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

Louise Baussard, Florence Cousson-Gélie, Marta Jarlier, Elodie Charbonnier, Sarah Le Vigouroux, Lucile Montalescot, Chloé Janiszewski, Michele Fourchon, Louise Coutant, Estelle Guerdoux, Fabienne Portales, Louise Baussard, Florence Cousson-Gélie, Marta Jarlier, Elodie Charbonnier, Sarah Le Vigouroux, Lucile Montalescot, Chloé Janiszewski, Michele Fourchon, Louise Coutant, Estelle Guerdoux, Fabienne Portales

Abstract

Background: In metastatic colorectal cancer (CRCm), fatigue is pervasive, reduces quality of life, and is negatively associated with survival. Its course is explained in part by psychosocial variables such as emotional distress, coping strategies, or perceived control. Thus, to reduce fatigue, psychosocial interventions appear to be relevant. In some cancers, Cognitive Behavioral Therapies (CBT) reduce fatigue. Hypnosis is also used as a complementary therapy to reduce the side effects of cancer. While CBT requires specific training often reserved for psychologists, hypnosis has the advantage of being increasingly practiced by caregivers and is therefore less expensive (Montgomery et al., 2007). On the other hand, CBT and hypnosis remain understudied in the CRC, do not focus on the symptom of fatigue and in Europe such programs have never been evaluated.

Objectives: Implementing an intervention in a healthcare setting is complex (e.g., economic and practical aspects) and recruiting participants can be challenging. The primary objective will therefore be to study the feasibility of two standardized interventions (hypnosis and CBT) that aim to reduce fatigue in patients with CRCm treated in a French cancer center.

Methods and design: A prospective, single-center, randomized interventional feasibility study, using mixed methods (both quantitative and qualitative). A total of 60 patients will be allocated to each intervention group [Hypnosis (n = 30) and CBT (n = 30)]. Participants will be randomized into two parallel groups (ratio 1:1). Both programs will consist of 6 weekly sessions focusing on the CRF management over a period of 6 weeks. Trained therapists will conduct the program combining 3 face-to-face sessions and 3 online sessions. The feasibility and experience of interventions will be evaluated by the outcome variables, including the adhesion rate, the reasons for acceptability, relevance or non-adherence, the satisfaction, the fatigue evolution (with ecological momentary assessments), and the quality of life. All questionnaires will be self-assessment using an online application from the cancer center.

Discussion: Results will highlight the barriers/facilitators to the implementation of the program and the relevance of the program to the patients, and will be used to generate hypotheses for a randomized control trial.

Clinical trial registration: ClinicalTrials.gov Identifier: NCT04999306; https://ichgcp.net/clinical-trials-registry/NCT04999306.

Keywords: cancer; cognitive behavioral therapy; fatigue; feasibility; hypnosis; intervention; protocol.

Conflict of interest statement

The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest.

Copyright © 2022 Baussard, Cousson-Gélie, Jarlier, Charbonnier, Le Vigouroux, Montalescot, Janiszewski, Fourchon, Coutant, Guerdoux and Portales.

Figures

Figure 1
Figure 1
(A,B) From theory to practice–psychosocial interventions (CBT and hypnosis) applied to the determinants of cancer-related fatigue.
Figure 2
Figure 2
Study design with two-arms randomization (hypnosis and CBT), 6 sessions each. Flexibility in terms of sessions is foreseen, i.e., a patient may have a session shifted by 1 or 2 weeks depending on its WHO performance status and/or the therapist's availability. This takes into account the toxicities, need to always have the same practitioner for the 6 sessions, and the reality of the field (absences, vacations, etc.).

