EssaiClinique_CBSM (CBSM)

August 31, 2020 updated by: University Hospital, Grenoble

Interest of Cognitive-behavioral Therapies Based on the CBSM (Cognitive Behavior Stress Management) for the Management of Patients Suffering From Pain Related to Cancer.

The CBSM is a program combining cognitive and behavioral therapies, relaxation provided in groups of 8 to 10 patients. This program has demonstrated benefits in stress management skills, adaptive strategies, anxiety, quality of life, social inclusion, medication adherence, depression, therapeutic alliance, and general well-being. It would also improve breast cancer survival after adjuvant therapy. This program has been put in place at the center of pain for patients with cancer pain in any stage. This study aims to evaluate the benefits of this technique on a patient population suffering from chronic pain related to cancer.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

Methodology: Observational study, prospective, open, mono-centric, comparative, evaluating a psychosocial intervention type CBSM versus no intervention (group "waiting list").

Main Objective: To evaluate the impact of the implementation of a "CBSM" program on the stress management capacities of a pilot group of 30 patients followed at the pain center of Grenoble-Alpes University Hospital for chronic pain related to cancer or its treatment, compared to a control group "waiting list"

Primary Outcome: Measurement of emotional stress (PSS14)

Secondary objective:

Determine patients' interest in this program and the feasibility of the program.

Determine patient satisfaction with this program To evaluate the impact of the program on the quality of life of patients. To evaluate the impact of the program on the handicap perceived by the patients in connection with their pains.

Evaluation of the impact of the program on the pain of the patients (on the daily behavior).

Evaluation of the impact of the program on depression and anxiety. Determine the impact of the 3-month program of the 9th session on the different dimensions described above

Inclusion criterion:

  • Over 18,
  • Currently treated or treated for cancer (solid or otherwise), any stage combined.
  • With chronic pain related to cancer or its treatment
  • Never benefited from the management of stress by this technique
  • Knowing how to read, write and speak French
  • Person affiliated with social security or beneficiary of an equivalent plan.

Criteria of non-inclusion:

  • Life expectancy of less than 6 months
  • Patients unable to travel for 10 sessions on the structure (CHUGA)
  • Person deprived of liberty by judicial or administrative decision, person subject to a legal protection measure.

Number of patients included: a minimum of 30 patients including, a minimum of 15 in the CBSM group and a minimum of 15 in the "waiting list" group (patients included in the waiting list group will participate in the CBSM program but will not be not analyzed in the CBSM group)

Study Type

Observational

Enrollment (Actual)

25

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

  • France
    • Isère
      • La Tronche, Isère, France, 30700
        • Grenoble University Hospital

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

N/A

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patient being treated for cancer, undergoing treatment or having completed treatment, at any stage and suffering from chronic pain

Description

Inclusion Criteria:

  • Over 18,
  • Currently treated or treated for cancer (solid or otherwise), any stage combined.
  • With chronic pain related to cancer or its treatment
  • Never benefited from the management of stress by this technique
  • Knowing how to read, write and speak French
  • Person affiliated with social security or beneficiary of an equivalent plan.

Exclusion Criteria:

  • Life expectancy of less than 6 months
  • Patients unable to travel for 10 sessions on the structure
  • Person deprived of liberty by judicial or administrative decision, person subject to a legal protection measure.

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
CBSM
Patients included in this group participate in the CBSM program. They attend 10 sessions of stress management according to the CBSM program, 9 take place over 3 months and the tenth session takes place 3 months after the 9th session. The session is composed of relaxation and cognitive and behavioral therapy, which is carried out in groups of 8 to 10 patients
Other: Cognitive behavioral stress management
Management of patients in 10 group sessions with cognitive and behavioral therapies associated with relaxation in order to learn how to manage stress
Waiting list
The CBSM group is compared to the "waiting list" group that does not benefit from the CBSM program. After completing their assessment in the "waiting list" group, patients in this group will be integrated into the CBSM group but will not be evaluated as such.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Measurement of emotional stress (PSS14)
Time Frame: evaluation at the beginning of the meeting and at 9 weeks
assessment of the evolution of stress over a period of 3 months: Questionnaire PSS14
evaluation at the beginning of the meeting and at 9 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Inclusion rate
Time Frame: up to 18 months
ratio of number of patients who agreed to participate in the program to the number of patients to whom the program was proposed
up to 18 months
Satisfaction
Time Frame: at 6 months
Satisfaction rate of CBSM program with a questionnaire
at 6 months
Measurement of quality of life
Time Frame: evaluation at the beginning of the meeting and at 9 weeks and then at 3 months
Evaluate the impact of the program on the quality of life of patients with a Physical and Mental Health Summary Scales with 12 questions (SF12) questionnaire
evaluation at the beginning of the meeting and at 9 weeks and then at 3 months
Pain Disability Index (PDI)
Time Frame: evaluation at the beginning of the meeting and at 9 weeks and then at 3 months
Evaluate the impact of the program on disability perceived by patients in relation to their pain: PDI questionnaire
evaluation at the beginning of the meeting and at 9 weeks and then at 3 months
concise questionnaire on pain short version (QCD)
Time Frame: evaluation at the beginning of the meeting and at 9 weeks and then at 3 months
Evaluation of the impact of the program on patients' pain (on daily behavior) with QCD questionnaire
evaluation at the beginning of the meeting and at 9 weeks and then at 3 months
Hospital Anxiety and Depression Scale (HADS)
Time Frame: evaluation at the beginning of the meeting and at 9 weeks and then at 3 months
Evaluation of the impact of the program on depression and anxiety with HADS questionnaire
evaluation at the beginning of the meeting and at 9 weeks and then at 3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Grenoble

Investigators

  • Principal Investigator: Claudine BERTHOZAT, MD, pain center, Grenoble University Hospital

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 (ACTUAL)

September 1, 2018

Primary Completion (ACTUAL)

February 1, 2020

Study Completion (ACTUAL)

February 1, 2020

Study Registration Dates

First Submitted

January 15, 2019

First Submitted That Met QC Criteria

March 18, 2019

First Posted (ACTUAL)

March 20, 2019

Study Record Updates

Last Update Posted (ACTUAL)

September 2, 2020

Last Update Submitted That Met QC Criteria

August 31, 2020

Last Verified

August 1, 2020

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 38RC17.291
  • 2017-A02618-45 (OTHER: ID RCB)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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