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

Not Applicable

• Conditions: Cancer
• Interventions: Behavioral: Nurse phone call

• Registration Number: NCT02459483
• Lead Sponsor: Institut de Cancérologie de la Loire

Brief Summary

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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-05-29
• Study First Submitted QC: 2015-05-29
• Study First Posted: 2015-06-02
• Study Start: 2015-12
• Status Verified: 2016-02
• Last Update Submitted: 2016-02-25
• Last Update Posted: 2016-02-26
• Primary Completion: 2017-11
• Study Completion: 2018-05

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 184

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Nurse phone call	Nurse phone call	a nurse will interview patients by phone every 14 +/- 2 days for 6 months

Primary Outcome Measures

Name	Time	Method
Toxicity score	6 months	Toxicity Score 9 most common side effects of oral chemotherapy (oral mucositis, hand-foot syndrome, diarrhea, nausea, vomiting, pain, asthenia, rash and anorexia) officers from the NCI-CTCAE v4.0 (Common Toxicity Criteria for Adverse Events) and turned into a single composite criterion (sum of 9 toxicity grades)

Trial Locations

Locations (2)

Hopital Privé de la Loire; 🇫🇷 Saint-Etienne, France

Institut de Cancerologie de la Loire; 🇫🇷 St Priest en Jarez, France