EssaiClinique_CBSM (CBSM)

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ClinicalTrials.gov Identifier: NCT03883321

Recruitment Status : Terminated (few patient feedback and principal investigator disponibility)

First Posted : March 20, 2019

Last Update Posted : September 2, 2020

Sponsor:

Information provided by (Responsible Party):

University Hospital, Grenoble

Tracking Information

First Submitted Date

January 15, 2019

First Posted Date

March 20, 2019

Last Update Posted Date

September 2, 2020

Actual Study Start Date

September 1, 2018

Actual Primary Completion Date

February 1, 2020 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures

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

Original Primary Outcome Measures

Same as current

Change History

Current Secondary Outcome Measures

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
Satisfaction [ Time Frame: at 6 months ]
Satisfaction rate of CBSM program with a questionnaire
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
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
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
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

Original Secondary Outcome Measures

Same as current

Current Other Pre-specified Outcome Measures

Not Provided

Original Other Pre-specified Outcome Measures

Not Provided

Descriptive Information

Brief Title

EssaiClinique_CBSM

Official Title

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

Brief Summary

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.

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

Study Design

Observational Model: Case-Control
Time Perspective: Prospective

Target Follow-Up Duration

Not Provided

Biospecimen

Not Provided

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

Condition

Perceived Stress

Intervention

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

Study Groups/Cohorts

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

Intervention: Other: Cognitive behavioral stress management
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.

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status

Terminated

Actual Enrollment

Original Estimated Enrollment

Actual Study Completion Date

February 1, 2020

Actual Primary Completion Date

February 1, 2020 (Final data collection date for primary outcome measure)

Eligibility Criteria

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.

Sex/Gender

Sexes Eligible for Study:

All

Ages

18 Years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Not Provided

Contacts

Contact information is only displayed when the study is recruiting subjects

Listed Location Countries

France

Removed Location Countries

Administrative Information

NCT Number

NCT03883321

Other Study ID Numbers

38RC17.291
2017-A02618-45 ( Other Identifier: ID RCB )

Has Data Monitoring Committee

U.S. FDA-regulated Product

Studies a U.S. FDA-regulated Drug Product:	No
Studies a U.S. FDA-regulated Device Product:	No

IPD Sharing Statement

Plan to Share IPD:

Undecided

Current Responsible Party

University Hospital, Grenoble

Original Responsible Party

Same as current

Current Study Sponsor

University Hospital, Grenoble

Original Study Sponsor

Same as current

Collaborators

Not Provided

Investigators

Principal Investigator:

Claudine BERTHOZAT, MD

pain center, Grenoble University Hospital

PRS Account

University Hospital, Grenoble

Verification Date

August 2020

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