Cervical CancerKYOCOLNCT06263283
Impact of an Educational Physiotherapy-Yoga Intervention on Perceived Stress in Women Treated With Brachytherapy for Cervical Cancer
A study testing session of Kine-Yoga in people with Cervical Cancer and Brachytherapy, run by Institut du Cancer de Montpellier - Val d'Aurelle at 3 sites in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Cervical Cancer, Brachytherapy
- What is being tested?
- session of Kine-Yoga
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 98 participants
- Where
- 3 sitesFrance
- Study dates
- 3 Jun 2024to 16 Feb 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
3 sites in 1 country.
France3 sites
ICM
Montpellier, 34298
Centre Eugène Marquis
Rennes, 35000
Oncopole Claudius Regaud
Toulouse, 21059
About this study
Official title: Impact of an Educational Physiotherapy-Yoga Intervention on Perceived Stress in Women Treated With Brachytherapy for Cervical Cancer: a Randomized Controlled Trial
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.
Read more
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
- Being tested
- session of Kine-Yoga
- Keywords
- cervical cancer, uterovaginal brachytherapy, stress, Prolonged immobilization, yoga
- Medical subject headings
- Uterine Cervical Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
session of Kine-YogaOther
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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: session of Kine-Yoga |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
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
Measured: 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.
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.
Measured: During the uterovaginal brachytherapy.
Evaluation of the evolution of fatigue during uterovaginal brachytherapy
Fatigue score obtained on Visual Analogue Scale (VAS) during uterovaginal brachytherapy
Measured: During the uterovaginal brachytherapy.
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
Measured: Time from the baseline to 15 days after uterovaginal brachytherapy
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
Measured: Time from the baseline to 15 days after uterovaginal brachytherapy
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
Measured: Between 7 or 12 days after the uterovaginal brachytherapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Feb 2024
- Study start3 Jun 2024
- Primary completion16 Feb 2026
- Study completion16 Feb 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (19)Papers the sponsor has linked to this study.
- Other trials for Cervical CancerStudies of the same condition, open and under way.
- More trials run by Institut du Cancer de Montpellier - Val d'AurelleThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- None (open label)
- Enrolment
- 98 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Aurore MOUSSION, Study director, INSTITUT REGIONAL DU CANCER DE MONTPELLIER Cancer de MontpellierKerstin FARAVEL, Principal investigator, INSTITUT REGIONAL DU CANCER DE MONTPELLIER Cancer de Montpellier
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06263283
- Sponsor's protocol ID
- PROICM 2023-04 KYO
- Acronym
- KYOCOL
- Status last verified
- Sep 2026
- First submitted
- 9 Feb 2024
- Last updated
- 14 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All data will be available after publication of the results in peer-reviewed revues, and in national and international meetings. It includes all de-identified participants' data, the study protocol, the statistical analysis plan and the clinical study report. The corresponding author will provide data and datasets generated and/or analyzed during the study upon reasonable request
Publications
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.
PubMed 15653253Kirchheiner 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.
PubMed 24721589Holt 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.
PubMed 25943136Humphrey 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.
PubMed 30292512Christiansen 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.
PubMed 32675630Blackburn 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.
PubMed 33855996Pascoe 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.
PubMed 26228429Schmalzl 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.
PubMed 30099318Danhauer 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.
PubMed 30933317Dhruva 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.
PubMed 22525009Banerjee 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.
PubMed 17761637Akkuzu 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.
PubMed 27743314Faravel 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.
PubMed 34939444Vieira 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.
PubMed 34000338Cohen S, Kamarck T, Mermelstein R. A global measure of perceived stress. J Health Soc Behav. 1983 Dec;24(4):385-96. No abstract available.
