The Unmet Needs and the Workplace Reintegration of Breast Cancer Patients: the NEW-BreCa Project

NCT05309252 | Completed DMC

• 1 other identifier: 2022/0035983
• Study Type: observational
• Target: 113
• Locations: 1 country
• Sites: 1

Brief Summary

Breast cancer (BC) have unmet needs that can impact negatively on participation in meaningful activities and the overall quality of life, if not addressed by the healthcare services. One of those needs is the return to work (RTW) for female in their working age. The perceived needs of BC patients and RTW process might be influenced by sociodemographic data, disease-related, and work-related factors. Moreover, needs might change (type and priority) from diagnosis onwards. Prospective data regarding these topics have never been collected in Italian BC patients.

Conditions

Breast Cancer; Breast Neoplasms

Keywords

Cancer Survivors; Unmet needs; Supportive care needs; Return to Work; Epidemiology; Observational study

Outcome Measures

Primary Outcomes (4)

• occupational status

  the identification of the occupational status at first contact and at the following observations. At each observation, we will ask the participants if they have returned to work or not

  12 months

• work difficulties

  the collection of the work-related difficulties that will be counted and classified using the Core Set-VR-Onco and, then, described qualitatively

  12 months

• sick leave

  the number of days of sick leave

  12 months

• perceived needs

  the identification of the perceived needs at first contact and at the following observations

  12 months

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

We will recruit breast cancer patients from those who will participate to an educational group session held by the physiotherapists of the Physical Medicine and Rehabilitation Unit (PMRU). Breast cancer patients who undergo surgery are offered to participate voluntarily in this educational group session after inpatients.

You may qualify if:

• breast cancer diagnosis (regardless of stage and treatment)
• breast cancer patients in adulthood (≥ 18 years)
• breast cancer patient who will participate to an educational group session held by the physiotherapists of the PMRU
• For patients who are not in working age or not employed at diagnosis, the work-related factors will not be collected.

You may not qualify if:

• breast cancer patients who do not speak fluently italian language

Sponsors & Collaborators

• Azienda USL Reggio Emilia - IRCCS: lead

Study Sites (1)

Azienda Unità Sanitaria Locale Reggio Emilia

Reggio Emilia, 42123, Italy

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

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

Study Officials

• Sara Paltrinieri, Msc OT

  Azienda USL Reggio Emilia - IRCCS

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MSc Occupational Therapist

Study Record Dates

• First Submitted: March 25, 2022
• First Posted: April 4, 2022
• Study Start: May 9, 2022
• Primary Completion: May 8, 2024
• Study Completion: May 8, 2024
• Last Updated: July 15, 2024

Record last verified: 2024-07

Locations

IT (1)