Non-metastatic Patients With Breast Cancer Clinical Trial
— EMOTIONOfficial title:
Impact of a Telephonic Monitoring During Neo Adjuvant or Adjuvant Chemotherapy
| Verified date | July 2019 |
| Source | Centre Antoine Lacassagne |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
In health care, the phone has emerged as a clinical tool in its own right, especially for the
development of psychological support to patients and that, in many pathologies. Its potential
in the development of psycho-social support was quickly identified.
However, to our knowledge, no prospective, randomized studies have evaluated the impact of a
telephone call to both the anxiety and the management of side effects of neoadjuvant or
adjuvant chemotherapy.
The patient incomplete care by the hospital system and the general practitioner during
chemotherapy, as well as the lack of information and poor preparation and / or management of
side effects, are a source of distress and lead to a decrease quality of life for the patient
and his family.
We propose to determine on a population of 280 patients, the impact of two phone calls during
3 first inter-treatment intervals on the overall measure of mood states of the patient and
his principal caregiver (anxiety, depression, confusion, angry, fatigue, force and
interpersonal relation). We will also study the gain in quality of life, on anxiety level,
frequency and severity of toxicities, as well as emotional comfort of the procedure.
| Status | Completed |
| Enrollment | 274 |
| Est. completion date | December 2018 |
| Est. primary completion date | October 2018 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility |
Inclusion Criteria: - Patient older than 18. - Patient surgically-treated or no for non inflammatory breast cancer or for colon cancer or rectal cancer. - Patient to be treated by neo-adjuvant or adjuvant chemotherapy by 5-fluorouracil, epirubicin and cyclophosphamide (FEC)-docetaxel, docetaxel-cyclophosphamide, 5-fluorouracil/leucovorin with oxaliplatin(FOLFOX) or XELOX. A treatment with trastuzumab is allowed in association. - Patient never treated by chemotherapy. - Patient with Performance Status under or equal to 2. - Patient with adequate hematopoietic, hepatic and cardiac functions according to the investigator. - Patient having read with the information note and having signed the informed consent. - Patient beneficiating from French health insurance cover. Exclusion Criteria: - Patient with psychological state, geographical remote or social problems that contraindicated the participation into the study according to the investigator. - Patient that must be treated for a metastatic disease. - Patient not able to attend all study visits. - Patient not understanding French. - Patient who don't have a phone. - Vulnerable patient: pregnant or breast-feeding women, person deprived of freedom by an administrative or judicial decision, person older than 18 being the object of a legal protection measure or outside state to express their consent. |
| Country | Name | City | State |
|---|---|---|---|
| France | Polyclinique St Jean | Cagnes sur Mer | |
| France | Centre Antoine Lacassagne | Nice | Cedex 2 |
| Lead Sponsor | Collaborator |
|---|---|
| Centre Antoine Lacassagne |
France,
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| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Other | intervention cost | To compare 2 types of supervision in terms of cost of the procedure (cost of consultations with psychologists, psychiatrists, cost of telephone calls) | up to 15 weeks | |
| Primary | emotional state (anxiety, depression, confusion, angry, fatigue, force and interpersonal relation) | comparison of the 2 types of monitoring in terms of overall measure of emotional state (anxiety, depression, confusion, angry, fatigue, force and interpersonal relation) of patients, with Profile of Mood States (POMS-f) questionnaire. | Change from baseline in POMS-f score at 6 weeks | |
| Secondary | Evolution of emotional states scores | To compare 2 types of supervision in terms of: The difference between the overall scores on the POMS-f before the start of treatment, at each treatment and after 3 courses of treatment |
Change from baseline in POMS-f score at 6 weeks; Change from baseline in POMS-f score at 9 weeks and Change from baseline in POMS-f score at 12 weeks | |
| Secondary | toxicities | To compare 2 types of supervision in terms of proportion of patients with toxicity during treatment, and the maximum grade observed per patient | up to 15 weeks | |
| Secondary | quality of life | To compare 2 types of supervision in terms of: The quality of life of the patient by the European Organization for Research and Treatment of Cancer Qulity of life questionnaire (EORTC QLQ-C30), before the start of treatment, during the 2nd cycle of chemotherapy and after three courses of treatment |
Change from baseline in EORTC QLQ-C30 score at 6 weeks and Change from baseline in EORTC QLQ-C30 score at 12 weeks | |
| Secondary | anxiety | To compare 2 types of supervision in terms of: The level of anxiety assessed by the number of visits to psychologists, psychiatrists, the sub-score "Anxiety" obtained in the Hospital Anxiety and Depression State (HADS) questionnaire, the anxiolytics and antidepressants intakes |
up to 15 weeks | |
| Secondary | caregiver mood states | To compare 2 types of supervision in terms of: - The overall scores obtained by the caregiver on the POMS-f before, during and after 3 courses of treatment |
Change from baseline in POMS-f score at 6 weeks; Change from baseline in POMS-f score at 9 weeks and Change from baseline in POMS-f score at 12 weeks | |
| Secondary | patient satisfaction | To compare 2 types of supervision in terms of overall satisfaction scores obtained by the patient after 3 courses of treatment | up to 12 weeks | |
| Secondary | relationship between psychosocial criteria and anxiety | To compare 2 types of supervision in terms of: - The relationship between the presence of psychosocial frailty criteria and the level of anxiety for patients in group B (number of visits to psychologists, psychiatrists; anxiolytics and antidepressants intake; HADS anxiety scores) |
up to 15 weeks |