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

U

University of Liege

Status

Completed

Conditions

Non-Metastatic Neoplasm

Treatments

Behavioral: Self-hypnosis + Self-care

Study type

Interventional

Funder types

Other

Identifiers

NCT03144154
Onco-Hypn-Fatigue

Details and patient eligibility

About

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.

Enrollment

104 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose

Supportive Care

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

104 participants in 2 patient groups

Experimental group : Hypnosis-based intervention
Experimental group
Description:
Groupal intervention combining self-care techniques and self-hypnosis exercises
Treatment:
Behavioral: Self-hypnosis + Self-care
Control group : Usual care
No Intervention group
Description:
Control group receiving usual care but not the intervention

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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