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

Cancer Clinical Trial

— ETICCO  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02459483
• Other study ID #: 2015-01
• Status: Recruiting
• Phase: N/A
• First received: May 29, 2015
• Last updated: February 25, 2016
• Start date: December 2015
• Est. completion date: May 2018

Study information

• Verified date: February 2016
• Source: Institut de Cancérologie de la Loire
• Contact: Mathieu ORIOL, MD
• Phone: 04 77 91 70 71
• Email: mathieu.oriol[@]icloire.fr
• Is FDA regulated: No
• Health authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 184
• Est. completion date: May 2018
• Est. primary completion date: November 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Cancer

Intervention

Behavioral:
• Nurse phone call

Locations

Country	Name	City	State
France	Hopital Privé de la Loire	Saint-Etienne
France	Institut de Cancerologie de la Loire	St Priest en Jarez

Sponsors (2)

Lead Sponsor	Collaborator
Institut de Cancérologie de la Loire	Hôpital Privé de la Loire

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Toxicity score	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)	6 months	No