Colorectal Cancer Metastatic
Conditions
Keywords
hypnosis, Cognitive Behavioral Therapy
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.
Interventions
BEHAVIORALHypnosis
one weekly session during 6 weeks (6 sessions of 30min/1 hour).
BEHAVIORALCBT
one weekly session during 6 weeks (6 sessions of 1 hour).
Sponsors
Institut du Cancer de Montpellier - Val d'Aurelle
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Intervention model description
Hypnosis vs Cognitive Behavioral Therapy
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| patient adherent to the program. | From first session to sixth session | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| reasons for non-adherence to the program | At 2 weeks post intervention | Individual semi-directive interview to understand the non-adherence to the program |
| To highlight the barriers/facilitators to the implementation of the protocol | At 2 weeks post intervention | Individual semi-directive interview to assessed the Barriers/facilitators to the implementation of the protocol |
| Client Satisfaction Questionnaire-Core 8 (CSQ-8) | At 2 weeks post intervention | 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. |
| acceptance of participation in the study | At the inclusion | Proportion of patients giving their consent to participate in the study relative to patients to whom the study was proposed |
| Multidimensional Fatigue Inventory-Core 20 (MFI20) | At inclusion, at 2 weeks post intervention and at 3 months post-intervention | 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. |
| Quality of life questionnaire-Core 30 (QLQ-C30) | At inclusion, at 2 weeks post intervention and at 3 months post-intervention | 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. |
| Visual Analog Scale of Fatigue | At inclusion, daily during all the intervention to 2 weeks post intervention, at 3 months post-intervention | Numeric rating scales 0 (no fatigue) to 10 (maximum fatigue) |
Countries
France
Outcome results
None listed