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

June 15, 2016 updated by: University Hospital, Angers

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 .

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Angers, France, 49000
        • Hematology Care Unit - UH Angers

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: without socio-asthetic care
Experimental: with socio-aesthetic cares
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Quality of life score
Time Frame: Change form baseline in Quality of life score at an average of 5 months (4 to 6 cycles of chemotherapy).
  • 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).

Secondary Outcome Measures

Outcome Measure
Time Frame
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).
Change form baseline in Coopersmith Self-esteem inventory score at an average of 5 months (4 to 6 cycles of chemotherapy).
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).
Change form baseline in body image scale assessment score at an average of 5 months (4 to 6 cycles of chemotherapy).
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).
Change form baseline in social life assessment score at an average of 5 months (4 to 6 cycles of chemotherapy).

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Angers

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2014

Primary Completion (Actual)

January 1, 2016

Study Completion (Actual)

January 1, 2016

Study Registration Dates

First Submitted

February 20, 2014

First Submitted That Met QC Criteria

February 24, 2014

First Posted (Estimate)

February 26, 2014

Study Record Updates

Last Update Posted (Estimate)

June 16, 2016

Last Update Submitted That Met QC Criteria

June 15, 2016

Last Verified

June 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AOI PM 2012-12

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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