CONNECTing Head and Neck Caregivers to Supportive Care Resources (CONNECT-HNC)
Status
Conditions
Treatments
Study type
Funder types
Identifiers
Details and patient eligibility
About
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.
Full 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 treated at Wake Forest Baptist Comprehensive Cancer Center to a study that uses a technology-based intervention, CONNECT, which may increase head and neck cancer caregivers' knowledge about the benefits of supportive care resources, identify their unmet needs, and connect them with supportive care resources. In this study the investigators also want to look at their ability to recruit a control group of caregivers, that is, caregivers of patients with head and neck cancer being treated at Wake Forest Baptist Comprehensive Cancer Center that will receive a list of supportive care resources. Control groups are used in research to see if the intervention being studied really does have an effect. In addition, the investigators will determine whether or not the intervention has led to improvements in caregivers' use of supportive care resources, quality of care, and overall quality of life.
Enrollment
Sex
Ages
Volunteers
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.
Trial design
Primary purpose
Allocation
Interventional model
Masking
40 participants in 2 patient groups
Trial contacts and locations
Loading...
Data sourced from clinicaltrials.gov
Clinical trials
Research sites
Resources
Legal