CancerETICCONCT02459483
Evaluation of a Telephone Care Nurse in the Management of Patients With Cancer and Treated by Oral Chemotherapy
A study testing Nurse phone call in people with Cancer, run by Institut de Cancérologie de la Loire at 2 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer
- What is being tested?
- Nurse phone call
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 184 participants
- Where
- 2 sitesFrance
- Study dates
- Dec 2015to May 2018
- 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
- 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
Who cannot join
- 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.
Show all 10Show fewer
- 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
Trial locations and contacts
2 sites in 1 country.
France2 sites, 2 recruiting
- Recruiting
Hopital Privé de la Loire
Saint-Etienne, 42100
Thierry MURON, MD, thierry.muron@icloire.fr
Thierry MURON, MD
- Recruiting
Institut de Cancerologie de la Loire
Saint-Priest-en-Jarez, 42271
Cécile Vassal, MD, +33(0)477917022, cecile.vassal@icloire.fr
Vassal Cécile, MD
About this study
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
- Being tested
- Nurse phone call
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nurse phone callBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Nurse phone call | Experimental | a nurse will interview patients by phone every 14 +/- 2 days for 6 months Receives: Behavioral: Nurse phone call |
| Control Group | No intervention | Common practice |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2015 (estimated)
- Study startDec 2015
- Primary completionNov 2017 (estimated)
- Study completionMay 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for CancerStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 184 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Institut de Cancérologie de la Loire
- Sponsor type
- University, hospital or other
- Collaborators
- Hôpital Privé de la Loire
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02459483
- Sponsor's protocol ID
- 2015-01
- Acronym
- ETICCO
- Status last verified
- Feb 2016
- First submitted
- 29 May 2015
- Last updated
- 26 Feb 2016
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 33409726
Study at a glance
From the registry record, last updated by the sponsor on 26 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of a Telephone Care Nurse in the Management of Patients With Cancer and Treated by Oral Chemotherapy
- ClinicalTrials.gov ID
- NCT02459483
- Acronym / sponsor ID
- ETICCO / 2015-01
- Conditions
- Cancer
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 184 participants (estimated)
- Lead sponsor
- Institut de Cancérologie de la LoireUniversity, hospital or other
- Collaborators
- Hôpital Privé de la Loire
- Study start
- Dec 2015
- Primary completion
- Nov 2017 (estimated)
- Study completion
- May 2018 (estimated)
- First posted
- 2 Jun 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.
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).
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Nurse phone call | Experimental | Behavioral: Nurse phone calla nurse will interview patients by phone every 14 +/- 2 days for 6 months |
| Control Group | No intervention | –Common practice |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (10 listed)
- 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.
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 |
|---|---|---|
| Nurse phone call | Behavioural | Nurse phone call |
Primary outcome
Toxicity score
Time frame: 6 months
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)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Feb 2016.
- Derived from this study: PubMed 33409726Bouleftour 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.
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nurse phone call in people with Cancer, run by Institut de Cancérologie de la Loire at 2 sites 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 3 inclusion and 10 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: status not confirmed, as of the sponsor's last update on 26 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mathieu ORIOL, MD (04 77 91 70 71, mathieu.oriol@icloire.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Toxicity score (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02459483, which also lists 1 linked publication.
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 26 Feb 2016.