Clinical trial NCT05689398: Rehabilitation on Equal Terms - The ReMig Study
Official title: Rehabilitation on Equal Terms - A Study Focusing on Recovery and Mortality of Migrated Women With Breast Cancer: The ReMig Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Breast Cancer
Breast Neoplasms
Keywords: Rehabilitation
Lead sponsor: Lund University
Sponsor class: OTHER
First posted: 2023-01-19
Enrollment: 140
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
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.

Brief 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. 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.

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.

Eligibility criteria: Inclusion Criteria:

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

Primary outcomes:
measure: Psychological Distress
timeFrame: 1 week pre-operative, after surgery at 2 weeks, 3 ,6 ,9 and 12 months postoperative. Evaluating change over time.
measure: General Quality of life
timeFrame: 1 week pre-operative, after surgery at 2 weeks, 3 ,6 ,9 and 12 months postoperative. Evaluating change over time.
measure: Breast cancer specific quality of life
timeFrame: 1 week pre-operative, after surgery at 2 weeks, 3 ,6 ,9 and 12 months postoperative. Evaluating change over time.
measure: Resilience
timeFrame: 1 week pre-operative, after surgery at 2 weeks, 3 ,6 ,9 and 12 months postoperative. Evaluating change over time.
measure: Body mass index
timeFrame: 1 week pre-operative, 6 ,9 and 12 months postoperative. Evaluating change over time.
measure: Working status/sick leave
timeFrame: 1 week pre-operative,after surgery at 2 weeks, 3 ,6 ,9 and 12 months postoperative. Evaluating change over time.
measure: Physical activity/life style
timeFrame: 1 week pre-operative,after surgery at 2 weeks, 3 ,6 ,9 and 12 months postoperative. Evaluating change over time.
measure: Rehabilitation process
timeFrame: After surgery at 6 ,9 and 12 months postoperative. Evaluating change over time.
Secondary outcomes:
Other outcomes:
Locations:
city: Lund
country: Sweden
facility: Lund University, Skåne university hospital, Helsingborgs sjukhus
Study officials:
References: