Impact of an Intervention Combining Self-care and Hypnosis on the Well-being of Cancer Patients and Their Partners

Non-Metastatic Neoplasm Clinical Trial

Official title:

Impact of an Intervention Combining Self-care and Hypnosis on the Well-being of Cancer Patients and Their Partners

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03144154
• Other study ID #: Onco-Hypn-Fatigue
• Status: Completed
• Phase: N/A
• Start date: February 13, 2017
• Est. completion date: September 18, 2020

Study information

• Verified date: September 2020
• Source: University of Liege
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 104
• Est. completion date: September 18, 2020
• Est. primary completion date: October 20, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Non-Metastatic Neoplasm

Intervention

Behavioral:
• Self-hypnosis + Self-care
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.

Locations

Country	Name	City	State
Belgium	University Hospital of Liege	Liege

Sponsors (4)

Lead Sponsor	Collaborator
University of Liege	FNRS, Jules Bordet Institute, King Baudouin Foundation

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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)
Secondary	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)
Secondary	Change in emotion regulation	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)
Secondary	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)
Secondary	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)
Secondary	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)