EssaiClinique_CBSM

Perceived Stress Clinical Trial

— 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.

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03883321
• Other study ID #: 38RC17.291
• Secondary ID: 2017-A02618-45
• Status: Terminated
• Start date: September 1, 2018
• Est. completion date: February 1, 2020

Study information

• Verified date: August 2020
• Source: University Hospital, Grenoble
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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)

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 25
• Est. completion date: February 1, 2020
• Est. primary completion date: February 1, 2020
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• 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

Locations

Country	Name	City	State
France	Grenoble University Hospital	La Tronche	Isère

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Grenoble

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Measurement of emotional stress (PSS14)	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	Inclusion rate	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
Secondary	Satisfaction	Satisfaction rate of CBSM program with a questionnaire	at 6 months
Secondary	Measurement of quality of life	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
Secondary	Pain Disability Index (PDI)	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
Secondary	concise questionnaire on pain short version (QCD)	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
Secondary	Hospital Anxiety and Depression Scale (HADS)	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