ExhaustionTANGONCT02551965
Nursing Follow up in Geriatric Oncology : Tracking Time of Caregiver Exhaustion Risk
A study testing Phone nursing follow-up in people with Exhaustion and Geriatric Disorder, run by University Hospital, Strasbourg, France at 1 site in France.
Trial summary
In geriatric oncology, caregivers are submitted to a risk of exhaustion. To investigate the clinical risk factor of exhaustion, the researchers propose to conduct a prospective observational study during 6 months phone follow up of the caregivers. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Exhaustion, Geriatric Disorder
- What is being tested?
- Phone nursing follow-up
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteFrance
- Study dates
- Jan 2016to Sep 2023
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Caregiver of :
- patient with 70 years old or more, suffered from cancer and receiving specific cancer treatment (chemotherapy or radiotherapy )
- Patient evaluated in a specific comprehensive oncogeriatric assessment
- informed patient given a non-opposition form
- Patient affiliated to a social protection scheme
- Informed consent given by the caregiver
Who cannot join
- Patient and caregiver under judicial protection
- Caregiver with understanding difficulties with French language
- Psychological, familial, social or geographic conditions that avoid a good clinical trial continuity
- Patient with ≤ 18 years old
- Caregiver and patient with significant cognitive troubles
- Caregiver and patient located in institution during inclusion period
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Unité de Coordination Régionale en Oncogériatrie - Hôpital de Hautepierre
Strasbourg, 67098
Damien HEITZ, PH, 03 88 12 86 57, damien.heitz@chru-strasbourg.fr
Gwenaelle BOSSU, 03 88 12 86 57, gwenaelle.bossu@chru-strasbourg.fr
About this study
In geriatric oncology, caregivers are submitted to a risk of exhaustion. To investigate the clinical risk factor of exhaustion, the researchers propose to conduct a prospective observational study during 6 months phone follow up of the caregivers. The recruitment will take place during the oncogeriatric assessment consultation.
Read the detailed description
The primary purpose aim to describe the caregiver of patient with 70 years old or more, suffered from cancer and for which a treatment is planned, along with their long term evolution.
The secondary purposes are to :
- Assess the exhaustion level felt by this caregiver
- Assess the medium delay of caregiver exhaustion apparition
- Relate factors associated to the medium delay of caregiver exhaustion apparition during patient chemotherapy and/or radiotherapy treatment
- Conditions
- Exhaustion, Geriatric Disorder
- Being tested
- Phone nursing follow-up
- Keywords
- Cancer, Patient, Oncology, Caregiver
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Phone nursing follow-upOther
From the day of geriatric cancer patient's consultation, nurses will identify caregiver and will follow them by phone (caregiver) during 6 months
| Study group | Role | What they receive |
|---|---|---|
| Caregiver of cancer patient followed in geriatric oncology | Experimental | caregiver of cancer patient with 70 years old or more, for which a treatment is planned, along with their long term evolution Receives: Other: Phone nursing follow-up |
What is being measured
The primary outcome is the main question the study is designed to answer.
Standard collection of sociodemographic caregivers features
subjects will be followed for the duration of patient treatment and follow-up in geriatric department, an average of 6 months. The sociodemographic features will be reported during this period, depending on patient disease and caregiver tasks.
Measured: 6 months
Standard collection of economic caregivers features
subjects will be followed for the duration of patient treatment and follow-up in geriatric department, an average of 6 months. The economic features will be reported during this period, depending on patient disease and caregiver tasks.
Measured: 6 months
Standard collection of physical health caregivers features
subjects will be followed for the duration of patient treatment and follow-up in geriatric department, an average of 6 months. The physical health features will be reported during this period, depending on patient disease and caregiver tasks.
Measured: 6 months
Standard collection of psychological health caregivers features
subjects will be followed for the duration of patient treatment and follow-up in geriatric department, an average of 6 months. The psychological health features will be reported during this period, depending on patient disease and caregiver tasks.
Measured: 6 months
Standard collection of caregivers support frequency
subjects will be followed for the duration of patient treatment and follow-up in geriatric department, an average of 6 months. The caregivers support frequency will be reported during this period, depending on patient disease and caregiver tasks.
Measured: 6 months
Secondary outcomes (3)
The exhaustion level felt by caregiver is assessed with Mini-Zarit scale
subjects will be followed for the duration of patient treatment and follow-up in geriatric department, an average of 6 months
Measured: 6 months
Medium delay of caregiver exhaustion apparition is assessed with Mini-Zarit scale
An exhaustion is noticed when caregiver score is ≥ 2 on Mini-Zarit scale. However, the medium delay of caregiver exhaustion apparition is also assessed with an increasing of 2 points from caregiver baseline score on mini-Zarit scale.
subjects will be followed for the duration of patient treatment and follow-up in geriatric department, an average of 6 months
Measured: 6 months
Factors associated with medium delay of caregiver exhaustion apparition are determined with caregiver and patient features
subjects will be followed for the duration of patient treatment and follow-up in geriatric department, an average of 6 months
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 posted16 Sep 2015 (estimated)
- Study startJan 2016
- Primary completionApr 2023 (estimated)
- Study completionSep 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ExhaustionStudies of the same condition, open and under way.
