NCT02627638

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2014

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2014

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2014

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

December 9, 2015

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 11, 2015

Completed
Last Updated

May 28, 2019

Status Verified

September 1, 2015

Enrollment Period

8 months

First QC Date

December 9, 2015

Last Update Submit

May 23, 2019

Conditions

Keywords

osteopathycomplementary therapysymptoms in cancer patients

Outcome Measures

Primary Outcomes (1)

  • 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.

    around day 14 (after the second session)

Study Arms (1)

Osteopathic treatment

OTHER
Other: Ostheopathic treatment

Interventions

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

Osteopathic treatment

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Advanced illness patients with cancer pain, PS 0 to 2, willing to take part in the study and having signed the informed consent form

You may not qualify if:

  • Non-communicating patients and patients whose cancer has been cured.
  • Patients with fractural risk.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Médecine palliative - Groupement Hospitalier Lyon Sud- Hospices Civils de Lyon

Pierre-Bénite, 69495, France

Location

Related Publications (1)

  • 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.

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 9, 2015

First Posted

December 11, 2015

Study Start

April 1, 2014

Primary Completion

December 1, 2014

Study Completion

December 1, 2014

Last Updated

May 28, 2019

Record last verified: 2015-09

Locations