Status:
COMPLETED
CONNECTing Head and Neck Caregivers to Supportive Care Resources
Lead Sponsor:
Wake Forest University Health Sciences
Collaborating Sponsors:
National Center for Advancing Translational Sciences (NCATS)
Conditions:
Head and Neck Cancer
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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 b...
Detailed Description
The registration is for Objective two and three that refers to the clinical trial. The investigators will determine their ability to recruit caregivers of patients with head and neck cancer being trea...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
September 16 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 31 2022
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT03875885
Start Date
September 16 2020
End Date
May 31 2022
Last Update
April 27 2023
Active Locations (1)
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1
Wake Forest Baptist Comprehensive Cancer Center
Winston-Salem, North Carolina, United States, 27157