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

NCT06263283 | Active Not Recruiting

• 1 other identifier: PROICM 2023-04 KYO
• Study Type: interventional
• Target: 98
• Locations: 1 country
• Sites: 3

Brief 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.

Conditions

Cervical Cancer; Brachytherapy

Keywords

cervical cancer; uterovaginal brachytherapy; stress; Prolonged immobilization; yoga

Outcome Measures

Primary Outcomes (1)

• Evaluation of the Kine-Yoga-PEP intervention to standard care during the uterovaginal brachytherapy on perceived stress at 15 days of treatment initiation in patients treated for cervical cancer.

  The Perceived Stress Score will be assessed by the 10-item Perceived Stress Scale (PSS) self-assessment 15 days after the start of the uterovaginal brachytherapy.

  Time from the randomization to 15 days after uterovaginal brachytherapy

Secondary Outcomes (6)

• assessment in the experimental group: safety and patient compliance at the Kine-Yoga-PEP intervention

  Time from the randomization to 15 days after uterovaginal brachytherapy

• Evaluation of the immediate effect of the Kine-Yoga-PEP intervention in the experimental group on perceived stress, pain (overall and due to immobility) and the evolution of these parameters during brachytherapy.

  During the uterovaginal brachytherapy.

• Evaluation of the evolution of fatigue during uterovaginal brachytherapy

  During the uterovaginal brachytherapy.

• assessment of the psychological distress at inclusion and 15 days after the uterovaginal brachytherapy

  Time from the baseline to 15 days after uterovaginal brachytherapy

• Description of the use of anxiolytics by group (experimental vs control)

  Time from the baseline to 15 days after uterovaginal brachytherapy

Study Arms (2)

Control Group

NO INTERVENTION

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

EXPERIMENTAL

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.

Other: session of Kine-Yoga

Interventions

session of Kine-Yoga OTHER

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

Experimental Group

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Institut du Cancer de Montpellier - Val d'Aurelle: lead

Study Sites (3)

ICM

Montpellier, 34298, France

Location

Centre Eugène Marquis

Rennes, 35000, France

Location

Oncopole Claudius Regaud

Toulouse, 21059, France

Location

Related Publications (19)

• 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.

  PMID: 15653253 BACKGROUND

• 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.

  PMID: 24721589 BACKGROUND

• 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.

  PMID: 25943136 BACKGROUND

• 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.

  PMID: 30292512 BACKGROUND

• 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.

  PMID: 32675630 BACKGROUND

• 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.

  PMID: 33855996 BACKGROUND

• 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.

  PMID: 26228429 BACKGROUND

• 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.

  PMID: 30099318 BACKGROUND

• 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.

  PMID: 30933317 BACKGROUND

• 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.

  PMID: 22525009 BACKGROUND

• 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.

  PMID: 17761637 BACKGROUND

• 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.

  PMID: 27743314 BACKGROUND

• 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.

  PMID: 34939444 BACKGROUND

• 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.

  PMID: 34000338 BACKGROUND

• 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.

  PMID: 6668417 BACKGROUND

• 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.

  PMID: 22528542 BACKGROUND

• 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.

  PMID: 17872937 BACKGROUND

• 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.

  PMID: 10737079 BACKGROUND

• 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.

  PMID: 40467316 DERIVED

Related Links

• https://www.e-cancer.fr/Patients-et-proches/Les-cancers/Cancer-du-col-de-l-uterus/Quelques-chiffres
• https://www.researchgate.net/publication/355647077\_Music\_Therapy\_to\_Alleviate\_Anxiety\_in\_Cervical\_Brachytherapy\_-\_Do\_We\_Change\_a\_Tune\_A\_Randomized\_Single\_Institute\_Study
• https://www.researchgate.net/publication/270634351\_Effects\_of\_music\_relaxation\_video\_on\_pain\_and\_anxiety\_for\_women\_with\_gynaecological\_cancer\_receiving\_intracavitary\_brachytherapy\_a\_randomised\_controlled\_trial

MeSH Terms

Conditions

Uterine Cervical Neoplasms

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Study Officials

• Aurore MOUSSION

  INSTITUT REGIONAL DU CANCER DE MONTPELLIER Cancer de Montpellier

  STUDY DIRECTOR

• Kerstin FARAVEL

  INSTITUT REGIONAL DU CANCER DE MONTPELLIER Cancer de Montpellier

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: February 9, 2024
• First Posted: February 16, 2024
• Study Start: June 3, 2024
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): August 1, 2026
• Last Updated: February 24, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

FR (3)