Breast Cancer
Conditions
Keywords
pain, quality of life, osteopathy, oncology, surgery, breast
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.
Interventions
OTHEROsteopathy sessions
\- Three osteopathy sessions every 14 days (D13, D27 and D41 post-surgery),
OTHERphone questionnaires
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
Sponsors
Hospices Civils de Lyon
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Assess the impact of osteopathic treatment on pain in patients following breast cancer surgery | at Day 9 | 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
| Measure | Time frame | Description |
|---|---|---|
| Assess the impact of osteopathic treatment on the quality of life in patients who have been operated on breast cancer. | at day 9 | 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. | at Day 9 | 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. |
Countries
France
Outcome results
None listed