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出境医 / 临床实验 / Feasibility Study: Yoga Educational Project (SKYPE)

Feasibility Study: Yoga Educational Project (SKYPE)

Study Description
Brief 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.


Condition or disease Intervention/treatment Phase
Breast Cancer Behavioral: educational yoga program Not Applicable

Detailed 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.

Study Design
Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Feasibility Study of the "SKYPE" Educational Project in Patients With Breast Cancer Treated With Hormonotherapy
Actual Study Start Date : August 31, 2018
Actual Primary Completion Date : July 30, 2019
Actual Study Completion Date : July 30, 2019
Arms and Interventions
Arm Intervention/treatment
Experimental: Therapeutic educational postural yoga program
Daily 15-min yoga sessions at home during 12 weeks. One 90-min yoga-therapeutic education session/week (during 6 weeks).
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.


Outcome Measures
Primary Outcome Measures :
  1. proportion of patient compliance to the educational yoga program [ Time Frame: 12 weeks ]
    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


Secondary Outcome Measures :
  1. the patients' satisfaction towards the program [ Time Frame: 12 weeks ]
    Satisfaction will be measured using the Likert scale (0 no satisfy to 10: strongly satisfy)

  2. the induced self-competency feeling [ Time Frame: 12 weeks ]
    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)

  3. To assess quality of life, [ Time Frame: 12 weeks ]
    Quality of life will be measured by EORTC QLQ-C30 (Quality of Life Questionnaire)

  4. To assess quality of life, [ Time Frame: 12 weeks ]
    Quality of life will be measured by EORTC QLQ-Br23 (Quality of Life Questionnaire specify for Breast Cancer)

  5. To assess fatigue and stress [ Time Frame: 12 weeks ]
    Fatigue and stress will be assessed using a Visual Analogous Scale (VAS) (0: no fatigue or no stress to 10 - maximum fatigue or stress)

  6. Anxiety and depression prevalence [ Time Frame: 12 weeks ]
    Anxiety and depression will be assessed by HADS (Hospital Anxiety and Depression Scale) questionnaire (7 questions about Anxiety and 7 questions about Depression)

  7. Osteoarticular pain [ Time Frame: 12 weeks ]
    osteoarticular pain will be assessed using a Visual Analogous scale (0: no pain to 10: maximum pain)

  8. Forward-flexion flexibility [ Time Frame: 12 weeks ]
    Forward-flexion flexibility is defined by the distance between the fingertips and the floor. It will be measured with a ruler.

  9. Respiratory capacity [ Time Frame: 12 weeks ]
    Respiratory capacity will be measured with a spirometer

  10. Compliance to hormonotherapy treatment [ Time Frame: 12 weeks ]
    Taking hormonotherapy treatments will be reported in a log-book by the patients.

  11. Patient enrolment rate [ Time Frame: at baseline ]
    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).

  12. Reasons of non-participation to the study. [ Time Frame: at baseline ]
    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.


