Clinical trial NCT04999306: Feasibility of 2 Interventions to Reduce Fatigue in Patients With Chemotherapy for Metastatic Colorectal Cancer
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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Colorectal Cancer Metastatic
Keywords: hypnosis
Cognitive Behavioral Therapy
Lead sponsor: Institut du Cancer de Montpellier - Val d'Aurelle
Sponsor class: OTHER
First posted: 2021-08-10
Enrollment: 1
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Hypnosis vs Cognitive Behavioral Therapy
Primary purpose: SUPPORTIVE_CARE

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.

Detailed 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.

Eligibility criteria: 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 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

Primary outcomes:
measure: patient adherent to the program.
timeFrame: From first session to sixth session
Secondary outcomes:
measure: acceptance of participation in the study
timeFrame: At the inclusion
measure: reasons for non-adherence to the program
timeFrame: At 2 weeks post intervention
measure: To highlight the barriers/facilitators to the implementation of the protocol
timeFrame: At 2 weeks post intervention
measure: Client Satisfaction Questionnaire-Core 8 (CSQ-8)
timeFrame: At 2 weeks post intervention
measure: Visual Analog Scale of Fatigue
timeFrame: At inclusion, daily during all the intervention to 2 weeks post intervention, at 3 months post-intervention
measure: Multidimensional Fatigue Inventory-Core 20 (MFI20)
timeFrame: At inclusion, at 2 weeks post intervention and at 3 months post-intervention
measure: Quality of life questionnaire-Core 30 (QLQ-C30)
timeFrame: At inclusion, at 2 weeks post intervention and at 3 months post-intervention
Other outcomes:
Locations:
city: Montpellier
country: France
facility: Institut régional du Cancer de Montpellier
state: Hérault
Study officials:
affiliation: Montpellier Cancer Institut (ICM)
name: Fabienne Portales, MD
role: STUDY_CHAIR
affiliation: University of Nimes
name: Louise Baussard, PhD
role: STUDY_CHAIR
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