EssaiClinique_CBSM

Grenoble Alpes University Hospital Center (CHU)

Status: Terminated

Conditions: Perceived Stress

Treatments: Other: Cognitive behavioral stress management

Study type: Observational

Funder types: Other

Identifiers

NCT03883321

38RC17.291

2017-A02618-45 (Other Identifier)

Details and patient eligibility

About

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.

Full 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)

Enrollment: 25 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

25 participants in 2 patient groups

CBSM

Description:

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

Treatment:

Other: Cognitive behavioral stress management

Waiting list

Description:

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.