N/A
Completed N=35
Prepare to Care, A Supported Self-Management Intervention for Head and Neck Cancer CaregiversHead and Neck Cancer
Caregiver · Head and Neck Cancer · Paranasal Sinus Squamous Cell Carcinoma · Salivary Gland Squamous Cell Carcinoma
Source: ClinicalTrials.gov NCT03032250 ↗
Enrolled (actual)
35
Serious AEs
0.0%
Results posted
Jul 2021
Primary outcomePrimary: Number of Participants Noting Quite a Bit/Very Much Helpful to Survey Questions — 4; 6; 7; 6 Participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants Noting Quite a Bit/Very Much Helpful to Survey Questions |
4; 6; 7; 6; 4; 0 | — |
| PRIMARY Accrual Assessed by Number of Caregivers Who Agreed to Participate Divided by the Number of Months of Recruitment |
1.7 | — |
| PRIMARY Change in Caregiver Burden Assessed by Caregiver Reaction Assessment (CRA) |
25.98; 25.88; 11.29; 11.25; 8.29; 8.89 | — |
| PRIMARY Change in Psychological Distress - Center for Epidemiological Studies Depression (CESD) |
19.71; 19.28; 19.00; 13.58 | — |
| PRIMARY Change in Quality of Life Assessed by Caregiver Quality of Life Index-Cancer (CqoL-Canc) |
87.63; 87.26; 92.55; 89.86 | — |
| PRIMARY Frequency of Intervention Modules Utilized Assessed by Caregiver Logs |
22.3; 38.7; 55.2; 40.3; 40.8; 66.7 | — |
| PRIMARY Number of Participants in Agreement to Perform Interventions |
38 | — |
| PRIMARY Retention Assessed by Number of Participants Who Completed the End of Radiotherapy Visit Divided by the Number Who Agreed to Participate |
12; 16 | — |
| PRIMARY Self-efficacy in Abbreviated Progressive Muscle Relaxation (APMR) |
11.88; 13.33; 16.08; 12.19 | — |
| PRIMARY Self-efficacy in Coping With Cancer Caregiver Inventory |
22.35; 22.00; 52.94; 55.11; 25.71; 28.06 | — |
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
Data sourced from ClinicalTrials.gov (NCT03032250). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.