NCT03032250View on ClinicalTrials.gov

Prepare to Care, A Supported Self-Management Intervention for Head and Neck Cancer CaregiversHead and Neck Cancer

NACompletedINTERVENTIONAL
Enrollment

35

Participants

Timeline

Start Date

May 15, 2017

Primary Completion Date

April 10, 2020

Study Completion Date

April 10, 2020

Conditions
CaregiverMalignant Head and Neck NeoplasmParanasal Sinus Squamous Cell CarcinomaSalivary Gland Squamous Cell CarcinomaStage I Hypopharyngeal Squamous Cell CarcinomaStage I Laryngeal Squamous Cell CarcinomaStage I Lip and Oral Cavity Squamous Cell CarcinomaStage I Oropharyngeal Squamous Cell CarcinomaStage II Hypopharyngeal Squamous Cell CarcinomaStage II Laryngeal Squamous Cell CarcinomaStage II Lip and Oral Cavity Squamous Cell CarcinomaStage II Oropharyngeal Squamous Cell CarcinomaStage III Hypopharyngeal Squamous Cell CarcinomaStage III Laryngeal Squamous Cell CarcinomaStage III Lip and Oral Cavity Squamous Cell CarcinomaStage III Oropharyngeal Squamous Cell CarcinomaStage IV Hypopharyngeal Squamous Cell CarcinomaStage IV Laryngeal Squamous Cell CarcinomaStage IV Lip and Oral Cavity Squamous Cell CarcinomaStage IV Oropharyngeal Squamous Cell CarcinomaStage IVA Hypopharyngeal Squamous Cell CarcinomaStage IVA Laryngeal Squamous Cell CarcinomaStage IVA Lip and Oral Cavity Squamous Cell CarcinomaStage IVA Oropharyngeal Squamous Cell CarcinomaStage IVB Hypopharyngeal Squamous Cell CarcinomaStage IVB Laryngeal Squamous Cell CarcinomaStage IVB Lip and Oral Cavity Squamous Cell CarcinomaStage IVB Oropharyngeal Squamous Cell CarcinomaStage IVC Hypopharyngeal Squamous Cell CarcinomaStage IVC Laryngeal Squamous Cell CarcinomaStage IVC Lip and Oral Cavity Squamous Cell CarcinomaStage IVC Oropharyngeal Squamous Cell CarcinomaRecurrent Head and Neck Squamous Cell CarcinomaRecurrent Hypopharyngeal Squamous Cell CarcinomaRecurrent Laryngeal Squamous Cell CarcinomaRecurrent Lip and Oral Cavity Squamous Cell CarcinomaRecurrent Oropharyngeal SCCRecurrent Paranasal Sinus Squamous Cell Carcinoma
Interventions
OTHER

Communication Intervention

Attend interventionist sessions

OTHER

Watch video

Watch video on a DVD

OTHER

Module completion of the Prepare to Care kit

Complete modules of the Prepare to Care kit

OTHER

Quality-of-Life Assessment

Ancillary studies

OTHER

Survey Administration

Ancillary studies

OTHER

Salivary cortisol collection

Obtained at three times a day (at awakening, 30 minutes post awakening and bedtime) for two consecutive days for eligible caregivers in both groups. Samples collected by placing a cotton ball under the tongue for approximately 1-2 minutes which is subsequently stored in a plastic tube and refrigerated.

Trial Locations (1)

27157

Comprehensive Cancer Center of Wake Forest University, Winston-Salem

All Listed Sponsors
collaborator

National Cancer Institute (NCI)

NIH

lead

Wake Forest University Health Sciences

OTHER

NCT03032250 - Prepare to Care, A Supported Self-Management Intervention for Head and Neck Cancer CaregiversHead and Neck Cancer | Biotech Hunter | Biotech Hunter