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

Cervical Cancer Clinical Trial

— KYOCOL  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06263283
• Other study ID #: PROICM 2023-04 KYO
• Status: Recruiting
• Phase: N/A
• Start date: June 3, 2024
• Est. completion date: March 2026

Study information

• Verified date: June 2024
• Source: Institut du Cancer de Montpellier - Val d'Aurelle
• Contact: Emmanuelle TEXIER
• Phone: 0467613102
• Email: emmanuelle.texier[@]icm.unicancer.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: March 2026
• Est. primary completion date: March 2026
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Brachytherapy
• Cervical Cancer
• Uterine Cervical Neoplasms

Intervention

Other:
• 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

Locations

Country	Name	City	State
France	ICM	Montpellier
France	Centre Eugène Marquis	Rennes
France	Oncopole Claudius Regaud	Toulouse

Sponsors (1)

Lead Sponsor	Collaborator
Institut du Cancer de Montpellier - Val d'Aurelle

Country where clinical trial is conducted

France, 

References & Publications (18)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

* Note: There are 18 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	assessment in the experimental group: safety and patient compliance at the Kine-Yoga-PEP intervention	The safety will be evaluated by Number of treatment interruptions due to applicator displacement and/or source friction following Kine-Yoga-PEP intervention. Patient compliance will be evaluated by the number of sessions performed (supervised and independent) collected on the logbooks filled out by the patients	Time from the randomization to 15 days after uterovaginal brachytherapy
Secondary	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.	Scores obtained at the Visual Analog Scales (VAS) of stress and EVA of pain (global and immobility-related), before and after Kine-Yoga-PEP intervention and during uterovaginal brachytherapy.	During the uterovaginal brachytherapy.
Secondary	Evaluation of the evolution of fatigue during uterovaginal brachytherapy	Fatigue score obtained on Visual Analogue Scale (VAS) during uterovaginal brachytherapy	During the uterovaginal brachytherapy.
Secondary	assessment of the psychological distress at inclusion and 15 days after the uterovaginal brachytherapy	Anxiety-Depressive Distress Score measured by the Hospital Anxiety and Depression Scale (HADS) Questionnaire for uterovaginal Brachytherapy at inclusion and 15 days after the uterovaginal brachytherapy	Time from the baseline to 15 days after uterovaginal brachytherapy
Secondary	Description of the use of anxiolytics by group (experimental vs control)	The use of anxiolytic treatments will be described in the logbooks filled out by the patients	Time from the baseline to 15 days after uterovaginal brachytherapy
Secondary	Description of the experiences of patients treated for cervical cancer during uterovaginal brachytherapy receiving a Kine-Yoga-PEP intervention (approximately 20 patients in the experimental group	The diversity of verbatim and semantic themes collected by a 40 - 60 minute semi-directional interview (qualitative analysis) in the week following the removal of the applicator from patients until data saturation (approximately 20 patients in the experimental group	Between 7 or 12 days after the uterovaginal brachytherapy

External Links

•   https://www.e-cancer.fr/Patients-et-proches/Les-cancers/Cancer-du-col-de-l-uterus/Quelques-chiffres
•   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
•   https://www.researchgate.net/publication/355647077_Music_Therapy_to_Alleviate_Anxiety_in_Cervical_Brachytherapy_-_Do_We_Change_a_Tune_A_Randomized_Single_Institute_Study