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

NCT02072655 | Completed

• 1 other identifier: AOI PM 2012-12
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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 .

Conditions

Lymphoma

Outcome Measures

Primary Outcomes (1)

• 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.

  Change form baseline in Quality of life score at an average of 5 months (4 to 6 cycles of chemotherapy).

Secondary Outcomes (3)

• Coopersmith Self-esteem inventory

  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

  Change form baseline in body image scale assessment score at an average of 5 months (4 to 6 cycles of chemotherapy).

• Social life assessment

  Change form baseline in social life assessment score at an average of 5 months (4 to 6 cycles of chemotherapy).

Study Arms (2)

without socio-asthetic care

NO INTERVENTION

with socio-aesthetic cares

EXPERIMENTAL

Procedure: socio-aesthetic care

Interventions

socio-aesthetic care PROCEDURE

* 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.

with socio-aesthetic cares

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University Hospital, Angers: lead

Study Sites (1)

Hematology Care Unit - UH Angers

Angers, 49000, France

Location

MeSH Terms

Conditions

Lymphoma

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 20, 2014
• First Posted: February 26, 2014
• Study Start: January 1, 2014
• Primary Completion: January 1, 2016
• Study Completion: January 1, 2016
• Last Updated: June 16, 2016

Record last verified: 2016-06

Locations

FR (1)