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



Status:Recruiting
Conditions:Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:19 - Any
Updated:7/8/2018
Start Date:May 15, 2017
End Date:May 2019

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

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. Prepare to Care kit may increase
knowledge about head and neck cancer and enhance stress-management skills.

PRIMARY OBJECTIVES:

I. To assess feasibility (accrual, participation, and retention) and acceptability of a
supported self-management intervention for psycho-education and stress management skills
building designed for informal caregivers (n=20) of head and neck cancer (HNC) patients
undergoing radiotherapy (RT).

II. To obtain preliminary data on caregiver intermediate (self-efficacy for [a] coping with
cancer and [b] abbreviated progressive muscle relaxation) and outcome variables (burden,
psychological distress, quality of life) before and after the intervention.

III. To refine intervention procedures and materials for future studies by examining
qualitative data from caregivers and interventionist notes.

IV. To refine intervention procedures and materials for future studies by examining
quantitative data regarding module utilization.

OUTLINE:

Caregivers watch introduction video on a digital video disc (DVD) over 10 minutes at
baseline. Caregivers receive Prepare to Care kit including 8 workbook modules and complete at
least 1 module over 30-45 minutes each week. Caregivers also attend interventionist session
over 10-30 minutes weekly.

Inclusion Criteria:

CAREGIVERS:

- Providing the majority of the informal (unpaid) care during RT for a patient meeting
inclusion criteria

- Planning to live with the patient for the duration of RT

CARE-RECIPIENTS:

- Has a new or recurrent American Joint Committee on Cancer (AJCC) stage I-IV squamous
cell carcinoma of the upper aerodigestive tract (including lip/oral cavity,
nasopharynx, salivary gland, oropharynx, hypopharynx, paranasal sinus, and larynx
cancers)

- Has planned external beam radiotherapy (+/- chemotherapy) for 6-7 weeks

Exclusion Criteria:

- CAREGIVERS: Has a current cancer diagnosis

- CAREGIVERS: Cannot read/communicate in English

- CARE-RECIPIENTS: Has an additional cancer diagnosis

- CARE-RECIPIENTS: Cannot read/communicate in English
We found this trial at
1
site
Medical Center Boulevard
Winston-Salem, North Carolina 27157
336-716-2255
Principal Investigator: Chandylen Nightingale
Phone: 336-713-1432
Comprehensive Cancer Center of Wake Forest University Our newly expanded Comprehensive Cancer Center is the...
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mi
from
Winston-Salem, NC
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