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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Colorectal Cancer Metastatic

Intervention / Treatment
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* Behavioral: Hypnosis
* Behavioral: CBT


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Hypnosis vs Cognitive Behavioral Therapy
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Hypnosis group<br>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<br>* one weekly session during 6 weeks (6 sessions of 30min/1 hour).<br>|
| Experimental: CBT group<br>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<br>* one weekly session during 6 weeks (6 sessions of 1 hour).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| reasons for non-adherence to the program | Individual semi-directive interview to understand the non-adherence to the program | At 2 weeks post intervention | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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hypnosis, Cognitive Behavioral Therapy