Clinical trial NCT03144154: Impact of an Intervention Combining Self-care and Hypnosis on the Well-being of Cancer Patients and Their Partners
Official title: Impact of an Intervention Combining Self-care and Hypnosis on the Well-being of Cancer Patients and Their Partners
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Non-Metastatic Neoplasm
Keywords: Cancer
Fatigue
Hypnosis
Self-hypnosis
Self-care
Emotional distress
Cancer survivors
Lead sponsor: University of Liege
Sponsor class: OTHER
Collaborators: name: King Baudouin Foundation
name: Jules Bordet Institute
name: Fonds National de la Recherche Scientifique
First posted: 2017-05-08
Enrollment: 104
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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).
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.


Eligibility criteria: Inclusion criteria are:

1. age 18 years or older;
2. Fluency in French;
3. Having received a diagnosis of non-metastatic cancer (all tumour localisations accepted).
4. Having completed all active treatments for no more than a year (surgery, chemotherapy and radiotherapy).
5. Not being in relapse at the time of inclusion
6. Exhibiting some difficulties as established by responses of at least 4 out of 10 on 1 of the 6 chosen items of the Edmonton Symptom Evaluation Scale (Chang, Hwang, \& Feuerman, 2000): physical fatigue, moral fatigue, depression, anxiety, fear of recurrence or ruminations).
7. Wishing to receive help in order to improve the difficulties identified.

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

Primary outcomes:
measure: Change in Cancer-Related Fatigue
timeFrame: T1 (before the intervention), T2 (right after the intervention), T3 (3.5 months follow-up)
measure: Change in emotional distress
timeFrame: T1 (before the intervention), T2 (right after the intervention), T3 (3.5 months follow-up)
Secondary outcomes:
measure: Change in fear of recurrence
timeFrame: T1 (before the intervention), T2 (right after the intervention), T3 (3.5 months follow-up)
measure: Change in emotion regulation
timeFrame: T1 (before the intervention), T2 (right after the intervention), T3 (3.5 months follow-up)
measure: Change in attentional bias towards threat
timeFrame: T1 (before the intervention), T2 (right after the intervention), T3 (3.5 months follow-up)
measure: Change in the quality of the conjugal relationship
timeFrame: T1 (before the intervention), T2 (right after the intervention), T3 (3.5 months follow-up)
measure: Change in partners' well-being
timeFrame: - Couples' Illness Communication Scale (CICS) (Arden-Close et al., 2010) Dyadic Coping Inventory (DCI)
Other outcomes:
Locations:
city: Liege
country: Belgium
facility: University Hospital of Liege
Study officials:
affiliation: CHU de Liège - Université de Liège
name: Marie-Elisabeth Faymonville
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.