Solid TumorsEVAL'COACHNCT02619045
Evaluation of the Impact of a Follow-up Phone Call Nurse Device in the Care of Patients With Chemotherapy Treatment
A study testing Telephone follow-up nursing device in people with Solid Tumors, run by Institut Claudius Regaud at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Solid Tumors
- What is being tested?
- Telephone follow-up nursing device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteFrance
- Study dates
- 9 Nov 2015to 21 Jun 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official 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
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.
Read the detailed description
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.
- Conditions
- Solid Tumors
- Being tested
- Telephone follow-up nursing device
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Telephone follow-up nursing deviceOther
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);
| Study group | Role | What they receive |
|---|---|---|
| Solid tumors | Other | Patients with solid tumor starting a intra venous chemotherapy with 21 days cycles. Receives: Other: Telephone follow-up nursing device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy : Proportion of patients for which there was a modification in their care through the nurse device
Measured: 24 months
Secondary outcomes (4)
Safety according to the classification of the CTCAE (Common for Toxicity Criteria for Adverse effects) V4.0
Measured: 24 months
Quality of life using the QLQ-C30 questionnaire and the Skindex®-16 questionnaire
Measured: 24 months
Cost of the follow-up nursing device for the establishing
Measured: 24 months
Medical costs
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
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2015 (estimated)
- Study start9 Nov 2015
- Primary completion21 Jun 2017
- Study completion21 Jun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Solid TumorsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institut Claudius Regaud
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jean-Pierre DELORD, PhD, Principal investigator, Institut Claudius Regaud
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02619045
- Sponsor's protocol ID
- 14 GENE 07
- Acronym
- EVAL'COACH
- Status last verified
- Mar 2018
- First submitted
- 30 Nov 2015
- Last updated
- 2 Mar 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT02619045
- Acronym / sponsor ID
- EVAL'COACH / 14 GENE 07
- Conditions
- Solid Tumors
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Institut Claudius RegaudUniversity, hospital or other
- Study start
- 9 Nov 2015 (actual)
- Primary completion
- 21 Jun 2017 (actual)
- Study completion
- 21 Jun 2017 (actual)
- First posted
- 2 Dec 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Solid tumors | Other | Other: Telephone follow-up nursing devicePatients with solid tumor starting a intra venous chemotherapy with 21 days cycles. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Telephone follow-up nursing deviceTelephone 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); | Other | Solid tumors |
Primary outcome
Efficacy : Proportion of patients for which there was a modification in their care through the nurse device
Time frame: 24 months
4 secondary outcomes
Safety according to the classification of the CTCAE (Common for Toxicity Criteria for Adverse effects) V4.0
Time frame: 24 months
Quality of life using the QLQ-C30 questionnaire and the Skindex®-16 questionnaire
Time frame: 24 months
Cost of the follow-up nursing device for the establishing
Time frame: 24 months
Medical costs
Time frame: 24 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Mar 2018.
Related trials for Solid Tumors
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Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
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A Study to Assess Safety, Tolerability, and Pharmacokinetics of ABSK043 in Patients With Advanced Solid Tumor
Neoplasms
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A Safety and Efficacy Extension Study of Pertuzumab in Patients With Solid Tumors Previously Enrolled in a Hoffmann-La Roche-Sponsored Pertuzumab Clinical Trial
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IL-12 Genetically Engineered Myeloid Cells in Participants With Relapsed, Refractory Solid Tumors
Relapsed Solid Tumor Malignancies, Refractory Solid Tumor Malignancies
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Immune Checkpoint Inhibitor Toxicity Risk Prediction in Solid Tumors
Malignant Solid Neoplasm
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jean-Pierre DELORD, PhD principal investigator
Institut Claudius Regaud
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Telephone follow-up nursing device in people with Solid Tumors, run by Institut Claudius Regaud at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Efficacy : Proportion of patients for which there was a modification in their care through the nurse device (time frame: 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Mar 2018.