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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02072655
First Posted: February 26, 2014
Last Update Posted: June 16, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
University Hospital, Angers
  Purpose

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 .


Condition Intervention
Lymphoma Procedure: socio-aesthetic care

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Impact of Socio-aesthetic Care in the Quality of Life of Patients Treated for Lymphoma During and After Hospitalization

Resource links provided by NLM:


Further study details as provided by University Hospital, Angers:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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). ]
  • 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). ]
  • 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). ]

Enrollment: 40
Study Start Date: January 2014
Study Completion Date: January 2016
Primary Completion Date: January 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02072655


Locations
France
Hematology Care Unit - UH Angers
Angers, France, 49000
Sponsors and Collaborators
University Hospital, Angers
  More Information

Responsible Party: University Hospital, Angers
ClinicalTrials.gov Identifier: NCT02072655     History of Changes
Other Study ID Numbers: AOI PM 2012-12
First Submitted: February 20, 2014
First Posted: February 26, 2014
Last Update Posted: June 16, 2016
Last Verified: June 2016

Additional relevant MeSH terms:
Lymphoma
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases