Back to resultsImpact of Osteopathy on Pain After Breast Cancer Surgery (IPOD)
Primary Purpose
Breast Cancer
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Osteopathy sessions
phone questionnaires
Sponsored by
About this trial
This is an interventional supportive care trial for Breast Cancer focused on measuring pain, quality of life, osteopathy, oncology, surgery, breast
Eligibility Criteria
Inclusion Criteria:
- Adult woman
- Surgery for a malignant breast tumor with sentinel lymph node technique
- Patient affiliated to a social security system
- Willing and able to provide written informed consent
Exclusion Criteria:
- Under-age women
- Pregnant woman
- Surgery for a malignant breast tumor with lymph node dissection
- Receiving adjuvant therapy during the study
- Receiving physiotherapy sessions (other than those made in immediate post-operative)
- Participating in the space "Au Fil de Soi": relaxing body massage and Energy Resonance by Cutaneous Stimulation (RESC)
- Person under guardianship or supervision
- Patient with impaired cognitive functions or lack of understanding of the French language
- Presenting a contraindication for osteopathy (major infectious and inflammatory conditions, trauma and other severe diseases)
Sites / Locations
- Service de gynécologie
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Other
Arm Label
Intervention group (osteopathy)
control group
Arm Description
Patients will have three sessions of osteopathy and 6 phone questionnaires.
Patients will have 6 phone questionnaires.
Outcomes
Primary Outcome Measures
Assess the impact of osteopathic treatment on pain in patients following breast cancer surgery
The primary outcome measure will be the evaluation of the "usual pain in the last eight days" measured from the pain score (digital scale). The pain score consists of asking the patient to quantify her pain on a virtual scale from 0 (absent pain) to 10 (worst pain imaginable).
Assess the impact of osteopathic treatment on pain in patients following breast cancer surgery
The primary outcome measure will be the evaluation of the "usual pain in the last eight days" measured from the pain score (digital scale). The pain score consists of asking the patient to quantify her pain on a virtual scale from 0 (absent pain) to 10 (worst pain imaginable).
Assess the impact of osteopathic treatment on pain in patients following breast cancer surgery
The primary outcome measure will be the evaluation of the "usual pain in the last eight days" measured from the pain score (digital scale). The pain score consists of asking the patient to quantify her pain on a virtual scale from 0 (absent pain) to 10 (worst pain imaginable).
Assess the impact of osteopathic treatment on pain in patients following breast cancer surgery
The primary outcome measure will be the evaluation of the "usual pain in the last eight days" measured from the pain score (digital scale). The pain score consists of asking the patient to quantify her pain on a virtual scale from 0 (absent pain) to 10 (worst pain imaginable).
Assess the impact of osteopathic treatment on pain in patients following breast cancer surgery
The primary outcome measure will be the evaluation of the "usual pain in the last eight days" measured from the pain score (digital scale). The pain score consists of asking the patient to quantify her pain on a virtual scale from 0 (absent pain) to 10 (worst pain imaginable).
Assess the impact of osteopathic treatment on pain in patients following breast cancer surgery
The primary outcome measure will be the evaluation of the "usual pain in the last eight days" measured from the pain score (digital scale). The pain score consists of asking the patient to quantify her pain on a virtual scale from 0 (absent pain) to 10 (worst pain imaginable).
Secondary Outcome Measures
Assess the impact of osteopathic treatment on the quality of life in patients who have been operated on breast cancer.
Assessment of quality of life by the SF-12 questionnaire, which is a shortened version of the " Medical Outcomes Study Short-Form General Health Survey " (SF-36), comprising only 12 of the 36 issues. The SF-12 is used to calculate two scores, which measure the functional health and well-being of the patient.
Assess the impact of osteopathic treatment on the quality of life in patients who have been operated on breast cancer.
Assessment of quality of life by the SF-12 questionnaire, which is a shortened version of the " Medical Outcomes Study Short-Form General Health Survey " (SF-36), comprising only 12 of the 36 issues. The SF-12 is used to calculate two scores, which measure the functional health and well-being of the patient.
Assess the impact of osteopathic treatment on the quality of life in patients who have been operated on breast cancer.
Assessment of quality of life by the SF-12 questionnaire, which is a shortened version of the " Medical Outcomes Study Short-Form General Health Survey " (SF-36), comprising only 12 of the 36 issues. The SF-12 is used to calculate two scores, which measure the functional health and well-being of the patient.
