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

Wake Forest University (WFU)

Status

Completed

Conditions

Stage I Laryngeal Squamous Cell Carcinoma

Stage II Lip and Oral Cavity Squamous Cell Carcinoma

Recurrent Hypopharyngeal Squamous Cell Carcinoma

Stage IVB Lip and Oral Cavity Squamous Cell Carcinoma

Stage III Laryngeal Squamous Cell Carcinoma

Recurrent Laryngeal Squamous Cell Carcinoma

Stage IV Oropharyngeal Squamous Cell Carcinoma

Stage IVA Hypopharyngeal Squamous Cell Carcinoma

Stage IV Hypopharyngeal Squamous Cell Carcinoma

Stage I Oropharyngeal Squamous Cell Carcinoma

Stage I Lip and Oral Cavity Squamous Cell Carcinoma

Stage IVA Oropharyngeal Squamous Cell Carcinoma

Recurrent Lip and Oral Cavity Squamous Cell Carcinoma

Stage II Oropharyngeal Squamous Cell Carcinoma

Recurrent Oropharyngeal SCC

Stage IVB Hypopharyngeal Squamous Cell Carcinoma

Salivary Gland Squamous Cell Carcinoma

Stage IVA Laryngeal Squamous Cell Carcinoma

Caregiver

Stage IV Lip and Oral Cavity Squamous Cell Carcinoma

Stage IV Laryngeal Squamous Cell Carcinoma

Stage III Lip and Oral Cavity Squamous Cell Carcinoma

Malignant Head and Neck Neoplasm

Stage III Oropharyngeal Squamous Cell Carcinoma

Stage III Hypopharyngeal Squamous Cell Carcinoma

Paranasal Sinus Squamous Cell Carcinoma

Recurrent Paranasal Sinus Squamous Cell Carcinoma

Stage IVC Oropharyngeal Squamous Cell Carcinoma

Stage II Hypopharyngeal Squamous Cell Carcinoma

Stage IVB Oropharyngeal Squamous Cell Carcinoma

Stage IVC Lip and Oral Cavity Squamous Cell Carcinoma

Stage IVB Laryngeal Squamous Cell Carcinoma

Stage II Laryngeal Squamous Cell Carcinoma

Stage IVC Hypopharyngeal Squamous Cell Carcinoma

Stage I Hypopharyngeal Squamous Cell Carcinoma

Stage IVA Lip and Oral Cavity Squamous Cell Carcinoma

Recurrent Head and Neck Squamous Cell Carcinoma

Stage IVC Laryngeal Squamous Cell Carcinoma

Treatments

Other: Salivary cortisol collection

Other: Survey Administration

Other: Quality-of-Life Assessment

Other: Communication Intervention

Other: Module completion of the Prepare to Care kit

Other: Watch video

Study type

Interventional

Funder types

Other

NIH

Identifiers

NCT03032250

NCI-2016-02045 (Registry Identifier)

P30CA012197 (U.S. NIH Grant/Contract)

IRB00038084

CCCWFU 99616 (Other Identifier)

R03CA208560 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full description

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 (intervention group n=20; waitlist control group, 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) in intervention caregivers and waitlist control caregivers at the start of radiation (T1), end of radiation (T2), and 6-weeks post-radiation (T3).

III. To compare intermediate (self-efficacy for (a) coping with cancer and (b) abbreviated progressive muscle relaxation) and outcome variables (burden, psychological distress, quality of life) between intervention caregivers and waitlist control caregivers at T1, T2, and T3.

IV. To obtain preliminary data on caregiver cortisol response (cortisol slope, cortisol awakening

OUTLINE: Patients are randomized to 1 of 2 groups.

GROUP I: 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.

GROUP II: Caregivers receive educational intervention as in Group I but do not attend interventionist sessions.

Enrollment

35 patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

CAREGIVERS:

Providing the majority of the informal (unpaid) care during radiation therapy for a patient meeting inclusion criteria and participating in study

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
Has an informal (unpaid) caregiver during radiation therapy who is participating in study

Exclusion criteria

CAREGIVERS: Has a current cancer diagnosis
CAREGIVERS: Cannot read/communicate in English
CAREGIVERS: Have an endocrine disorder (e.g., diabetes and thyroid disorders), or is currently taking a steroid based medication will not be eligible to participate in the saliva portion of the study
CARE-RECIPIENTS: Cannot read/communicate in English

Trial design

Primary purpose

Supportive Care

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

35 participants in 2 patient groups

Group I Supportive Care (Prepare to Care kit)

Experimental group

Description:

Caregivers watch introduction video on a 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.

Treatment: