Feasibility of 2 Interventions to Reduce Fatigue in Patients With Chemotherapy for Metastatic Colorectal Cancer

Colorectal Cancer Metastatic Clinical Trial

— COLOFIGHT  

Official title:

Feasibility Study of a Hypnosis Intervention and a Cognitive Behavioral Therapy Intervention to Reduce Fatigue in Patients Undergoing Chemotherapy for Metastatic Colorectal Cancer

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04999306
• Other study ID #: PROICM 2021-07 COL
• Secondary ID: 2021-A01031-40
• Status: Recruiting
• Phase: N/A
• Start date: May 17, 2023
• Est. completion date: September 2025

Study information

• Verified date: June 2023
• Source: Institut du Cancer de Montpellier - Val d'Aurelle
• Contact: Fabienne Portales, MD
• Phone: 04 67 61 23 53
• Email: fabienne.portales[@]icm.unicancer.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

In patients with colorectal cancer, fatigue ranks as the number one chemotherapy-related adverse event, with 75% of patients experiencing grade 3-4 physical and psychological consequences. Metastatic progression and increasing number of courses of chemotherapy are also aggravating factors.

In this study, the investigator will evaluate the feasibility of two standardized interventions aimed at reducing fatigue in patients with metastatic colorectal cancer. One of the two interventions will focus on hypnosis sessions while the other will implement Cognitive Behavioral Therapy (CBT) sessions.

Description:

In patients with cancer, fatigue appears to be one of the most common and persistent symptoms, reported by patients as severe and intense. In a previous observational study, the investigator identified fatigue trajectories of patients undergoing chemotherapy for metastatic colorectal cancer. the investigator were able to show an association between each trajectory and survival curves, where intense fatigue is associated with poor survival rate. Moreover, the investigator were able to identify psychosocial predictors of this fatigue: significant emotional distress, poor adjustment (inadequate coping strategy) and low perceived control over the evolution of the disease. the investigator know that psychosocial intervention programs can act on these variables.

Among the psychosocial interventions, there are Cognitive and Behavioral Therapies (CBT), which are defined as a "new learning that corrects pathological or maladaptive behavior". They are based on an experimental scientific approach and are inspired by behaviorist theories. The effectiveness of CBT in the management of cancer-related symptoms, including sleep problems and fatigue, has been demonstrated by several authors. However, these therapies are too often implemented in non-standardized studies (no specific protocol, little evaluation, and difficult replication), or are confounded with other complementary therapies.

In order to improve the management of fatigue, hypnosis also seems to be an interesting approach. The French National Academy of Medicine, in its report on complementary therapies of March 2013, underlines the interest of hypnosis in the management of the chemotherapy side effects. Studies in breast cancer patients show a positive effect of hypnosis combined with CBT on symptoms of distress and physical fatigue. However, like CBT, there is a lack of standardized studies on the subject.

Therefore, before conducting a Randomized Controlled Trial (RCT), a feasibility study seems essential to measure the proportion of volunteers who want to participate in this study as well as the acceptability of the program and the method of data collection.

In this study, the investigator will evaluate the feasibility of two standardized interventions (hypnosis and CBT) aimed at reducing fatigue in patients with metastatic colorectal cancer.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: September 2025
• Est. primary completion date: June 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Age = 18 years

• World Health Organization (WHO) status = 2

• Colorectal adenocarcinoma in progression after first line metastatic chemotherapy

• Able to understand and read French

• Visual Analog Scale (VAS) fatigue = 4

• Patient starting a second or third line of metastatic chemotherapy

• Patient having signed the informed consent

• Patient subscribing to a French Social Security system

Exclusion Criteria:

• Patients without phones or devices for sessions at home

• Bradycardia (< 50 beats/minute) with ß-blockers

• Known severe heart failure with ventricular ejection fraction < 40%.

• Presence of known or symptomatic brain metastases

• Chronic pain evolving for more than three months and using morphine

• Patient used to and having a regular and habitual practice of relaxation techniques such as yoga, hypnosis, sophrology, meditation.

• Medical (neurological, psychiatric, etc.) or psychological conditions that do not allow participation in the protocol (filling out the questionnaires, the booklet, as well as following the sessions)

• Hearing-impaired patient without hearing aids

• Patient under guardianship or legal protection

Related Conditions & MeSH terms

• Colorectal Cancer Metastatic
• Colorectal Neoplasms

Intervention

Behavioral:
• Hypnosis
one weekly session during 6 weeks (6 sessions of 30min/1 hour).
• CBT
one weekly session during 6 weeks (6 sessions of 1 hour).

Locations

Country	Name	City	State
France	Institut régional du Cancer de Montpellier	Montpellier	Hérault

Sponsors (1)

Lead Sponsor	Collaborator
Institut du Cancer de Montpellier - Val d'Aurelle

Country where clinical trial is conducted

France, 

References & Publications (27)

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Schnur JB, Kafer I, Marcus C, Montgomery GH. HYPNOSIS TO MANAGE DISTRESS RELATED TO MEDICAL PROCEDURES: A META-ANALYSIS. Contemp Hypn. 2008 Aug 21;25(3-4):114-128. doi: 10.1002/ch.364. — View Citation

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* Note: There are 27 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	patient adherent to the program.	Proportion of patient adherent to the program: A patient will be considered adherent if he/she participates in at least 4 of the 6 intervention sessions.	From first session to sixth session
Secondary	acceptance of participation in the study	Proportion of patients giving their consent to participate in the study relative to patients to whom the study was proposed	At the inclusion
Secondary	reasons for non-adherence to the program	Individual semi-directive interview to understand the non-adherence to the program	At 2 weeks post intervention
Secondary	To highlight the barriers/facilitators to the implementation of the protocol	Individual semi-directive interview to assessed the Barriers/facilitators to the implementation of the protocol	At 2 weeks post intervention
Secondary	Client Satisfaction Questionnaire-Core 8 (CSQ-8)	Self-report statement of satisfaction with health and human services. The CSQ-8 contains 8 items organized into 4-point Likert. For overall score, sum item responses, range from 8-32, higher score indicates higher satisfaction.	At 2 weeks post intervention
Secondary	Visual Analog Scale of Fatigue	Numeric rating scales 0 (no fatigue) to 10 (maximum fatigue)	At inclusion, daily during all the intervention to 2 weeks post intervention, at 3 months post-intervention
Secondary	Multidimensional Fatigue Inventory-Core 20 (MFI20)	The Multidimensional Fatigue Inventory (MFI-20) developed basically to assess 5 main kinds of fatigue: General Fatigue, Physical Fatigue, Mental Fatigue, Reduced Motivation and Reduced Activity.; The MFI20 contains 20 items that measure the previously mentioned dimension of fatigue. Each item ask the individuals to mark on a (1-5 or 1-7) point rating scale to what extent the statement "is true" and applies to them or "not true".	At inclusion, at 2 weeks post intervention and at 3 months post-intervention
Secondary	Quality of life questionnaire-Core 30 (QLQ-C30)	Developed by the EORTC, this self-reported questionnaire assesses the health-related quality of life of cancer patients in clinical trials.; The questionnaire includes five functional scales (physical, everyday activity, cognitive, emotional, and social), three symptom scales (fatigue, pain, nausea and vomiting), a health/quality of life overall scale, and a number of additional elements assessing common symptoms (including dyspnea, loss of appetite, insomnia, constipation, and diarrhea), as well as, the perceived financial impact of the disease.; All of the scales and single-item measures range in score from 0 to 100. A high scale score represents a higher response level.	At inclusion, at 2 weeks post intervention and at 3 months post-intervention

External Links

•   Bontoux D, Couturier D, Menkes C-J. Thérapies complémentaires - acupuncture, hypnose, ostéopathie, tai-chi - leur place parmi les ressources de soins - Académie nationale de médecine | Une institution dans son temps
•   Institut National du Cancer Inc. Les cancers en France
•   National Comprehensive Cancer Network (NCCN). Cancer-Related Fatigue