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Clinical Trial NCT05750836 (PREPAC-01) for Oncology, Caregiver Burden is not yet recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here. | ||
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Assessment and Prevention of Caregiver Burden in Oncology (PREPAC-01) 250 Randomized Prevention
Clinical Trial NCT05750836 (PREPAC-01) is an interventional study for Oncology, Caregiver Burden and is currently not yet recruiting. Enrollment is planned to begin on 1 July 2023 and continue until the study accrues 250 participants. Led by Institut Cancerologie de l'Ouest, this study is expected to complete by 1 June 2027. The latest data from ClinicalTrials.gov was last updated on 28 June 2023.
Brief 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. At the same time, we will also evaluate the impact of this personalised support for the caregiver on their anxiety ...Show More
Official Title
Assessment and Prevention of Caregiver Burden in Oncology
Conditions
OncologyCaregiver BurdenOther Study IDs
- PREPAC-01
- ICO-2022-03
NCT ID Number
Start Date (Actual)
2023-07
Last Update Posted
2023-06-28
Completion Date (Estimated)
2027-06
Enrollment (Estimated)
250
Study Type
Interventional
PHASE
N/A
Status
Not yet recruiting
Keywords
Nurse
Supportive Care
Zarit scale
Caregiver Burden
Supportive Care
Zarit scale
Caregiver Burden
Primary Purpose
Supportive Care
Design Allocation
Randomized
Interventional Model
Parallel
Masking
None (Open Label)
Arms / Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
ExperimentalSpecific nursing support The caregivers benefit from specific nursing support. | 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...Show More |
Active ComparatorNo specific nursing support Caregivers do not receive any specific support from the nurses. | Non-specific nursing support 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. |
Primary Outcome Measures
Secondary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
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 | at 6 months post-randomisation |
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
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). | 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. | 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. | at month 6 (M6) and month 12 (M12) post-randomisation. |
Participation Assistant
Eligibility Criteria
Eligible Ages
Adult, Older Adult
Minimum Age
18 Years
Eligible Sexes
All
- 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;
- 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.
Institut Cancerologie de l'OuestStudy Central Contact
Contact: Céline THOMAS, Nurse, (0)2 40 67 97 49, [email protected]
Contact: Emilie DEBEAUPUIS, (0)240679844, [email protected]
5 Study Locations in 1 Countries
CH Cholet, Cholet, 49300, France
Margot NOBLECOURT, MD, Contact, [email protected]
Centre Antoine Lacassagne, Nice, 06 189, France
julie OUDIN, Nurse, Contact, [email protected]
Centre Henri Bequerel, Rouen, 76038, France
Amel CONSTANTIN, Nurse, Contact, [email protected]
Institut de Cancérologie de l'Ouest, Saint-Herblain, 44805, France
Céline THOMAS, Nurse, Contact, [email protected]
CH Mémorial de Saint Lo, Saint-Lô, 50000, France
Emillie LEFEVRE, Nurse, Contact, [email protected]