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Completed

NCT Number: NCT02619045

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

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.

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Key information

Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Institut claudius regaud

Toulouse, 31059, France

About this study

This study is a monocentric prospective cohort study designed to monitor the care of patients undergoing an intra venous chemotherapy. Patients with a solid tumor (200 patients in total), starting a first cycle of intravenous chemotherapy with 21 days cycle will be included in this study. Patients will be followed all over the chemotherapy period through regular and defined telephone appointments carried out by a dedicated nurse. During phone call, a specific questionnaire will be used in order to retrieve data regarding patients toxicities, general care, quality of life, ...Actions taken following each phone call will also be documented (consultation, hospitalization, prescription,...). The main objective of this study is to evaluate the impact of this telephone follow-up program on the care of patients under chemotherapy treatment. In addition, a medico-economic analysis of this device compared with historical data from the national database SNIIRAM will be done.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.
  • Patient who signed the informed consent before study inclusion and before any study specific procedure.

Exclusion criteria

  • 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.

Treatment and study plan

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);

Primary outcomes

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

    Time frame: 24 months

Secondary outcomes

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

    Time frame: 24 months

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

    Time frame: 24 months

  3. Cost of the follow-up nursing device for the establishing

    Time frame: 24 months

  4. Medical costs

    Time frame: 24 months

    Direct medical and non-medical costs of patients with malignant disease and followed by COACH will be compared to those of patients with the same types of cancer pathologies with traditional monitoring

Sponsors and collaborators

Lead sponsor

Institut Claudius Regaud

Other

Registry information

Official study title

Evaluation of 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

Acronym: EVAL'COACH

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Dec 2, 2015
Registry last updated
Mar 2, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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