Assess the impact of osteopathic treatment on the quality of life in patients who have been operated on breast cancer.
Assessment of quality of life by the SF-12 questionnaire, which is a shortened version of the " Medical Outcomes Study Short-Form General Health Survey " (SF-36), comprising only 12 of the 36 issues. The SF-12 is used to calculate two scores, which measure the functional health and well-being of the patient.
Assess the impact of osteopathic treatment on the quality of life in patients who have been operated on breast cancer.
Assessment of quality of life by the SF-12 questionnaire, which is a shortened version of the " Medical Outcomes Study Short-Form General Health Survey " (SF-36), comprising only 12 of the 36 issues. The SF-12 is used to calculate two scores, which measure the functional health and well-being of the patient.
Assess the impact of osteopathic treatment on the quality of life in patients who have been operated on breast cancer.
Assessment of quality of life by the SF-12 questionnaire, which is a shortened version of the " Medical Outcomes Study Short-Form General Health Survey " (SF-36), comprising only 12 of the 36 issues. The SF-12 is used to calculate two scores, which measure the functional health and well-being of the patient.
Assess the impact of osteopathic treatment on the reduction of anxiety of patients operated for breast cancer.
Assessment of anxiodepressive disorders from the HAD scale (Hospital and Anxiety Depression), each response is rated from 0-3 on a scale evaluating semi-quantitatively the intensity of symptoms during the past week. This study will use just the score of anxiety.
Assess the impact of osteopathic treatment on the reduction of anxiety of patients operated for breast cancer.
Assessment of anxiodepressive disorders from the HAD scale (Hospital and Anxiety Depression), each response is rated from 0-3 on a scale evaluating semi-quantitatively the intensity of symptoms during the past week. This study will use just the score of anxiety.
Assess the impact of osteopathic treatment on the reduction of anxiety of patients operated for breast cancer.
Assessment of anxiodepressive disorders from the HAD scale (Hospital and Anxiety Depression), each response is rated from 0-3 on a scale evaluating semi-quantitatively the intensity of symptoms during the past week. This study will use just the score of anxiety.
Assess the impact of osteopathic treatment on the reduction of anxiety of patients operated for breast cancer.
Assessment of anxiodepressive disorders from the HAD scale (Hospital and Anxiety Depression), each response is rated from 0-3 on a scale evaluating semi-quantitatively the intensity of symptoms during the past week. This study will use just the score of anxiety.
Assess the impact of osteopathic treatment on the reduction of anxiety of patients operated for breast cancer.
Assessment of anxiodepressive disorders from the HAD scale (Hospital and Anxiety Depression), each response is rated from 0-3 on a scale evaluating semi-quantitatively the intensity of symptoms during the past week. This study will use just the score of anxiety.
Assess the impact of osteopathic treatment on the reduction of anxiety of patients operated for breast cancer.
Assessment of anxiodepressive disorders from the HAD scale (Hospital and Anxiety Depression), each response is rated from 0-3 on a scale evaluating semi-quantitatively the intensity of symptoms during the past week. This study will use just the score of anxiety.
Full Information
NCT ID
NCT02621437
First Posted
November 27, 2015
Last Updated
January 27, 2021
Sponsor
Hospices Civils de Lyon
1. Study Identification
Unique Protocol Identification Number
NCT02621437
Brief Title
Impact of Osteopathy on Pain After Breast Cancer Surgery
Acronym
IPOD
Official Title
Study of the Impact of Osteopathic Care, Complementary Therapy to Standard Care, on Pain in Patients With Breast Cancer Surgery
Study Type
Interventional
2. Study Status
Record Verification Date
January 2021
Overall Recruitment Status
Completed
Study Start Date
February 2016 (Actual)
Primary Completion Date
June 2020 (Actual)
Study Completion Date
June 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hospices Civils de Lyon
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Breast cancer can be painful following surgery or can develop later and remain persistent. Pain occurrence is frequent with 50% of women developing sequelae pain of varying intensity with an impact on the quality of life. One of the priorities of the 3rd French Cancer Plan is to preserve quality of life.
Osteopathy, complementary therapy, may help to reduce inconvenience caused by the disease, treatments and their side effects (asthenia, anxiety and pain).
The main objective is to assess the impact of osteopathic treatment on pain in patients following breast cancer surgery. The impact will be considered beneficial if the pain score (digital scale) in the intervention group is lower, by at least two points, than the pain score in the control group at the end of the study.
This is a monocentric, randomized, parallel group, single-blind and prospective clinical trial.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer
Keywords
pain, quality of life, osteopathy, oncology, surgery, breast
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
161 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Intervention group (osteopathy)
Arm Type
Experimental
Arm Description
Patients will have three sessions of osteopathy and 6 phone questionnaires.
Arm Title
control group
Arm Type
Other
Arm Description
Patients will have 6 phone questionnaires.
Intervention Type
Other
Intervention Name(s)
Osteopathy sessions
Intervention Description
- Three osteopathy sessions every 14 days (D13, D27 and D41 post-surgery),
Intervention Type
Other
Intervention Name(s)
phone questionnaires
Intervention Description
Six phone questionnaires (D9, D20, D26, D34, D40 and D48):
pain questionnaire with digital scale,
quality of life survey: SF-12
HAD (Hospital and Anxiety Depression) questionnaire
Primary Outcome Measure Information:
Title
Assess the impact of osteopathic treatment on pain in patients following breast cancer surgery
Description
The primary outcome measure will be the evaluation of the "usual pain in the last eight days" measured from the pain score (digital scale). The pain score consists of asking the patient to quantify her pain on a virtual scale from 0 (absent pain) to 10 (worst pain imaginable).
Time Frame
at Day 9
Title
Assess the impact of osteopathic treatment on pain in patients following breast cancer surgery
Description
The primary outcome measure will be the evaluation of the "usual pain in the last eight days" measured from the pain score (digital scale). The pain score consists of asking the patient to quantify her pain on a virtual scale from 0 (absent pain) to 10 (worst pain imaginable).
Time Frame
at day 20
Title
Assess the impact of osteopathic treatment on pain in patients following breast cancer surgery
Description
The primary outcome measure will be the evaluation of the "usual pain in the last eight days" measured from the pain score (digital scale). The pain score consists of asking the patient to quantify her pain on a virtual scale from 0 (absent pain) to 10 (worst pain imaginable).
Time Frame
at day 26
Title
Assess the impact of osteopathic treatment on pain in patients following breast cancer surgery
Description
The primary outcome measure will be the evaluation of the "usual pain in the last eight days" measured from the pain score (digital scale). The pain score consists of asking the patient to quantify her pain on a virtual scale from 0 (absent pain) to 10 (worst pain imaginable).
Time Frame
at Day 34
Title
Assess the impact of osteopathic treatment on pain in patients following breast cancer surgery
Description
The primary outcome measure will be the evaluation of the "usual pain in the last eight days" measured from the pain score (digital scale). The pain score consists of asking the patient to quantify her pain on a virtual scale from 0 (absent pain) to 10 (worst pain imaginable).
Time Frame
at Day 40
Title
Assess the impact of osteopathic treatment on pain in patients following breast cancer surgery
Description
The primary outcome measure will be the evaluation of the "usual pain in the last eight days" measured from the pain score (digital scale). The pain score consists of asking the patient to quantify her pain on a virtual scale from 0 (absent pain) to 10 (worst pain imaginable).
Time Frame
at Day 48
Secondary Outcome Measure Information:
Title
Assess the impact of osteopathic treatment on the quality of life in patients who have been operated on breast cancer.
Description
Assessment of quality of life by the SF-12 questionnaire, which is a shortened version of the " Medical Outcomes Study Short-Form General Health Survey " (SF-36), comprising only 12 of the 36 issues. The SF-12 is used to calculate two scores, which measure the functional health and well-being of the patient.
Time Frame
at day 9
Title
Assess the impact of osteopathic treatment on the quality of life in patients who have been operated on breast cancer.
Description
Assessment of quality of life by the SF-12 questionnaire, which is a shortened version of the " Medical Outcomes Study Short-Form General Health Survey " (SF-36), comprising only 12 of the 36 issues. The SF-12 is used to calculate two scores, which measure the functional health and well-being of the patient.
Time Frame
at day 20
Title
Assess the impact of osteopathic treatment on the quality of life in patients who have been operated on breast cancer.
Description
Assessment of quality of life by the SF-12 questionnaire, which is a shortened version of the " Medical Outcomes Study Short-Form General Health Survey " (SF-36), comprising only 12 of the 36 issues. The SF-12 is used to calculate two scores, which measure the functional health and well-being of the patient.
Time Frame
at day 26
Title
Assess the impact of osteopathic treatment on the quality of life in patients who have been operated on breast cancer.
