Clinical trial NCT04518085: Psychological Interventions to Prevent Late Effects in Breast Cancer
Official title: Pre- and Post-operative Psychological Interventions to Prevent Pain and Fatigue After Breast Cancer Surgery: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pain, Postoperative
Fatigue
Breast Cancer
Keywords: Breast cancer
Post-surgical pain
Fatigue
Hypnosis
Acceptance and commitment therapy
Lead sponsor: University of Oslo
Sponsor class: OTHER
Collaborators: name: Oslo University Hospital
First posted: 2020-08-19
Enrollment: 203
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized Controlled Trial, in which participants are randomly allocated to either the intervention group or an active control group.
Primary purpose: PREVENTION

Brief 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.

Detailed description: The trial will include 200 patients undergoing breast cancer surgery at Oslo University Hospital. The patients will be randomized into two groups. One group will receive a 20 minute pre-surgical hypnosis session delivered by an experienced clinical psychologist plus a post-surgical internet-based acceptance and commitment intervention. The control group will receive a 20 minute pre-surgical mindfulness session delivered through an audio recording plus treatment as usual. The primary outcomes of the study are quantitative measures of post-surgical pain and fatigue. In addition, relationships between biomarkers of stress and subacute post-surgical pain and fatigue will be analyzed using using blood- and hair samples. The study uses a longitudinal design with baseline measures obtained pre-surgery and follow up measures obtained 3 and 12 months post-surgery.

Eligibility criteria: Inclusion Criteria:

* Women diagnosed with breast cancer and scheduled for surgery
* Be able to provide informed consent

Exclusion Criteria:

* Insufficient Norwegian speaking or writing skills to participate in the interventions and fill out questionnaires
* Cognitive and psychiatric impairment
* Other serious malignancies

Primary outcomes:
measure: Chronic post-surgical pain
timeFrame: 3 months after surgery
measure: Post-surgical fatigue
timeFrame: 3 months after surgery
Secondary outcomes:
measure: Pain intensity, pain unpleasantness, fatigue, nausea, physical discomfort and emotional upset
timeFrame: On the day of surgery right before discharge
measure: Stress (immunological) reactivity
timeFrame: Baseline (pre-surgery) plus 4 weeks post-surgery (Cortisol will only be measured at baseline)
measure: Number of psychotropic and pain-related prescriptions
timeFrame: 3 and 12 months post-surgery
measure: Number of sick leave days
timeFrame: 3 and 12 months post-surgery
measure: Psychological flexibility
timeFrame: 3 and 12 months post-surgery
measure: Psychological distress
timeFrame: 3 and 12 months post-surgery
Other outcomes:
Locations:
city: Oslo
country: Norway
facility: Oslo University Hospital (Aker Hospital)
Study officials:
affiliation: University of Oslo + Oslo University Hospital
name: Silje E Reme, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Oslo + Oslo University Hospital
name: Henrik B Jacobsen, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Lind SB, Jacobsen HB, Solbakken OA, Reme SE. Clinical Hypnosis in Medical Care: A Mixed-Method Feasibility Study. Integr Cancer Ther. 2021 Jan-Dec;20:15347354211058678. doi: 10.1177/15347354211058678.
citation: Engel S, Jacobsen HB, Reme SE. A cross-sectional study of fear of surgery in female breast cancer patients: Prevalence, severity, and sources, as well as relevant differences among patients experiencing high, moderate, and low fear of surgery. PLoS One. 2023 Jun 23;18(6):e0287641. doi: 10.1371/journal.pone.0287641. eCollection 2023.
citation: Munk A, Jacobsen HB, Schnur J, Montgomery G, Reme SE. Acute and subacute postsurgical pain in women with breast cancer: incidence and associations with biopsychosocial predictors-a secondary analysis of a randomized controlled trial. Pain Rep. 2023 Jan 10;8(1):e1058. doi: 10.1097/PR9.0000000000001058. eCollection 2023 Jan.
citation: Reme SE, Munk A, Holter MTS, Falk RS, Jacobsen HB. Pre- and post-operative psychological interventions to prevent pain and fatigue after breast cancer surgery (PREVENT): Protocol for a randomized controlled trial. PLoS One. 2022 Jul 8;17(7):e0268606. doi: 10.1371/journal.pone.0268606. eCollection 2022.