Impact of Socio-aesthetic Care in the Quality of Life of Patients Treated for Lymphoma During and After Hospitalization (CareSSE)
Primary Purpose
Lymphoma
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
socio-aesthetic care
Sponsored by
About this trial
This is an interventional supportive care trial for Lymphoma
Eligibility Criteria
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.
Sites / Locations
- Hematology Care Unit - UH Angers
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
without socio-asthetic care
with socio-aesthetic cares
Arm Description
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Coopersmith Self-esteem inventory
Body Image Scale assessment
Social life assessment
Full Information
NCT ID
NCT02072655
First Posted
February 20, 2014
Last Updated
June 15, 2016
Sponsor
University Hospital, Angers
1. Study Identification
Unique Protocol Identification Number
NCT02072655
Brief Title
Impact of Socio-aesthetic Care in the Quality of Life of Patients Treated for Lymphoma During and After Hospitalization
Acronym
CareSSE
Official Title
Impact of Socio-aesthetic Care in the Quality of Life of Patients Treated for Lymphoma During and After Hospitalization
Study Type
Interventional
2. Study Status
Record Verification Date
June 2016
Overall Recruitment Status
Completed
Study Start Date
January 2014 (undefined)
Primary Completion Date
January 2016 (Actual)
Study Completion Date
January 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Angers
4. Oversight
5. Study Description
Brief 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 .
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lymphoma
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
without socio-asthetic care
Arm Type
No Intervention
Arm Title
with socio-aesthetic cares
Arm Type
Experimental
Intervention Type
Procedure
Intervention Name(s)
socio-aesthetic care
Intervention Description
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.
Primary Outcome Measure Information:
Title
Quality of life score
Description
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.
Time Frame
Change form baseline in Quality of life score at an average of 5 months (4 to 6 cycles of chemotherapy).
Secondary Outcome Measure Information:
Title
Coopersmith Self-esteem inventory
Time Frame
Change form baseline in Coopersmith Self-esteem inventory score at an average of 5 months (4 to 6 cycles of chemotherapy).
Title
Body Image Scale assessment
Time Frame
Change form baseline in body image scale assessment score at an average of 5 months (4 to 6 cycles of chemotherapy).
Title
Social life assessment
Time Frame
Change form baseline in social life assessment score at an average of 5 months (4 to 6 cycles of chemotherapy).
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Hematology Care Unit - UH Angers
City
Angers
ZIP/Postal Code
49000
Country
France
12. IPD Sharing Statement
Learn more about this trial
Impact of Socio-aesthetic Care in the Quality of Life of Patients Treated for Lymphoma During and After Hospitalization
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