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History of Changes for Study: NCT03883321
EssaiClinique_CBSM (CBSM)
Latest version (submitted August 31, 2020) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 March 18, 2019 None (earliest Version on record)
2 August 31, 2020 Recruitment Status, Study Status, Contacts/Locations and Study Design
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Study NCT03883321
Submitted Date:  March 18, 2019 (v1)

Open or close this module Study Identification
Unique Protocol ID: 38RC17.291
Brief Title: EssaiClinique_CBSM (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.
Secondary IDs: 2017-A02618-45 [ID RCB]
Open or close this module Study Status
Record Verification: March 2019
Overall Status: Recruiting
Study Start: September 1, 2018
Primary Completion: September 1, 2019 [Anticipated]
Study Completion: September 1, 2019 [Anticipated]
First Submitted: January 15, 2019
First Submitted that
Met QC Criteria:
March 18, 2019
First Posted: March 20, 2019 [Actual]
Last Update Submitted that
Met QC Criteria:
March 18, 2019
Last Update Posted: March 20, 2019 [Actual]
Open or close this module Sponsor/Collaborators
Sponsor: University Hospital, Grenoble
Responsible Party: Sponsor
Collaborators:
Open or close this module Oversight
U.S. FDA-regulated Drug: No
U.S. FDA-regulated Device: No
Data Monitoring: No
Open or close this module Study Description
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)

Open or close this module Conditions
Conditions: Perceived Stress
Keywords: stress management
CBSM
Chronic Pain
Cancer
Open or close this module Study Design
Study Type: Observational
Observational Study Model: Case-Control
Time Perspective: Prospective
Biospecimen Retention:
Biospecimen Description:
Enrollment: 45 [Anticipated]
Number of Groups/Cohorts 2
Open or close this module Groups and Interventions
Groups/Cohorts Interventions
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
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.
Open or close this module Outcome Measures
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
Open or close this module Eligibility
Study Population: Patient being treated for cancer, undergoing treatment or having completed treatment, at any stage and suffering from chronic pain
Sampling Method: Non-Probability Sample
Minimum Age: 18 Years
Maximum Age:
Sex: All
Gender Based:
Accepts Healthy Volunteers:
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.
Open or close this module Contacts/Locations
Central Contact Person: Claudine BERTHOZAT, MD
Telephone: +33675270073 Ext. Grenoble
Email: cberthozatbatailler@chu-grenoble.fr
Central Contact Backup: Caroline MAINDET, MD
Telephone: +33662401076 Ext. Grenoble
Email: cmaindetdominici@chu-grenoble.fr
Study Officials: Claudine BERTHOZAT, MD
Principal Investigator
pain center, Grenoble University Hospital
Locations: France, Isère
Grenoble University Hospital
[Recruiting]
La Tronche, Isère, France, 30700
Contact:Contact: Claudine BERTHOZAT, MD +33675270073 cberthozatbatailler@chu-grenoble.fr
Contact:Contact: Caroline MAINDET, MD +33675270073 cmaindetdominici@chu-grenoble.fr
Open or close this module IPDSharing
Plan to Share IPD: Undecided
Open or close this module References
Citations:
Links:
Available IPD/Information:

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