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AMAZONE: Prevention of Persistent Pain after Breast Cancer Treatment by web-based Cognitive Behavioural Therapy

AMAZONE: Prevention of Persistent Pain after Breast Cancer Treatment by web-based Cognitive Behavioural Therapy - AMAZONE trial

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON52491
Enrollment
460
Registered
2021-03-09
Start date
2021-06-22
Completion date
Unknown
Last updated
2024-04-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

chronische pijn chronic pain after breastcancer treatment

Interventions

The internet CBT intervention will consist of one preoperative session to decrease anxious apprehension of the upcoming procedure and to provide patients with tools to handle acute post-operative pa
pleasant activity scheduling
PRM and guided imagery. Session 3 is devoted to reducing fear of recurrence. It consists of learning to distinguish between benign symptoms and symptoms needing attention
identification of FCR-triggers and coping with them, learning to control excessive worries and threat monitoring. PRM and guided imagery are continued. Session 4 is de

Sponsors

Universiteit Maastricht
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Women undergoing surgery for breast cancer Age above 18

Exclusion criteria

Exclusion criteria: Preventive breast surgery; Not able to understand Dutch; No internet access; Visual or hearing impairments; Known or suspected severe psychiatric

Design outcomes

Primary

MeasureTime frame
Incidence of pain on movement of the ipsilateral shoulder of at least moderate intensity (> NRS 3) 6 months after breast-surgery.

Secondary

MeasureTime frame
Postoperative pain-intensity (at moment of completion questionnaire, and worst & average pain over last 24 hours) during the first post-operative week, (measured 1 times daily on a NRS); Pain during last week (worst & average pain) at 2, 6 and 12 months (NRS); Pain interference at 2, 6 and 12 months as measured with the Brief Pain Inventory; Quality of life at 6 and12 months (EORTC QLQ-C30 summary score); Pain sensitivity as measured with QST and CPM at 1 week and 6 months post surgery

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)