Impact of an Educational Physiotherapy-Yoga Intervention on Perceived Stress in Women Treated With Brachytherapy for Cervical Cancer
NCT ID: NCT06263283
Last Updated: 2025-09-23
Study Results
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Basic Information
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RECRUITING
NA
100 participants
INTERVENTIONAL
2024-06-03
2026-08-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
NONE
Study Groups
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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)
No interventions assigned to this group
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.
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.
session of Kine-Yoga
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
Interventions
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session of Kine-Yoga
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
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
FEMALE
No
Sponsors
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Institut du Cancer de Montpellier - Val d'Aurelle
OTHER
Responsible Party
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Principal Investigators
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Aurore MOUSSION
Role: STUDY_DIRECTOR
INSTITUT REGIONAL DU CANCER DE MONTPELLIER Cancer de Montpellier
Kerstin FARAVEL
Role: PRINCIPAL_INVESTIGATOR
INSTITUT REGIONAL DU CANCER DE MONTPELLIER Cancer de Montpellier
Locations
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ICM
Montpellier, , France
Centre Eugène Marquis
Rennes, , France
Oncopole Claudius Regaud
Toulouse, , France
Countries
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Central Contacts
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Facility Contacts
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References
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Booth K, Beaver K, Kitchener H, O'Neill J, Farrell C. Women's experiences of information, psychological distress and worry after treatment for gynaecological cancer. Patient Educ Couns. 2005 Feb;56(2):225-32. doi: 10.1016/j.pec.2004.02.016.
Kirchheiner K, Czajka-Pepl A, Ponocny-Seliger E, Scharbert G, Wetzel L, Nout RA, Sturdza A, Dimopoulos JC, Dorr W, Potter R. Posttraumatic stress disorder after high-dose-rate brachytherapy for cervical cancer with 2 fractions in 1 application under spinal/epidural anesthesia: incidence and risk factors. Int J Radiat Oncol Biol Phys. 2014 Jun 1;89(2):260-7. doi: 10.1016/j.ijrobp.2014.02.018. Epub 2014 Apr 7.
Holt KA, Mogensen O, Jensen PT, Hansen DG. Goal setting in cancer rehabilitation and relation to quality of life among women with gynaecological cancer. Acta Oncol. 2015 Nov;54(10):1814-23. doi: 10.3109/0284186X.2015.1037009. Epub 2015 May 6.
Humphrey P, Bennett C, Cramp F. The experiences of women receiving brachytherapy for cervical cancer: A systematic literature review. Radiography (Lond). 2018 Nov;24(4):396-403. doi: 10.1016/j.radi.2018.06.002. Epub 2018 Jul 18.
Christiansen MG, Piil K, Jarden M. The Symptom Experience and Self-management Strategies of Women Undergoing Cervical Cancer Treatment: A Qualitative Study. Cancer Nurs. 2022 Jan-Feb 01;45(1):12-20. doi: 10.1097/NCC.0000000000000843.
Blackburn L, Hill C, Lindsey AL, Sinnott LT, Thompson K, Quick A. Effect of Foot Reflexology and Aromatherapy on Anxiety and Pain During Brachytherapy for Cervical Cancer. Oncol Nurs Forum. 2021 May 1;48(3):265-276. doi: 10.1188/21.ONF.265-276.
Pascoe MC, Bauer IE. A systematic review of randomised control trials on the effects of yoga on stress measures and mood. J Psychiatr Res. 2015 Sep;68:270-82. doi: 10.1016/j.jpsychires.2015.07.013. Epub 2015 Jul 13.
Schmalzl L, Powers C, Zanesco AP, Yetz N, Groessl EJ, Saron CD. The effect of movement-focused and breath-focused yoga practice on stress parameters and sustained attention: A randomized controlled pilot study. Conscious Cogn. 2018 Oct;65:109-125. doi: 10.1016/j.concog.2018.07.012. Epub 2018 Aug 9.
