NCT02862002

Brief Summary

A first empirical evidence on the difficulties of observance of morphine in cancer patients invited a multidisciplinary team to initiate an innovative quality approach. It shows the lack of transcript of a comprehensive care causing a problem for monitoring actions undertaken for the relief of pain. In addition, two exploratory studies targeting the expectations and needs of the Patient Therapeutic Education (E.T.P) receiving strong opioids. The E.T.P, public health priority, provides a framework for action and improving care. In oncology, the involvement of the patient in pain relief and management of opioids represents an axis of intervention more appropriate. Yet, it is not found in literature. In our department, we conduct an experimental therapeutic education program type "caratif" and a nurse consultation FTE receiving opioids on the model of nursing "care" of J. Watson (humanist emphasis promoting interpersonal teaching-learning mobilizing the patient experience). The ETP folder and its tools have been continuously validated with patients. The heart of the educational process is in the patient's complex path neat oncology and relies on interaction and creativity between patient and caregivers.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2013

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

August 1, 2013

Completed
3 years until next milestone

First Submitted

Initial submission to the registry

August 5, 2016

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 10, 2016

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2017

Completed
Last Updated

August 10, 2016

Status Verified

August 1, 2016

Enrollment Period

3.3 years

First QC Date

August 5, 2016

Last Update Submit

August 9, 2016

Conditions

Pain Management

Keywords

opioid therapymedical oncology.

Outcome Measures

Primary Outcomes (1)

  • Pain assessment

    Using a digital scale

    21 days

Secondary Outcomes (4)

  • Treatment adherence morphine

    21 days

  • Strategies Adjustment disease

    21 days

  • Anxiety

    21 days

  • Depression

    21 days

Study Arms (2)

Therapeutic Patient Education (E.T.P)of type "caratif

EXPERIMENTAL

Patients in arm E.T.P benefit of the nursing consultation E.T.P,

Other: therapeutic education of type "caratifOther: Standard care

standard care

ACTIVE COMPARATOR

patients receiving standard care of cancer pain.

Other: therapeutic education of type "caratifOther: Standard care

Interventions

therapeutic education of type "caratifOTHER

study the effects of a therapeutic education program type "caratif", based on a communication pedagogy, with the patient receiving opioid therapy in medical oncology

Therapeutic Patient Education (E.T.P)of type "caratifstandard care
Standard careOTHER

patients receiving standard care of cancer pain.

Therapeutic Patient Education (E.T.P)of type "caratifstandard care

Eligibility Criteria

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

You may qualify if:

  • Adult
  • Cancer patients receiving opioids
  • Suffering from pain caused by their disease or treatment with chemotherapy and / or radiotherapy and / or surgery
  • Supported within the oncology or palliative care
  • Receiving at least 3 courses of chemotherapy
  • Having read, understood and signed the informed consent
  • Subject beneficiary of a social security scheme or an equivalent -

You may not qualify if:

  • adults subject to a legal protection measure or unable to consent
  • Non-beneficiaries of a social security scheme,
  • persons deprived of liberty by a judicial or administrative decision,
  • patients with neurological or psychiatric disorders

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Assistance Publique Hôpitaux de Marseille Hôpital de la Timone

Marseille, 13354, France

RECRUITING

MeSH Terms

Conditions

Agnosia

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Perceptual DisordersNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Quality Indicators, Health CareQuality of Health CareHealth Services AdministrationHealth Care Quality, Access, and Evaluation

Study Officials

  • Urielle DESALBRES

    Assistance Publique Hôpitaux de Marseille

    STUDY DIRECTOR

Central Study Contacts

Florence DUFFAUD

CONTACT

04.91.38.57.08fduffaud@mail.ap-hm.fr

Jeanne-Francette FUTO

CONTACT

04 91 38 45 47jeanne.futo@ap-hm.fr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 5, 2016

First Posted

August 10, 2016

Study Start

August 1, 2013

Primary Completion

December 1, 2016

Study Completion

March 1, 2017

Last Updated

August 10, 2016

Record last verified: 2016-08

Locations

FR(1)