OncologyPREPAC-01NCT05750836
Assessment and Prevention of Caregiver Burden in Oncology
A study testing Specific nursing support and Non-specific nursing support in people with Oncology and Caregiver Burden, run by Institut Cancerologie de l'Ouest at 5 sites in France.
Trial summary
The goal of this randomized, open and controlled supportive care study is to see if we can reduce the burden on the caregiver by offering the caregiver systematic and regular support from the nurse (APN, nurse coordinator in French health care organisations) compared to a support focused on the patient. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Oncology, Caregiver Burden
- What is being tested?
- Specific nursing support and Non-specific nursing support
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 250 participants
- Where
- 5 sitesFrance
- Study dates
- Jul 2023to Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Caregiver designated by the patient;
- Caregiver of a patient who started a line (any line) of systemic treatment for a solid tumour since less than 3 months or in an active palliative situation since less than 1 month;
- Caregiver of patient already cared for by a nurse before inclusion or going to start a nursing follow-up;
- Caregiver of a patient with a score ≥2 of social fragility and/or psychological fragility and/or nutritional fragility and/or complexity;
Who cannot join
- Patient whose life expectancy is assumed to be < 6 months;
- Patient living in an institution (EHPAD, MAS, SSR, MCO, USLD) at inclusion;
- Caregiver declared as having a pathology that could alter his/her capacity to support (psychiatric history, dementia…) or under guardianship.
Trial locations and contacts
5 sites in 1 country. Contact the study team or a site near you to ask about taking part.
5 sites in 1 country
France5 sites
CH Cholet
Cholet, 49300
Margot NOBLECOURT, MD, margot.noblecourt@ch-cholet.fr
Centre Antoine Lacassagne
Nice, 06 189
julie OUDIN, Nurse, Julie.oudin@nice.unicancer.fr
Centre Henri Bequerel
Rouen, 76038
Amel CONSTANTIN, Nurse, amel.benchemam@chb.unicancer.fr
Institut de Cancérologie de l'Ouest
Saint-Herblain, 44805
Céline THOMAS, Nurse, celine.thomas@ico.unicancer.fr
CH Mémorial de Saint Lo
Saint-Lô, 50000
Emillie LEFEVRE, Nurse, emilie.lefevre@ch-stlo.fr
About this study
The goal of this randomized, open and controlled supportive care study is to see if we can reduce the burden on the caregiver by offering the caregiver systematic and regular support from the nurse (APN, nurse coordinator in French health care organisations) compared to a support focused on the patient. At the same time, we will also evaluate the impact of this personalised support for the caregiver on their anxiety and quality of life.
Participants will caregivers of a patient who started a line (any line) of systemic treatment for a solid tumour since less than 3 months or in an active palliative situation since less than 1 month.
Read more
Researchers will compare 2 groups : a group where caregivers benefit from specific nursing support and a group of caregivers with no specific nursing support.
The specific support includes 3 mandatory on-site nursing consultations with the patient's caregiver and interviews once a month with a nurse either by phone, on-site consultation or teleconsultation.
- Conditions
- Oncology, Caregiver Burden
- Being tested
- Specific nursing support, Non-specific nursing support
- Keywords
- Nurse, Supportive Care, Zarit scale, Caregiver Burden
- Medical subject headings
- Neoplasms, Caregiver Burden
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Specific nursing supportOther
- 3 mandatory on-site nursing consultations with the patient's caregiver at inclusion, 6 months and 12 months post-randomisation.The caregivers will complete the questionnaires (Zarit scale, Hospital Anxiety and Depression scale, Medical Outcome Study Short Form - 36, Caregiver's satisfaction).
- interviews once a month with a nurse either by phone, on-site consultation or teleconsultation.
Nurses assess the general health of the caregiver and Identify the socio-professional situation of the caregiver
Non-specific nursing supportOther
Caregivers will only have to complete on site Health indicators, Zarit scale, Hospital Anxiety and Depression scale, Medical Outcome Study Short Form - 36 at inclusion, 6 months and 12 months post-randomisation.
| Study group | Role | What they receive |
|---|---|---|
| Specific nursing support | Experimental | The caregivers benefit from specific nursing support. Receives: Other: Specific nursing support |
| No specific nursing support | Active comparator | Caregivers do not receive any specific support from the nurses. Receives: Other: Non-specific nursing support |
What is being measured
The primary outcome is the main question the study is designed to answer.
Caregiver burden
Comparison in the 2 groups. Burden score is assessed using the ZARIT SCALE. The test consists of 22 questions that the caregiver has to score from 0 to 4, the whole giving a score from 0 to 88. 0 means no burden, 88 means that the burden is severe
Measured: at 6 months post-randomisation
Secondary outcomes (3)
The level of anxiety/depression of the caregiver
Comparaison in the 2 groups.
Hospital Anxiety and Depression scale consists of 14 items to which participants respond on a 4-point Likert scale. Seven items assess anxiety and seven items assess depression. Anxiety and depression scores can range from 0 (no symptoms) to 21 (significant presence of symptoms). Threshold scores were determined as follows:
- between 0 and 7 : no symptoms of anxiety or depression;
- between 8 and 10 : some moderate symptoms (mild anxiety or depression);
- score of 11 or more : significant number of symptoms (severe anxiety or depression).
Measured: at month 6 (M6) and month 12 (M12) post-randomisation.
Caregiver's quality of life
Comparison in the 2 groups. The generic self-questionnaire SF36 consists of 36 items concerning the last four weeks before the test and divided into 8 dimensions (Physical activity ; Life and relationships with others ; Physical pain; Perceived health ; Vitality; Limitations due to the psychological state; Limitations due to the physical state; Psychological health).
