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

NCT ID: NCT02459483

Last Updated: 2016-02-26

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 184 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-12-31
• Study Completion Date: 2018-05-31

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).

Conditions

Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Nurse phone call

a nurse will interview patients by phone every 14 +/- 2 days for 6 months

Group Type: EXPERIMENTAL

Nurse phone call

Intervention Type: BEHAVIORAL

Control Group

Common practice

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Nurse phone call

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hôpital Privé de la Loire

UNKNOWN

Sponsor Role: collaborator

Institut de Cancérologie de la Loire

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Hopital Privé de la Loire

Saint-Etienne, , France

Site Status: RECRUITING

Institut de Cancerologie de la Loire

Saint-Priest-en-Jarez, , France

Site Status: RECRUITING

Countries

France

Central Contacts

Mathieu ORIOL, MD

Role: CONTACT

mathieu.oriol@icloire.fr

04 77 91 70 71

Facility Contacts

Thierry MURON, MD

Role: primary

thierry.muron@icloire.fr

Cécile Vassal, MD

Role: primary

cecile.vassal@icloire.fr

+33(0)477917022

References

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.

Reference Type: DERIVED

PMID: 33409726 (View on PubMed)

Other Identifiers

2015-01

Identifier Type: -

Identifier Source: org_study_id