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| Name | Class |
|---|---|
| King Baudouin Foundation | OTHER |
| Jules Bordet Institute | OTHER |
| Fonds National de la Recherche Scientifique | OTHER |
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Hypnosis-based interventions are starting to be tested in order to improve emotional distress and fatigue of cancer patients. However, most of these studies only include breast cancer patients and do no measure long-term effects of such interventions.
Our randomized controlled trial aims to propose to 116 post-treatment cancer patients (all tumour localisations accepted) an 8-week groupal intervention combining hypnosis and self-care techniques.
Primary outcomes (emotion regulation, emotional distress, fatigue) and secondary outcomes (sleep difficulties, fear of recurrence, attentional bias, conjugal communication) will be investigated at 3 measurement times: before the intervention (T1), 3 months later (T2 - right after the intervention of the experimental group, and right before the intervention of the control group) and again 3 months later (T3 - after the intervention of the control group). Some questionnaires, two relaxation tasks, an attentional task, an actigraph and a smartphone application will be used to collect data. The indirect impact of the intervention on participants' partners will also be measured by questionnaires (emotional distress, conjugal communication).
Data collection has started on March 2017. Our results should bring new knowledge about the efficacy of an hypnosis-based intervention to improve fatigue and well-being in cancer patients, which are often under-diagnosed and under-treated, but also about the indirect efficacy to improve partners' well-being. Those results might contribute to spread this kind of inexpensive intervention in oncology settings.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental group : Hypnosis-based intervention | Experimental | Groupal intervention combining self-care techniques and self-hypnosis exercises |
|
| Control group : Usual care | No Intervention | Control group receiving usual care but not the intervention |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Self-hypnosis + Self-care | Behavioral | Our groupal intervention is divided into 8 weekly 2-hour sessions in which one self-hypnosis exercise is proposed to participants. Self-care techniques are also discussed (knowing our own needs, self-respect, assertiveness, coping with ruminations...) and homework assignments are proposed to participants, in order to foster positive change. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Cancer-Related Fatigue | A sense of tiredness or exhaustion linked with cancer and its treatments, that is not alleviated by sleep. It will be measured with the Multidimensional Fatigue Inventory (MFI-20) and the Insomnia Severity Index (ISI). | T1 (before the intervention), T2 (right after the intervention), T3 (3.5 months follow-up) |
| Change in emotional distress | Anxiety + Depression, measured with the Hospital Anxiety and Depression Scale (HADS) | T1 (before the intervention), T2 (right after the intervention), T3 (3.5 months follow-up) |
| Measure | Description | Time Frame |
|---|---|---|
| Change in fear of recurrence | Fear that cancer could return. Measured with the Fear of Cancer Recurence Inventory | T1 (before the intervention), T2 (right after the intervention), T3 (3.5 months follow-up) |
| Change in emotion regulation |
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Inclusion criteria are:
Exclusion Criteria:
Psychiatric disorders, such as dementia, psychosis or delirium, that do not allow to participate in a group intervention or to complete the evaluations
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| Name | Affiliation | Role |
|---|---|---|
| Marie-Elisabeth Faymonville | CHU de Liège - Université de Liège | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital of Liege | Liège | B-4000 | Belgium |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39387227 | Derived | Baussard L, Ernst M, Diep A, Jerusalem G, Vanhaudenhuyse A, Marie N, Bragard I, Faymonville ME, Gosseries O, Gregoire C. Network Analyses Applied to the Dimensions of Cancer-Related Fatigue in Women With Breast Cancer. Cancer Med. 2024 Oct;13(19):e70268. doi: 10.1002/cam4.70268. | |
| 37682079 | Derived | Gregoire C, Faymonville ME, Vanhaudenhuyse A, Jerusalem G, Monseur J, Bragard I. A Group Intervention Combining Self-Hypnosis and Self-Care in Oncology: Implementation in Daily Life and Perceived Usefulness. Int J Clin Exp Hypn. 2023 Oct-Dec;71(4):313-337. doi: 10.1080/00207144.2023.2249044. Epub 2023 Sep 8. |
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| ID | Term |
|---|---|
| D009369 | Neoplasms |
| D005221 | Fatigue |
| ID | Term |
|---|---|
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D006990 | Hypnosis |
| D012648 | Self Care |
| ID | Term |
|---|---|
| D026441 | Mind-Body Therapies |
| D000529 | Complementary Therapies |
| D013812 | Therapeutics |
| D011613 | Psychotherapy |
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Participants are randomized into 2 groups: the experimental group receives the intervention immediately while the control group only receives usual care. When the control group has received the intervention and that evaluations have been done for all participants, the control group will receive the intervention (randomized controlled trial).
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The way people deal with their emotions. Measured with one questionnaire (Cognitive Emotion Regulation Questionnaire) and a smartphone application asking participants about their daily emotion and how they deal with it. The application is used during 9 days at each measurement time.
| T1 (before the intervention), T2 (right after the intervention), T3 (3.5 months follow-up) |
| Change in attentional bias towards threat | Attentional bias toward emotional information especially negative ones. It is linked with anxiety and will be measured by an computerized task. | T1 (before the intervention), T2 (right after the intervention), T3 (3.5 months follow-up) |
| Change in the quality of the conjugal relationship | Communication about cancer and dyadic coping, measured with questionnaires (Couples' Illness Communication Scale ; Dyadic Coping Inventory). The two partners will complete these questionnaires. | T1 (before the intervention), T2 (right after the intervention), T3 (3.5 months follow-up) |
| Change in partners' well-being | Anxiety and depression of the partners, measured with the HADS. | - Couples' Illness Communication Scale (CICS) (Arden-Close et al., 2010) Dyadic Coping Inventory (DCI) |
| 35344461 | Derived | Gregoire C, Faymonville ME, Vanhaudenhuyse A, Jerusalem G, Willems S, Bragard I. Randomized, Controlled Trial of an Intervention Combining Self-Care and Self-Hypnosis on Fatigue, Sleep, and Emotional Distress in Posttreatment Cancer Patients: 1-Year Follow-Up. Int J Clin Exp Hypn. 2022 Apr-Jun;70(2):136-155. doi: 10.1080/00207144.2022.2049973. Epub 2022 Mar 28. |
| 33025372 | Derived | Gregoire C, Faymonville ME, Vanhaudenhuyse A, Jerusalem G, Willems S, Bragard I. 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. Qual Life Res. 2021 Feb;30(2):425-436. doi: 10.1007/s11136-020-02655-7. Epub 2020 Oct 6. |
| 32297396 | Derived | Gregoire C, Faymonville ME, Vanhaudenhuyse A, Charland-Verville V, Jerusalem G, Willems S, Bragard I. Effects of an intervention combining self-care and self-hypnosis on fatigue and associated symptoms in post-treatment cancer patients: A randomized-controlled trial. Psychooncology. 2020 Jul;29(7):1165-1173. doi: 10.1002/pon.5395. Epub 2020 Apr 24. |
| 30442120 | Derived | Gregoire C, Faymonville ME, Vanhaudenhuyse A, Charland-Verville V, Jerusalem G, Bragard I. Randomized controlled trial of an 8-week intervention combining self-care and hypnosis for post-treatment cancer patients: study protocol. BMC Cancer. 2018 Nov 15;18(1):1113. doi: 10.1186/s12885-018-5046-6. |
| D004191 |
| Behavioral Disciplines and Activities |
| D012046 | Rehabilitation |
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |