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

NCT05542706 | Recruiting

• 2 other identifiers: CHB22.012022-A00687-36
• Study Type: interventional
• Target: 76
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Head and Neck Cancer

Outcome Measures

Primary Outcomes (1)

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

  Via Zarit Burden Interview

  At 20 weeks after surgery

Secondary Outcomes (10)

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

  At 8 weeks after surgery

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

  At 12 weeks after surgery

• Measure of quality of life in the two groups

  baseline

• Measure of quality of life in the two groups

  baseline

• Measure of quality of life in the two groups

  one week after hospital discharge

Study Arms (2)

Accompanying caregivers by paramedical team

EXPERIMENTAL

Other: Accompanying caregivers by paramedical team

No dedicated accompanying by medical team

NO INTERVENTION

Interventions

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.

Accompanying caregivers by paramedical team

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre Henri Becquerel: lead

Study Sites (1)

Centre Henri Becquerel

Rouen, France

RECRUITING

MeSH Terms

Conditions

Head and Neck Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms

Study Officials

• Yveline David

  Centre Henri Becquerel

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yveline David

CONTACT

+33232082542; yveline.david@chb.unicancer.fr

Doriane Richard

CONTACT

+33232082985; doriane.richard@chb.unicancer.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 9, 2022
• First Posted: September 15, 2022
• Study Start: October 31, 2022
• Primary Completion (Estimated): October 31, 2026
• Study Completion (Estimated): October 31, 2027
• Last Updated: January 2, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)