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Psychological Interventions to Prevent Late Effects in Breast Cancer

NCT04518085 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 203

Last updated 2023-12-08

No results posted yet for this study

Summary

The study aims to investigate whether a combined pre-operative medical hypnosis plus a post-operative internet-based acceptance and commitment intervention are more effective in preventing post-surgical pain and fatigue following breast cancer surgery compared with pre-operative mindfulness plus treatment as usual.

Conditions

Interventions

BEHAVIORAL

Medical hypnosis

Single session 20 minutes hypnosis session originally developed and tested by Montgomery et al. (2007) in a similar setting. Delivered by an experienced clinical psychologist.

BEHAVIORAL

Internet-based Acceptance and Commitment Therapy (iACT)

Access to an online platform developed to this study containing video clips and audio files with ACT consistent material

BEHAVIORAL

Mindfulness session

Single session mindfulness session delivered by audio file

BEHAVIORAL

Treatment as Usual (TAU)

Treatment as usual as part of post-surical care

Sponsors & Collaborators

  • Oslo University Hospital

    collaborator OTHER

  • University of Oslo

    lead OTHER

Principal Investigators

  • Silje E Reme, PhD · University of Oslo + Oslo University Hospital

  • Henrik B Jacobsen, PhD · University of Oslo + Oslo University Hospital

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-10-01
Primary Completion
2022-03-03
Completion
2023-11-01

Countries

  • Norway

Study Locations

More Related Trials

Entities

Diseases

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 NCT04518085 on ClinicalTrials.gov