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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
University Hospital, Angers
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Lymphoma

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

First Posted
February 20, 2014
Last Updated
June 15, 2016
Sponsor
University Hospital, Angers
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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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