Clinical trial NCT03875885: CONNECTing Head and Neck Caregivers to Supportive Care Resources
Official title: CONNECTing Caregivers to Supportive Services (CONNECT): A Technology-Based Intervention to Connect Cancer Caregivers With Supportive Care Resources
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Head and Neck Cancer
Keywords: Head and Neck Cancer Caregivers
Lead sponsor: Wake Forest University Health Sciences
Sponsor class: OTHER
Collaborators: name: National Center for Advancing Translational Sciences (NCATS)
First posted: 2019-03-15
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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 benefits of supportive care resources, identify their unmet needs, and connect them with resources.

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 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.

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.

Primary outcomes:
measure: Proportion of Caregivers Who Agree to Participate
timeFrame: 19 months
measure: Number of Eligible Participants
timeFrame: 9 months
measure: Number of Retention of Participants
timeFrame: 9 months
measure: Acceptability - (Intervention Arm Only)
timeFrame: 9 months
measure: Acceptability - (Intervention Arm Only)
timeFrame: 9 months
Secondary outcomes:
Other outcomes:
measure: SF-12 Patient Measures - Physical/Emotional Well-being
timeFrame: 1 year
measure: Unplanned Healthcare Utilization Survey
timeFrame: 1 year
measure: FAMCARE Questionnaire (Patient)
timeFrame: 1 year
measure: PROMIS Emotional Distress-Anxiety-Short Form 8a for Patients
timeFrame: 1 year
measure: PROMIS Emotional Distress- Depression-Short Form 8a for Patients
timeFrame: 1 year
measure: Patient - Quality of Life Functional Assessment of Cancer Therapy - Head and Neck (FACT-H&N)
timeFrame: 1 year
measure: Supportive Care Utilization
timeFrame: 1 year
measure: FAMCARE Questionnaire (Caregiver)
timeFrame: 1 year
measure: Caregiver Reaction Assessment
timeFrame: 1 year
measure: PROMIS Emotional Distress-Anxiety-Short Form 8a
timeFrame: 1 year
measure: PROMIS Emotional Distress- Depression-Short Form 8a
timeFrame: 1 year
measure: Caregiver Quality of Life Index-Cancer (CqoL-Canc)
timeFrame: 1 year
measure: Caregiver Risk Scale
timeFrame: 1 year
measure: Caregiver Adherence to Referral Survey
timeFrame: 1 year
measure: Caregiving Self-Efficacy Scale
timeFrame: 1 year
measure: Barriers to Supportive Care Use Survey
timeFrame: 1 year
Locations:
city: Winston-Salem
country: United States
facility: Wake Forest Baptist Comprehensive Cancer Center
state: North Carolina
Study officials:
affiliation: Wake Forest University Health Sciences
name: Chandylen Nightingale, PhD, MPH
role: PRINCIPAL_INVESTIGATOR
References: