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Optimized Rehabilitation Following Primary Breast Cancer Surgery (RE-SCREEN)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03434717
Recruitment Status : Recruiting
First Posted : February 15, 2018
Last Update Posted : December 12, 2019
Sponsor:
Information provided by (Responsible Party):
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 .

Condition or disease Intervention/treatment Phase
Rehabilitation Breast Neoplasms Psychological Distress Other: Individualised rehabilitation Other: Care as usual Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 950 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: RCT
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Optimized Rehabilitation Following Primary Breast Cancer Surgery - Systematic Screening as a Tool for Individualised Rehabilitation: Study Protocol for the RE-SCREEN Randomized Controlled Trial
Actual Study Start Date : November 15, 2018
Estimated Primary Completion Date : December 2021
Estimated Study Completion Date : December 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Control (high distress)
Control group receiving care as usual
Other: Care as usual
Patients will get care as usual

Experimental: Individualised rehabilitation
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
Patients will get access/support to individualised rehabilitation based on their needs identified through the distress thermometer

Experimental: Control group (low distress)
Control group receiving care as usual
Other: Care as usual
Patients will get care as usual




Primary Outcome Measures :
  1. Psychological Distress [ Time Frame: Instrument will be answered approximately 1 week pre-operative and after surgery at 2 weeks, 3 ,6 ,9 and 12 months 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 :
  1. General Quality of life [ Time Frame: Instrument will be answered approximately 1 week pre-operative and after surgery at 2 weeks, 3 ,6 ,9 and 12 months 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

  2. Information needs [ Time Frame: Instrument will be answered approximately 1 week pre-operative and after surgery at 2 weeks, 3 ,6 ,9 and 12 months postoperative. Evaluating change over time. ]
    The INFO35 instrument is developed by the EORTC and measures the patients perception of information received

  3. Hospital Anxiety depression scale [ Time Frame: Instrument will be answered approximately 1 week pre-operative and after surgery at 2 weeks, 3 ,6 ,9 and 12 months postoperative. Evaluating change over time. ]
    HADS anxiety and depression scale will be used to measure the patients level of anxiety and depression. Measured with 14 question ranging from 0-3. Higher score indicates more problems.

  4. Resilience [ Time Frame: Instrument will be answered approximately 1 week pre-operative and after surgery at 2 weeks, 3 ,6 ,9 and 12 months 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

  5. Life style changes [ Time Frame: Instrument will be answered approximately 1 week pre-operative and after surgery at 2 weeks, 3 ,6 ,9 and 12 months 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)

  6. Health economics [ Time Frame: 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)

  7. Breast cancer specific quality of life [ Time Frame: Instrument will be answered approximately 1 week pre-operative and after surgery at 2 weeks, 3 ,6 ,9 and 12 months 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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03434717


Contacts
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Contact: Marlene Malmström, PhD +4646175950 marlene.malmstrom@med.lu.se
Contact: Ulrika Olsson Möller, PhD +46705896983 ulrika.olsson_moller@hkr.se

Locations
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Sweden
Skåne university hospital Recruiting
Malmö, Sweden
Contact: Marlene Malmström, PHD         
Sponsors and Collaborators
Lund University
Investigators
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Principal Investigator: Marlene Malmström, PhD Lund university, department of health siences, Lund
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Lund University
ClinicalTrials.gov Identifier: NCT03434717    
Other Study ID Numbers: RESCREEN
First Posted: February 15, 2018    Key Record Dates
Last Update Posted: December 12, 2019
Last Verified: December 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases