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

Study Overview
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Brief Summary
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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).

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

Conditions
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Cancer

Intervention / Treatment
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* Behavioral: Nurse phone call


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Nurse phone call<br>a nurse will interview patients by phone every 14 +/- 2 days for 6 months | Behavioral: Nurse phone call<br> <br> |
| No Intervention: Control Group<br>Common practice | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |