Clinical trial NCT02459483: Evaluation of a Telephone Care Nurse in the Management of Patients With Cancer and Treated by Oral Chemotherapy
Official title: Evaluation of a Telephone Care Nurse in the Management of Patients With Cancer and Treated by Oral Chemotherapy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Cancer
Lead sponsor: Institut de Cancérologie de la Loire
Sponsor class: OTHER
Collaborators: name: Hôpital Privé de la Loire
First posted: 2015-06-02
Enrollment: 184
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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).


Eligibility criteria: 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

Primary outcomes:
measure: Toxicity score
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Saint-Etienne
country: France
facility: Hopital Privé de la Loire
city: St Priest en Jarez
country: France
facility: Institut de Cancerologie de la Loire
Study officials:
References:
citation: Bouleftour W, Muron T, Guillot A, Tinquaut F, Rivoirard R, Jacquin JP, Saban-Roche L, Boussoualim K, Tavernier E, Augeul-Meunier K, Collard O, Mery B, Pupier S, Oriol M, Bourmaud A, Fournel P, Vassal C. Effectiveness of a nurse-led telephone follow-up in the therapeutic management of patients receiving oral antineoplastic agents: a randomized, multicenter controlled trial (ETICCO study). Support Care Cancer. 2021 Aug;29(8):4257-4267. doi: 10.1007/s00520-020-05955-3. Epub 2021 Jan 7.