Feasibility Study: Yoga Educational Project

Breast Cancer Clinical Trial

— SKYPE  

Official title:

Feasibility Study of the "SKYPE" Educational Project in Patients With Breast Cancer Treated With Hormonotherapy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04001751
• Other study ID #: PROICM 2018-02 SKY
• Secondary ID: 2018-A00208-47
• Status: Completed
• Phase: N/A
• Start date: August 31, 2018
• Est. completion date: July 30, 2019

Study information

• Verified date: November 2022
• Source: Institut du Cancer de Montpellier - Val d'Aurelle
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

As much as 45 to 60% of patients treated with hormonotherapy (HT) for breast cancer (BC) suffer from osteoarticular pain during treatment. Secondary effects have become a real issue because of their consequences on the patients' quality of life, but also on treatment efficacy and survival when they induce dose reduction or premature withdrawal of treatment.

Additional medicines (acupuncture, hypnosis, yoga) have become more and more popular these last years. 48 to 80% of patients with BC eventually choose them. A review comparing efficacy of various therapies to decrease osteoarticular pain concludes to a highest efficacy of anti-inflammatory treatments, paracetamol and yoga.

With this project, the investigators will assess the feasibility of a therapeutic yoga program with home practice for patients with breast cancer treated with hormonotherapy. The investigators will measure adhesion of the patients to perform yoga postures in an autonomous manner. Our study will also allow collection of data on the effect of such a program on quality of life, in view of setting-up an intervention study.

Description:

Numerous initiatives have started in France, often associative. It is essential to evaluate in a rigorous manner, these therapies before making them part of the patient's care pathway.

Yoga has shown a real benefit in terms of pain reduction in patients with BC treated with HT. These osteoarticular pains are the secondary effect on which a physical therapeutic care can have a real benefit.

It thus appears innovative to complete this care with a therapeutic education program (TEP) in postural yoga which will enable patients to practice yoga postures at home by themselves. Yoga allows a large adaptation to pains expressed by each patient. It will favor the development of the feeling of control that they have in particular on their pain. participants will so improve the self-efficacy, the quality of life, and will reduce their fatigue and their pain. The patients involved have already lived major body transformations because of the disease and treatments. Yoga will help them put their lives together again, both physically and psychologically, and reclaim their body.

Studies have shown the short-term effects of yoga practice on anxiety, stress, pain and quality of life. Few rare studies have suggested that patients could add yoga practice at home to the supervised sessions, but these studies lacked therapeutic patient education. To date, to our knowledge, no data on the effect of the realization of yoga postures at home on increase of the patients' self-competency feeling are available in France. Also, the long-term effects of such programs need to be assessed.

The Montpellier Cancer Institute (ICM) has set-up 8 years ago yoga sessions for women with breast cancer, together with an association located in Montpellier.

With this study, the investigators will assess the feasibility of an educational yoga program given by a trained physical therapist in patients with beast cancer treated with hormonotherapy.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: July 30, 2019
• Est. primary completion date: July 30, 2019
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Age = 18 years

• Non metastatic breast cancer

• Ongoing hormonotherapy, with no treatment modification in the 30 days before inclusion

• Osteoarticular pain = 4 (resting or moving) on the VAS (Visual Analogue Scale)

• Previous treatment (surgery, chemotherapy or radiotherapy) ended at least 2 months before inclusion

• Informed patient and signed informed consent received

• Affiliation to a social security category

Exclusion Criteria:

• Chronic rheumatologic pain with specific care needed

• Yoga practice in the 3 months before inclusion

• Contra-indication or clinical state not allowing physical practice

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Behavioral:
• educational yoga program
Daily 15-min yoga sessions at home with the "Le guide du yoga" and the audio-guide, during 12 weeks. One 90-min yoga-therapeutic education session/week (during 6 weeks) given by a physical therapist trained to postural yoga.

