N/A
Completed N=40
CONNECTing Head and Neck Caregivers to Supportive Care Resources
Source: ClinicalTrials.gov NCT03875885 ↗Enrolled (actual)
40
Serious AEs
0.0%
Results posted
Apr 2023
Primary outcomePrimary: Proportion of Caregivers Who Agree to Participate — 2.1 participants per month
Summary
The purpose of this research is to determine feasibility and acceptability of randomized pilot trial to evaluate a technology-based intervention (CONNECT) to empower and educate caregivers about the benefits of supportive care resources, identify their unmet needs, and connect them with resources.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Proportion of Caregivers Who Agree to Participate |
2.1 | — |
| PRIMARY Number of Eligible Participants |
40 | — |
| PRIMARY Number of Retention of Participants |
32 | — |
| PRIMARY Acceptability - (Intervention Arm Only) |
2; 7; 5 | — |
Eligibility Criteria
Inclusion Criteria
Eligible caregivers include those who are:
- Caregivers must be providing some capacity of informal (unpaid) care for a patient meeting patient eligibility criteria. If a patient unexpectedly becomes deceased during the study period, caregivers will be allowed to continue participation in the assigned study arm and complete study assessments if they wish to.
- Greater than or equal to 18 years of age.
- Ability to access study materials by internet or complete study activities in person as institutional and government policies allow.
Eligible patients include those who:
- Have new or recurrent American Joint Committee on Cancer (AJCC) stage I-IV head and neck cancer.
- Are receiving cancer treatment or awaiting planned treatment initiation, excluding those receiving neoadjuvant surgery or surgery only.
- Patients must be ambulatory and up more than 50% of waking hours, as measured by an ECOG Performance Status rating of level 0, 1, or 2.
- Greater than or equal to 18 years of age.
- Ability to access study materials by internet or complete study activities in person as institutional and government policies allow.
- Patients must be receiving some capacity of informal care from a caregiver meeting the above criteria. If the caregiver unexpectedly becomes deceased during the study period, the patient will be un-enrolled from this study as we are evaluating a caregiver-only delivered intervention.
Exclusion Criteria
Caregivers will be excluded if:
- Cannot read/communicate in English
Patients will be excluded if they:
- Cannot read/communicate in English
Eligibility to participate in the study is conditional on participation of both the caregiver and patient.
Data sourced from ClinicalTrials.gov (NCT03875885). 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.