Skip to main content
OpenTrials
Recruiting

NCT Number: NCT05542706

Benefit of Paramedical Care in Accompanying Caregivers of Patients That Had Surgery for an Head and Neck Invasive Cancer

Head and Neck invasive cancer usually requires surgery that is associated with modifications of the body structure of patient regarding breathing, eating and communication. These modifications are correlated with an important loss of autonomy in patients. During the study, while the patient is hospitalised after the surgery, the paramedical team will train the caregiver of the patient from experimental group a new dimension of autonomy in order to assure a safe return home. The level of learning depends on each caregiver and patient; therefore, an adapted training is provided.

This study evaluates the impact of paramedical care in accompanying caregivers of patients that had surgery for an ENT invasive cancer, by comparing the experimental group (paramedical care) to the standard group (standard care).

The hypothesis of the study is that a benefit will be seen in the experimental group, by reducing the caregiver burden, improving the quality of life of patients and lowering the rate of hospitalisations and prolonged hospitalisations in these patients.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Head and Neck Cancer Head and Neck Neoplasms Neoplasms Neoplasms by Site

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

Patients :

  • Age between 18 and 85 years old
  • ECOG ≤ 2
  • Patient diagnosed with an head and neck squamous-cell carcinoma, stage T2-T4/N+, non-metastatic, localised at larynx, pharynx, oropharynx, oral cavity or maxillary, needing curative surgery, with indication of radiotherapy after surgery, in accordance to decision of the regular multidisciplinary meetings in cancerology
  • No ongoing measure of corrective justice for the patient
  • Informed consent form signed
  • Patient covered by health system

Exclusion criteria

  • Patient scheduled for surgery after radiotherapy or for surgery on site already irradiated
  • Patient or caregiver that do not agree to participate in the study (the pair patient-caregiver is needed)
  • History of psychological or sensorial disorder or anomaly that can prevent the patient from understanding the conditions for study participation

Treatment and study plan

Accompanying caregivers by paramedical team

Other

At each study visit (baseline, one week after hospital discharge, 4-8 weeks after surgery, 8-12 weeks after surgery and 16-20 weeks after surgery), the paramedical team have a dedicated meeting with the caregiver of the patient (at hospital or remote) and teach them the care procedures needed in accompanying the patient and the evaluate the learning progress. The training is adapted to each caregiver, according to his/her motivation and his/her ability. The goal is to have the training regarding the enteral nutrition, prevention of dehydration, pain management.

Primary outcomes

  1. Comparison of the impact of paramedical care on the caregiving burden between the two groups

    Time frame: At 20 weeks after surgery

    Via Zarit Burden Interview

Secondary outcomes

  1. Comparison of the impact of paramedical care on the caregiving burden between the two groups

    Time frame: At 8 weeks after surgery

    Via Zarit Burden Interview

  2. Comparison of the impact of paramedical care on the caregiving burden between the two groups

    Time frame: At 12 weeks after surgery

    Via Zarit Burden Interview

  3. Measure of quality of life in the two groups

    Time frame: baseline

    WHOQOL-26

  4. Measure of quality of life in the two groups

    Time frame: baseline

    QLQ-H&N35

  5. Measure of quality of life in the two groups

    Time frame: one week after hospital discharge

    QLQ-H&N35

  6. Measure of quality of life in the two groups

    Time frame: one week after hospital discharge

    WHOQOL-26

  7. Measure of quality of life in the two groups

    Time frame: between 4 and 8 weeks after surgery

    QLQ-H&N35

  8. Measure of quality of life in the two groups

    Time frame: between 8 and 12 weeks after surgery

    WHOQOL-26

  9. Measure of quality of life in the two groups

    Time frame: between 16 and 20 weeks after surgery

    WHOQOL-26

  10. Measure of quality of life in the two groups

    Time frame: between 16 and 20 weeks after surgery

    Via QLQ-H&N35

Study contacts

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

Doriane Richard

CONTACT

[email protected]

+33232082985

Yveline David

CONTACT

[email protected]

+33232082542

Sponsors and collaborators

Lead sponsor

Centre Henri Becquerel

Other

Registry information

Acronym: AIDORL

Important dates

Study start
2022
Primary completion
2026
Study completion
2027
First posted
Sep 15, 2022
Registry last updated
Jan 2, 2026

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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.