Perceived StressCBSMNCT03883321
EssaiClinique_CBSM
An observational study of Perceived Stress, run by University Hospital, Grenoble at 1 site in France.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Perceived Stress
- What is being tested?
- Cognitive behavioral stress management
- How many people
- 25 participants
- Where
- 1 siteFrance
- Study dates
- 1 Sep 2018to 1 Feb 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
Study population: Patient being treated for cancer, undergoing treatment or having completed treatment, at any stage and suffering from chronic pain
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
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.
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.
Read the 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)
- Conditions
- Perceived Stress
- Being tested
- Cognitive behavioral stress management
- Keywords
- stress management, CBSM, Chronic Pain, Cancer
- Medical subject headings
- Chronic Pain, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive behavioral stress managementOther
Management of patients in 10 group sessions with cognitive and behavioral therapies associated with relaxation in order to learn how to manage stress
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measurement of emotional stress (PSS14)
assessment of the evolution of stress over a period of 3 months: Questionnaire PSS14
Measured: evaluation at the beginning of the meeting and at 9 weeks
Secondary outcomes (6)
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
Measured: up to 18 months
Satisfaction
Satisfaction rate of CBSM program with a questionnaire
Measured: at 6 months
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
Measured: evaluation at the beginning of the meeting and at 9 weeks and then at 3 months
Pain Disability Index (PDI)
Evaluate the impact of the program on disability perceived by patients in relation to their pain: PDI questionnaire
Measured: evaluation at the beginning of the meeting and at 9 weeks and then at 3 months
concise questionnaire on pain short version (QCD)
Evaluation of the impact of the program on patients' pain (on daily behavior) with QCD questionnaire
Measured: evaluation at the beginning of the meeting and at 9 weeks and then at 3 months
Hospital Anxiety and Depression Scale (HADS)
Evaluation of the impact of the program on depression and anxiety with HADS questionnaire
Measured: evaluation at the beginning of the meeting and at 9 weeks and then at 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2019
- Study start1 Sep 2018
- Primary completion1 Feb 2020
- Study completion1 Feb 2020
Why it stopped: few patient feedback and principal investigator disponibility
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Perceived StressStudies of the same condition, open and under way.
- More trials run by University Hospital, GrenobleThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Grenoble
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Claudine BERTHOZAT, MD, Principal investigator, pain center, Grenoble University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03883321
- Sponsor's protocol ID
- 38RC17.291
- Other IDs
- 2017-A02618-45
- Acronym
- CBSM
- Status last verified
- Aug 2020
- First submitted
- 15 Jan 2019
- Last updated
- 2 Sep 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT03883321
- Acronym / sponsor ID
- CBSM / 38RC17.291
- Conditions
- Perceived Stress
- Keywords
- stress management, CBSM, Chronic Pain, Cancer
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: few patient feedback and principal investigator disponibility
- Enrolment
- 25 participants (actual)
- Lead sponsor
- University Hospital, GrenobleUniversity, hospital or other
- Study start
- 1 Sep 2018 (actual)
- Primary completion
- 1 Feb 2020 (actual)
- Study completion
- 1 Feb 2020 (actual)
- First posted
- 20 Mar 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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)
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CBSM | – | Other: Cognitive behavioral stress managementPatients 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 |
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patient being treated for cancer, undergoing treatment or having completed treatment, at any stage and suffering from chronic pain
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cognitive behavioral stress managementManagement of patients in 10 group sessions with cognitive and behavioral therapies associated with relaxation in order to learn how to manage stress | Other | CBSM |
Primary outcome
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
6 secondary outcomes
Inclusion rate
Time frame: up to 18 months
Satisfaction
Time frame: at 6 months
Measurement of quality of life
Time frame: evaluation at the beginning of the meeting and at 9 weeks and then at 3 months
Pain Disability Index (PDI)
Time frame: evaluation at the beginning of the meeting and at 9 weeks and then at 3 months
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
Hospital Anxiety and Depression Scale (HADS)
Time frame: evaluation at the beginning of the meeting and at 9 weeks and then at 3 months
Results and safety
The study was stopped early (reason given: few patient feedback and principal investigator disponibility). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Sep 2020.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Claudine BERTHOZAT, MD principal investigator
pain center, Grenoble University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Perceived Stress, run by University Hospital, Grenoble at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 2 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: few patient feedback and principal investigator disponibility). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measurement of emotional stress (PSS14) (time frame: evaluation at the beginning of the meeting and at 9 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Sep 2020; AzTrials last refreshed its copy on 2 Nov 2026.