Ignite Creation Date:
2024-05-06 @ 8:07 PM
Last Modification Date:
2024-10-26 @ 3:21 PM
Study NCT ID:
NCT06263283
Status:
RECRUITING
Last Update Posted:
2024-06-05
First Post:
2024-02-09
Brief Title:
Impact of an Educational Physiotherapy-Yoga Intervention on Perceived Stress in Women Treated With Brachytherapy for Cervical Cancer
Sponsor:
Institut du Cancer de Montpellier - Val dAurelle
Organization:
Institut du Cancer de Montpellier - Val dAurelle
Study Overview
Official Title:
Impact of an Educational Physiotherapy-Yoga Intervention on Perceived Stress in Women Treated With Brachytherapy for Cervical Cancer a Randomized Controlled Trial
Status:
RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
KYOCOL
Brief Summary:
Every year in France nearly 3000 women develop a cervical cancer The average age of women diagnosed is 51 Uterovaginal brachytherapy is one of the reference treatments
To allow this treatment an applicator is first placed under general anaesthesia in the vaginal zone Then the pulsed Dose Rate PDR or high dose rate HDR uterovaginal brachytherapy requires 2-5 days hospitalization in an isolated room Uterovaginal brachytherapy requires strict bed rest without movements allowed for the pelvic area until the applicator is removed
Prolonged immobilization the context of the illness and the intimacy of the area to be treated are all recognized sources of anxiety According to a study 40 of patients have post-traumatic stress at 3 months of treatment A Danish team highlights the significant decrease in physical capacity during and after treatment
Thus as a recent literature review concludes there is a real need to develop Non-Pharmacological-Interventions NPI to limit the aftereffects It also seems important to provide support for self-management of symptoms
Among NPI of interest Yoga is a mind-body practice that can decrease perceived stress A systematic review confirms that yoga can reduce stress during cancer treatment This underlines the importance of proposing this practice for patients treated for all types of cancers and further evaluations on the effects of respiratory and meditation exercises Another team showed the feasibility of respiratory exercise intervention in patients undergoing chemotherapy while also talking about mental health benefits Finally a reduction in perceived stress was achieved in women treated with radiotherapy for breast cancer through yoga intervention A lot of work has been done with promising results without the result of a consensus applicable to all care situations
Moreover educational requirements are high in women treated to gynecological cancer
Meeting these needs helps to improve quality of life pain management and drug use
Integrating Patient Educational Project PEP therefore seems relevant as an additional tool in patient empowerment In addition the fact that a combined Physiotherapy-Yoga-PEP intervention is feasible in women treated for breast cancer allows us to offer adjusted version in patients with brachytherapy
The literature review thus invites us to propose the educational intervention Kine-Yoga-PEP in the very particular context of brachytherapy
To allow this treatment an applicator is first placed under general anaesthesia in the vaginal zone Then the pulsed Dose Rate PDR or high dose rate HDR uterovaginal brachytherapy requires 2-5 days hospitalization in an isolated room Uterovaginal brachytherapy requires strict bed rest without movements allowed for the pelvic area until the applicator is removed
Prolonged immobilization the context of the illness and the intimacy of the area to be treated are all recognized sources of anxiety According to a study 40 of patients have post-traumatic stress at 3 months of treatment A Danish team highlights the significant decrease in physical capacity during and after treatment
Thus as a recent literature review concludes there is a real need to develop Non-Pharmacological-Interventions NPI to limit the aftereffects It also seems important to provide support for self-management of symptoms
Among NPI of interest Yoga is a mind-body practice that can decrease perceived stress A systematic review confirms that yoga can reduce stress during cancer treatment This underlines the importance of proposing this practice for patients treated for all types of cancers and further evaluations on the effects of respiratory and meditation exercises Another team showed the feasibility of respiratory exercise intervention in patients undergoing chemotherapy while also talking about mental health benefits Finally a reduction in perceived stress was achieved in women treated with radiotherapy for breast cancer through yoga intervention A lot of work has been done with promising results without the result of a consensus applicable to all care situations
Moreover educational requirements are high in women treated to gynecological cancer
Meeting these needs helps to improve quality of life pain management and drug use
Integrating Patient Educational Project PEP therefore seems relevant as an additional tool in patient empowerment In addition the fact that a combined Physiotherapy-Yoga-PEP intervention is feasible in women treated for breast cancer allows us to offer adjusted version in patients with brachytherapy
The literature review thus invites us to propose the educational intervention Kine-Yoga-PEP in the very particular context of brachytherapy
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None