CancerTelOGNCT02583035
Telephone OncoGériatric Followed in the Management of Elderly Patients Treated for Cancer or Haematological Malignancy
A study testing Nurse telephone contact in people with Cancer and Hematologic Malignancy, run by Centre Francois Baclesse at 5 sites in France.
Trial summary
There are no recommendations and few studies on the monitoring of fragile patients in the oncological treatment, both on the organizational arrangements on its interest in the prevention of functional deterioration of the patient and adaptation of the potential cancer treatment. Read more about this study
- Who is it for?
- Ages 70 years and older
- Conditions the study is for
- Cancer, Hematologic Malignancy
- What is being tested?
- Nurse telephone contact
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 131 participants
- Where
- 5 sitesFrance
- Study dates
- Feb 2015to 14 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 70 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Patients 70 years and older with cancer or hematologic malignancies;
- Faced benefit from cancer treatment (systemic treatment, curative radiotherapy) in one of the clinical sites;
- Addressed in onco-gériatric consultation in the usual routine care sector;
- Mastery of the French language;
- Patient affiliated to the social security system;
- Patient has given its written consent.
Who cannot join
- Life expectancy <3 months
- Inability to communicate by telephone (deafness, speech disorder, ..)
- Inability collection of written consent
- Group 4 SiO (International Society of Geriatric Oncology), Performance status (PS) 4
- initial MMSE (Mini-Mental State Examination) <18/30
- oncological treatment envisaged: analgesic radiotherapy or exclusive decompressive, brain radiation therapy in toto
- Patient under guardianship
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
France5 sites
Centre Hospitalier
Bayeux
CHU
Caen, 14033
Centre François Baclesse
Caen, 14400
Centre Hospitalier
Dieppe
Centre Hospitalier du Havre
Le Havre
About this study
There are no recommendations and few studies on the monitoring of fragile patients in the oncological treatment, both on the organizational arrangements on its interest in the prevention of functional deterioration of the patient and adaptation of the potential cancer treatment.
The oncogériatrique evaluation being time-consuming, requiring the movement of these more or less frail elderly patients, it seems difficult to envisage repeated and systematic standardized geriatric assessments during cancer treatment. Geriatric fragility can be detected by telephone. Craven et al. has already assessed the telephone follow-up by a nurse in patients treated for cancer, but with the aim to detect toxicities of cancer treatment, patients are not very old (mean age 64.8 years).
Read more
External evaluation by the nurse coordinator of UCOG (Coordination Unit in geriatric oncology) not knowing the patients included avoids bias of subjectivity in the interrogation.
However the telephone monitoring, with the aim to evaluate the evolution of geriatric frailty, has not been specifically studied in the elderly population treated for cancer, while taking oncology load.
The investigators wish to study the feasibility and validity of telephone follow-up which could eventually be used routinely to identify patients requiring further medical consultation oncogériatrique.
- Conditions
- Cancer, Hematologic Malignancy
- Being tested
- Nurse telephone contact
- Keywords
- cancer, geriatric
- Medical subject headings
- Neoplasms, Hematologic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nurse telephone contactOther
Nurse will contact patient 3 days before consultation
| Study group | Role | What they receive |
|---|---|---|
| Nurse telephone contact | Other | 3 days of consultation, telephone follow-up of the patient by the nurse coordinator of the Geriatric Oncology Unit to validate Receives: Other: Nurse telephone contact |
What is being measured
The primary outcome is the main question the study is designed to answer.
