EssaiClinique_CBSM

NCT03883321 | Terminated

• 2 other identifiers: 38RC17.2912017-A02618-45
• Study Type: observational
• Target: 25
• Locations: 1 country
• Sites: 1

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.

Conditions

Perceived Stress

Keywords

stress management; CBSM; Chronic Pain; Cancer

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Inclusion rate

  up to 18 months

• Satisfaction

  at 6 months

• Measurement of quality of life

  evaluation at the beginning of the meeting and at 9 weeks and then at 3 months

• Pain Disability Index (PDI)

  evaluation at the beginning of the meeting and at 9 weeks and then at 3 months

• concise questionnaire on pain short version (QCD)

  evaluation at the beginning of the meeting and at 9 weeks and then at 3 months

Study Arms (2)

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

Other: Cognitive behavioral stress management

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.

Interventions

Cognitive behavioral stress management OTHER

Management of patients in 10 group sessions with cognitive and behavioral therapies associated with relaxation in order to learn how to manage stress

CBSM

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University Hospital, Grenoble: lead

Study Sites (1)

Grenoble University Hospital

La Tronche, Isère, 30700, France

Location

MeSH Terms

Conditions

Chronic Pain; Neoplasms

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Claudine BERTHOZAT, MD

  pain center, Grenoble University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 15, 2019
• First Posted: March 20, 2019
• Study Start: September 1, 2018
• Primary Completion: February 1, 2020
• Study Completion: February 1, 2020
• Last Updated: September 2, 2020

Record last verified: 2020-08

Locations

FR (1)