References

    1. Aaronson N. K., Ahmedzai S., Bergman B., Bullinger M., Cull A., Duez N. J., et al. . (1993). The European organization for research and treatment of cancer QLQ-C30: a quality-of-life instrument for use in international clinical trials in oncology. J. Natl. Cancer Inst. 85, 365–376. 10.1093/jnci/85.5.365
    1. APA Presidential Task Force on Evidence-Based Practice (2006). Evidence-based practice in psychology. Am. Psychol. 61, 271–285. 10.1037/0003-066X.61.4.271
    1. Askay S. W., Patterson D. R., Sharar S. R. (2009). Virtual reality hypnosis. Contemp. Hypn. 26, 40–47. 10.1002/ch.371
    1. Barsevick A. M., Irwin M. R., Hinds P., Miller A., Berger A., Jacobsen P., et al. . (2013). Recommendations for high-priority research on cancer-related fatigue in children and adults. Jnci-J. Natl. Cancer Inst. 105, 1432–1440. 10.1093/jnci/djt242
    1. Baussard L.. (2018). Déterminants psychosociaux des trajectoires de fatigue chez des patients traités en chimiothérapie pour un cancer colorectal métastatique. Available online at: (accessed June 24, 2019).
    1. Baussard L., Carayol M., Porro B., Baguet F., Cousson-Gelie F. (2018). Fatigue in cancer patients: Development and validation of a short form of the Multidimensional Fatigue Inventory (MFI-10). Eur. J. Oncol. Nurs. 36, 62–67. 10.1016/j.ejon.2018.07.005
    1. Baussard L., Cousson-Gélie F., Nicklès I. (2020). Efficacité de l'hypnose pour prendre en charge la fatigue associée au cancer : une revue de la littérature internationale. Psycho-Oncol 14, 122–136. 10.3166/pson-2020-0135
    1. Baussard L., Proust-Lima C., Philipps V., Portales F., Ychou M., Mazard T., et al. . (2022). Determinants of distinct trajectories of fatigue in patients undergoing chemotherapy for a metastatic colorectal cancer: 6-month follow-up using growth mixture modeling. J. Pain Symptom Manage. 63, 140–150. 10.1016/j.jpainsymman.2021.06.019
    1. Baussard L., Stoebner-Delbarre A., Bonnabel L., Huteau M.-E., Gastou A., Cousson-Gélie F. (2017). Development and validation of the daily fatigue cancer scale (DFCS): Single-item questions for clinical practice. Eur. J. Oncol. Nurs. Off. J. Eur. Oncol. Nurs. Soc. 26, 42–48. 10.1016/j.ejon.2016.12.004
    1. Berger A. M., Kuhn B. R., Farr L. A., Lynch J. C., Agrawal S., Chamberlain J., et al. . (2009). Behavioral therapy intervention trial to improve sleep quality and cancer-related fatigue. Psychooncology. 18, 634–646. 10.1002/pon.1438
    1. Blesch K. S., Paice J. A., Wickham R., Harte N., Schnoor D. K., Purl S., et al. . (1991). Correlates of fatigue in people with breast or lung cancer. Oncol. Nurs. Forum Fam. Plan. West. Hemisph. 18, 81–87.
    1. Bontoux D., Couturier D., Menkes C.-J. (2013). Thérapies complémentaires – acupuncture, hypnose, ostéopathie, tai-chi – leur place parmi les ressources de soins – Académie nationale de médecine | Une institution dans son temps. Academie Nationale de Médecine. Available online at: (accessed February 15, 2021).
    1. Bragard I., Etienne A.-M., Faymonville M.-E., Coucke P., Lifrange E., Schroeder H., et al. . (2017). A nonrandomized comparison study of self-hypnosis, yoga, and cognitive-behavioral therapy to reduce emotional distress in breast cancer patients. Int. J. Clin. Exp. Hypn. 65, 189–209. 10.1080/00207144.2017.1276363
