NCT02459483

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).

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
184

participants targeted

Target at P50-P75 for not_applicable cancer

Timeline
Completed

Started Dec 2015

Typical duration for not_applicable cancer

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 29, 2015

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 2, 2015

Completed
6 months until next milestone

Study Start

First participant enrolled

December 1, 2015

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2017

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2018

Completed
Last Updated

February 26, 2016

Status Verified

February 1, 2016

Enrollment Period

1.9 years

First QC Date

May 29, 2015

Last Update Submit

February 25, 2016

Conditions

Cancer

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

Nurse phone call

EXPERIMENTAL

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

Behavioral: Nurse phone call

Control Group

NO INTERVENTION

Common practice

Interventions

Nurse phone callBEHAVIORAL
Nurse phone call

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Hopital Privé de la Loire

Saint-Etienne, 42100, France

RECRUITING

Institut de Cancerologie de la Loire

Saint-Priest-en-Jarez, 42271, France

RECRUITING

Related Publications (1)

  • 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.

    PMID: 33409726DERIVED

MeSH Terms

Conditions

Neoplasms

Central Study Contacts

Mathieu ORIOL, MD

CONTACT

04 77 91 70 71mathieu.oriol@icloire.fr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 29, 2015

First Posted

June 2, 2015

Study Start

December 1, 2015

Primary Completion

November 1, 2017

Study Completion

May 1, 2018

Last Updated

February 26, 2016

Record last verified: 2016-02

Locations

FR(2)