Assessment and Prevention of Caregiver Burden in Oncology (PREPAC-01)
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 Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Céline THOMAS, Nurse
- Phone Number: +33 (0)2 40 67 97 49
- Email: celine.thomas@ico.unicancer.fr
Study Contact Backup
- Name: Emilie DEBEAUPUIS
- Phone Number: +33 (0)240679844
- Email: emilie.debeaupuis@ico.unicancer.fr
Study Locations
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Cholet, France, 49300
- CH Cholet
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Contact:
- Margot NOBLECOURT, MD
- Email: margot.noblecourt@ch-cholet.fr
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Nice, France, 06 189
- Centre Antoine Lacassagne
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Contact:
- julie OUDIN, Nurse
- Email: Julie.oudin@nice.unicancer.fr
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Rouen, France, 76038
- Centre Henri Bequerel
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Contact:
- Amel CONSTANTIN, Nurse
- Email: amel.benchemam@chb.unicancer.fr
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Saint Herblain, France, 44805
- Institut de Cancérologie de l'Ouest
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Contact:
- Céline THOMAS, Nurse
- Email: celine.thomas@ico.unicancer.fr
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Saint Lo, France, 50000
- CH Mémorial de Saint Lo
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Contact:
- Emillie LEFEVRE, Nurse
- Email: emilie.lefevre@ch-stlo.fr
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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;
Exclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Specific nursing support
The caregivers benefit from specific nursing support.
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Nurses assess the general health of the caregiver and Identify the socio-professional situation of the caregiver |
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Active Comparator: No specific nursing support
Caregivers do not receive any specific support from the nurses.
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Caregiver burden
Time Frame: at 6 months post-randomisation
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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
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at 6 months post-randomisation
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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The level of anxiety/depression of the caregiver
Time Frame: at month 6 (M6) and month 12 (M12) post-randomisation.
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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:
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at month 6 (M6) and month 12 (M12) post-randomisation.
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Caregiver's quality of life
Time Frame: at month 6 (M6) and month 12 (M12) post-randomisation.
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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.
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Caregiver's satisfaction
Time Frame: at month 6 (M6) and month 12 (M12) post-randomisation.
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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.
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at month 6 (M6) and month 12 (M12) post-randomisation.
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Céline THOMAS, Nurse, Institut de Cancérologie de l'Ouest
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- ICO-2022-03
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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