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

NCT ID: NCT05542706

Last Updated: 2022-12-23

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 76 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-10-31
• Study Completion Date: 2025-09-13

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Accompanying caregivers by paramedical team

Group Type: EXPERIMENTAL

Accompanying caregivers by paramedical team

Intervention Type: 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.

No dedicated accompanying by medical team

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Accompanying caregivers by paramedical team

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.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Centre Henri Becquerel

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Yveline David

Role: PRINCIPAL_INVESTIGATOR

Centre Henri Becquerel

Locations

Centre Henri Becquerel

Rouen, , France

Site Status: RECRUITING

Countries

France

Central Contacts

Yveline David

Role: CONTACT

Phone: +33232082542

Email: yveline.david@chb.unicancer.fr

Doriane Richard

Role: CONTACT

Phone: +33232082985

Email: doriane.richard@chb.unicancer.fr

Facility Contacts

Yveline David

Role: primary

Other Identifiers

2022-A00687-36

Identifier Type: OTHER

Identifier Source: secondary_id

CHB22.01

Identifier Type: -

Identifier Source: org_study_id