Clinical trial · Interventional
Feasibility of 2 Interventions to Reduce Fatigue in Patients With Chemotherapy for Metastatic Colorectal Cancer
Feasibility Study of a Hypnosis Intervention and a Cognitive Behavioral Therapy Intervention to Reduce Fatigue in Patients Undergoing Chemotherapy for Metastatic Colorectal Cancer
NCT04999306CI-TRIAL-00085918COLOFIGHTterminatedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Recruitment difficulties
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Colorectal Cancer Metastatic | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| CBT | Behavioral | — | UNRESOLVED |
| Hypnosis | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Hypnosis group
- description
- 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.
- interventionNames
- Behavioral: Hypnosis
- type
- EXPERIMENTAL
- label
- CBT group
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (28)
- BACKGROUNDStone P, Richardson A, Ream E, Smith AG, Kerr DJ, Kearney N. Cancer-related fatigue: inevitable, unimportant and untreatable? Results of a multi-centre patient survey. Cancer Fatigue Forum. Ann Oncol. 2000 Aug;11(8):971-5. doi: 10.1023/a:1008318932641. PMID 11038033
- BACKGROUNDForlenza MJ, Hall P, Lichtenstein P, Evengard B, Sullivan PF. Epidemiology of cancer-related fatigue in the Swedish twin registry. Cancer. 2005 Nov 1;104(9):2022-31. doi: 10.1002/cncr.21373. PMID 16206253
- BACKGROUNDLawrence DP, Kupelnick B, Miller K, Devine D, Lau J. Evidence report on the occurrence, assessment, and treatment of fatigue in cancer patients. J Natl Cancer Inst Monogr. 2004;(32):40-50. doi: 10.1093/jncimonographs/lgh027. PMID 15263040
- BACKGROUNDKangas M, Bovbjerg DH, Montgomery GH. Cancer-related fatigue: a systematic and meta-analytic review of non-pharmacological therapies for cancer patients. Psychol Bull. 2008 Sep;134(5):700-741. doi: 10.1037/a0012825. PMID 18729569
- BACKGROUNDMustian KM, Alfano CM, Heckler C, Kleckner AS, Kleckner IR, Leach CR, Mohr D, Palesh OG, Peppone LJ, Piper BF, Scarpato J, Smith T, Sprod LK, Miller SM. Comparison of Pharmaceutical, Psychological, and Exercise Treatments for Cancer-Related Fatigue: A Meta-analysis. JAMA Oncol. 2017 Jul 1;3(7):961-968. doi: 10.1001/jamaoncol.2016.6914. PMID 28253393
- BACKGROUNDBerger AM, Kuhn BR, Farr LA, Lynch JC, Agrawal S, Chamberlain J, Von Essen SG. Behavioral therapy intervention trial to improve sleep quality and cancer-related fatigue. Psychooncology. 2009 Jun;18(6):634-46. doi: 10.1002/pon.1438. PMID 19090531
- BACKGROUNDCousson-Gelie F, Bruchon-Schweitzer M, Atzeni T, Houede N. Evaluation of a psychosocial intervention on social support, perceived control, coping strategies, emotional distress, and quality of life of breast cancer patients. Psychol Rep. 2011 Jun;108(3):923-42. doi: 10.2466/02.07.15.20.PR0.108.3.923-942.