Clinical trial NCT03919864: Connect Oncology Needs Evaluation Tool
Official title: Caregiver Oncology Needs Evaluation Tool (CONNECT): A Technology-Based Intervention to Connect Lung Cancer Caregivers With Supportive Care Resources
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Lung Cancer
Keywords: Lung cancer caregivers
Lead sponsor: Wake Forest University Health Sciences
Sponsor class: OTHER
Collaborators: name: Lung Cancer Research Foundation
First posted: 2019-04-18
Enrollment: 78
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose of this research study is to evaluate a technology-based intervention, Caregiver Oncology Needs Evaluation Tool (CONNECT), which may increase lung cancer caregivers' knowledge about the benefits of supportive care resources, identify their unmet needs, and connect them with supportive care resources. The investigators will also determine their ability to recruit and keep patients and caregivers in the study.

Detailed description: The long-term goal of this program of research is to improve supportive care delivery and lung cancer caregiver and patient well-being through a caregiver delivered intervention, Caregiver Oncology Needs Evaluation Tool (CONNECT). The investigators propose to evaluate a novel technology-based intervention, CONNECT, informed by theory with input from an advisory panel including a lung cancer caregiver and stakeholders. The purpose of CONNECT is to empower and educate caregivers about the benefits of supportive care resources and to systematically identify unmet needs and connect lung cancer caregivers with tailored supportive care resources. CONNECT is designed to be low cost and to capture the various resources offered in different oncology environments to support future adaptation and dissemination for heterogeneous healthcare settings.

Eligibility criteria: Inclusion Criteria:

For Caregivers:

* 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.
* Caregivers must be \> 18 years of age, as this study is focused on the experience of adult patient-caregiver dyads.

For Patients:

* Patients must have a current diagnosis of limited stage small cell or stage 1-4 nonsmall cell lung cancer.
* Patients must be currently receiving or planning to receive treatment for their cancer at the time of enrollment. For patients receiving surgery, the eligibility timeframe will include 6 weeks following the date of surgery to account for the acute recovery period.
* 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.
* Patients must be \> 18 years of age, as this study is focused on the experience of adult patient-caregiver dyads.
* 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:

For Caregivers:

• Caregivers cannot read/ communicate in English.

For Patients:

* Patients who are post-treatment survivors at the time of study enrollment. For patients receiving surgery only, this includes the period beyond acute recovery (i.e. ≥ 7 weeks post-surgery).
* Caregivers cannot read/ communicate in English.

Eligibility to participate in the study is conditional on participation of both the caregiver and patient.

Primary outcomes:
measure: Number of Eligible Participants
timeFrame: Approximately 3 months
measure: Accrual
timeFrame: Approximately 3 months
measure: Retention of Participants
timeFrame: Approximately 3 months
measure: Participants Acceptability of the CONNECT Program Survey
timeFrame: Approximately 3 months
measure: Acceptability of CONNECT Program Interview
timeFrame: Approximately 3 months
Secondary outcomes:
Other outcomes:
measure: Supportive Care Service Utilization Survey for Caregivers
timeFrame: Baseline to 3 months
measure: PROMIS Emotional Distress-Anxiety-Short Form 8a for Caregivers
timeFrame: Baseline to 3 months
measure: PROMIS Emotional Distress- Depression Short Form 8a for Caregivers
timeFrame: Baseline to 3 months
measure: Caregiver Reaction Assessment (Burden) for Caregivers
timeFrame: Baseline to 3 months
measure: Caregiver Quality of Life Index-Cancer (CqoL-Canc) for Caregivers
timeFrame: Baseline to 3 months
measure: FAMCARE (Perceived care quality) Questionnaire for Caregivers
timeFrame: Baseline to 3 months
measure: FAMCARE (Perceived care quality) Questionnaire for Participants
timeFrame: Baseline to 3 months
measure: SF-1247 (Mental and physical well-being) Survey for Participants
timeFrame: Baseline to 3 months
measure: Proportion of Unplanned Hospitalizations
timeFrame: Baseline to 3 months
measure: Interventionist Notes - E-Tool Preference Survey
timeFrame: Baseline to 3 months
measure: MD Anderson Symptom Inventory for Lung Cancer Questionnaire
timeFrame: Baseline to 3 months
measure: Caregiver Risk Scale
timeFrame: Baseline to 3 months
measure: Caregiver Barriers Survey
timeFrame: Baseline to 3 months
measure: Snyder State Hope Scale for Participants
timeFrame: Baseline to 3 months.
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, Ph.D
role: PRINCIPAL_INVESTIGATOR
References: