Colorectal Cancer MetastaticCOLOFIGHTNCT04999306
Feasibility of 2 Interventions to Reduce Fatigue in Patients With Chemotherapy for Metastatic Colorectal Cancer
A study testing Hypnosis and CBT in people with Colorectal Cancer Metastatic, run by Institut du Cancer de Montpellier - Val d'Aurelle at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colorectal Cancer Metastatic
- What is being tested?
- Hypnosis and CBT
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- 1 siteFrance
- Study dates
- 17 May 2023to 25 Jul 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Show all 9Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
France1 site
Institut régional du Cancer de Montpellier
Montpellier, Hérault, 34298
About this study
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
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.
Read the 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.
- Conditions
- Colorectal Cancer Metastatic
- Being tested
- Hypnosis, CBT
- Keywords
- hypnosis, Cognitive Behavioral Therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HypnosisBehavioural
one weekly session during 6 weeks (6 sessions of 30min/1 hour).
CBTBehavioural
one weekly session during 6 weeks (6 sessions of 1 hour).
| Study group | Role | What they receive |
|---|---|---|
| Hypnosis group | Experimental | 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. Receives: Behavioral: Hypnosis |
| CBT group | Experimental | 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. Receives: Behavioral: CBT |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From first session to sixth session
Secondary outcomes (7)
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
Measured: At the inclusion
reasons for non-adherence to the program
Individual semi-directive interview to understand the non-adherence to the program
Measured: 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
Measured: 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.
Measured: At 2 weeks post intervention
Visual Analog Scale of Fatigue
Numeric rating scales 0 (no fatigue) to 10 (maximum fatigue)
Measured: 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".
Measured: 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.
Measured: At inclusion, at 2 weeks post intervention and at 3 months post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2021
- Study start17 May 2023
- Primary completion17 Jul 2023
- Study completion25 Jul 2023
Why it stopped: Recruitment difficulties
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (28)Papers the sponsor has linked to this study.
- Other trials for Colorectal Cancer MetastaticStudies of the same condition, open and under way.
- More trials run by Institut du Cancer de Montpellier - Val d'AurelleThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Hypnosis vs Cognitive Behavioral Therapy
- Masking
- None (open label)
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Fabienne Portales, MD, Study chair, Montpellier Cancer Institut (ICM)Louise Baussard, PhD, Study chair, University of Nimes
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04999306
- Sponsor's protocol ID
- PROICM 2021-07 COL
- Other IDs
- 2021-A01031-40
- Acronym
- COLOFIGHT
- Status last verified
- Feb 2025
- First submitted
- 5 Aug 2021
- Last updated
- 13 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Stone 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.
PubMed 11038033Forlenza 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.
PubMed 16206253Lawrence 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.
PubMed 15263040Kangas 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.
PubMed 18729569Mustian 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.
PubMed 28253393Berger 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.
PubMed 19090531Cousson-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.
PubMed 21879639Page 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.
PubMed 17193942Morin CM, Vallieres A, Guay B, Ivers H, Savard J, Merette C, Bastien C, Baillargeon L. Cognitive behavioral therapy, singly and combined with medication, for persistent insomnia: a randomized controlled trial. JAMA. 2009 May 20;301(19):2005-15. doi: 10.1001/jama.2009.682.
PubMed 19454639Carlson 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.
PubMed 28822063Barsevick 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.
PubMed 24047960Sood 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.
PubMed 17351022Cramer 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.
PubMed 25233905Montgomery 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.
PubMed 17728216Montgomery 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.
PubMed 28506144
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04999306
- Acronym / sponsor ID
- COLOFIGHT / PROICM 2021-07 COL
- Conditions
- Colorectal Cancer Metastatic
- Keywords
- hypnosis, Cognitive Behavioral Therapy
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Recruitment difficulties
- Enrolment
- 1 participants (actual)
- Lead sponsor
- Institut du Cancer de Montpellier - Val d'AurelleUniversity, hospital or other
- Study start
- 17 May 2023 (actual)
- Primary completion
- 17 Jul 2023 (actual)
- Study completion
- 25 Jul 2023 (actual)
- First posted
- 10 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Hypnosis vs Cognitive Behavioral Therapy
| Arm | Type | Receives |
|---|---|---|
| Hypnosis group | Experimental | Behavioral: Hypnosisthe 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. |
| CBT group | Experimental | Behavioral: CBTThis 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hypnosisone weekly session during 6 weeks (6 sessions of 30min/1 hour). | Behavioural | Hypnosis group |
| CBTone weekly session during 6 weeks (6 sessions of 1 hour). | Behavioural | CBT group |
Primary outcome
patient adherent to the program.
Time frame: 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.
7 secondary outcomes
acceptance of participation in the study
Time frame: At the inclusion
reasons for non-adherence to the program
Time frame: At 2 weeks post intervention
To highlight the barriers/facilitators to the implementation of the protocol
Time frame: At 2 weeks post intervention
Client Satisfaction Questionnaire-Core 8 (CSQ-8)
Time frame: At 2 weeks post intervention
Visual Analog Scale of Fatigue
Time frame: At inclusion, daily during all the intervention to 2 weeks post intervention, at 3 months post-intervention
Multidimensional Fatigue Inventory-Core 20 (MFI20)
Time frame: At inclusion, at 2 weeks post intervention and at 3 months post-intervention
Quality of life questionnaire-Core 30 (QLQ-C30)
Time frame: At inclusion, at 2 weeks post intervention and at 3 months post-intervention
Results and safety
The study was stopped early (reason given: Recruitment difficulties). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2025.
- Background: PubMed 11038033Stone 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.
- Background: PubMed 16206253Forlenza 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.
- Background: PubMed 15263040Lawrence 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.
- Background: PubMed 18729569Kangas 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.
- Background: PubMed 28253393Mustian 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.
- Background: PubMed 19090531Berger 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.
- Background: PubMed 21879639Cousson-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.
- Background: PubMed 17193942Page 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.
- Background: PubMed 19454639Morin CM, Vallieres A, Guay B, Ivers H, Savard J, Merette C, Bastien C, Baillargeon L. Cognitive behavioral therapy, singly and combined with medication, for persistent insomnia: a randomized controlled trial. JAMA. 2009 May 20;301(19):2005-15. doi: 10.1001/jama.2009.682.
- Background: PubMed 28822063Carlson 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.
- Background: PubMed 24047960Barsevick 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.
- Background: PubMed 17351022Sood 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.
- Institut National du Cancer Inc. Les cancers en FranceLink provided by the sponsor.
- 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 tempsLink provided by the sponsor.
- Individual participant dataSharing planned: No
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CRC
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Fabienne Portales, MD study chair
Montpellier Cancer Institut (ICM)
Louise Baussard, PhD study chair
University of Nimes
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hypnosis and CBT in people with Colorectal Cancer Metastatic, run by Institut du Cancer de Montpellier - Val d'Aurelle at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 13 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Recruitment difficulties). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
patient adherent to the program. (time frame: From first session to sixth session). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04999306, which also lists 28 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Feb 2025.