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Breast CancerNCT05689398

Rehabilitation on Equal Terms - The ReMig Study

An observational study of Breast Cancer and Breast Neoplasms, run by Lund University at 1 site in Sweden.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

The ReMig-study aims to increase knowledge about rehabilitation needs, the rehabilitation process of arabic-speaking migrated women with BC, to increase the prerequisites for optimized and equal cancer care. Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Breast Cancer, Breast Neoplasms
How many people
140 participants
Where
1 siteSweden
Study dates
24 May 2023to 15 May 2025
Phase
Observational
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

Study population: Participants are planned to be recruited at breast cancer clinics in southern Sweden. The selection is coming to consist of Arabic-speaking women, ≤18 years of age who have migrated to Sweden and who have been diagnosed with BC (N=140). To this data comes a matched sample with data for Swedish-speaking women from the ReScreen study (dnr 201/505) to be used as a basis for the comparative analyses.

Who may be able to join

  • Undergone treatment for primary breast cancer
  • ≤18 years old
  • Ability to communicate in the Arabic language
  • 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.

Annette EW Holst-Hansson, PhD contact

+46762726799

annette.holst-hansson@med.lu.se

Marlene Malmström, PhD contact

+4646175950

marlene.malmstrom@med.lu.se

Sweden1 site, 1 recruiting

  • Lund University, Skåne university hospital, Helsingborgs sjukhus

    Lund, 221 00

    Marlene Malmström, Phd, +4646175950, marlene.malmstrom@skane.se

    Annette EW Holst-Hansson, PhD

    Recruiting

Other trials in Sweden

About this study

Official title: Rehabilitation on Equal Terms - A Study Focusing on Recovery and Mortality of Migrated Women With Breast Cancer: The ReMig Study

The ReMig-study aims to increase knowledge about rehabilitation needs, the rehabilitation process of arabic-speaking migrated women with BC, to increase the prerequisites for optimized and equal cancer care. The study aims to map migrated Arabic-speaking women's breast cancer rehabilitation with a focus on mental and physical recovery, lifestyle habits as well as satisfaction and goals with the rehabilitation and compare these outcomes with the outcomes of Swedish-speaking women. Further aim is to explore migrated Arabic-speaking women´s experiences and attitudes towards breast cancer rehabilitation.

Read the detailed description

Annually, over 2 million women are diagnosed with breast cancer (BC) globally, of which about 8300 in Sweden. Today, 20% of the Swedish population is foreign born and previous research has shown that women who have migrated are particularly vulnerable when diagnosed with BC. Research focusing on migrated women is sparse as they are often excluded from research, but available research shows that experience and management of BC differs depending on ethnicity, that the women to a lesser extent participate in BC screening and rehabilitation and that they have a higher mortality than Swedish born women. In recent years, measures to promote early BC diagnosis have been initiated, but knowledge of how optimized rehabilitation should be ensured to promote recovery and reduce the socioeconomic burden is lacking.

This study aims to map the rehabilitation of migrant Arabic-speaking women with a focus on mental and physical recovery, lifestyle habits and satisfaction and goals with the rehabilitation in the first year after BC diagnosis and compare these outcomes with Swedish-speaking women. Further to elucidate migrated Arabic-speaking women´s experiences and attitudes towards breast cancer rehabilitation.

Keywords
Rehabilitation
Medical subject headings
Breast Neoplasms

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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: 1 week pre-operative, after surgery at 2 weeks, 3 ,6 ,9 and 12 months postoperative. Evaluating change over time.

  2. General Quality of life

    The instrument EORTC Core Quality of Life questionnaire (QLQ-C30), developed by the EORTC (European Organization for Research and Treatment of Cancer) and measures quality of life. The QLQ-C30 is composed of both multi-item scales and single-item measures (total 28 questions)

    , including. five functional scales, three symptom scales, a global health status / QoL scale, and six single items. Each of the multi-item scales includes a different set of items - no item occurs in more than one scale. All of the scales and single-item measures transforms to range in score from 0 to 100. A high scale score represents a higher response level, which means that a high score for a functional scale represents a high / healthy level of functioning, a high score for the global health status / QoL represents a high QoL, but a high score for a symptom scale / item represents a high level of symptomatology / problems.

