Randomized controlled trial of an 8-week intervention combining self-care and hypnosis for post-treatment cancer patients: study protocol

Grégoire, Charlotte; Faymonville, Marie-Élisabeth; Vanhaudenhuyse, Audrey; Charland‐Verville, Vanessa; Jérusalem, Guy; Bragard, Isabelle

doi:10.1186/s12885-018-5046-6

Cited by 9 publications

(15 citation statements)

References 87 publications

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“…The protocol of the study has been published 21 and displays detailed information about the design, recruitment and randomization procedures, sample size calculation, assessments and intervention. Therefore, we will only summarize these aspects here.…”

Section: Methods and Designmentioning

confidence: 99%

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Effects of an intervention combining self‐care and self‐hypnosis on fatigue and associated symptoms in post‐treatment cancer patients: A randomized‐controlled trial

et al. 2020

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ObjectiveCancer has a lot of consequences such as fatigue, sleep disturbances, emotional distress, cognitive impairment and reduced physical activity. Some hypnosis‐based psychological interventions showed positive effects on fatigue, sleep and emotional distress, but generally focused on breast cancer patients. Our study aimed at assessing the effects of a group intervention combining self‐care and self‐hypnosis on quality of life of cancer patients.MethodsOur longitudinal randomized‐controlled trial assessed the benefits of the intervention first on fatigue and secondly on associated symptoms (sleep, emotional distress, cognitive impairment and reduced physical activity) of post‐treatment cancer patients, and investigated predictors of the evolution of fatigue. All variables were measured with questionnaires and an actigraph (for sleep and physical activity).ResultsNinety five women with different cancers were included in our study. Group‐by‐time effects were showed for fatigue, sleep, emotional distress and cognitive functioning: symptoms have improved in the intervention group compared to wait‐list control group. Three predictors of the evolution of fatigue were revealed: depression, anxiety and worry.ConclusionsOur group intervention had benefits for post‐treatment cancer patients' quality of life. Impacting emotional distress could be important in order to decrease fatigue. Further studies are needed to replicate our results. This intervention could be easily implemented to improve quality of life of cancer patients.Registration: ClinicalTrials.gov (NCT03144154). Retrospectively registered on the 1st of May, 2017.

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Section: Methods and Designmentioning

confidence: 99%

“…12,25 In this way, self-hypnosis is complementary to self-care tasks. More details about the content of the sessions are displayed in our protocol 21 and (see Appendix S1 in Online Supplementary Material).…”

Section: Interventionmentioning

confidence: 99%

Effects of an intervention combining self‐care and self‐hypnosis on fatigue and associated symptoms in post‐treatment cancer patients: A randomized‐controlled trial

et al. 2020

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“…Inclusion criteria will be: to be at least 18 years old, no psychiatric or neurological disorders, no current and regular practice of hypnosis, meditation or trance, diagnosis of cancer (any localization except brain tumors to avoid any effect on EEG data or severe cognitive impairments that could prevent filling the questionnaires adequately), and completion of active treatments (surgery, chemotherapy, radiotherapy) for less than a year. Interested patients will be screened for fatigue, emotional distress, sleep difficulties, and pain (VAS score ≥ 4/10 for one of these four symptoms for inclusion), based on recommendations from our past studies ( Grégoire et al, 2018a , b ).…”

Section: Methods and Analysismentioning

confidence: 99%

Hypnosis, Meditation, and Self-Induced Cognitive Trance to Improve Post-treatment Oncological Patients’ Quality of Life: Study Protocol

Grégoire

Marie

Sombrun³

et al. 2022

Front. Psychol.