Eligibility Criteria
Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations

Locations
Layout table for location information
France
Institut du Cancer de Montpellier
Montpellier, France, 34298
Sponsors and Collaborators
Institut du Cancer de Montpellier - Val d'Aurelle
Investigators
Layout table for investigator information
Study Chair: Kerstin FARAVEL Institut du Cancer de Montpellier
Tracking Information
First Submitted Date  ICMJE June 7, 2019
First Posted Date  ICMJE June 28, 2019
Last Update Posted Date May 20, 2020
Actual Study Start Date  ICMJE August 31, 2018
Actual Primary Completion Date July 30, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 27, 2019)
proportion of patient compliance to the educational yoga program [ Time Frame: 12 weeks ]
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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 19, 2020)
  • the patients' satisfaction towards the program [ Time Frame: 12 weeks ]
    Satisfaction will be measured using the Likert scale (0 no satisfy to 10: strongly satisfy)
  • the induced self-competency feeling [ Time Frame: 12 weeks ]
    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)
  • To assess quality of life, [ Time Frame: 12 weeks ]
    Quality of life will be measured by EORTC QLQ-C30 (Quality of Life Questionnaire)
  • To assess quality of life, [ Time Frame: 12 weeks ]
    Quality of life will be measured by EORTC QLQ-Br23 (Quality of Life Questionnaire specify for Breast Cancer)
  • To assess fatigue and stress [ Time Frame: 12 weeks ]
    Fatigue and stress will be assessed using a Visual Analogous Scale (VAS) (0: no fatigue or no stress to 10 - maximum fatigue or stress)
  • Anxiety and depression prevalence [ Time Frame: 12 weeks ]
    Anxiety and depression will be assessed by HADS (Hospital Anxiety and Depression Scale) questionnaire (7 questions about Anxiety and 7 questions about Depression)
  • Osteoarticular pain [ Time Frame: 12 weeks ]
    osteoarticular pain will be assessed using a Visual Analogous scale (0: no pain to 10: maximum pain)
  • Forward-flexion flexibility [ Time Frame: 12 weeks ]
    Forward-flexion flexibility is defined by the distance between the fingertips and the floor. It will be measured with a ruler.
  • Respiratory capacity [ Time Frame: 12 weeks ]
    Respiratory capacity will be measured with a spirometer
  • Compliance to hormonotherapy treatment [ Time Frame: 12 weeks ]
    Taking hormonotherapy treatments will be reported in a log-book by the patients.
  • Patient enrolment rate [ Time Frame: at baseline ]
    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).
  • Reasons of non-participation to the study. [ Time Frame: at baseline ]
    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.
Original Secondary Outcome Measures  ICMJE
 (submitted: June 27, 2019)
  • the patients' satisfaction towards the program [ Time Frame: 12 weeks ]
    Satisfaction will be measured using the Likert scale (0 no satisfy to 10: strongly satisfy)
  • the induced self-competency feeling [ Time Frame: 12 weeks ]
    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)
  • To assess quality of life, [ Time Frame: 12 weeks ]
    Quality of life will be measured by EORTC QLQ-C30 (Quality of Life Questionnaire) and QLQ-Br23 (Quality of Life Questionnaire specify for Breast Cancer)
  • To assess fatigue and stress [ Time Frame: 12 weeks ]
    Fatigue and stress will be assessed using a Visual Analogous Scale (VAS) (0: no fatigue or no stress to 10 - maximum fatigue or stress)
  • Anxiety and depression prevalence [ Time Frame: 12 weeks ]
    Anxiety and depression will be assessed by HADS (Hospital Anxiety and Depression Scale) questionnaire (7 questions about Anxiety and 7 questions about Depression)
  • Osteoarticular pain [ Time Frame: 12 weeks ]
    osteoarticular pain will be assessed using a Visual Analogous scale (0: no pain to 10: maximum pain)
  • Forward-flexion flexibility [ Time Frame: 12 weeks ]
    Forward-flexion flexibility is defined by the distance between the fingertips and the floor. It will be measured with a ruler.
  • Respiratory capacity [ Time Frame: 12 weeks ]
    Respiratory capacity will be measured with a spirometer
  • Compliance to hormonotherapy treatment [ Time Frame: 12 weeks ]
    Taking hormonotherapy treatments will be reported in a log-book by the patients.
  • Patient enrolment rate [ Time Frame: at baseline ]
    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).
  • Reasons of non-participation to the study. [ Time Frame: at baseline ]
    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.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Feasibility Study: Yoga Educational Project
Official Title  ICMJE Feasibility Study of the "SKYPE" Educational Project in Patients With Breast Cancer Treated With Hormonotherapy
Brief 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.

Detailed 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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Condition  ICMJE Breast Cancer
Intervention  ICMJE 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.

Study Arms  ICMJE Experimental: Therapeutic educational postural yoga program
Daily 15-min yoga sessions at home during 12 weeks. One 90-min yoga-therapeutic education session/week (during 6 weeks).
Intervention: Behavioral: educational yoga program
Publications *
  • 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.
  • 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©® 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.
  • 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.
  • 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. Review. Erratum in: J Natl Cancer Inst Monogr. 2015 May;2015(51):98.
  • 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 27, 2019)
24
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE July 30, 2019
Actual Primary Completion Date July 30, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04001751
Other Study ID Numbers  ICMJE PROICM 2018-02 SKY
2018-A00208-47 ( Registry Identifier: ID-RCB )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Institut du Cancer de Montpellier - Val d'Aurelle
Study Sponsor  ICMJE Institut du Cancer de Montpellier - Val d'Aurelle
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Kerstin FARAVEL Institut du Cancer de Montpellier
PRS Account Institut du Cancer de Montpellier - Val d'Aurelle
Verification Date June 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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