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NCT06263283Completed

Impact of an Educational Physiotherapy-Yoga Intervention on Perceived Stress in Women Treated With Brachytherapy for Cervical Cancer

Impact of an Educational Physiotherapy-Yoga Intervention on Perceived Stress in Women Treated With Brachytherapy for Cervical Cancer: a Randomized Controlled Trial

Source: ClinicalTrials.gov · Last updated 14 Sept 2026

Brief summary (registry, in English)

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.

Status (registry)
Completed
Study type
Interventional
Enrollment
98 (actual)
First submitted
9 Feb 2024
Start date
3 Jun 2024
Primary completion date
16 Feb 2026
Lead sponsor
Institut du Cancer de Montpellier - Val d'Aurelle
NCT number
NCT06263283

What you commit to

  • Study type: Interventional
  • Participants enrolled: 98
  • From 3 Jun 2024 to the primary completion date, 16 Feb 2026
  • 3 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other

  • 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

Who the study is looking for

  • 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

Age in the registry: 18 years to - · Sex: Female · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (3)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
ICM
Coordinator of this site? Confirm its status
MontpellierFranceUnknown status
Centre Eugène Marquis
Coordinator of this site? Confirm its status
RennesFranceUnknown status
Oncopole Claudius Regaud
Coordinator of this site? Confirm its status
ToulouseFranceUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.