Clinical trial · Interventional
Prepare to Care, A Supported Self-Management Intervention for Head and Neck Cancer CaregiversHead and Neck Cancer
Prepare to Care, A Supported Self-Management Intervention for Head and Neck Cancer Caregivers
NCT03032250CI-TRIAL-00063081completedN/AResults postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (38)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Caregiver | — | UNRESOLVED | — |
| Malignant Head and Neck Neoplasm | Malignant Head and Neck Neoplasm | ONTOLOGY_EXACT | 0.98 |
| Paranasal Sinus Squamous Cell Carcinoma | Paranasal Sinus Squamous Cell Carcinoma | ONTOLOGY_EXACT | 0.98 |
| Recurrent Head and Neck Squamous Cell Carcinoma | Head and Neck Squamous Cell Carcinoma | CURATED_BROADER | 0.78 |
| Recurrent Hypopharyngeal Squamous Cell Carcinoma | Hypopharyngeal Squamous Cell Carcinoma | CURATED_BROADER | 0.78 |
| Recurrent Laryngeal Squamous Cell Carcinoma | Laryngeal Squamous Cell Carcinoma | CURATED_BROADER | 0.78 |
| Recurrent Lip and Oral Cavity Squamous Cell Carcinoma | Lip and Oral Cavity Squamous Cell Carcinoma | CURATED_BROADER | 0.78 |
| Recurrent Oropharyngeal SCC | — | UNRESOLVED |
Interventions
Interventions (6)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Communication Intervention | Other | — | UNRESOLVED |
| Module completion of the Prepare to Care kit | Other | — | UNRESOLVED |
| Quality-of-Life Assessment | Other | — | UNRESOLVED |
| Salivary cortisol collection | Other | — | UNRESOLVED |
| Survey Administration | Other | — | UNRESOLVED |
| Watch video | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Group I Supportive Care (Prepare to Care kit)
- 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.
- interventionNames
- Other: Communication Intervention
- Other: Watch video
- Other: Module completion of the Prepare to Care kit
- Other: Quality-of-Life Assessment
- Other: Survey Administration
- Other: Salivary cortisol collection
- type
- EXPERIMENTAL
- label
- Group II Control Group
- description
- Caregivers received standard of care throughout course of intervention, with option to receive study intervention at end of study
- interventionNames
- Other: Watch video
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (1)
- DERIVEDNightingale 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. PMID 35575280