- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02627638
Cancer Patient Perceptions of the Osteopathy Treatment: a Qualitative Study
May 23, 2019 updated by: Hospices Civils de Lyon
For more than seven years an osteopath has been working in the palliative care unit (PCU) and in both palliative care mobile team (PCMT) as a member of the multidisciplinary team.
The patients referred to the osteopath by the palliative care physicians present pains related to cancer, but also to the treatment, in particular to surgery or radiotherapy.
The osteopath can help with other symptoms such as constipation or dyspnoea.
As this approach is provided in complement of the medicinal approach, it is not considered as an alternative medicine but as a complementary medicine associated to a conventional care.
It seemed relevant to the investigators to ask the cancer patients undergoing osteopathic sessions for pain how they saw this complementary therapy.
Study Overview
Study Type
Interventional
Enrollment (Actual)
20
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Pierre-Bénite Cedex, France, 69495
- Médecine palliative - Groupement Hospitalier Lyon Sud- Hospices Civils de Lyon
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Advanced illness patients with cancer pain, PS 0 to 2, willing to take part in the study and having signed the informed consent form
Exclusion Criteria:
- Non-communicating patients and patients whose cancer has been cured.
- Patients with fractural risk.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Other: Osteopathic treatment
|
Once their clinical data were collected and their symptoms were assessed, all the enrolled patients had an osteopathic session a week during two weeks.
After those sessions, they had an interview (scheduled between D11 and D14) with a psychologist
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Thoughs and emotions of patients undergoing the two osteopathic sessions as complementary therapy for pain, evaluated using semi-directed interviews
Time Frame: around day 14 (after the second session)
|
Once clinical data were collected and symptoms were assessed, all the enrolled patients had an osteopathic session a week during two weeks.
After those sessions, they had an interview (scheduled between J11 and J14) with a psychologist.
The research assistant psychologist conducted the semi-directed interviews.
The interview questions were geared toward eliciting open-ended responses to acquire specific information about the patient thoughts and emotions associated with osteopathic treatment.
In our study, we conducted two preliminary interviews to test the quality of the questions we planned to use with the participants.
The specific questions that were used during the interview are available on request from the authors.
|
around day 14 (after the second session)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
April 1, 2014
Primary Completion (Actual)
December 1, 2014
Study Completion (Actual)
December 1, 2014
Study Registration Dates
First Submitted
December 9, 2015
First Submitted That Met QC Criteria
December 10, 2015
First Posted (Estimate)
December 11, 2015
Study Record Updates
Last Update Posted (Actual)
May 28, 2019
Last Update Submitted That Met QC Criteria
May 23, 2019
Last Verified
September 1, 2015
More Information
Terms related to this study
Other Study ID Numbers
- 2013.826
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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