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

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ClinicalTrials.gov Identifier: NCT02072655
Recruitment Status : Completed
First Posted : February 26, 2014
Last Update Posted : June 16, 2016
Sponsor:
Information provided by (Responsible Party):
University Hospital, Angers

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 .


Condition or disease Intervention/treatment Phase
Lymphoma Procedure: socio-aesthetic care Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
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
Study Start Date : January 2014
Actual Primary Completion Date : January 2016
Actual Study Completion Date : January 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lymphoma

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.




Primary Outcome Measures :
  1. 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 :
  1. 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). ]
  2. 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). ]
  3. 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). ]


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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older 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.

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

Responsible Party: University Hospital, Angers
ClinicalTrials.gov Identifier: NCT02072655     History of Changes
Other Study ID Numbers: AOI PM 2012-12
First Posted: February 26, 2014    Key Record Dates
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