Feasibility of 2 Interventions to Reduce Fatigue in Patients With Chemotherapy for Metastatic Colorectal Cancer
NCT ID: NCT04999306
Last Updated: 2025-02-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
NA
1 participants
INTERVENTIONAL
2023-05-17
2023-07-25
Brief Summary
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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.
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
NONE
Study Groups
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Hypnosis group
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.
Hypnosis
one weekly session during 6 weeks (6 sessions of 30min/1 hour).
CBT group
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.
CBT
one weekly session during 6 weeks (6 sessions of 1 hour).
Interventions
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Hypnosis
one weekly session during 6 weeks (6 sessions of 30min/1 hour).
CBT
one weekly session during 6 weeks (6 sessions of 1 hour).
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Institut du Cancer de Montpellier - Val d'Aurelle
OTHER
Responsible Party
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Principal Investigators
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Fabienne Portales, MD
Role: STUDY_CHAIR
Montpellier Cancer Institut (ICM)
Louise Baussard, PhD
Role: STUDY_CHAIR
University of Nimes
Locations
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Institut régional du Cancer de Montpellier
Montpellier, Hérault, France
Countries
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References
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Lawrence 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.
Kangas 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.
Cousson-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.
Page MS, Berger AM, Johnson LB. Putting evidence into practice: evidence-based interventions for sleep-wake disturbances. Clin J Oncol Nurs. 2006 Dec;10(6):753-67. doi: 10.1188/06.CJON.753-767.
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Carlson LE, Zelinski E, Toivonen K, Flynn M, Qureshi M, Piedalue KA, Grant R. Mind-Body Therapies in Cancer: What Is the Latest Evidence? Curr Oncol Rep. 2017 Aug 18;19(10):67. doi: 10.1007/s11912-017-0626-1.
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Barsevick AM, Irwin MR, Hinds P, Miller A, Berger A, Jacobsen P, Ancoli-Israel S, Reeve BB, Mustian K, O'Mara A, Lai JS, Fisch M, Cella D; National Cancer Institute Clinical Trials Planning Meeting. Recommendations for high-priority research on cancer-related fatigue in children and adults. J Natl Cancer Inst. 2013 Oct 2;105(19):1432-40. doi: 10.1093/jnci/djt242. Epub 2013 Sep 18.
Sood A, Barton DL, Bauer BA, Loprinzi CL. A critical review of complementary therapies for cancer-related fatigue. Integr Cancer Ther. 2007 Mar;6(1):8-13. doi: 10.1177/1534735406298143.
Cramer H, Lauche R, Paul A, Langhorst J, Kummel S, Dobos GJ. Hypnosis in breast cancer care: a systematic review of randomized controlled trials. Integr Cancer Ther. 2015 Jan;14(1):5-15. doi: 10.1177/1534735414550035. Epub 2014 Sep 18.
Montgomery GH, Bovbjerg DH, Schnur JB, David D, Goldfarb A, Weltz CR, Schechter C, Graff-Zivin J, Tatrow K, Price DD, Silverstein JH. A randomized clinical trial of a brief hypnosis intervention to control side effects in breast surgery patients. J Natl Cancer Inst. 2007 Sep 5;99(17):1304-12. doi: 10.1093/jnci/djm106. Epub 2007 Aug 28.
Montgomery GH, Sucala M, Baum T, Schnur JB. Hypnosis for Symptom Control in Cancer Patients at the End-of-Life: A Systematic Review. Int J Clin Exp Hypn. 2017 Jul-Sep;65(3):296-307. doi: 10.1080/00207144.2017.1314728.
Jensen MP, Gralow JR, Braden A, Gertz KJ, Fann JR, Syrjala KL. Hypnosis for symptom management in women with breast cancer: a pilot study. Int J Clin Exp Hypn. 2012;60(2):135-59. doi: 10.1080/00207144.2012.648057.
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Gielissen MF, Verhagen S, Witjes F, Bleijenberg G. Effects of cognitive behavior therapy in severely fatigued disease-free cancer patients compared with patients waiting for cognitive behavior therapy: a randomized controlled trial. J Clin Oncol. 2006 Oct 20;24(30):4882-7. doi: 10.1200/JCO.2006.06.8270.
Gielissen MF, Verhagen CA, Bleijenberg G. Cognitive behaviour therapy for fatigued cancer survivors: long-term follow-up. Br J Cancer. 2007 Sep 3;97(5):612-8. doi: 10.1038/sj.bjc.6603899. Epub 2007 Jul 24.
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Baussard L, Cousson-Gelie F, Jarlier M, Charbonnier E, Le Vigouroux S, Montalescot L, Janiszewski C, Fourchon M, Coutant L, Guerdoux E, Portales F. Hypnosis and cognitive behavioral therapy with online sessions to reduce fatigue in patients undergoing chemotherapy for a metastatic colorectal cancer: Rational and study protocol for a feasibility study. Front Psychol. 2022 Jul 27;13:953711. doi: 10.3389/fpsyg.2022.953711. eCollection 2022.
Related Links
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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
Other Identifiers
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2021-A01031-40
Identifier Type: OTHER
Identifier Source: secondary_id
PROICM 2021-07 COL
Identifier Type: -
Identifier Source: org_study_id
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