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Trial Title:
Impact of an Educational Physiotherapy-Yoga Intervention on Perceived Stress in Women Treated With Brachytherapy for Cervical Cancer
NCT ID:
NCT06263283
Condition:
Cervical Cancer
Brachytherapy
Conditions: Official terms:
Uterine Cervical Neoplasms
Conditions: Keywords:
cervical cancer
uterovaginal brachytherapy
stress
Prolonged immobilization
yoga
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Intervention model description:
Control Group: Standard care according to the modalities of each center (concomitant
treatment prescription, psychological support, physiotherapy or dietetic are supports
that can be proposed if needed) Experimental Group: Standard support with Daily
realization of a session of Kine-Yoga supervised by a physiotherapist at J2, J3 and J4 of
uterovaginal brachytherapy.
Primary purpose:
Supportive Care
Masking:
None (Open Label)
Intervention:
Intervention type:
Other
Intervention name:
session of Kine-Yoga
Description:
Daily performance of a Kine-Yoga-PEP intervention supervised by a physiotherapist of the
department trained in the Kine-Yoga-PEP intervention at J2, J3 and J4 of uterovaginal
brachytherapy.
Possibility for the patient to practice this session in autonomy (using PEP tools given
to the Shared Educational Check-up) according to her wish during the duration of the
treatment and up to 15 days post treatment
Arm group label:
Experimental Group
Summary:
Every year in France, nearly 3,000 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.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- Woman 18 ≥ years old, no age limit
- Patient treated for cervical cancer (histologically proven) by uterovaginal
brachytherapy
- Patient with stress level ≥ 3 on VAS from 0 to 10
- Patient´s signed written informed consent
- Affiliation to a French Social Security System
Exclusion Criteria:
- Physical alteration not allowing the practice of Yoga,
- Patient does not understand and does not speak French
- Patient whose regular follow-up is initially impossible for psychological, family,
social or geographical reasons,
- Patient under guardianship or safeguard of justice
Gender:
Female
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
ICM
Address:
City:
Montpellier
Zip:
34298
Country:
France
Status:
Recruiting
Contact:
Last name:
Kerstin FARAVEL
Email:
kerstin.faravel@icm.unicancer.fr
Facility:
Name:
Centre Eugène Marquis
Address:
City:
Rennes
Zip:
35000
Country:
France
Status:
Recruiting
Contact:
Last name:
Corale GEFFROY
Email:
c.hulot@rennes.unicancer.fr
Facility:
Name:
Oncopole Claudius Regaud
Address:
City:
Toulouse
Zip:
21059
Country:
France
Status:
Not yet recruiting
Contact:
Last name:
Anne DUCASSOU, MD
Email:
ducassou.anne@iuct-oncopole.fr
Start date:
June 3, 2024
Completion date:
March 2026
Lead sponsor:
Agency:
Institut du Cancer de Montpellier - Val d'Aurelle
Agency class:
Other
Source:
Institut du Cancer de Montpellier - Val d'Aurelle
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06263283
https://www.e-cancer.fr/Patients-et-proches/Les-cancers/Cancer-du-col-de-l-uterus/Quelques-chiffres