PubMed 6668417
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of an Educational Physiotherapy-Yoga Intervention on Perceived Stress in Women Treated With Brachytherapy for Cervical Cancer: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06263283
- Acronym / sponsor ID
- KYOCOL / PROICM 2023-04 KYO
- Conditions
- Cervical Cancer, Brachytherapy
- Keywords
- cervical cancer, uterovaginal brachytherapy, stress, Prolonged immobilization, yoga
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 98 participants (actual)
- Lead sponsor
- Institut du Cancer de Montpellier - Val d'AurelleUniversity, hospital or other
- Study start
- 3 Jun 2024 (actual)
- Primary completion
- 16 Feb 2026 (actual)
- Study completion
- 16 Feb 2026 (actual)
- First posted
- 16 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| 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 | Other: session of Kine-YogaStandard 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| session of Kine-YogaDaily 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 | Other | Experimental Group |
Primary outcome
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.
Time frame: Time from the randomization to 15 days after uterovaginal brachytherapy
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.
6 secondary outcomes
assessment in the experimental group: safety and patient compliance at the Kine-Yoga-PEP intervention
Time frame: 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.
Time frame: During the uterovaginal brachytherapy.
Evaluation of the evolution of fatigue during uterovaginal brachytherapy
Time frame: During the uterovaginal brachytherapy.
assessment of the psychological distress at inclusion and 15 days after the uterovaginal brachytherapy
Time frame: Time from the baseline to 15 days after uterovaginal brachytherapy
Description of the use of anxiolytics by group (experimental vs control)
Time frame: Time from the baseline to 15 days after uterovaginal brachytherapy
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
Time frame: Between 7 or 12 days after the uterovaginal brachytherapy
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 2026.
- Background: PubMed 15653253Booth 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.
- Background: PubMed 24721589Kirchheiner 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.
- Background: PubMed 25943136Holt 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.
- Background: PubMed 30292512Humphrey 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.
- Background: PubMed 32675630Christiansen 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.
- Background: PubMed 33855996Blackburn 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.
- Background: PubMed 26228429Pascoe 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.
- Background: PubMed 30099318Schmalzl 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.
- Background: PubMed 30933317Danhauer 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.
- Background: PubMed 22525009Dhruva 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.
- Background: PubMed 17761637Banerjee 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.
- Background: PubMed 27743314Akkuzu 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.
- https://www.e-cancer.fr/Patients-et-proches/Les-cancers/Cancer-du-col-de-l-uterus/Quelques-chiffresLink provided by the sponsor.
- 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\_trialLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. All data will be available after publication of the results in peer-reviewed revues, and in national and international meetings. It includes all de-identified participants' data, the study protocol, the statistical analysis plan and the clinical study report. The corresponding author will provide data and datasets generated and/or analyzed during the study upon reasonable request
Related trials for Cervical Cancer
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
RecruitingObservational study
Proton Re-irradiation in Patients With Recurrent or Second Primary Head and Neck Cancer , a Multicentre Phase II Single Arm Trial
Head & Neck Cancer
RecruitingPhase 2/3
Multicenter Validation Trial of [18F]AlF-FAPI-74 for PET Imaging of Cancer-associated Fibroblasts Through Fibroblast Activation Protein Inhibitors (FAPI) in Different Tumor Types
Oesophageal Cancer, Gastric Cancer
RecruitingPhase 2
Proton Spatially Fractionated Radiotherapy or Photon Stereotactic Body Radiotherapy in Combination With Pembrolizumab Before Surgery for the Treatment of Locally Advanced and Radiation-Naive Locoregionally Recurrent Oral Cavity Cancer, OSPRI Trial
Locally Advanced Oral Cavity Squamous Cell Carcinoma, Locally Recurrent Oral Cavity Squamous Cell Carcinoma
RecruitingPhase 4
Lidocaine Infiltration and Neuroimmunomodulation in Head and Neck Cancer Surgery
Head and Neck Cancer (H&N)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Aurore MOUSSION study director
INSTITUT REGIONAL DU CANCER DE MONTPELLIER Cancer de Montpellier
Kerstin FARAVEL principal investigator
INSTITUT REGIONAL DU CANCER DE MONTPELLIER Cancer de Montpellier
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing session of Kine-Yoga in people with Cervical Cancer and Brachytherapy, run by Institut du Cancer de Montpellier - Val d'Aurelle at 3 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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. (time frame: Time from the randomization to 15 days after uterovaginal brachytherapy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06263283, which also lists 19 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Sep 2026.