    1. Brebach R., Sharpe L., Costa D. S. J., Rhodes P., Butow P. (2016). Psychological intervention targeting distress for cancer patients: a meta-analytic study investigating uptake and adherence. Psychooncology 25, 882–890. 10.1002/pon.4099
    1. Bruchon-Schweitzer M., Boujut E. (2014). Psychologie de la santé: Modèles, concetps et méthodes. 2ème. Dunod. Available online at: (accessed October 7, 2017). 10.3917/dunod.bruch.2014.01.0525
    1. Carlson L. E., Zelinski E., Toivonen K., Flynn M., Qureshi M., Piedalue K.-A., et al. . (2017). Mind-body therapies in cancer: what is the latest evidence? Curr. Oncol. Rep. 19:67. 10.1007/s11912-017-0626-1
    1. Chaloult L., Ngo T.-L., Cousineau P., Goulet J. (2010). La thérapie cognitivo-comportementale - Théorie et pratique. Montréal: GAETAN MORIN.
    1. Cousson-Gélie F., Bruchon-Schweitzer M., Atzeni T., Houede N. (2011). Evaluation of a psychosocial intervention on social support perceived control, coping strategies, emotional distress, and quality of life of breast cancer patients. Psychol. Rep. 108, 923–942. 10.2466/02.07.15.20.PR0.108.3.923-942
    1. Cramer H., Lauche R., Paul A., Langhorst J., Kümmel S., Dobos G. J. (2015). Hypnosis in breast cancer care, hypnosis in breast cancer care: a systematic review of randomized controlled trials, a systematic review of randomized controlled trials. Integr. Cancer Ther. 14, 5–15. 10.1177/1534735414550035
    1. Duijts S. F. A., Faber M. M., Oldenburg H. S. A., van Beurden M., Aaronson N. K. (2011). Effectiveness of behavioral techniques and physical exercise on psychosocial functioning and health-related quality of life in breast cancer patients and survivors–a meta-analysis. Psychooncology 20, 115–126. 10.1002/pon.1728
    1. Elkins G. R., Barabasz A. F., Council J. R., Spiegel D. (2015). Advancing research and practice: The revised APA division 30 definition of hypnosis. Am. J. Clin. Hypn. 57, 378–385. 10.1080/00029157.2015.1011465
    1. Fisher A., Wardle J., Beeken R. J., Croker H., Williams K., Grimmett C. (2016). Perceived barriers and benefits to physical activity in colorectal cancer patients. Support. Care Cancer Off. J. Multinatl. Assoc. Support. Care Cancer 24, 903–910. 10.1007/s00520-015-2860-0
    1. Forlenza M. J., Hall P., Lichtenstein P., Evengard B., Sullivan P. F. (2005). Epidemiology of cancer-related fatigue in the Swedish twin registry. Cancer 104, 2022–2031. 10.1002/cncr.21373
    1. Gielissen M. F. M., Verhagen C. H. H. V. M., Bleijenberg G. (2007). Cognitive behaviour therapy for fatigued cancer survivors: long-term follow-up. Br. J. Cancer 97, 612–618. 10.1038/sj.bjc.6603899
    1. Gielissen M. F. M., Verhagen S., Witjes F., Bleijenberg G. (2006). 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. Off. J. Am. Soc. Clin. Oncol. 24, 4882–4887. 10.1200/JCO.2006.06.8270
    1. Gregoire C., Faymonville M.-E., Jérusalem G., Bragard I., Charland-Verville V., Vanhaudenhuyse A. (2017). Intérêt et utilisation de l'hypnose pour améliorer le bien-être physique et psychologique en oncologie | . Hegel 4, 267–275. 10.3917/heg.074.0267
    1. Grégoire C., Marie N., Sombrun C., Faymonville M.-E., Kotsou I., van Nitsen V., et al. . (2022). Hypnosis, meditation, and self-induced cognitive trance to improve post-treatment oncological patients' quality of life: study protocol. Front. Psychol. 13, e807741. 10.3389/fpsyg.2022.807741