Locations

Country	Name	City	State
France	Institut du Cancer de Montpellier	Montpellier

Sponsors (1)

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

Country where clinical trial is conducted

France, 

References & Publications (5)

Crew KD, Greenlee H, Capodice J, Raptis G, Brafman L, Fuentes D, Sierra A, Hershman DL. Prevalence of joint symptoms in postmenopausal women taking aromatase inhibitors for early-stage breast cancer. J Clin Oncol. 2007 Sep 1;25(25):3877-83. doi: 10.1200/JCO.2007.10.7573. — View Citation

Greenlee H, Balneaves LG, Carlson LE, Cohen M, Deng G, Hershman D, Mumber M, Perlmutter J, Seely D, Sen A, Zick SM, Tripathy D; Society for Integrative Oncology. Clinical practice guidelines on the use of integrative therapies as supportive care in patients treated for breast cancer. J Natl Cancer Inst Monogr. 2014 Nov;2014(50):346-58. doi: 10.1093/jncimonographs/lgu041. Erratum In: J Natl Cancer Inst Monogr. 2015 May;2015(51):98. — View Citation

Lintermans A, Van Asten K, Wildiers H, Laenen A, Paridaens R, Weltens C, Verhaeghe J, Vanderschueren D, Smeets A, Van Limbergen E, Leunen K, Christiaens MR, Neven P. A prospective assessment of musculoskeletal toxicity and loss of grip strength in breast cancer patients receiving adjuvant aromatase inhibitors and tamoxifen, and relation with BMI. Breast Cancer Res Treat. 2014 Jul;146(1):109-16. doi: 10.1007/s10549-014-2986-7. Epub 2014 May 11. — View Citation

Lombard JM, Zdenkowski N, Wells K, Beckmore C, Reaby L, Forbes JF, Chirgwin J. Aromatase inhibitor induced musculoskeletal syndrome: a significant problem with limited treatment options. Support Care Cancer. 2016 May;24(5):2139-2146. doi: 10.1007/s00520-015-3001-5. Epub 2015 Nov 10. — View Citation

Peppone LJ, Janelsins MC, Kamen C, Mohile SG, Sprod LK, Gewandter JS, Kirshner JJ, Gaur R, Ruzich J, Esparaz BT, Mustian KM. The effect of YOCAS(c)(R) yoga for musculoskeletal symptoms among breast cancer survivors on hormonal therapy. Breast Cancer Res Treat. 2015 Apr;150(3):597-604. doi: 10.1007/s10549-015-3351-1. Epub 2015 Mar 27. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	proportion of patient compliance to the educational yoga program	Compliance will be posittive if 70% of daily sessions at home and 4 sessions out of the 6 therapeutic educational (TEP) sessions delivered in the center by a physical therapist are realised	12 weeks
Secondary	the patients' satisfaction towards the program	Satisfaction will be measured using the Likert scale (0 no satisfy to 10: strongly satisfy)	12 weeks
Secondary	the induced self-competency feeling	self-competency feeling induced will be assessed using the GSES (General Self Efficacy-Schwarzer) questionnaire (10 questions - scale 1- not at all true to 4-totally true)	12 weeks
Secondary	To assess quality of life by Quality of Life Questionnaire	Quality of life will be measured by EORTC QLQ-C30 (Quality of Life Questionnaire)	12 weeks
Secondary	To assess quality of life by Quality of Life Questionnaire specify for Breast Cancer	Quality of life will be measured by EORTC QLQ-Br23 (Quality of Life Questionnaire specify for Breast Cancer)	12 weeks
Secondary	To assess fatigue and stress	Fatigue and stress will be assessed using a Visual Analogous Scale (VAS) (0: no fatigue or no stress to 10 - maximum fatigue or stress)	12 weeks
Secondary	Anxiety and depression prevalence	Anxiety and depression will be assessed by HADS (Hospital Anxiety and Depression Scale) questionnaire (7 questions about Anxiety and 7 questions about Depression)	12 weeks
Secondary	Osteoarticular pain	osteoarticular pain will be assessed using a Visual Analogous scale (0: no pain to 10: maximum pain)	12 weeks
Secondary	Forward-flexion flexibility	Forward-flexion flexibility is defined by the distance between the fingertips and the floor. It will be measured with a ruler.	12 weeks
Secondary	Respiratory capacity	Respiratory capacity will be measured with a spirometer	12 weeks
Secondary	Compliance to hormonotherapy treatment	Taking hormonotherapy treatments will be reported in a log-book by the patients.	12 weeks
Secondary	Patient enrolment rate	The patient enrolment rate will be estimated (i.e. the proportion of patients giving their consent to participate in the study among eligible screened patients).	at baseline
Secondary	Reasons of non-participation to the study.	The reason of non-participation to the study (difficulty of coming, not concerning by the project, not interesting by the project, fatigue, other) will be reported by the patient to the doctor.	at baseline