Evaluation of a Telephone Care Nurse in the Management of Patients With Cancer and Treated by Oral Chemotherapy (ETICCO)

Institut de Cancérologie de la Loire

Status

Unknown

Conditions

Cancer

Treatments

Behavioral: Nurse phone call

Study type

Interventional

Funder types

Other

Identifiers

NCT02459483

2015-01

Details and patient eligibility

About

The purpose of this study is to assess the effectiveness of a nurse telephone interview in the management of cancer patients treated by oral chemotherapy. This is a multicenter prospective randomized controlled pragmatic interventional trial conducted in collaboration with two oncology care facilities. Eligible population consists of all patients suffering from advanced cancer and treated by oral chemotherapy except hormonotherapy. 184 patients will be enrolled in the study. The experimental group will receive a standard followed by a medical oncologist, hematologist or radiation therapist as part of routine care, and telephone interviews by a nurse every 14 +/- 2 days for 6 months. The control group will receive a standard followed by a medical oncologist, hematologist or radiation therapist as part of routine care.

The effectiveness of the intervention will be evaluated by a toxicity score of the 9 most common side effects of oral cancer (oral mucositis, hand-foot syndrome, diarrhea, nausea, vomiting, pain, asthenia, rash and anorexia) officers from NCI CTCAE v4.0-(Common Toxicity Criteria for Adverse Events) and turned into a single composite criterion (sum of 9 Toxicity grades).

Enrollment

184 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

aged over 18 years
treated in medical oncology, hematology or radiotherapy
to receive any oral chemotherapy for any cancer except hormone therapy according to decision of the Meeting of Consultation Multidisciplinary

Exclusion criteria

Refusal of participation, protected adult patient under guardianship.
Patient currently treated with oral chemotherapy
Patient already included in another clinical research protocol including telephone follow-up
Patient followed by a Nurse navigators or participating in a therapeutic education program
Patient concomitantly treated with an injectable chemotherapy regimen or radiotherapy unless irradiation palliative analgesic.
Patient in inability to understand how the study or inability to follow a telephone conversation.
Patient with documented history of cognitive or psychiatric disorders.
Patient residing outside the Rhône Alpes area
Patient doesn't understand French
Patient with no phone means