Improving Emotion Regulation at the End of Breast Cancer Treatment

NCT03336827 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2020-12-08

No results posted yet for this study

Summary

The end of treatment marks the beginning of a challenging period for breast cancer patients. While this period often provokes a sense of relief, it can also be a source of apprehension and vulnerability regarding the future. Patients may be brought to feel contradictory thoughts and emotions impacting their quality of life such as anxiety linked to uncertainty and fear of cancer recurrence. In order to accompany breast cancer patients during this transition period and to address these emotional difficulties, the Institut Jules Bordet has launched an 8-session psychological multi-component group intervention. Its objective is to bring patients tools and competencies (e.g., hypnosis, treatment of intrusive thoughts, learning to cope with uncertainty, attention reorientation toward positive thoughts) to promote emotion management and well-being.

Conditions

  • Breast Cancer
  • Emotional Disturbances
  • Emotional Dysfunction
  • Anxiety Depression
  • Fear of Cancer

Interventions

BEHAVIORAL

Cognitive-Behavioral Group Therapy and Hypnosis

The intervention consists in a pre-group interview and eight 2,5 h-session extended over 4 months. The intervention is based on cognitive-behavioral group therapy and hypnosis. To promote use of hypnosis at home, patients will receive audiorecordings of the hypnosis exercises. Starting immediately after the pre-group interview, the group will receive 3 app prompts a day promoting self-awareness and modulation of internal states, orientation of attention toward positive stimuli and inviting them to increase physical activity. Patients will be given a patient manual to promote an active approach to changes.

BEHAVIORAL

Cognitive-Behavioral Group Therapy and Hypnosis

The intervention consists in a pre-group interview and eight 2,5 h-session extended over 4 months. The intervention is based on cognitive-behavioral group therapy and hypnosis. To promote use of hypnosis at home, patients will receive audiorecordings of the hypnosis exercises. Starting immediately after the pre-group interview, the group will receive 3 app prompts a day promoting self-awareness and modulation of internal states, orientation of attention toward positive stimuli and inviting them to increase physical activity. Patients will be given a patient manual to promote an active approach to changes.

Sponsors & Collaborators

  • Jules Bordet Institute

    collaborator OTHER
  • Centre de Psycho-Oncologie (CPO)

    collaborator OTHER
  • Université Libre de Bruxelles

    lead OTHER

Principal Investigators

  • Darius Razavi, Prof · Université Libre de Bruxelles, Institut Jules Bordet

  • Isabelle Merckaert, Prof · Université Libre de Bruxelles, Institut Jules Bordet

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-01-01
Primary Completion
2020-02-28
Completion
2020-02-28

Countries

  • Belgium

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03336827 on ClinicalTrials.gov