Danhauer SC, Addington EL, Cohen L, Sohl SJ, Van Puymbroeck M, Albinati NK, Culos-Reed SN. Yoga for symptom management in oncology: A review of the evidence base and future directions for research. Cancer. 2019 Jun 15;125(12):1979-1989. doi: 10.1002/cncr.31979. Epub 2019 Apr 1.
Dhruva A, Miaskowski C, Abrams D, Acree M, Cooper B, Goodman S, Hecht FM. Yoga breathing for cancer chemotherapy-associated symptoms and quality of life: results of a pilot randomized controlled trial. J Altern Complement Med. 2012 May;18(5):473-9. doi: 10.1089/acm.2011.0555. Epub 2012 Apr 23.
Banerjee B, Vadiraj HS, Ram A, Rao R, Jayapal M, Gopinath KS, Ramesh BS, Rao N, Kumar A, Raghuram N, Hegde S, Nagendra HR, Prakash Hande M. Effects of an integrated yoga program in modulating psychological stress and radiation-induced genotoxic stress in breast cancer patients undergoing radiotherapy. Integr Cancer Ther. 2007 Sep;6(3):242-50. doi: 10.1177/1534735407306214.
Akkuzu G, Kurt G, Guvenc G, Kok G, Simsek S, Dogrusoy S, Ayhan A. Learning Needs of Gynecologic Cancer Survivors. J Cancer Educ. 2018 Jun;33(3):544-550. doi: 10.1007/s13187-016-1118-y.
Faravel K, Huteau ME, Jarlier M, de Forges H, Meignant L, Senesse P, Norton J, Jacot W, Stoebner A. Importance of Patient Education for At-home Yoga Practice in Women With Hormonal Therapy-induced Pain During Adjuvant Breast Cancer Treatment: A Feasibility Study. Integr Cancer Ther. 2021 Jan-Dec;20:15347354211063791. doi: 10.1177/15347354211063791.
Vieira JS, de Souza GR, Kalil-Cutti B, Giusti-Paiva A, Vilela FC. Post-traumatic stress disorder increases pain sensitivity by reducing descending noradrenergic and serotoninergic modulation. Behav Brain Res. 2021 Aug 6;411:113367. doi: 10.1016/j.bbr.2021.113367. Epub 2021 May 14.
Cohen S, Kamarck T, Mermelstein R. A global measure of perceived stress. J Health Soc Behav. 1983 Dec;24(4):385-96. No abstract available.
Lesage FX, Berjot S, Deschamps F. Psychometric properties of the French versions of the Perceived Stress Scale. Int J Occup Med Environ Health. 2012 Jun;25(2):178-84. doi: 10.2478/S13382-012-0024-8. Epub 2012 Apr 19.
Tong A, Sainsbury P, Craig J. Consolidated criteria for reporting qualitative research (COREQ): a 32-item checklist for interviews and focus groups. Int J Qual Health Care. 2007 Dec;19(6):349-57. doi: 10.1093/intqhc/mzm042. Epub 2007 Sep 14.
Sovik R. The science of breathing--the yogic view. Prog Brain Res. 2000;122:491-505. doi: 10.1016/s0079-6123(08)62159-7. No abstract available.
Faravel K, Demontoy S, Jarlier M, De-Meric-de-Bellefon M, Cantaloube M, Laboureur E, Meignant L, Del Rio M, Guerdoux E. Impact of an educational physiotherapy-yoga intervention on perceived stress in women treated with brachytherapy for cervical cancer: a randomised controlled mixed study protocol (KYOCOL). BMJ Open. 2025 Jun 4;15(6):e098570. doi: 10.1136/bmjopen-2024-098570.
Related Links
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https://www.e-cancer.fr/Patients-et-proches/Les-cancers/Cancer-du-col-de-l-uterus/Quelques-chiffres
Other Identifiers
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PROICM 2023-04 KYO
Identifier Type: -
Identifier Source: org_study_id
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