- More trials run by University Hospital, Strasbourg, FranceThe sponsor's other registered studies.
- 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
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Strasbourg, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Damien HEITZ, MD, Principal investigator, Strasbourg's University Hospitals - UCROG
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02551965
- Sponsor's protocol ID
- 6116
- Acronym
- TANGO
- Status last verified
- Jul 2020
- First submitted
- 7 Sep 2015
- Last updated
- 28 Jul 2020
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nursing Follow up in Geriatric Oncology : Tracking Time of Caregiver Exhaustion Risk
- ClinicalTrials.gov ID
- NCT02551965
- Acronym / sponsor ID
- TANGO / 6116
- Conditions
- Exhaustion, Geriatric Disorder
- Keywords
- Cancer, Patient, Oncology, Caregiver
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- University Hospital, Strasbourg, FranceUniversity, hospital or other
- Study start
- Jan 2016
- Primary completion
- Apr 2023 (estimated)
- Study completion
- Sep 2023 (estimated)
- First posted
- 16 Sep 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.
In geriatric oncology, caregivers are submitted to a risk of exhaustion. To investigate the clinical risk factor of exhaustion, the researchers propose to conduct a prospective observational study during 6 months phone follow up of the caregivers. The recruitment will take place during the oncogeriatric assessment consultation.
Detailed description
The primary purpose aim to describe the caregiver of patient with 70 years old or more, suffered from cancer and for which a treatment is planned, along with their long term evolution.
The secondary purposes are to :
- Assess the exhaustion level felt by this caregiver
- Assess the medium delay of caregiver exhaustion apparition
- Relate factors associated to the medium delay of caregiver exhaustion apparition during patient chemotherapy and/or radiotherapy treatment
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Caregiver of cancer patient followed in geriatric oncology | Experimental | Other: Phone nursing follow-upcaregiver of cancer patient with 70 years old or more, for which a treatment is planned, along with their long term evolution |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Caregiver of :
- Informed consent given by the caregiver
Key exclusion criteria (6 listed)
- Patient and caregiver under judicial protection
- Caregiver with understanding difficulties with French language
- Psychological, familial, social or geographic conditions that avoid a good clinical trial continuity
- Patient with ≤ 18 years old
- Caregiver and patient with significant cognitive troubles
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 |
|---|---|---|
| Phone nursing follow-upFrom the day of geriatric cancer patient's consultation, nurses will identify caregiver and will follow them by phone (caregiver) during 6 months | Other | Caregiver of cancer patient followed in geriatric oncology |
Primary outcome
Standard collection of sociodemographic caregivers features
Time frame: 6 months
subjects will be followed for the duration of patient treatment and follow-up in geriatric department, an average of 6 months. The sociodemographic features will be reported during this period, depending on patient disease and caregiver tasks.
Standard collection of economic caregivers features
Time frame: 6 months
subjects will be followed for the duration of patient treatment and follow-up in geriatric department, an average of 6 months. The economic features will be reported during this period, depending on patient disease and caregiver tasks.
Standard collection of physical health caregivers features
Time frame: 6 months
subjects will be followed for the duration of patient treatment and follow-up in geriatric department, an average of 6 months. The physical health features will be reported during this period, depending on patient disease and caregiver tasks.
Standard collection of psychological health caregivers features
Time frame: 6 months
subjects will be followed for the duration of patient treatment and follow-up in geriatric department, an average of 6 months. The psychological health features will be reported during this period, depending on patient disease and caregiver tasks.
Standard collection of caregivers support frequency
Time frame: 6 months
subjects will be followed for the duration of patient treatment and follow-up in geriatric department, an average of 6 months. The caregivers support frequency will be reported during this period, depending on patient disease and caregiver tasks.
3 secondary outcomes
The exhaustion level felt by caregiver is assessed with Mini-Zarit scale
Time frame: 6 months
Medium delay of caregiver exhaustion apparition is assessed with Mini-Zarit scale
Time frame: 6 months
Factors associated with medium delay of caregiver exhaustion apparition are determined with caregiver and patient features
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2020.
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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.
Damien HEITZ, MD principal investigator
Strasbourg's University Hospitals - UCROG
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Phone nursing follow-up in people with Exhaustion and Geriatric Disorder, run by University Hospital, Strasbourg, France 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 6 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 28 Jul 2020. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Anne Laudamy (+33 3 88 11 66 88, anne.laudamy@chru-strasbourg.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Standard collection of sociodemographic caregivers features (time frame: 6 months). The study lists 5 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 28 Jul 2020.