    1. Gueguen J., Barry C., Hassler C., Falissard B. (2015). Evaluation de l'efficacité de la pratique de l'hypnose. Available online at: (accessed June 6, 2017).
    1. Heckler C. E., Garland S. N., Peoples A. R., Perlis M. L., Shayne M., Morrow G. R., et al. . (2016). Cognitive behavioral therapy for insomnia, but not armodafinil, improves fatigue in cancer survivors with insomnia: a randomized placebo-controlled trial. Support. Care Cancer 24, 2059–2066. 10.1007/s00520-015-2996-y
    1. Jensen G. J. R., Braden A., Gertz K. J., Fann J. R., Syrjala K. L. (2012). Hypnosis for symptom management in womenwith breast cancer: A pilot study. Int. J. Clin. Exp. Hypn. 60, 135–159. 10.1080/00207144.2012.648057
    1. Jensen M., Patterson D. R. (2006). Hypnotic treatment of chronic pain. J. Behav. Med. 29, 95–124. 10.1007/s10865-005-9031-6
    1. Jensen M. P., Barber J., Hanley M. A., Engel J. M., Romano J. M., Cardenas D. D., et al. . (2008). Long-term outcome of hypnotic-analgesia treatment for chronic pain in persons with disabilities. Int. J. Clin. Exp. Hypn. 56, 156–169. 10.1080/00207140701849486
    1. Kangas M., Bovbjerg D. H., Montgomery G. H. (2008). Cancer-related fatigue: A systematic and meta-analytic review of non-pharmacological therapies for cancer patients. Psychol. Bull. 134, 700–741. 10.1037/a0012825
    1. Kapp C., Perlini T., Baggio S., Stéphan P., Rojas-Urrego A., Rengade C.-E., et al. . (2014). Qualités psychométriques du Consumer satisfaction questionnaire (CSQ-8) et du Helping alliance questionnaire (HAQ). Sante Publique 26, 337–344. 10.3917/spub.139.0337
    1. Lawrence D. P., Kupelnick B., Miller K., Devine D., Lau J. (2004). Evidence report on the occurrence, assessment, and treatment of fatigue in cancer patients. JNCI Monogr. 2004, 40–50. 10.1093/jncimonographs/lgh027
    1. Lawsin C., DuHamel K., Itzkowitz S. H., Brown K., Lim H., Thelemaque L., et al. . (2007). Demographic, medical, and psychosocial correlates to CAM use among survivors of colorectal cancer. Support. Care Cancer 15, 557–564. 10.1007/s00520-006-0198-3
    1. Machin D., Tan S. B., Tan S. H. (2009). Sample Size Tables for Clinical Studies. Wiley. 10.1002/9781444300710
    1. Mayrbaeurl B., Giesinger J. M., Burgstaller S., Piringer G., Holzner B., Thaler J. (2016). Quality of life across chemotherapy lines in patients with advanced colorectal cancer: a prospective single-center observational study. Support. Care Cancer 24, 667–674. 10.1007/s00520-015-2828-0
    1. Mitry E., Zelek L., Chouaïd C., Colin P., Maloisel F., Le Calve P. (2010). ≪ Regards croisés 2009 ≫: perceptions croisées des patients atteints de cancer et des professionnels de santé sur les conséquences de la fatigue et de l'anémie chimio-induite, analyse des sous-populations. Oncologie 12, 709–717. 10.1007/s10269-010-1962-z
    1. Miyamoto Y., Yuki S., Shimokawa M., Tanioka H., Tsuji A., Asayama M., et al. . (2016). A randomized, double-blind, placebo-controlled phase II study of prophylactic dexamethasone (dex) therapy for fatigue and malaise due to regorafenib in patient (pts) with metastatic colorectal cancer (mCRC): (KSCC1402/HGCSG1402). J. Clin. Oncol. 34:e10127. 10.1200/JCO.2016.34.15_suppl.10127
    1. Molassiotis A., Fernandez-Ortega P., Pud D., Ozden G., Platin N., Hummerston S., et al. . (2005). Complementary and alternative medicine use in colorectal cancer patients in seven European countries. Complement. Ther. Med. 13, 251–257. 10.1016/j.ctim.2005.07.002
