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NCT Number: NCT03144154

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

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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Key information

Conditions

Non-Metastatic Neoplasm Fatigue Neoplasms Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Hospital of Liege

Liège, B-4000, Belgium

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

are:

  • age 18 years or older;
  • Fluency in French;
  • Having received a diagnosis of non-metastatic cancer (all tumour localisations accepted).
  • Having completed all active treatments for no more than a year (surgery, chemotherapy and radiotherapy).
  • Not being in relapse at the time of inclusion
  • 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).
  • 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

Treatment and study plan

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.

Primary outcomes

  1. Change in Cancer-Related Fatigue

    Time frame: T1 (before the intervention), T2 (right after the intervention), T3 (3.5 months follow-up)

    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).

  2. Change in emotional distress

    Time frame: T1 (before the intervention), T2 (right after the intervention), T3 (3.5 months follow-up)

    Anxiety + Depression, measured with the Hospital Anxiety and Depression Scale (HADS)

Secondary outcomes

  1. Change in fear of recurrence

    Time frame: T1 (before the intervention), T2 (right after the intervention), T3 (3.5 months follow-up)

    Fear that cancer could return. Measured with the Fear of Cancer Recurence Inventory

  2. Change in emotion regulation

    Time frame: T1 (before the intervention), T2 (right after the intervention), T3 (3.5 months follow-up)

    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.

  3. Change in attentional bias towards threat

    Time frame: T1 (before the intervention), T2 (right after the intervention), T3 (3.5 months follow-up)

    Attentional bias toward emotional information especially negative ones. It is linked with anxiety and will be measured by an computerized task.

  4. Change in the quality of the conjugal relationship

    Time frame: T1 (before the intervention), T2 (right after the intervention), T3 (3.5 months follow-up)

    Communication about cancer and dyadic coping, measured with questionnaires (Couples' Illness Communication Scale ; Dyadic Coping Inventory). The two partners will complete these questionnaires.

  5. Change in partners' well-being

    Time frame: - Couples' Illness Communication Scale (CICS) (Arden-Close et al., 2010) Dyadic Coping Inventory (DCI)

    Anxiety and depression of the partners, measured with the HADS.

Sponsors and collaborators

Lead sponsor

University of Liege

Other

Collaborators

  • Fonds National de la Recherche Scientifique
  • Jules Bordet Institute
  • King Baudouin Foundation

Registry information

Important dates

Study start
2017
Primary completion
2019
Study completion
2020
First posted
May 8, 2017
Registry last updated
Sep 28, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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