    Measured: 1 week pre-operative, after surgery at 2 weeks, 3 ,6 ,9 and 12 months postoperative. Evaluating change over time.

  3. Breast cancer specific quality of life

    The instrument QLQ-BR23 is developed by the EORTC (European Organization for Research and Treatment of Cancer) and measures diagnose specific quality of life. The QLQ-BR23 includes five multi-item scales to assess body image, sexual functioning, systemic therapy side effects, breast symptoms, and arm symptoms. Additionally, single items assess sexual enjoyment, future perspective and being upset by hair loss. The range in score from 0 to 100. A high score for the functional scales represents a high/healthy level of functioning, while a high score for the symptom scales represents a high level of symptomatology or problems.

    Measured: 1 week pre-operative, after surgery at 2 weeks, 3 ,6 ,9 and 12 months postoperative. Evaluating change over time.

  4. Resilience

    Connor-Davidson Resilience scale (CD-RISC) will be used to measure patients resilience trough 25 questions ranging from 0-4. Lower scores indicates more problems. Scoring of the scale CD-RISC-25 is based on summing the total of all items, each of which is scored from 0-4, the full range is from 0 to 100, with higher scores reflecting greater resilience.

    Measured: 1 week pre-operative, after surgery at 2 weeks, 3 ,6 ,9 and 12 months postoperative. Evaluating change over time.

  5. Body mass index

    Body mass index, based on weight (in kilograms) and height (in meters). Weight and height will be combined to report BMI in kg/m^2. Height will be reported only at baseline (eg. 1 week pre-operative) and weight at baseline (1 week pre-operative), 6 ,9 and 12 months postoperative.

    Measured: 1 week pre-operative, 6 ,9 and 12 months postoperative. Evaluating change over time.

  6. Working status/sick leave

    Sick leave may indicate that the woman experience more complications of the surgery or /and cancer treatment. Follow-up question regarding the extent in percent of the sickleave.

    Measured: 1 week pre-operative,after surgery at 2 weeks, 3 ,6 ,9 and 12 months postoperative. Evaluating change over time.

  7. Physical activity/life style

    Four questions regarding life style and physical activity. The questions is about the amount of time per week the woman is performing physical activity with high intensity, performing physical activity with low intensity, the grade of physical strenuous of work or daily activities and the hours spent sedentary. The answer options is given in minutes from 0 up to more than 300 minutes for physical activity respectively from 0 minutes to more than 8 hours for time spent sedentary.

    Measured: 1 week pre-operative,after surgery at 2 weeks, 3 ,6 ,9 and 12 months postoperative. Evaluating change over time.

  8. Rehabilitation process

    Questions regarding the experiences of the rehabilitation process, the extent of information, the extent of participation in decisions regarding rehabilitation,support from healthcare and the satisfaction of recovery and rehabilitation. The answer options range from not at all to a very high extent.

    Measured: After surgery at 6 ,9 and 12 months 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.

  1. First posted19 Jan 2023
  2. Study start24 May 2023
  3. Primary completion20 Dec 2024 (estimated)
  4. Study completion15 May 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
140 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05689398
Sponsor's protocol ID
ReMig
Status last verified
May 2023
First submitted
29 Nov 2022
Last updated
31 May 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

An observational study of Breast Cancer 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 31 May 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 Annette EW Holst-Hansson, PhD (+46762726799, annette.holst-hansson@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: 1 week pre-operative, after surgery at 2 weeks, 3 ,6 ,9 and 12 months postoperative. Evaluating change over time.). The study lists 8 primary outcomes in all. 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 NCT05689398.

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 31 May 2023.

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