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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
 (submitted: March 18, 2019)
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
 (submitted: March 18, 2019)
  • 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
 (submitted: August 31, 2020)
25
Original Estimated Enrollment
 (submitted: March 18, 2019)
45
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 No
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
Responsible Party University Hospital, Grenoble
Study Sponsor University Hospital, Grenoble
Collaborators Not Provided
Investigators
Principal Investigator: Claudine BERTHOZAT, MD pain center, Grenoble University Hospital
PRS Account University Hospital, Grenoble
Verification Date August 2020