Cancer PatientsNCT02627638
Cancer Patient Perceptions of the Osteopathy Treatment: a Qualitative Study
A study testing Ostheopathic treatment in people with Cancer Patients, run by Hospices Civils de Lyon at 1 site in France.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer Patients
- What is being tested?
- Ostheopathic treatment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteFrance
- Study dates
- Apr 2014to Dec 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Advanced illness patients with cancer pain, PS 0 to 2, willing to take part in the study and having signed the informed consent form
Who cannot join
- Non-communicating patients and patients whose cancer has been cured.
- Patients with fractural risk.
Trial locations and contacts
1 site in 1 country.
France1 site
Médecine palliative - Groupement Hospitalier Lyon Sud- Hospices Civils de Lyon
Pierre-Bénite, 69495
About this study
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.
- Conditions
- Cancer Patients
- Being tested
- Ostheopathic treatment
- Keywords
- osteopathy, complementary therapy, symptoms in cancer patients
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ostheopathic treatmentOther
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
| Study group | Role | What they receive |
|---|---|---|
| Osteopathic treatment | Other | Not described Receives: Other: Ostheopathic treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Thoughs and emotions of patients undergoing the two osteopathic sessions as complementary therapy for pain, evaluated using semi-directed interviews
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.
Measured: around day 14 (after the second session)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2015 (estimated)
- Study startApr 2014
- Primary completionDec 2014
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cancer PatientsStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02627638
- Sponsor's protocol ID
- 2013.826
- Status last verified
- Sep 2015
- First submitted
- 9 Dec 2015
- Last updated
- 28 May 2019
- Results posted
- No
- Data monitoring committee
- No
Publications
Steel A, Tricou C, Monsarrat T, Ruer M, Deslandes C, Sisoix C, Filbet M. The perceptions and experiences of osteopathic treatment among cancer patients in palliative care: a qualitative study. Support Care Cancer. 2018 Oct;26(10):3627-3633. doi: 10.1007/s00520-018-4233-y. Epub 2018 May 4.
PubMed 29728845
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cancer Patient Perceptions of the Osteopathy Treatment: a Qualitative Study
- ClinicalTrials.gov ID
- NCT02627638
- Acronym / sponsor ID
- 2013.826
- Conditions
- Cancer Patients
- Keywords
- osteopathy, complementary therapy, symptoms in cancer patients
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- Apr 2014
- Primary completion
- Dec 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 11 Dec 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Osteopathic treatment | Other | Other: Ostheopathic treatment |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Advanced illness patients with cancer pain, PS 0 to 2, willing to take part in the study and having signed the informed consent form
Key exclusion criteria (2 listed)
- Non-communicating patients and patients whose cancer has been cured.
- Patients with fractural risk.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ostheopathic treatmentOnce 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 | Other | Osteopathic treatment |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 May 2019.
- Results publication: PubMed 29728845Steel A, Tricou C, Monsarrat T, Ruer M, Deslandes C, Sisoix C, Filbet M. The perceptions and experiences of osteopathic treatment among cancer patients in palliative care: a qualitative study. Support Care Cancer. 2018 Oct;26(10):3627-3633. doi: 10.1007/s00520-018-4233-y. Epub 2018 May 4.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ostheopathic treatment in people with Cancer Patients, run by Hospices Civils de Lyon at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 May 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02627638, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 May 2019.