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IntroductionA symptom cluster is very common among oncological patients: cancer-related fatigue (CRF), emotional distress, sleep difficulties, pain, and cognitive difficulties. Clinical applications of interventions based on non-ordinary states of consciousness, mostly hypnosis and meditation, are starting to be investigated in oncology settings. They revealed encouraging results in terms of improvements of these symptoms. However, these studies often focused on breast cancer patients, with methodological limitations (e.g., small sample size, no control group, and no follow-up). Another non-ordinary state of consciousness may also have therapeutic applications in oncology: self-induced cognitive trance (SICT). It seems to differ from hypnosis and meditation, as it involves the body more directly. Thus, investigating its clinical applications, along with hypnosis and meditation interventions, could improve available therapeutic options in oncology. This article details the study protocol of a preference-based longitudinal controlled superiority trial aiming to assess the effectiveness of 3 group interventions (hypnosis, meditation, and SICT) to improve oncological patients’ quality of life, and more specifically CRF, emotional distress, sleep, pain, and cognitive difficulties (primary outcomes).Methods and analysisA power analysis required a total sample of 160 patients. Main inclusion criteria are: cancer diagnosis, active treatments completed for less than a year, no practice of hypnosis, meditation, or SICT, and presence of at least one of these four symptoms: fatigue, sleep difficulties, depression, or anxiety. Each participant will choose the intervention in which they want to participate (hypnosis, mindful self-compassion meditation, SICT, or no intervention—control group). To test the effectiveness of the interventions, data will be collected by questionnaires and neurobiological measures and directly from the medical record at four time points: before inclusion in the study (baseline); immediately after the intervention; and at 3- and 12-month follow-up. The longitudinal data in each group will then be measured.DiscussionIn addition to standard cancer therapies, there is a growing interest from patients in complementary approaches, such as hypnosis, meditation, and SICT. The results of this study will be useful to increase knowledge about short- and long-term effectiveness of 3 group interventions for CRF, emotional distress, sleep, pain, and cognitive difficulties in patients with different cancers.Clinical Trial RegistrationClinicalTrials.gov/ (NCT04873661). Retrospectively registered on the 29th of April 2021. url: https://clinicaltrials.gov/ct2/show/NCT04873661

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“…We published the protocol of this study [ 41 ] with detailed information about the design, recruitment and randomisation procedures, sample size calculation, assessments, and intervention. Therefore, we will only summarize these aspects here.…”

Section: Methods and Designmentioning

confidence: 99%

Randomized controlled trial of a group intervention combining self-hypnosis and self-care: secondary results on self-esteem, emotional distress and regulation, and mindfulness in post-treatment cancer patients

et al. 2020

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Purpose Cancer patients often report low self-esteem and high emotional distress. Two factors seem particularly linked to these symptoms: emotion regulation strategies and mindfulness. The interest of hypnosis and self-care to relieve these symptoms is not well documented. Our randomized controlled trial aimed at assessing the effect of a group intervention combining self-hypnosis and self-care on self-esteem, emotional distress, emotion regulation, and mindfulness abilities of post-treatment cancer patients, as well as investigating the links between these variables. Methods One hundred and four patients who had suffered from cancer were randomized into the intervention group (N = 52) and the wait-list control group (N = 52). They had to answer questionnaires before (T1) and after the intervention (T2). Nine men were excluded from the analyses, leading to a final sample of 95 women with cancer. Group-by-time changes were assessed with MANOVA, and associations with self-esteem and emotional distress were investigated with hierarchical linear regression models. Results Participants in the intervention group (mean age = 51.65; SD = 12.54) reported better self-esteem, lower emotional distress, a decreased use of maladaptive emotion regulation strategies, and more mindfulness abilities after the intervention, compared to the WLCG. This increase in mindfulness explained 33% of the improvement of self-esteem and 41.6% of the decrease of emotional distress in the intervention group. Self-esteem and emotional distress also predicted each other. Conclusion Our study showed the efficacy of our hypnosis-based intervention to improve all the investigated variables. Mindfulness predicted the improvement of self-esteem and emotional distress. The primary impact of our intervention on mindfulness abilities seems to explain, at least in part, its efficacy. Registration: ClinicalTrials.gov (NCT03144154). Retrospectively registered on the 1st of May, 2017.

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Randomized controlled trial of an 8-week intervention combining self-care and hypnosis for post-treatment cancer patients: study protocol

Cited by 9 publications

References 87 publications

Effects of an intervention combining self‐care and self‐hypnosis on fatigue and associated symptoms in post‐treatment cancer patients: A randomized‐controlled trial

Effects of an intervention combining self‐care and self‐hypnosis on fatigue and associated symptoms in post‐treatment cancer patients: A randomized‐controlled trial

Hypnosis, Meditation, and Self-Induced Cognitive Trance to Improve Post-treatment Oncological Patients’ Quality of Life: Study Protocol

Randomized controlled trial of a group intervention combining self-hypnosis and self-care: secondary results on self-esteem, emotional distress and regulation, and mindfulness in post-treatment cancer patients

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