Evaluation of the Impact of a Follow-up Phone Call Nurse Device in the Care of Patients With Chemotherapy Treatment

NCT02619045 | Completed

• 1 other identifier: 14 GENE 07
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

This study evaluate the Impact of a Follow-up Phone Call Nurse Device in the Care of Patients With Chemotherapy Treatment, in their Quality of Life and Medico-economic Analysis of this Follow-up Program Device.

Conditions

Solid Tumors

Outcome Measures

Primary Outcomes (1)

• Efficacy : Proportion of patients for which there was a modification in their care through the nurse device

  24 months

Secondary Outcomes (4)

• Safety according to the classification of the CTCAE (Common for Toxicity Criteria for Adverse effects) V4.0

  24 months

• Quality of life using the QLQ-C30 questionnaire and the Skindex®-16 questionnaire

  24 months

• Cost of the follow-up nursing device for the establishing

  24 months

• Medical costs

  24 months

Study Arms (1)

Solid tumors

OTHER

Patients with solid tumor starting a intra venous chemotherapy with 21 days cycles.

Other: Telephone follow-up nursing device

Interventions

Telephone follow-up nursing device OTHER

Telephone follow-up nursing device involving: * telephone appointments made by a dedicated nurse and set up at key stage of treatment (1 phone call per week during chemotherapy cycles), * specific questionnaire used by the nurse at each phone call (toxicity, general care, quality of life...), * actions taken for the patient following each phone call (consultation with a doctor, patient hospitalization, sending of a prescription, coordination with the city medical caregiver);

Solid tumors

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient with a solid tumor.
• Patient starting a first cycle of chemotherapy (+ - targeted therapy).
• Patient starting intravenous chemotherapy including 21-day cycles.
• Patient ≥18 years old.
• Patient affiliated to a social security system in France.

You may not qualify if:

• Patient already included in another interventional biomedical research.
• Patient who began intravenous chemotherapy.
• Patient who must receive an oral chemotherapy.
• Patient who must be treated with a weekly chemotherapy or with concomitant radiotherapy.
• Patient unreachable by phone.
• Patient with no caregiver who can answer the phone in his place.
• Pregnant or breastfeeding women.
• Any psychological condition, family, geographic or social not to comply with medical monitoring and / or procedures in the study protocol.
• Patient protected by law.

Sponsors & Collaborators

• Institut Claudius Regaud: lead

Study Sites (1)

Institut claudius regaud

Toulouse, 31059, France

Location

Study Officials

• Jean-Pierre DELORD, PhD

  Institut Claudius Regaud

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 30, 2015
• First Posted: December 2, 2015
• Study Start: November 9, 2015
• Primary Completion: June 21, 2017
• Study Completion: June 21, 2017
• Last Updated: March 2, 2018

Record last verified: 2018-03

Locations

FR (1)