Cancer
Conditions
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).
Interventions
BEHAVIORALNurse phone call
Sponsors
Hôpital Privé de la Loire
Institut de Cancérologie de la Loire
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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) |
Countries
France
Contacts
Primary ContactMathieu ORIOL, MD
Outcome results
None listed