RehabilitationRE-SCREENNCT03434717
Optimized Rehabilitation Following Primary Breast Cancer Surgery
A study testing Individualised rehabilitation and Care as usual in people with Rehabilitation and Breast Neoplasms, run by Lund University at 1 site in Sweden.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Rehabilitation, Breast Neoplasms, Psychological Distress
- What is being tested?
- Individualised rehabilitation and Care as usual
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 643 participants
- Where
- 1 siteSweden
- Study dates
- 15 Nov 2018to Nov 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Undergone treatment for primary breast cancer
- ≤18 years old
- Ability to communicate in Swedish
- Written informed consent
Who cannot join
- Recurrent disease
- Palliative diagnosis
- Pregnancy
- Prior history of breast cancer
- Inability to participate in the study due to cognitive impairment
Trial locations and contacts
1 site in 1 country.
Sweden1 site, 1 recruiting
- Recruiting
Skåne university hospital
Malmö
Marlene Malmström, PHD
About this study
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
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 .
Read the 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.
- Conditions
- Rehabilitation, Breast Neoplasms, Psychological Distress
- Being tested
- Individualised rehabilitation, Care as usual
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Individualised rehabilitationOther
Patients will get access/support to individualised rehabilitation based on their needs identified through the distress thermometer
Care as usualOther
Patients will get care as usual
| Study group | Role | What they receive |
|---|---|---|
| Control (high distress) | Experimental | Control group receiving care as usual Receives: Other: Care as usual |
| Individualised rehabilitation | Experimental | 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. Receives: Other: Individualised rehabilitation |
| Control group (low distress) | Experimental | Control group receiving care as usual Receives: Other: Care as usual |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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 outcomes (7)
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
Measured: 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
Measured: 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
Measured: 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)
Measured: 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)
Measured: 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
Measured: 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
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2018
- Study start15 Nov 2018
- Primary completionNov 2025 (estimated)
- Study completionNov 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for RehabilitationStudies of the same condition, open and under way.
- More trials run by Lund UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- RCT
- Masking
- None (open label)
- Enrolment
- 643 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Lund University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Marlene Malmström, PhD, Principal investigator, Lund university, department of health siences, Lund
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03434717
- Sponsor's protocol ID
- RESCREEN
- Acronym
- RE-SCREEN
- Status last verified
- Dec 2023
- First submitted
- 15 Jan 2018
- Last updated
- 14 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Olsson IM, Dykes C, Ryden L, Olsson-Moller U, Malmstrom M. Experiences of rehabilitation one year after breast cancer diagnosis-A focus group study from the ReScreen randomized controlled trial. PLoS One. 2025 Feb 13;20(2):e0315814. doi: 10.1371/journal.pone.0315814. eCollection 2025.
PubMed 39946344Malmstrom M, Holst-Hansson A, Olsson Moller U. The complexity of needs and roles of family members during breast cancer rehabilitation: a qualitative study. BMC Cancer. 2024 Nov 21;24(1):1430. doi: 10.1186/s12885-024-13200-x.
PubMed 39567939Olsson Moller U, Ryden L, Malmstrom M. Systematic screening as a tool for individualized rehabilitation following primary breast cancer treatment: study protocol for the ReScreen randomized controlled trial. BMC Cancer. 2020 May 29;20(1):484. doi: 10.1186/s12885-020-06815-3.
PubMed 32471390
Study at a glance
From the registry record, last updated by the sponsor on 14 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03434717
- Acronym / sponsor ID
- RE-SCREEN / RESCREEN
- Conditions
- Rehabilitation, Breast Neoplasms, Psychological Distress
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 643 participants (estimated)
- Lead sponsor
- Lund UniversityUniversity, hospital or other
- Study start
- 15 Nov 2018 (actual)
- Primary completion
- Nov 2025 (estimated)
- Study completion
- Nov 2025 (estimated)
- First posted
- 15 Feb 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- RCT
| Arm | Type | Receives |
|---|---|---|
| Control (high distress) | Experimental | Other: Care as usualControl group receiving care as usual |
| Individualised rehabilitation | Experimental | Other: Individualised rehabilitationPatients 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. |
| Control group (low distress) | Experimental | Other: Care as usualControl group receiving care as usual |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Undergone treatment for primary breast cancer
- ≤18 years old
- Ability to communicate in Swedish
- Written informed consent
Key exclusion criteria (5 listed)
- Recurrent disease
- Palliative diagnosis
- Pregnancy
- Prior history of breast cancer
- Inability to participate in the study due to cognitive impairment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Individualised rehabilitationPatients will get access/support to individualised rehabilitation based on their needs identified through the distress thermometer | Other | Individualised rehabilitation |
| Care as usualPatients will get care as usual | Other | Control (high distress), Control group (low distress) |
Primary outcome
Psychological Distress
Time frame: 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.
7 secondary outcomes
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 1, 2 and 3 years postoperative. Evaluating change over time.
Information needs
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Evaluations will be conducted after data collection is finished. 6 months and one year after inclusion.
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 1, 2 and 3 years postoperative. Evaluating change over time.
Satisfaction with care
Time frame: 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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Dec 2023.
- Derived from this study: PubMed 39946344Olsson IM, Dykes C, Ryden L, Olsson-Moller U, Malmstrom M. Experiences of rehabilitation one year after breast cancer diagnosis-A focus group study from the ReScreen randomized controlled trial. PLoS One. 2025 Feb 13;20(2):e0315814. doi: 10.1371/journal.pone.0315814. eCollection 2025.
- Derived from this study: PubMed 39567939Malmstrom M, Holst-Hansson A, Olsson Moller U. The complexity of needs and roles of family members during breast cancer rehabilitation: a qualitative study. BMC Cancer. 2024 Nov 21;24(1):1430. doi: 10.1186/s12885-024-13200-x.
- Derived from this study: PubMed 32471390Olsson Moller U, Ryden L, Malmstrom M. Systematic screening as a tool for individualized rehabilitation following primary breast cancer treatment: study protocol for the ReScreen randomized controlled trial. BMC Cancer. 2020 May 29;20(1):484. doi: 10.1186/s12885-020-06815-3.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marlene Malmström, PhD principal investigator
Lund university, department of health siences, Lund
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Individualised rehabilitation and Care as usual in people with Rehabilitation and Breast Neoplasms, run by Lund University at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Marlene Malmström, Ass professor (+4646175950, marlene.malmstrom@med.lu.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Psychological Distress (time frame: 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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03434717, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Dec 2023.