Rehabilitation on Equal Terms - The ReMig Study

NCT05689398 | Unknown

• 1 other identifier: ReMig
• Study Type: observational
• Target: 140
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Cancer; Breast Neoplasms

Keywords

Rehabilitation

Outcome Measures

Primary Outcomes (8)

• 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.

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

• 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.

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

• 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.

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

• 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.

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

• 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.

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

• 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.

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

• 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.

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

• 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.

  After surgery at 6 ,9 and 12 months postoperative. Evaluating change over time.

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• Recurrent disease
• Palliative diagnosis
• Pregnancy
• Prior history of breast cancer
• Inability to participate in the study due to cognitive impairment

Sponsors & Collaborators

• Lund University: lead

Study Sites (1)

Lund University, Skåne university hospital, Helsingborgs sjukhus

Lund, 221 00, Sweden

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Central Study Contacts

Annette EW Holst-Hansson, PhD

CONTACT

+46762726799; annette.holst-hansson@med.lu.se

Marlene Malmström, PhD

CONTACT

+4646175950; marlene.malmstrom@med.lu.se

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 29, 2022
• First Posted: January 19, 2023
• Study Start: May 24, 2023
• Primary Completion: December 20, 2024
• Study Completion: May 15, 2025
• Last Updated: May 31, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)