Clinical trial NCT03883321: 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.
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Perceived Stress
Keywords: stress management
CBSM
Chronic Pain
Cancer
Lead sponsor: University Hospital, Grenoble
Sponsor class: OTHER
First posted: 2019-03-20
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
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

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)

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.

Primary outcomes:
measure: Measurement of emotional stress (PSS14)
timeFrame: evaluation at the beginning of the meeting and at 9 weeks
Secondary outcomes:
measure: Inclusion rate
timeFrame: up to 18 months
measure: Satisfaction
timeFrame: at 6 months
measure: Measurement of quality of life
timeFrame: evaluation at the beginning of the meeting and at 9 weeks and then at 3 months
measure: Pain Disability Index (PDI)
timeFrame: evaluation at the beginning of the meeting and at 9 weeks and then at 3 months
measure: concise questionnaire on pain short version (QCD)
timeFrame: evaluation at the beginning of the meeting and at 9 weeks and then at 3 months
measure: Hospital Anxiety and Depression Scale (HADS)
timeFrame: evaluation at the beginning of the meeting and at 9 weeks and then at 3 months
Other outcomes:
Locations:
city: La Tronche
country: France
facility: Grenoble University Hospital
state: Isère
Study officials:
affiliation: pain center, Grenoble University Hospital
name: Claudine BERTHOZAT, MD
role: PRINCIPAL_INVESTIGATOR
References: