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COMPLETED
NCT01977053
NA

Impact of a Telephonic Monitoring During Inter-treatment Intervals on Emotional State, Quality of Life and Toxicities, on Neo Adjuvant or Adjuvant Chemotherapy-treated Patients

Sponsor: Centre Antoine Lacassagne

View on ClinicalTrials.gov

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.

Official title: Impact of a Telephonic Monitoring During Neo Adjuvant or Adjuvant Chemotherapy

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

274

Start Date

2013-09

Completion Date

2018-12

Last Updated

2026-04-23

Healthy Volunteers

No

Interventions

OTHER

Clinical and psychosocial phone calls

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.

Locations (2)

Centre Antoine Lacassagne

Nice, Cedex 2, France

Polyclinique St Jean

Cagnes-sur-Mer, France