Optimized Rehabilitation Following Primary Breast Cancer Surgery

Study Overview
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Brief Summary
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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
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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.

Official Title
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Optimized Rehabilitation Following Primary Breast Cancer Surgery - Systematic Screening as a Tool for Individualised Rehabilitation: Study Protocol for the RE-SCREEN Randomized Controlled Trial

Conditions
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Rehabilitation, Breast Neoplasms, Psychological Distress

Intervention / Treatment
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* Other: Individualised rehabilitation
* Other: Care as usual


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: RCT
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Control (high distress)<br>Control group receiving care as usual | Other: Care as usual<br>* Patients will get care as usual<br>|
| Experimental: Individualised rehabilitation<br>Patients with high distress receive the intervention individualized rehabilitation including evaluation of individual needs and based on that physical, psychological or social interventions to promote rehabilitation. | Other: Individualised rehabilitation<br>* Patients will get access/support to individualised rehabilitation based on their needs identified through the distress thermometer<br>|
| Experimental: Control group (low distress)<br>Control group receiving care as usual | Other: Care as usual<br>* Patients will get care as usual<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Psychological Distress | 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. | 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. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| General Quality of life | The instrument QLQ-C30 is developed by the EORTC (European Organization for Research and Treatment of Cancer) and measurers 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. | 
| Information needs | The INFO35 instrument is developed by the EORTC and measures the patients perception of information received | 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. | 
| Resilience | 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 | 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 | 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) | 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. | 
| Health economics | 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) | Evaluations will be conducted after data collection is finished. 6 months and one year after inclusion. | 
| Breast cancer specific quality of life | The instrument QLQ-BR23 is developed by the EORTC (European Organization for Research and Treatment of Cancer) and measurers diagnose 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. | 
| Satisfaction with care | Singel items focusing on 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. |