LymphomaCareSSENCT02072655
Impact of Socio-aesthetic Care in the Quality of Life of Patients Treated for Lymphoma During and After Hospitalization
A study testing socio-aesthetic care in people with Lymphoma, run by University Hospital, Angers at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Lymphoma
- What is being tested?
- socio-aesthetic care
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteFrance
- Study dates
- Jan 2014to Jan 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
- Being tested
- socio-aesthetic care
- Medical subject headings
- Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
socio-aesthetic careProcedure or surgery
- 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.
| Study group | Role | What they receive |
|---|---|---|
| without socio-asthetic care | No intervention | Not described |
| with socio-aesthetic cares | Experimental | Not described Receives: Procedure: socio-aesthetic care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: 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
Measured: Change form baseline in body image scale assessment score at an average of 5 months (4 to 6 cycles of chemotherapy).
Social life assessment
Measured: Change form baseline in social life assessment score at an average of 5 months (4 to 6 cycles of chemotherapy).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2014 (estimated)
- Study startJan 2014
- Primary completionJan 2016
- Study completionJan 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for LymphomaStudies of the same condition, open and under way.
- More trials run by University Hospital, AngersThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Angers
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02072655
- Sponsor's protocol ID
- AOI PM 2012-12
- Acronym
- CareSSE
- Status last verified
- Jun 2016
- First submitted
- 20 Feb 2014
- Last updated
- 16 Jun 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Socio-aesthetic Care in the Quality of Life of Patients Treated for Lymphoma During and After Hospitalization
- ClinicalTrials.gov ID
- NCT02072655
- Acronym / sponsor ID
- CareSSE / AOI PM 2012-12
- Conditions
- Lymphoma
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University Hospital, AngersOther government
- Study start
- Jan 2014
- Primary completion
- Jan 2016 (actual)
- Study completion
- Jan 2016 (actual)
- First posted
- 26 Feb 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| without socio-asthetic care | No intervention | – |
| with socio-aesthetic cares | Experimental | Procedure: socio-aesthetic care |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Procedure or surgery | with socio-aesthetic cares |
Primary outcome
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.
3 secondary outcomes
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).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jun 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing socio-aesthetic care in people with Lymphoma, run by University Hospital, Angers at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Jun 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jun 2016.