PREPAC-01: Assessment and Prevention of Caregiver Burden in Oncology

Sponsor

Institut Cancerologie de l'Ouest (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05750836

Collaborator

(none)

250

Enrollment

Locations

Arms

Anticipated Duration (Months)

Patients Per Site

Patients Per Site Per Month

Study Details

Study Description

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 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.

Condition or Disease	Intervention/Treatment	Phase
Oncology Caregiver Burden	Other: Specific nursing support Other: Non-specific nursing support	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

250 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Supportive Care

Official Title:

Assessment and Prevention of Caregiver Burden in Oncology

Anticipated Study Start Date :

May 1, 2023

Anticipated Primary Completion Date :

Jan 1, 2027

Anticipated Study Completion Date :

Jun 1, 2027

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Arm B The caregivers benefit from specific nursing support.	Other: 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
Active Comparator: Arm A Caregivers do not receive any specific support from the nurses.	Other: 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.

Arm

Intervention/Treatment

Experimental: Arm B

The caregivers benefit from specific nursing support.

Other: 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

Active Comparator: Arm A

Caregivers do not receive any specific support from the nurses.

Other: 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.

Outcome Measures

Primary Outcome Measures

Caregiver burden [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

Secondary Outcome Measures

The level of anxiety/depression of the caregiver [at month 6 (M6) and month 12 (M12) post-randomisation.]
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).
Caregiver's quality of life [at month 6 (M6) and month 12 (M12) post-randomisation.]
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.
Caregiver's satisfaction [at month 6 (M6) and month 12 (M12) post-randomisation.]
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	Country	Postal Code
1	CH Cholet	Cholet	France	49300
2	Centre Antoine Lacassagne	Nice	France	06 189
3	Centre Henri Bequerel	Rouen	France	76038
4	Institut de Cancérologie de l'Ouest	Saint Herblain	France	44805
5	CH Mémorial de Saint Lo	Saint Lo	France	50000