Not provided
Not provided
Not provided
Not provided
Enrolement difficulties
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Proposition of a sensory rehabilitation program that could reduce the olfactory-gustatory alterations in patients who have been treated with chemotherapy for Haematological Cancer, and also improve their life quality, psychological well-being, and nutrition.
Disturbances in taste and smell affect a considerable proportion of patients treated with chemotherapy. In hematology, dysgeusia depends on the type pathology and the treatments themselves. It impacts the quality of life, leads to significant emotional and social consequences, affects the intake, weight and nutritional status of patients.
Olfactory-taste disorders can be assessed using subjective and objective tests. There are no international clinical recommendations for the management of taste and olfactory disturbances associated with chemotherapy in hematological cancers. Also, this study proposes to evaluate a taste and olfaction rehabilitation program based on national standards and recent research. It will help fill gaps in the assessment and management of patients treated for Haematological cancer.
Hypothesis is that this sensory rehabilitation program should make it possible to reduce the olfactory-gustatory changes in patients who have been treated with Chemotherapy for Haematological cancer and significantly improve their quality of life, their psychological well-being and their nutrition.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Interventional | Experimental | Patients in the interventional arm will follow a multifactorial sensory rehabilitation program focused on smell and taste that integrates several non-drug interventions, which are part of the current recommendations: program of workshops at the technical center, hydration of the mucous membranes with daily (3 times a day) liposomal sprays (LipoSaliva® and LipoNasal) between V0 and V1, presentation of visual dishes. The workshops will take place at the frequency of one session of 2 hours per week and will last for 3 weeks. Each session will accommodate a minimum of 2 participants. The program will include 3 workshops on olfactory rehabilitation and taste rehabilitation. Exercises (taking up the themes discussed) will be carried out at home between 2 workshops. |
|
| Control | Other | The control group only receives the usual care provided for as part of routine care. It consists of a nutritional assessment at home by a dietician, with monitoring of intake and weight, in order to readjust nutritional support. A systematic search for oral mycosis is carried out in order to treat. The foods that the patient prefers, identified from a list of authorized foods, are preferred or even fortified. Patients in the control group will be able to benefit from the rehabilitation workshops if they wish at the end of the study. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Multifactorial sensory rehabilitation workshops | Other | A multifactorial sensory rehabilitation Workshops : a multifactorial program in order to optimize the recovery of flavors, focused on smell and taste which integrates several non-drug interventions, which are part of the current recommendations: hydration of the mucous membranes with daily (3 times a day) liposomal sprays (nose and mouth), presentation of visual dishes. |
| Measure | Description | Time Frame |
|---|---|---|
| Assessment of the olfactometry | Evolution of the Score of the "Sniffin'sticks" test from the initial score (V0), which itself includes an olfactory discrimination, olfactory threshold and olfactory identification score (with a cut-off of ≤ 15 for anosmia, ≥ for normonosmia and hypoanosmia for a score between 15 and 30) | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Assessment of the gustometry | Score in the "Taste Strips" test, Hypoageusia scores being for participants aged 18 to 40, <19 for women and <17 for men; for participants aged 41 to 60, score <15 for women and 9 for men; for participants over 60, score <10.2 for women and <9 for men | up to 6 months |
| Variation of Taste and Smell Survey score |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Franciane PAUL, Dr. | UH of Montpellier | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hematology Department, University Hospital Center | Montpellier | 34 295 | France |
Not provided
Ramdonized, controlled study with 2 parallel arms (interventional and control). Patients in the interventional arm will follow a multi-factor sensory rehabilitation program focused on smell and taste with daily use (3 times a day) of Liposomal sprays (LipoSaliva® : mouth and LipoNasal® : nose) between V0 and V1.
The control group will only receive the usual care provided for as part of routine care. It consists of a nutritional assessment at home by a dietician, with monitoring of intake and weight, in order to readjust nutritional care.
Not provided
Not provided
Not provided
Not provided
|
| Usual care | Other | The control group only receives the usual care provided for as part of routine care. It consists of a nutritional assessment at home by a dietician, with monitoring of intake and weight, in order to readjust nutritional support. A systematic search for oral mycosis is carried out in order to treat. The foods that the patient prefers, identified from a list of authorized foods, are preferred or even fortified. |
|
| Tests and Questionnaire | Other | fulfillment of Taste Strips Test, Sniffin'sticks test and QGO, FACT-G, HADS, l'EVA des ingesta and GPAQ questionnaires to assess the quality of life of patients |
|
Variation of the taste and Smell Survey score |
| up to 6 months |
| Assessment of the Quality of life | Quality of life scores, obtained on the FACT-G scale. This is a 27-point self-administered questionnaire that measures the quality of life of patients with cancer. The FACT-G measures physical, functional, social / family factors, and emotional well-being as well as physician / patient relationship satisfaction and concerns. All items are rated on a 5-point Likert scale based on the week prior to the assessment. | Up to 6 months |
| Assessment of the Psychological distress | The psychological distress score objectified by the Hospital Anxiety Depression Scale (HADS). This self-questionnaire, validated in French, contains 14 items. It is simple, sensitive and specific. It has been validated in cancer patients, that it is rapid (completion time around 5 minutes), and allows the calculation of 2 sub-scores for anxiety and depression in addition to an overall level. Finally, this tool is sensitive to changes both during the course of medical illnesses and in response to psychopharmacological interventions. | u pto 6 months |
| Assessment of the physical activity | assessed by the score at GPAQ scale (Bull, Maslin, & Armstrong, 2009) | up to 6 months |
| Variation of the patient weight | assessed by BMI between the beginning and the end of the study | up to 6 months |
| ID | Term |
|---|---|
| D009101 | Multiple Myeloma |
| D008223 | Lymphoma |
| D000086582 | Anosmia |
| ID | Term |
|---|---|
| D054219 | Neoplasms, Plasma Cell |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D020141 | Hemostatic Disorders |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D010265 | Paraproteinemias |
| D001796 | Blood Protein Disorders |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D006474 | Hemorrhagic Disorders |
| D008232 | Lymphoproliferative Disorders |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D008206 | Lymphatic Diseases |
| D000857 | Olfaction Disorders |
| D012678 | Sensation Disorders |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
| ID | Term |
|---|---|
| D011795 | Surveys and Questionnaires |
| ID | Term |
|---|---|
| D003625 | Data Collection |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D017531 | Health Care Evaluation Mechanisms |
| D011787 | Quality of Health Care |
| D017530 | Health Care Quality, Access, and Evaluation |
| D011634 | Public Health |
| D004778 | Environment and Public Health |
Not provided
Not provided