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NCT Number: NCT05750836

Assessment and Prevention of Caregiver Burden in Oncology

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.

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Key information

Conditions

Oncology Behavior Behavioral Symptoms Caregiver Burden Neoplasms Stress, Psychological

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CH Cholet, Cholet, France

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Specific nursing support

Other
  • 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 support

Other

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 outcomes

  1. 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

Secondary outcomes

  1. The level of anxiety/depression of the caregiver

    Time frame: 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).

  2. Caregiver's quality of life

    Time frame: 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.

  3. Caregiver's satisfaction

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Céline THOMAS, Nurse

CONTACT

[email protected]

(0)2 40 67 97 49 ext. +33

Emilie DEBEAUPUIS

CONTACT

[email protected]

(0)240679844 ext. +33

Sponsors and collaborators

Lead sponsor

Institut Cancerologie de l'Ouest

Other

Registry information

Acronym: PREPAC-01

Important dates

Study start
2023
Primary completion
2027
Study completion
2027
First posted
Mar 2, 2023
Registry last updated
Jun 28, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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