Clinical trial NCT03032250: Prepare to Care, A Supported Self-Management Intervention for Head and Neck Cancer CaregiversHead and Neck Cancer
Official title: Prepare to Care, A Supported Self-Management Intervention for Head and Neck Cancer Caregivers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Caregiver
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
Lead sponsor: Wake Forest University Health Sciences
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2017-01-26
Enrollment: 35
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Number of Participants Noting Quite a Bit/Very Much Helpful to Survey Questions
timeFrame: Six weeks post radiation therapy
measure: Accrual Assessed by Number of Caregivers Who Agreed to Participate Divided by the Number of Months of Recruitment
timeFrame: Up to 1 year
measure: Change in Caregiver Burden Assessed by Caregiver Reaction Assessment (CRA)
timeFrame: Baseline and following radiotherapy, assessed up to 1 year
measure: Change in Psychological Distress - Center for Epidemiological Studies Depression (CESD)
timeFrame: Before and after radiotherapy, assessed up to 1 year
measure: Change in Quality of Life Assessed by Caregiver Quality of Life Index-Cancer (CqoL-Canc)
timeFrame: Before and after radiotherapy, assessed up to 1 year
measure: Frequency of Intervention Modules Utilized Assessed by Caregiver Logs
timeFrame: Up to 1 year
measure: Number of Participants in Agreement to Perform Interventions
timeFrame: Up to 1 year
measure: Retention Assessed by Number of Participants Who Completed the End of Radiotherapy Visit Divided by the Number Who Agreed to Participate
timeFrame: Up to 1 year
measure: Self-efficacy in Abbreviated Progressive Muscle Relaxation (APMR)
timeFrame: At baseline and up to the end of radiotherapy, assessed up to 1 year
measure: Self-efficacy in Coping With Cancer Caregiver Inventory
timeFrame: At baseline and up to the end of radiotherapy, assessed up to 1 year
Secondary outcomes:
Other outcomes:
measure: Salivary Cortisol Collection
timeFrame: Up to 1 year
Locations:
city: Winston-Salem
country: United States
facility: Comprehensive Cancer Center of Wake Forest University
state: North Carolina
Study officials:
affiliation: Wake Forest University Health Sciences
name: Chandylen Nightingale
role: PRINCIPAL_INVESTIGATOR
References:
citation: Nightingale C, Sterba KR, Levine B, Tooze JA, Greven K, Frizzell B, Hughes RT, Snavely A, Lesser GJ, Norona S, Pleasant K, Weaver KE. Feasibility and Acceptability of a Multi-Modality Self-Management Intervention for Head and Neck Cancer Caregivers: A Pilot Randomized Trial. Integr Cancer Ther. 2022 Jan-Dec;21:15347354221098984. doi: 10.1177/15347354221098984.