CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 274 enrolled
Drug / intervention
Clinical and psychosocial phone callsother
Likely dose
Not stated in record
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Search/NCT01977053
NCT01977053N/ACompleted

Impact of a Telephonic Monitoring During Neo Adjuvant or Adjuvant Chemotherapy

Centre Antoine Lacassagne·interventional·Posted Nov 6, 2013·Updated Apr 23, 2026

In Brief

A clinical study evaluating Clinical and psychosocial phone calls for Non-metastatic Patients With Breast Cancer and 3 related conditions. Completed, enrolled 274 participants across 2 sites.

Detailed Summary

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.

Study Details

Timeline

N/ACompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedNov 6, 2013
Enrollment StartSep 1, 2013
Primary CompletionOct 1, 2018
Study CompletionDec 1, 2018
TodayJul 2, 2026
Enrollment to primary: 5.1 yearsPosted 12.7 years ago

Interventions

Clinical and psychosocial phone callsother

The standard medical supervision is defined as follows: * Prescription of prophylactics medication (corticoid, antiemetic, cream, mouthwash, etc) at each cycle of chemotherapy. * Nominative notebook containing details of chemotherapy administered and medical contacts. * Consultations with psycho-oncologist or psychiatrist (if necessary). The intervention further comprises: nurse phone calls the 3rd and the 8th day of the first three cycles of treatment, and personalized medical care according to toxicities reported.