and post-surgery, including adapted physical activity sessions, therapeutic education workshops, and systematic referral to the department's DAPAP program.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control group | No Intervention | The control group will consist of patients with bladder or kidney cancer receiving standard care, which includes a comprehensive assessment by an oncogeriatrician followed by surgery approximately 4 weeks later. Postoperatively, patients will be transferred to a rehabilitation center (SSR) for recovery, in line with standard clinical practice. As part of the study protocol, control group patients will undergo additional follow-up assessments alongside their usual care. These follow-ups-conducted at baseline, and at 1, 2, 3 months, and at the final endpoint-will mirror those of the intervention group. They will include patients- completed questionnaires and physical assessments conducted by an adapted physical activity teacher. | |
| Interventional group | Experimental | The interventional group will consist of bladder and kidney cancer patients who will follow a personalized 6-month care pathway in addition to standard care. This pathway includes:
The study will be conducted in the oncogeriatrics departments of Saint-Etienne University Hospital and Loire Private Hospital. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| APA | Procedure | 2 adapted physical activity (APA) sessions per week for 4 weeks before and after surgery |
|
| Measure | Description | Time Frame |
|---|---|---|
| Patient frailty | Frailty will be measured using the walking distance (in metres) achieved during the 6-minute walk test (6MWT) 6 months after the patient's inclusion. | Day : 1 and Month : 6 |
| Measure | Description | Time Frame |
|---|---|---|
| Cumulative Illness Rating Scale for Geriatrics (CIRS-G) | The CIRS (Cumulative Illness Rating Scale) score provides a relevant comparison of the medical burden and treatment outcomes in geriatric patients with variable and complex pathologies. The score ranges from 0: no problem to 4: very serious problem. | Months : 1, 2, 3 and 6 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Evolène FAYOLLE, student | Contact | (0)4 77 12 78 35 | +33 | evolene.fayolle@chu-st-etienne.fr |
| Amandine BAUDOT, Project Manager | Contact | (0)4 77 82 94 50 | +33 | amandine.baudot@chu-st-etienne.fr |
| Name | Affiliation | Role |
|---|---|---|
| David HUPIN, MD | CHU de Saint Etienne | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chu Saint-Etienne | Recruiting | Saint-Etienne | 42055 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 42286520 | Derived | Fayolle E, Baudot A, Chaneliere-Sauvant AF, Favier E, Rambaud F, Torche F, Celarier T, Hupin D. Effectiveness of a personalised 6-month programme on physical frailty in older patients treated for bladder or kidney cancer - FRAGECO program - multicenter, controlled, randomized study protocol. BMC Geriatr. 2026 Jun 12. doi: 10.1186/s12877-026-07821-z. Online ahead of print. |
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| Therapeutic education workshops | Behavioral | Therapeutic education workshops tailored to individual needs, covering topics as physical activity, nutrition, treatments, fatigue, and relaxation. |
|
| DAPAP | Procedure | Referral to the department's DAPAP for a 12-week "bridge program", consisting of one session per week. |
|
| Fried's frailty phenotype (FP) |
Frailty will be measured using Fried's frailty phenotype (FP), defined by exhaustion (EX), unexplained weight loss (WL), weakness (WK), sluggishness (SL) and low physical activity (LA). Three or more components define the frailty state, and one or two the pre-fragility state. |
| Months : 1, 2, 3 and 6 |
| level of physical activity | Objective measures of PA (in MET-hours/week) via accelerometry (Actigraph GT3x, Pensacola, Florida, USA) and subjective measurements of PA (in METhours/week) using the e-Adult Physical Activity Questionnaire (EA SNA-EPIS, Université Jean Monnet, Saint-Etienne, France). | Months : 1, 2, 3 and 6 |
| level of sedentary lifestyle | Objective measures of sedentary time (in h/d) via accelerometry (Actigraph GT3x, Pensacola, Florida, USA) and subjective measurements of sedentary behaviour (in hours/day) using the e-Adult Physical Activity Questionnaire (EA SNA-EPIS, Université Jean Monnet, Saint-Etienne, France). | Months : 1, 2, 3 and 6 |
| Nutritional status | With the Mini Nutritional Assessment (MNA) and albumin analysis in g/l, a level <35g/l: undernutrition, <30g/l: severe undernutrition. | Months : 1, 2, 3 and 6 |
| Memory | Mini-Mental State Examination (MMSE), which consists of 30 questions and is scored out of 30. The severity of memory impairment is considered mild if the score is above 20, moderate if the score is between 10 and 20, and severe if the score is below 10. | Months : 1, 2, 3 and 6 |
| Healthy quality of life | With the EORTC-QLC30 version 3. This 30-item questionnaire assesses 15 dimensions of quality of life (5 functional scales: physical, cognitive, social, emotional or psychological and limitations in daily activities; 1 global health/quality of life scale; 9 symptom scales: fatigue, nausea and vomiting, pain, dyspnea, insomnia, loss of appetite, constipation and diarrhea, financial problems related to the disease). | Months : 1, 2, 3 and 6 |
| Fatigue | With the Functional Assessment of Chronic Illness Therapy - Fatigue Scale (FACIT-F). The questionnaire consists of 13 questions, each of which corresponds to a Likert scale ranging from 0 to 4 (0 = not at all, 4 = very much). A score is obtained out of 52, with the higher the score, the less fatigued the patient is. | Months : 1, 2, 3 and 6 |
| Depression | Using the Mini Geriatric Depression Scale (GDS) to 4 questions. If the score is greater than 1: high probability of depression, if the score is 0: high probability of no depression. | Months : 1, 2, 3 and 6 |
| Muscular strength | Muscle strength (in kilogram) on the handgrip. | Months : 1, 2, 3 and 6 |
| Balance | Assessed using the time (in seconds) taken to complete the Timed Up and Go (TUG). A time ≥ 20 seconds is associated with a risk of falling. | Months : 1, 2, 3 and 6 |
| Hôpital privé de la Loire | Not yet recruiting | Saint-Etienne | 42100 | France |
|
| ID | Term |
|---|---|
| D009369 | Neoplasms |
| D002292 | Carcinoma, Renal Cell |
| D009043 | Motor Activity |
| D000073496 | Frailty |
| ID | Term |
|---|---|
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D007680 | Kidney Neoplasms |
| D014571 | Urologic Neoplasms |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052801 | Male Urogenital Diseases |
| D001519 | Behavior |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| C029014 | diacetamate |
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