NCT05530824

Brief Summary

The care pathway for breast cancer is complex, punctuated by consultations, complementary examinations and treatments. Patients benefit from close medical and paramedical support. At the end of the treatment, the post-cancer phase begins and the surveillance begins. The National Cancer Institute's (INCa) ten-year cancer control strategy for 2021-2030 defines in its second axis the objective of limiting the after-effects and improving the quality of life of cancer patients. Indeed, ensuring rapid access to functional rehabilitation and post-treatment reconstruction, and setting up personalized and graduated follow-up between the city and the hospital, are crucial. Better information for patients on the post-cancer period is a way for them to acquire greater autonomy, to enable them to take an active role in it and to approach it with greater serenity. The Paris Saint-Joseph Hospital Group (GHPSJ) has therefore created an outpatient medical unit (UMAb) dedicated to post-cancer treatment in July 2021. It is offered to all patients who have had localized breast cancer and have received curative treatment. Each patient, 3-4 months after the end of treatment (surgery and/or chemotherapy and/or radiotherapy), will benefit from a half-day session including 3 consultations: medical, nursing and physiotherapy. The medical consultation allows for additional information if there are any questions about the care received, a clinical examination, reassessment of the tolerance of adjuvant hormone therapy if it is indicated, and delivery of the personalized post-cancer program (PPAC). The nursing consultation is conducted by a person certified in therapeutic patient education. Numerous items are discussed, with the aim of identifying personal difficulties (financial, family or work-related, for example) that may hinder post-cancer rehabilitation, detecting specific support care needs and promoting post-cancer health (encouraging normal weight, smoking cessation, recommended nutritional factors and physical activity). Finally, the physical therapy consultation consists of a joint, muscle and scar assessment to promote normal functionality and the implementation of recommended physical activity. Imaging examinations (cardiac ultrasound and/or mammography/ultrasound and/or bone densitometry) may be associated with the consultation. As part of investigator's quality and continuous improvement approach, investigators would like to collect the opinions of patients who have benefited from the UMAb post breast cancer since its creation.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
163

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jul 2022

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 18, 2022

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 18, 2022

Completed
15 days until next milestone

First Submitted

Initial submission to the registry

September 2, 2022

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 7, 2022

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 6, 2023

Completed
Last Updated

March 7, 2023

Status Verified

March 1, 2023

Enrollment Period

1 month

First QC Date

September 2, 2022

Last Update Submit

March 6, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • Satisfaction reported by patients regarding the implementation of UMAb post breast cancer

    This outcome corresponds to the number of satisfied patients who felt a benefit after participating in UMAb post breast cancer, using the satisfaction questionnaire.

    Month 1

Secondary Outcomes (2)

  • Improvement in the post-breast cancer AMU

    Month 1

  • Profile of patients with lower post-cancer UMAb scores to optimize their management, with specific measures

    Monthe 1

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patient whose age is ≥ 18 years, who has participated in post-cancer UMAB for breast cancer

You may qualify if:

  • Patient whose age is ≥ 18 years
  • Patient who has participated in post-cancer UMAB for breast cancer
  • French-speaking patient

You may not qualify if:

  • Patient under guardianship or curatorship
  • Patient deprived of liberty
  • Patient under court protection
  • Patient objecting to the use of her data for this research

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Groupe Hospitalier Paris Saint-Joseph

Paris, 75014, France

Location

Related Publications (3)

  • de Boer AG, Taskila T, Ojajarvi A, van Dijk FJ, Verbeek JH. Cancer survivors and unemployment: a meta-analysis and meta-regression. JAMA. 2009 Feb 18;301(7):753-62. doi: 10.1001/jama.2009.187.

    PMID: 19224752BACKGROUND
  • Duijts SF, van Egmond MP, Spelten E, van Muijen P, Anema JR, van der Beek AJ. Physical and psychosocial problems in cancer survivors beyond return to work: a systematic review. Psychooncology. 2014 May;23(5):481-92. doi: 10.1002/pon.3467. Epub 2013 Dec 23.

    PMID: 24375630BACKGROUND
  • Spei ME, Samoli E, Bravi F, La Vecchia C, Bamia C, Benetou V. Physical activity in breast cancer survivors: A systematic review and meta-analysis on overall and breast cancer survival. Breast. 2019 Apr;44:144-152. doi: 10.1016/j.breast.2019.02.001. Epub 2019 Feb 12.

    PMID: 30780085BACKGROUND

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Olivia NGUYEN, MD

    Fondation Hôpital Saint-Joseph

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 2, 2022

First Posted

September 7, 2022

Study Start

July 18, 2022

Primary Completion

August 18, 2022

Study Completion

March 6, 2023

Last Updated

March 7, 2023

Record last verified: 2023-03

Locations