Memory on the Mini Mental Scale
Measured: 3 months after inclusion
Falls on the number of falls
Measured: 3 months after inclusion
Pain on the EVS (verbal scale) scale
Measured: 3 months after inclusion
Autonomy on the ADL (activities of daily living) score
Measured: 3 months after inclusion
Pain on the EN (numericale scale) scale
Measured: 3 months after inclusion
Autonomy on the IADL (The Lawton Instrumental Activities of Daily Living Scale ) score
Measured: 3 months after inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2015 (estimated)
- Study startFeb 2015
- Primary completion16 Feb 2018
- Study completion14 May 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 131 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Francois Baclesse
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Bérengère Beauplet, MD, Principal investigator, University Hospital, Caen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02583035
- Sponsor's protocol ID
- TelOG
- Acronym
- TelOG
- Status last verified
- Jan 2019
- First submitted
- 17 Sep 2015
- Last updated
- 16 Jan 2019
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 16 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Telephone OncoGériatric Followed in the Management of Elderly Patients Treated for Cancer or Haematological Malignancy
- ClinicalTrials.gov ID
- NCT02583035
- Acronym / sponsor ID
- TelOG / TelOG
- Conditions
- Cancer, Hematologic Malignancy
- Keywords
- cancer, geriatric
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 131 participants (actual)
- Lead sponsor
- Centre Francois BaclesseUniversity, hospital or other
- Study start
- Feb 2015
- Primary completion
- 16 Feb 2018 (actual)
- Study completion
- 14 May 2018 (actual)
- First posted
- 21 Oct 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.
There are no recommendations and few studies on the monitoring of fragile patients in the oncological treatment, both on the organizational arrangements on its interest in the prevention of functional deterioration of the patient and adaptation of the potential cancer treatment.
The oncogériatrique evaluation being time-consuming, requiring the movement of these more or less frail elderly patients, it seems difficult to envisage repeated and systematic standardized geriatric assessments during cancer treatment. Geriatric fragility can be detected by telephone. Craven et al. has already assessed the telephone follow-up by a nurse in patients treated for cancer, but with the aim to detect toxicities of cancer treatment, patients are not very old (mean age 64.8 years).
External evaluation by the nurse coordinator of UCOG (Coordination Unit in geriatric oncology) not knowing the patients included avoids bias of subjectivity in the interrogation.
However the telephone monitoring, with the aim to evaluate the evolution of geriatric frailty, has not been specifically studied in the elderly population treated for cancer, while taking oncology load.
The investigators wish to study the feasibility and validity of telephone follow-up which could eventually be used routinely to identify patients requiring further medical consultation oncogériatrique.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Nurse telephone contact | Other | Other: Nurse telephone contact3 days of consultation, telephone follow-up of the patient by the nurse coordinator of the Geriatric Oncology Unit to validate |
Who may qualify
- Ages
- 70 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (6 listed)
- Patients 70 years and older with cancer or hematologic malignancies;
- Faced benefit from cancer treatment (systemic treatment, curative radiotherapy) in one of the clinical sites;
- Addressed in onco-gériatric consultation in the usual routine care sector;
- Mastery of the French language;
- Patient affiliated to the social security system;
Key exclusion criteria (7 listed)
- Life expectancy <3 months
- Inability to communicate by telephone (deafness, speech disorder, ..)
- Inability collection of written consent
- Group 4 SiO (International Society of Geriatric Oncology), Performance status (PS) 4
- initial MMSE (Mini-Mental State Examination) <18/30
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 telephone contactNurse will contact patient 3 days before consultation | Other | Nurse telephone contact |
Primary outcome
Memory on the Mini Mental Scale
Time frame: 3 months after inclusion
Falls on the number of falls
Time frame: 3 months after inclusion
Pain on the EVS (verbal scale) scale
Time frame: 3 months after inclusion
Autonomy on the ADL (activities of daily living) score
Time frame: 3 months after inclusion
Pain on the EN (numericale scale) scale
Time frame: 3 months after inclusion
Autonomy on the IADL (The Lawton Instrumental Activities of Daily Living Scale ) score
Time frame: 3 months after inclusion
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 16 Jan 2019.
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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.
Bérengère Beauplet, MD principal investigator
University Hospital, Caen
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nurse telephone contact in people with Cancer and Hematologic Malignancy, run by Centre Francois Baclesse at 5 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 6 inclusion and 7 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 16 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 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?
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?
Memory on the Mini Mental Scale (time frame: 3 months after inclusion). The study lists 6 primary outcomes in all. 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 16 Jan 2019.