These eight dimensions are used to measure two summary scores of the quality of life of individuals: the physical composite score (PCS) and the mental composite score (MCS). (score from 0 to 100).
A low score reflects a perception of poor health, loss of function, presence of pain. A high score reflects a perception of good health, absence of functional deficit and pain.
Measured: at month 6 (M6) and month 12 (M12) post-randomisation.
Caregiver's satisfaction
Only arm B. P-GIC questionnaire consists of a single question asking the caregiver about their overall impression of change in specific support care. The caregiver is given the following 8 options and asked to indicate which of these best describes the perceived change: I don't know, Very strongly positive, Strongly positive, Slightly positive, No change, Slightly negative, Strongly negative, Very strongly negative.
Measured: at month 6 (M6) and month 12 (M12) post-randomisation.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2023
- Study startJul 2023 (estimated)
- Primary completionJan 2027 (estimated)
- Study completionJun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OncologyStudies 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
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Institut Cancerologie de l'Ouest
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Céline THOMAS, Nurse, Principal investigator, Institut de Cancérologie de l'Ouest
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05750836
- Sponsor's protocol ID
- ICO-2022-03
- Acronym
- PREPAC-01
- Status last verified
- Feb 2023
- First submitted
- 20 Feb 2023
- Last updated
- 28 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment and Prevention of Caregiver Burden in Oncology
- ClinicalTrials.gov ID
- NCT05750836
- Acronym / sponsor ID
- PREPAC-01 / ICO-2022-03
- Conditions
- Oncology, Caregiver Burden
- Keywords
- Nurse, Supportive Care, Zarit scale, Caregiver Burden
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- Institut Cancerologie de l'OuestUniversity, hospital or other
- Study start
- Jul 2023 (estimated)
- Primary completion
- Jan 2027 (estimated)
- Study completion
- Jun 2027 (estimated)
- First posted
- 2 Mar 2023 (actual)
- 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 goal of this randomized, open and controlled supportive care study is to see if we can reduce the burden on the caregiver by offering the caregiver systematic and regular support from the nurse (APN, nurse coordinator in French health care organisations) compared to a support focused on the patient. At the same time, we will also evaluate the impact of this personalised support for the caregiver on their anxiety and quality of life.
Participants will caregivers of a patient who started a line (any line) of systemic treatment for a solid tumour since less than 3 months or in an active palliative situation since less than 1 month.
Researchers will compare 2 groups : a group where caregivers benefit from specific nursing support and a group of caregivers with no specific nursing support.
The specific support includes 3 mandatory on-site nursing consultations with the patient's caregiver and interviews once a month with a nurse either by phone, on-site consultation or teleconsultation.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Specific nursing support | Experimental | Other: Specific nursing supportThe caregivers benefit from specific nursing support. |
| No specific nursing support | Active comparator | Other: Non-specific nursing supportCaregivers do not receive any specific support from the nurses. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Caregiver designated by the patient;
- Caregiver of a patient who started a line (any line) of systemic treatment for a solid tumour since less than 3 months or in an active palliative situation since less than 1 month;
- Caregiver of patient already cared for by a nurse before inclusion or going to start a nursing follow-up;
- Caregiver of a patient with a score ≥2 of social fragility and/or psychological fragility and/or nutritional fragility and/or complexity;
Key exclusion criteria (3 listed)
- Patient whose life expectancy is assumed to be < 6 months;
- Patient living in an institution (EHPAD, MAS, SSR, MCO, USLD) at inclusion;
- Caregiver declared as having a pathology that could alter his/her capacity to support (psychiatric history, dementia…) or under guardianship.
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 |
|---|---|---|
| Specific nursing support* 3 mandatory on-site nursing consultations with the patient's caregiver at inclusion, 6 months and 12 months post-randomisation.The caregivers will complete the questionnaires (Zarit scale, Hospital Anxiety and Depression scale, Medical Outcome Study Short Form - 36, Caregiver's satisfaction). * interviews once a month with a nurse either by phone, on-site consultation or teleconsultation. Nurses assess the general health of the caregiver and Identify the socio-professional situation of the caregiver | Other | Specific nursing support |
| Non-specific nursing supportCaregivers will only have to complete on site Health indicators, Zarit scale, Hospital Anxiety and Depression scale, Medical Outcome Study Short Form - 36 at inclusion, 6 months and 12 months post-randomisation. | Other | No specific nursing support |
Primary outcome
Caregiver burden
Time frame: at 6 months post-randomisation
Comparison in the 2 groups. Burden score is assessed using the ZARIT SCALE. The test consists of 22 questions that the caregiver has to score from 0 to 4, the whole giving a score from 0 to 88. 0 means no burden, 88 means that the burden is severe
3 secondary outcomes
The level of anxiety/depression of the caregiver
Time frame: at month 6 (M6) and month 12 (M12) post-randomisation.
Caregiver's quality of life
Time frame: at month 6 (M6) and month 12 (M12) post-randomisation.
Caregiver's satisfaction
Time frame: at month 6 (M6) and month 12 (M12) post-randomisation.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jun 2023.
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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.
Céline THOMAS, Nurse principal investigator
Institut de Cancérologie de l'Ouest
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Specific nursing support and Non-specific nursing support in people with Oncology and Caregiver Burden, run by Institut Cancerologie de l'Ouest 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 4 inclusion and 3 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: opening soon, as of the sponsor's last update on 28 Jun 2023. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Céline THOMAS, Nurse ((0)2 40 67 97 49 ext. +33, celine.thomas@ico.unicancer.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Caregiver burden (time frame: at 6 months post-randomisation). 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 Jun 2023.