Non-metastatic Patients With Breast Cancer Clinical Trial
Official title:
Impact of a Telephonic Monitoring During Neo Adjuvant or Adjuvant Chemotherapy
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.
Cancer is widely associated with the concept of psychological distress in a population of
patients subject to numerous stressful events. Between 10 to 50% of patients with cancer and
their families suffer from clinically significant psychological disorders.
The existence of a broad continuum of manifestations of distress makes it difficult for
clinical evaluation. Underestimated and misjudged, it is not always taken into account
appropriately. However, these problems have a direct impact not only on the quality of life
of patients but also on their ability to share decisions , adhere to treatment, and therefore
to get the best care available for the treatment of their cancer.
Interactions between the presence of psychopathological disorders, quality of life and
treatment toxicities will be the focus of this study assessing the impact of telephonic
monitoring (targeting clinical, psychological and social objectives) in patients with current
chemotherapy.
There are communication difficulties on the distress between the patient and the doctor, in
part due to the gap between the perceptions of the patient and the caregiver. Indeed, many
studies have highlighted the important differences existing between subjective psychosocial
needs of the patient and the physician's ability to detect them. In particular, the study of
Fallowfield on nearly 2300 medical consultations shows that only 29% of patients whose
threshold of distress is clinically significant are identified by their doctors. Similarly,
the synthesis carried out in 2005 by Thorne et al. reported the impact of failures of
communication between clinicians and patients on the psychosocial experience of illness and
treatment, symptom management, decision making and quality of life.
Justification and research hypothesis
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
the first 3 inter-treatment intervals, the overall measure of mood states (anxiety,
depression , confusion , anger , fatigue , vigor and interpersonal ) of the patient and his
entourage . We also study the gain in quality of life, anxiety level, frequency and severity
of toxicities, as well as emotional comfort of the procedure.
We propose to determine on a population of 280 patients, the impact of two phone calls during
the 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.
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