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|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
|Condition or disease||Intervention/treatment|
|Perceived Stress||Other: Cognitive behavioral stress management|
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)
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
- 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)
|Study Type :||Observational|
|Actual Enrollment :||25 participants|
|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|
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
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.
- 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
- 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
- Satisfaction [ Time Frame: at 6 months ]Satisfaction rate of CBSM program with a questionnaire
- 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
- 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
- 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
- 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
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
|Grenoble University Hospital|
|La Tronche, Isère, France, 30700|
|Principal Investigator:||Claudine BERTHOZAT, MD||pain center, Grenoble University Hospital|