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

NCT04999306 | Terminated

• 2 other identifiers: PROICM 2021-07 COL2021-A01031-40
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Colorectal Cancer Metastatic

Keywords

hypnosis; Cognitive Behavioral Therapy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• acceptance of participation in the study

  At the inclusion

• reasons for non-adherence to the program

  At 2 weeks post intervention

• To highlight the barriers/facilitators to the implementation of the protocol

  At 2 weeks post intervention

• Client Satisfaction Questionnaire-Core 8 (CSQ-8)

  At 2 weeks post intervention

• Visual Analog Scale of Fatigue

  At inclusion, daily during all the intervention to 2 weeks post intervention, at 3 months post-intervention

Study Arms (2)

Hypnosis group

EXPERIMENTAL

the sessions will be conducted following the same dynamics and the same exercises (safe place, reification, anchoring): introduction of the session (conversational hypnosis in order to probe the patient's perceptions of his or her illness and fatigue, discussion of myths and realities); induction with the creation of a "safe place" that will be used for each session; visualization; deepening of the trance with work on metaphors (reification technique); making specific suggestions on sensations of fatigue, on regaining energy; then instruction for self-hypnosis or anchoring.

Behavioral: Hypnosis

CBT group

EXPERIMENTAL

This program will work specifically on the psychosocial determinants of fatigue. The first session will be patient education on cancer-related fatigue. S2 will address the concept of perceived control and allow the patient to understand what factors accentuate this condition. S3 will allow the patient to work on the emotions associated with cancer and will be complemented by a hypnosis audio. S4 will address the notion of social support and how the patient can learn to delegate or ask for help. S5 will address the notion of coping strategies, the patient will then be able to identify what he/she puts in place, what is productive and what is not. Finally, the S6 will be a synthesis session that will allow to come back to the points that deserve to be deepened.

Behavioral: CBT

Interventions

Hypnosis BEHAVIORAL

one weekly session during 6 weeks (6 sessions of 30min/1 hour).

Hypnosis group

CBT BEHAVIORAL

one weekly session during 6 weeks (6 sessions of 1 hour).

CBT group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Patients without phones or devices for sessions at home
• Bradycardia (\< 50 beats/minute) with β-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

Sponsors & Collaborators

• Institut du Cancer de Montpellier - Val d'Aurelle: lead

Study Sites (1)

Institut régional du Cancer de Montpellier

Montpellier, Hérault, 34298, France

Location

Related Publications (28)

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  PMID: 35967617 DERIVED

Related Links

• Institut National du Cancer Inc. Les cancers en France
• 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

MeSH Terms

Interventions

Hypnosis

Intervention Hierarchy (Ancestors)

Mind-Body Therapies; Complementary Therapies; Therapeutics; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Fabienne Portales, MD

  Montpellier Cancer Institut (ICM)

  STUDY CHAIR

• Louise Baussard, PhD

  University of Nimes

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Hypnosis vs Cognitive Behavioral Therapy

Study Record Dates

• First Submitted: August 5, 2021
• First Posted: August 10, 2021
• Study Start: May 17, 2023
• Primary Completion: July 17, 2023
• Study Completion: July 25, 2023
• Last Updated: February 13, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)