Impact of Socio-aesthetic Care in the Quality of Life of Patients Treated for Lymphoma During and After Hospitalization

Lymphoma Clinical Trial

— CareSSE  

Official title:

Impact of Socio-aesthetic Care in the Quality of Life of Patients Treated for Lymphoma During and After Hospitalization

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02072655
• Other study ID #: AOI PM 2012-12
• Status: Completed
• Phase: N/A
• First received: February 20, 2014
• Last updated: June 15, 2016
• Start date: January 2014
• Est. completion date: January 2016

Study information

• Verified date: June 2016
• Source: University Hospital, Angers
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

In the early 2000s , professional and patient organizations are mobilizing to highlight the psychosocial impact of cancer disease , not only during but also after the acute phase.

In 2003, the government launched the Cancer Plan I reinforced in December 2011 by the Cancer Plan II whose objectives include : " Develop a personalized care taking into account the pain and psychological and social support " and " increase opportunities for patients to benefit from supportive care "and" promote the professional integration .

This study aims to show that beyond the immediate benefits of the social aesthetic cares in hospital (direct soothing, improving the quality of the skin injured by chemotherapy , feeling of escape ... ), these treatments can also affect quality of life for patients during and after hospitalization. They also may have an impact on the maintenance of social and / or professional satisfactory throughout the planned chemotherapy aplastic period .

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: January 2016
• Est. primary completion date: January 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• 18 to 65 years old

• Hospitalized in the Hematology care unit in UH Angers

• Initial Hodgkin lymphoma, diffuse large B-cell lymphoma and mantle cell lymphoma

• Without previous socio-aesthetic care.

Exclusion Criteria:

• Age <18 years old.

• Patient protected by the law.

• Patient at end of life.

• Patient unable to respond to the questionnaire.

• Previous Socio aesthetic care.

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Lymphoma

Intervention

Procedure:
• socio-aesthetic care
care of the face skin cleansing with cleansing milk to remove impurities a gentle scrub to exfoliate and cleanse the skin a relaxing massage moisturizing mask application of a moisturizer suited to specific patient skin: skin reactivity, dehydration ... care manicure / pedicure, massages makeup, advice (scarves, wigs care products adapted to the skin changes ...) and helping relationship.

Locations

Country	Name	City	State
France	Hematology Care Unit - UH Angers	Angers

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Angers

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Quality of life score	For patients in control group, arbitrarily during their fifth cycle of chemotherapy; For patients in interventional group during the course of chemotherapy after the third socio-aesthetic care, or at the latest, at the sixth treatment.	Change form baseline in Quality of life score at an average of 5 months (4 to 6 cycles of chemotherapy).	No
Secondary	Coopersmith Self-esteem inventory		Change form baseline in Coopersmith Self-esteem inventory score at an average of 5 months (4 to 6 cycles of chemotherapy).	No
Secondary	Body Image Scale assessment		Change form baseline in body image scale assessment score at an average of 5 months (4 to 6 cycles of chemotherapy).	No
Secondary	Social life assessment		Change form baseline in social life assessment score at an average of 5 months (4 to 6 cycles of chemotherapy).	No