- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT07560397
Feasibility Study on the Implementation of a Supervised, Home-based Adapted Physical Activity Program for Patients With Head and Neck Cancer (PREPACHIR ORL)
Feasibility Study on the Implementation of a Supervised, Home-based Adapted Physical Activity Program During the Preoperative Phase for Patients With Head and Neck Cancer
Head and neck cancers are the seventh most common type of cancer worldwide. The standard of care is surgical removal of the tumor, often accompanied by simultaneous reconstruction of the affected structures.
Enhanced post-surgical rehabilitation programs are offered to promote early recovery of functional abilities; they are applicable to all patients and all surgical specialties. Studies have shown a very significant benefit of physical activity prior to surgery in the context of cancers of the digestive or thoracic systems. Multimodal programs that incorporate nutritional and psychosocial factors and include physical exercise have been shown to improve postoperative mobility and physical activity levels in patients with colorectal, gastrointestinal, lung, and prostate cancers.
Our hypothesis is based on the premise that implementing an exercise program during the preoperative period could promote a return to optimal functional capacity, reduce the incidence of postoperative pulmonary complications, and lower overall morbidity. Furthermore, we believe that the proposed support would encourage greater patient involvement in their care journey starting in the preoperative period and raise their awareness of the importance of postoperative mobilization. Early patient involvement would thus help develop their sense of self-efficacy and promote behavioral change toward a more active lifestyle suited to their health status. Consequently, maintaining physical activity after surgery and in the post-cancer period-recognized as a factor in secondary and tertiary prevention-would be encouraged.
Studieöversikt
Status
Betingelser
Intervention / Behandling
Studietyp
Inskrivning (Beräknad)
Fas
- Inte tillämpbar
Kontakter och platser
Studiekontakt
- Namn: Doriane Richard, PhD
- Telefonnummer: +33232082985
- E-post: doriane.richard@chb.unicancer.fr
Studera Kontakt Backup
- Namn: Elise Carpentier
- Telefonnummer: +33232082985
- E-post: elise.carpentier@chb.unicancer.fr
Studieorter
-
-
-
Rouen, Frankrike
- Rekrytering
- Centre Henri Becquerel
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
- Vuxen
- Äldre vuxen
Tar emot friska volontärer
Beskrivning
Inclusion Criteria:
- surgery requiring the placement of a covering flap)
- Medical prescription of adapted physical activity
- A period of more than 2 weeks between the announcement of surgery and the surgery itself
Exclusion Criteria:
- Absolute contraindications to physical activity
- Pregnant or breastfeeding women
- Patients who, for any reason, are unable to understand the study or comply with the trial requirements (language, psychological, or geographical barriers, etc.)
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Övrig
- Tilldelning: N/A
- Interventionsmodell: Enskild gruppuppgift
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: Supervised physical activity program
Realisation of a supervised home-based physical activity program
|
Supervised physical activity exercices
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Assessment of the feasibility of implementing a preoperative adapted physical activity program, supervised via weekly phone calls at home, for patients with head and neck cancer
Tidsram: 21 days
|
Number of patients who completed the adapted physical activity program out of the total number of patients who agreed to participate
|
21 days
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Assess the impact of the physical activity program on self-efficacy
Tidsram: 21 days
|
Assessment by General Self Efficacy scale
|
21 days
|
Samarbetspartners och utredare
Sponsor
Utredare
- Huvudutredare: Elise Carpentier, Centre Henri Becquerel
Studieavstämningsdatum
Studera stora datum
Studiestart (Faktisk)
Primärt slutförande (Beräknad)
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
Andra studie-ID-nummer
- CHB25.07
- 2025-A01638-41 (Annan identifierare: ANSM)
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
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