Description
Assessment of quality of life by the SF-12 questionnaire, which is a shortened version of the " Medical Outcomes Study Short-Form General Health Survey " (SF-36), comprising only 12 of the 36 issues. The SF-12 is used to calculate two scores, which measure the functional health and well-being of the patient.
Time Frame
at day 34
Title
Assess the impact of osteopathic treatment on the quality of life in patients who have been operated on breast cancer.
Description
Assessment of quality of life by the SF-12 questionnaire, which is a shortened version of the " Medical Outcomes Study Short-Form General Health Survey " (SF-36), comprising only 12 of the 36 issues. The SF-12 is used to calculate two scores, which measure the functional health and well-being of the patient.
Time Frame
at day 40
Title
Assess the impact of osteopathic treatment on the quality of life in patients who have been operated on breast cancer.
Description
Assessment of quality of life by the SF-12 questionnaire, which is a shortened version of the " Medical Outcomes Study Short-Form General Health Survey " (SF-36), comprising only 12 of the 36 issues. The SF-12 is used to calculate two scores, which measure the functional health and well-being of the patient.
Time Frame
at day 48
Title
Assess the impact of osteopathic treatment on the reduction of anxiety of patients operated for breast cancer.
Description
Assessment of anxiodepressive disorders from the HAD scale (Hospital and Anxiety Depression), each response is rated from 0-3 on a scale evaluating semi-quantitatively the intensity of symptoms during the past week. This study will use just the score of anxiety.
Time Frame
at Day 9
Title
Assess the impact of osteopathic treatment on the reduction of anxiety of patients operated for breast cancer.
Description
Assessment of anxiodepressive disorders from the HAD scale (Hospital and Anxiety Depression), each response is rated from 0-3 on a scale evaluating semi-quantitatively the intensity of symptoms during the past week. This study will use just the score of anxiety.
Time Frame
at Day 20
Title
Assess the impact of osteopathic treatment on the reduction of anxiety of patients operated for breast cancer.
Description
Assessment of anxiodepressive disorders from the HAD scale (Hospital and Anxiety Depression), each response is rated from 0-3 on a scale evaluating semi-quantitatively the intensity of symptoms during the past week. This study will use just the score of anxiety.
Time Frame
at Day 26
Title
Assess the impact of osteopathic treatment on the reduction of anxiety of patients operated for breast cancer.
Description
Assessment of anxiodepressive disorders from the HAD scale (Hospital and Anxiety Depression), each response is rated from 0-3 on a scale evaluating semi-quantitatively the intensity of symptoms during the past week. This study will use just the score of anxiety.
Time Frame
at Day 34
Title
Assess the impact of osteopathic treatment on the reduction of anxiety of patients operated for breast cancer.
Description
Assessment of anxiodepressive disorders from the HAD scale (Hospital and Anxiety Depression), each response is rated from 0-3 on a scale evaluating semi-quantitatively the intensity of symptoms during the past week. This study will use just the score of anxiety.
Time Frame
at Day 40
Title
Assess the impact of osteopathic treatment on the reduction of anxiety of patients operated for breast cancer.
Description
Assessment of anxiodepressive disorders from the HAD scale (Hospital and Anxiety Depression), each response is rated from 0-3 on a scale evaluating semi-quantitatively the intensity of symptoms during the past week. This study will use just the score of anxiety.
Time Frame
at Day 48
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Adult woman
Surgery for a malignant breast tumor with sentinel lymph node technique
Patient affiliated to a social security system
Willing and able to provide written informed consent
Exclusion Criteria:
Under-age women
Pregnant woman
Surgery for a malignant breast tumor with lymph node dissection
Receiving adjuvant therapy during the study
Receiving physiotherapy sessions (other than those made in immediate post-operative)
Participating in the space "Au Fil de Soi": relaxing body massage and Energy Resonance by Cutaneous Stimulation (RESC)
Person under guardianship or supervision
Patient with impaired cognitive functions or lack of understanding of the French language
Presenting a contraindication for osteopathy (major infectious and inflammatory conditions, trauma and other severe diseases)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gil DUBERNARD, Pr
Organizational Affiliation
Hospices Civils de Lyon
Official's Role
Principal Investigator
Facility Information:
Facility Name
Service de gynécologie
City
Lyon
ZIP/Postal Code
69004
Country
France
12. IPD Sharing Statement
Learn more about this trial
Impact of Osteopathy on Pain After Breast Cancer Surgery
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