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Feasibility Study: Yoga Educational Project (SKYPE)

Primary Purpose

Breast Cancer

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
educational yoga program
Sponsored by
Institut du Cancer de Montpellier - Val d'Aurelle
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Breast Cancer focused on measuring breast cancer, hormonotherapy, osteoarticular pain, yoga, therapeutic patient education

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Institut du Cancer de Montpellier

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Therapeutic educational postural yoga program

Arm Description

Daily 15-min yoga sessions at home during 12 weeks. One 90-min yoga-therapeutic education session/week (during 6 weeks).

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

the patients' satisfaction towards the program
Satisfaction will be measured using the Likert scale (0 no satisfy to 10: strongly satisfy)
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)
To assess quality of life by Quality of Life Questionnaire
Quality of life will be measured by EORTC QLQ-C30 (Quality of Life Questionnaire)
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)
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)
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)
Osteoarticular pain
osteoarticular pain will be assessed using a Visual Analogous scale (0: no pain to 10: maximum pain)
Forward-flexion flexibility
Forward-flexion flexibility is defined by the distance between the fingertips and the floor. It will be measured with a ruler.
Respiratory capacity
Respiratory capacity will be measured with a spirometer
Compliance to hormonotherapy treatment
Taking hormonotherapy treatments will be reported in a log-book by the patients.
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).
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.

Full Information

First Posted
June 7, 2019
Last Updated
June 6, 2023
Sponsor
Institut du Cancer de Montpellier - Val d'Aurelle
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1. Study Identification

Unique Protocol Identification Number
NCT04001751
Brief Title
Feasibility Study: Yoga Educational Project
Acronym
SKYPE
Official Title
Feasibility Study of the "SKYPE" Educational Project in Patients With Breast Cancer Treated With Hormonotherapy
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Completed
Study Start Date
August 31, 2018 (Actual)
Primary Completion Date
July 30, 2019 (Actual)
Study Completion Date
July 30, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Institut du Cancer de Montpellier - Val d'Aurelle

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer
Keywords
breast cancer, hormonotherapy, osteoarticular pain, yoga, therapeutic patient education

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
24 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Therapeutic educational postural yoga program
Arm Type
Experimental
Arm Description
Daily 15-min yoga sessions at home during 12 weeks. One 90-min yoga-therapeutic education session/week (during 6 weeks).
Intervention Type
Behavioral
Intervention Name(s)
educational yoga program
Intervention Description
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.
Primary Outcome Measure Information:
Title
proportion of patient compliance to the educational yoga program
Description
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
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
the patients' satisfaction towards the program
Description
Satisfaction will be measured using the Likert scale (0 no satisfy to 10: strongly satisfy)
Time Frame
12 weeks
Title
the induced self-competency feeling
Description
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)
Time Frame
12 weeks
Title
To assess quality of life by Quality of Life Questionnaire
Description
Quality of life will be measured by EORTC QLQ-C30 (Quality of Life Questionnaire)
Time Frame
12 weeks
Title
To assess quality of life by Quality of Life Questionnaire specify for Breast Cancer
Description
Quality of life will be measured by EORTC QLQ-Br23 (Quality of Life Questionnaire specify for Breast Cancer)
Time Frame
12 weeks
Title
To assess fatigue and stress
Description
Fatigue and stress will be assessed using a Visual Analogous Scale (VAS) (0: no fatigue or no stress to 10 - maximum fatigue or stress)
Time Frame
12 weeks
Title
Anxiety and depression prevalence
Description
Anxiety and depression will be assessed by HADS (Hospital Anxiety and Depression Scale) questionnaire (7 questions about Anxiety and 7 questions about Depression)
Time Frame
12 weeks
Title
Osteoarticular pain
Description
osteoarticular pain will be assessed using a Visual Analogous scale (0: no pain to 10: maximum pain)
Time Frame
12 weeks
Title
Forward-flexion flexibility
Description
Forward-flexion flexibility is defined by the distance between the fingertips and the floor. It will be measured with a ruler.
Time Frame
12 weeks
Title
Respiratory capacity
Description
Respiratory capacity will be measured with a spirometer
Time Frame
12 weeks
Title
Compliance to hormonotherapy treatment
Description
Taking hormonotherapy treatments will be reported in a log-book by the patients.
Time Frame
12 weeks
Title
Patient enrolment rate
Description
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).
Time Frame
at baseline
Title
Reasons of non-participation to the study.
Description
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.
Time Frame
at baseline

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kerstin FARAVEL
Organizational Affiliation
Institut du Cancer de Montpellier
Official's Role
Study Chair
Facility Information:
Facility Name
Institut du Cancer de Montpellier
City
Montpellier
ZIP/Postal Code
34298
Country
France

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
24816806
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.
Results Reference
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PubMed Identifier
25814054
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.
Results Reference
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PubMed Identifier
17761973
Citation
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.
Results Reference
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PubMed Identifier
25749602
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.
Results Reference
background
PubMed Identifier
26556210
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.
Results Reference
background
PubMed Identifier
34939444
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.
Results Reference
derived

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Feasibility Study: Yoga Educational Project

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