    1. Mols F., Thong M. S. Y., de Poll-Franse L. V., van Roukema, J. A., Denollet J. (2012). Type D (distressed) personality is associated with poor quality of life and mental health among 3080 cancer survivors. J. Affect. Disord. 136, 26–34. 10.1016/j.jad.2011.08.034
    1. Montgomery G. H., Bovbjerg D. H., Schnur J. B., David D., Goldfarb A., Weltz C. R., et al. . (2007). A randomized clinical trial of a brief hypnosis intervention to control side effects in breast surgery patients. J. Natl. Cancer Inst. 99, 1304–1312. 10.1093/jnci/djm106
    1. Montgomery G. H., Schnur J. B., Kravits K. (2013). Hypnosis for cancer care: Over 200 years young. CA Cancer J. Clin. 63, 31–44. 10.3322/caac.21165
    1. Montgomery G. H., Weltz C. R., Seltz M., Bovbjerg D. H. (2002). Brief presurgery hypnosis reduces distress and pain in excisional breast biopsy patients. Int. J. Clin. Exp. Hypn. 50, 17–32. 10.1080/00207140208410088
    1. Morin C. M., Vallières A., Guay B. (2009). Cognitive behavioral therapy, singly and combined with medication, for persistent insomnia: a randomized controlled trial. JAMA 301, 2005–2015. 10.1001/jama.2009.682
    1. Mota D. D. C. F., Pimenta C. A. M., Caponero R. (2012). Fatigue in colorectal cancer patients: prevalence and associated factors. Rev. Lat. Am. Enfermagem 20, 495–503. 10.1590/S0104-11692012000300010
    1. Müller F., Wijayanto F., Abrahams H., Gielissen M., Prinsen H., Braamse A., vanăLaarhoven H. W. M., Groot P., Heskes T., Knoop H. (2021). Potential mechanisms of the fatigue-reducing effect of cognitive-behavioral therapy in cancer survivors: Three randomized controlled trials. Psychooncology 30, 1476–1484. 10.1002/pon.5710
    1. Mustian K. M., Alfano C. M., Heckler C., Kleckner A. S., Kleckner I. R., Leach C. R., et al. . (2017). Comparison of pharmaceutical, psychological, and exercise treatments for cancer-related fatigue: a meta-analysis. JAMA Oncol. 3, 961–968. 10.1001/jamaoncol.2016.6914
    1. NCCN National Comprehensive Cancer Network (2017). Cancer-Related Fatigue. . Available online at: (accessed October 12, 2017).
    1. Page M., Berger A., Johnson L. (2006). Putting evidence into practice: evidence-based interventions for sleep-wake disturbances - ProQuest. Clin. J. Oncol. Nurs. 10, 753–767. 10.1188/06.CJON.753-767
    1. Peria F. M., Sa L. A., Oliveira H. F., Vettori J. C., da Cunha Tirapelli D. P., Vieira N. F., et al. . (2012). Fatigue control in metastatic colon cancer treated with capecitabine and oxaliplatin. J. Clin. Oncol. 30:e19628. 10.1200/jco.2012.30.15_suppl.e19628
    1. Poort H., Verhagen C. A. H. H. V. M., Peters M. E. W. J., Goedendorp M. M., Donders A. R. T., Hopman M. T. E., et al. . (2017). Study protocol of the TIRED study: a randomised controlled trial comparing either graded exercise therapy for severe fatigue or cognitive behaviour therapy with usual care in patients with incurable cancer. BMC Cancer 17:3076. 10.1186/s12885-017-3076-0
    1. Roe K., Visovatti M. K., Brooks T., Baydoun M., Clark P., Barton D. L. (2016). Use of complementary therapies for side effect management in breast cancer: evidence and rationale. Breast Cancer Manag. 5, 125–138. 10.2217/bmt-2016-0013
    1. Rycroft-Malone J., Seers K., Titchen A., Harvey G., Kitson A., McCormack B. (2004). What counts as evidence in evidence-based practice? J. Adv. Nurs. 47, 81–90. 10.1111/j.1365-2648.2004.03068.x
