CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 35 enrolled
Drug / intervention
Communication Intervention +5 moreother
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03032250
NCT03032250N/ACompleted
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Prepare to Care, A Supported Self-Management Intervention for Head and Neck Cancer Caregivers

Wake Forest University Health Sciences·interventional·Posted Jan 26, 2017·Updated Jan 9, 2023

In Brief

A clinical study evaluating Communication Intervention, Watch video, and 4 other interventions for Caregiver and 37 related conditions. Completed, enrolled 35 participants across 1 site.

Detailed Summary

This pilot clinical trial studies how well Prepare to Care kit works in improving caregiver support in patients with stage I-IV head and neck cancer that is new or has come back. Prepare to Care kit may increase knowledge about head and neck cancer and enhance stress-management skills.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCaregiver, Malignant Head and Neck Neoplasm, Paranasal Sinus Squamous Cell Carcinoma, Salivary Gland Squamous Cell Carcinoma, Stage I Hypopharyngeal Squamous Cell Carcinoma, Stage I Laryngeal Squamous Cell Carcinoma, Stage I Lip and Oral Cavity Squamous Cell Carcinoma, Stage I Oropharyngeal Squamous Cell Carcinoma, Stage II Hypopharyngeal Squamous Cell Carcinoma, Stage II Laryngeal Squamous Cell Carcinoma, Stage II Lip and Oral Cavity Squamous Cell Carcinoma, Stage II Oropharyngeal Squamous Cell Carcinoma, Stage III Hypopharyngeal Squamous Cell Carcinoma, Stage III Laryngeal Squamous Cell Carcinoma, Stage III Lip and Oral Cavity Squamous Cell Carcinoma, Stage III Oropharyngeal Squamous Cell Carcinoma, Stage IV Hypopharyngeal Squamous Cell Carcinoma, Stage IV Laryngeal Squamous Cell Carcinoma, Stage IV Lip and Oral Cavity Squamous Cell Carcinoma, Stage IV Oropharyngeal Squamous Cell Carcinoma, Stage IVA Hypopharyngeal Squamous Cell Carcinoma, Stage IVA Laryngeal Squamous Cell Carcinoma, Stage IVA Lip and Oral Cavity Squamous Cell Carcinoma, Stage IVA Oropharyngeal Squamous Cell Carcinoma, Stage IVB Hypopharyngeal Squamous Cell Carcinoma, Stage IVB Laryngeal Squamous Cell Carcinoma, Stage IVB Lip and Oral Cavity Squamous Cell Carcinoma, Stage IVB Oropharyngeal Squamous Cell Carcinoma, Stage IVC Hypopharyngeal Squamous Cell Carcinoma, Stage IVC Laryngeal Squamous Cell Carcinoma, Stage IVC Lip and Oral Cavity Squamous Cell Carcinoma, Stage IVC Oropharyngeal Squamous Cell Carcinoma, Recurrent Head and Neck Squamous Cell Carcinoma, Recurrent Hypopharyngeal Squamous Cell Carcinoma, Recurrent Laryngeal Squamous Cell Carcinoma, Recurrent Lip and Oral Cavity Squamous Cell Carcinoma, Recurrent Oropharyngeal SCC, Recurrent Paranasal Sinus Squamous Cell Carcinoma
CountriesUnited States
CollaboratorsNational Cancer Institute (NCI)

Timeline

N/ACompletedFinished
2017201820192020202120222023202420252026
First PostedJan 26, 2017
Enrollment StartMay 15, 2017
Primary CompletionApr 10, 2020
TodayJul 2, 2026
Enrollment to primary: 2.9 yearsPosted 9.4 years ago

Interventions

Communication Interventionother

Attend interventionist sessions

Watch videoother

Watch video on a DVD

Module completion of the Prepare to Care kitother

Complete modules of the Prepare to Care kit

Quality-of-Life Assessmentother

Ancillary studies

Survey Administrationother

Ancillary studies

Salivary cortisol collectionother

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.