Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

EssaiClinique_CBSM (CBSM)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

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.

Condition or disease Intervention/treatment
Perceived Stress Other: Cognitive behavioral stress management

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)

Layout table for study information
Study Type : Observational
Actual Enrollment : 25 participants
Observational Model: Case-Control
Time Perspective: Prospective
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.
Actual Study Start Date : September 1, 2018
Actual Primary Completion Date : February 1, 2020
Actual Study Completion Date : February 1, 2020

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.



Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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

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

  3. 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

  4. 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

  5. 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

  6. 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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes 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
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03883321


Locations
Layout table for location information
France
Grenoble University Hospital
La Tronche, Isère, France, 30700
Sponsors and Collaborators
University Hospital, Grenoble
Investigators
Layout table for investigator information
Principal Investigator: Claudine BERTHOZAT, MD pain center, Grenoble University Hospital
Layout table for additonal information
Responsible Party: University Hospital, Grenoble
ClinicalTrials.gov Identifier: NCT03883321    
Other Study ID Numbers: 38RC17.291
2017-A02618-45 ( Other Identifier: ID RCB )
First Posted: March 20, 2019    Key Record Dates
Last Update Posted: September 2, 2020
Last Verified: August 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University Hospital, Grenoble:
stress management
CBSM
Chronic Pain
Cancer