    1. Sales P. M. G., Carvalho A. F., McIntyre R. S., Pavlidis N., Hyphantis T. N. (2014). Psychosocial predictors of health outcomes in colorectal cancer: A comprehensive review. Cancer Treat. Rev. 40, 800–809. 10.1016/j.ctrv.2014.03.001
    1. Salkind N. J.. (2010). Encyclopedia of Research Design. Sage. 10.4135/9781412961288
    1. Schnur J. B., Kafer I., Marcus C., Montgomery G. H. (2008). Hypnosis to manage distress related to medical procedures: a meta-analysis. Contemp. Hypn. 25, 114–128. 10.1002/ch.364
    1. Sood A., Barton D. L., Bauer B. A., Loprinzi C. L. (2007). A critical review of complementary therapies for cancer-related fatigue, a critical review of complementary therapies for cancer-related fatigue. Integr. Cancer Ther. 6, 8–13. 10.1177/1534735406298143
    1. Stiles W. B.. (1980). Session evaluation questionnaire. J. Consult. Clin. Psychol. 48, 176–185. 10.1037/0022-006X.48.2.176
    1. Stone P., Richardson A., Ream E., Smith A. G., Kerr D. J., Kearney N. (2000). Cancer-related fatigue: inevitable, unimportant and untreatable? Results of a multi-centre patient survey. Cancer Fatigue Forum. Ann. Oncol. Off. J. Eur. Soc. Med. Oncol. 11, 971–975. 10.1023/A:1008318932641
    1. Teo I., Tan Y. P., Finkelstein E. A., Yang G. M., Pan F. T., Lew H. Y. F., et al. . (2020). The feasibility and acceptability of a cognitive behavioral therapy-based intervention for patients with advanced colorectal cancer. J. Pain Symptom Manage. 60, 1200–1207. 10.1016/j.jpainsymman.2020.06.016
    1. Trinder L.. (2008). Evidence-Based Practice: A Critical Appraisal. John Wiley & Sons.
    1. Tung H.-Y., Chao T.-B., Lin Y.-H., Wu S.-F., Lee H.-Y., Ching C.-Y., et al. . (2016). Depression, fatigue, and QoL in colorectal cancer patients during and after treatment. West. J. Nurs. Res. 38, 893–908. 10.1177/0193945916630256
    1. van Lankveld J. J. D. M., Fleer J., Schroevers M. J., Sanderman R., den Oudsten B. L., Dekker J. (2018). Recruitment problems in psychosocial oncology research. Psychooncology 27, 2296–2298. 10.1002/pon.4792
    1. Vardy J., Dhillon H. M., Pond G. R., Rourke S. B., Xu W., Dodd A., et al. . (2014). Cognitive function and fatigue after diagnosis of colorectal cancer. Ann. Oncol. Off. J. Eur. Soc. Med. Oncol. 25, 2404–2412. 10.1093/annonc/mdu448
    1. Wagland R., Richardson A., Armes J., Hankins M., Lennan E., Griffiths P. (2015). Treatment-related problems experienced by cancer patients undergoing chemotherapy: a scoping review. Eur. J. Cancer Care 24, 605–617. 10.1111/ecc.12246
    1. Wong C. H., Sundberg T., Chung V. C., Voiss P., Cramer H. (2021). Complementary medicine use in US adults with a history of colorectal cancer: a nationally representative survey. Support. Care Cancer 29, 271–278. 10.1007/s00520-020-05494-x
    1. Wynn R., Gabarron E., Johnsen J.-A. K., Traver V. (2020). Special issue on e-health services. Int. J. Environ. Res. Public Health 17:2885. 10.3390/ijerph17082885
    1. Yennurajalingam S., Tayjasanant S., Balachandran D., Padhye N. S., Williams J. L., Liu D. D., et al. . (2016). Association between daytime activity, fatigue, sleep, anxiety, depression, and symptom burden in advanced cancer patients: A preliminary report. J. Palliat. Med. 19, 849–856. 10.1089/jpm.2015.0276

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