Optimized Rehabilitation Following Primary Breast Cancer Surgery

Not Applicable

Recruiting

• Conditions: Rehabilitation; Breast Neoplasms; Psychological Distress

• Registration Number: NCT03434717
• Lead Sponsor: Lund University

Brief Summary

This study aims to evaluate the effects of an intervention based on systematic screening of psychological distress as the basis for individualised support and rehabilitation following primary breast cancer surgery focusing on psychological , physical and health-economics outcomes. The aim is also to illuminate patients' and relatives' experiences and need of support during the rehabilitation .

Detailed Description

Breast cancer survivors are known to suffer from remaining problems from their treatment after surgery. Despite numerous of studies evaluating the effect of various rehabilitation programs it is know that patients often receive rehabilitation recommendations that are general rather than individualised to their needs. The large amount of studies within this area have contributed to knowledge about potential beneficial rehabilitation interventions for these patients but there is still a lack of knowledge about how patients specific needs of rehabilitation can be identified and how health care can adjust and individualize rehabilitation to optimize rehabilitation. This study aims to evaluate the effects of an intervention based on systematic screening of psychological distress as the basis for individualised support and rehabilitation following primary breast cancer surgery focusing on psychological , physical and health-economics outcomes. The aim is also to illuminate patients' and relatives' experiences and need of support during the rehabilitation.

Study Timeline

• Study First Submitted: 2018-01-15
• Study First Submitted QC: 2018-02-08
• Study First Posted: 2018-02-15
• Study Start: 2018-11-15
• Status Verified: 2023-12
• Last Update Submitted: 2023-12-13
• Last Update Posted: 2023-12-14
• Primary Completion: 2025-11
• Study Completion: 2025-11

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 643

Inclusion Criteria

• Undergone treatment for primary breast cancer
• ≤18 years old
• Ability to communicate in Swedish
• Written informed consent

Exclusion Criteria

• Recurrent disease
• Palliative diagnosis
• Pregnancy
• Prior history of breast cancer
• Inability to participate in the study due to cognitive impairment

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Psychological Distress	Instrument will be answered approximately 1 week pre-operative and after surgery at 2 weeks, 3 ,6 ,9 and 1, 2 and 3 years postoperative. Evaluating change over time.	Psychological Distress measured by the "Distress thermometer". A instrument that the patients answer themselves measuring the level of distress and the potential problems the may have.

Secondary Outcome Measures

Name	Time	Method
General Quality of life	Instrument will be answered approximately 1 week pre-operative and after surgery at 2 weeks, 3 ,6 ,9 and 1, 2 and 3 years postoperative. Evaluating change over time.	The instrument QLQ-C30 is developed by the EORTC (European Organization for Research and Treatment of Cancer) and measurers quality of life
Information needs	Instrument will be answered approximately 1 week pre-operative and after surgery at 2 weeks, 3 ,6 ,9 and 1, 2 and 3 years postoperative. Evaluating change over time.	The INFO35 instrument is developed by the EORTC and measures the patients perception of information received
Health economics	Evaluations will be conducted after data collection is finished. 6 months and one year after inclusion.	Cost-effectiveness analysis will be performed by evaluations of health care consumption (number of and total cost of health care visits) and by evaluating sickness absence (number of days)
Breast cancer specific quality of life	Instrument will be answered approximately 1 week pre-operative and after surgery at 2 weeks, 3 ,6 ,9 and 1, 2 and 3 years postoperative. Evaluating change over time.	The instrument QLQ-BR23 is developed by the EORTC (European Organization for Research and Treatment of Cancer) and measurers diagnose specific quality of life
Satisfaction with care	Instrument will be answered approximately 1 week pre-operative and after surgery at 2 weeks, 3 ,6 ,9 and 1, 2 and 3 years postoperative. Evaluating change over time.	Singel items focusing on satisfaction with care
Resilience	Instrument will be answered approximately 1 week pre-operative and after surgery at 2 weeks, 3 ,6 ,9 and 1, 2 and 3 years postoperative. Evaluating change over time.	Conner-Davidsson Resilience scale (CD-RISC) will be used to measure patients resilience trough 25 questions ranging from 0-4. Lower scores indicates more problems
Life style changes	Instrument will be answered approximately 1 week pre-operative and after surgery at 2 weeks, 3 ,6 ,9 and 1, 2 and 3 years postoperative. Evaluating change over time.	Life style changes will be measured by single items concerning exercise (amount hours of physical activity/day), Body mass index (based on weight and length), alcohol (units/glasses/ day) and tobacco habits (yes/no)

Trial Locations

Locations (1)

Skåne university hospital; 🇸🇪 Malmö, Sweden