Satisfaction Survey for the Outpatient Unit Dedicated to Post-cancer Treatment

Breast Cancer Clinical Trial

— BAC  

Official title:

Satisfaction Survey for the Outpatient Unit Dedicated to Post-cancer Treatment

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05530824
• Other study ID #: BAC
• Status: Completed
• Start date: July 18, 2022
• Est. completion date: March 6, 2023

Study information

• Verified date: March 2023
• Source: Groupe Hospitalier Paris Saint Joseph
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 163
• Est. completion date: March 6, 2023
• Est. primary completion date: August 18, 2022
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

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

Related Conditions & MeSH terms

• Ambulatory
• Breast Cancer

Locations

Country	Name	City	State
France	Groupe Hospitalier Paris Saint-Joseph	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Groupe Hospitalier Paris Saint Joseph

Country where clinical trial is conducted

France, 

References & 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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Improvement in the post-breast cancer AMU	This outcome corresponds to the patient expectations and areas for improvement in post-breast cancer UMAb.	Month 1
Secondary	Profile of patients with lower post-cancer UMAb scores to optimize their management, with specific measures	This outcome corresponds to the characteristics of patients with lower post-cancer UMAb scores (Scale: Very dissatisfied, Dissatisfied, Neutral, Satisfied, Very satisfied).	Monthe 1