Connect Oncology Needs Evaluation Tool

Not Applicable

Completed

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.

Recruitment & Eligibility

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.

Arm && Interventions

Group	Intervention	Description
CONNECT Intervention Group	CONNECT Intervention	CONNECT includes a multi-component e-tool with the following: (1) a brief educational video that seeks to empower and educate caregivers about the importance of self-care and benefits of supportive care resource use; (2) an assessment of multidimensional supportive care needs (e.g., psychological, behavioral, social, financial, educational, spiritual); (3) a tailored resource list that includes local and national resources corresponding to caregivers needs (Table1); and (4) an optional automated referral to a caregiver navigator to facilitate connection to resources.
CONTROL Group	CONTROL Group	Control arm participants will receive a generic (i.e., not tailored) printed list of hospital, community, and national supportive care resources. Control participants will not receive the educational video, complete the E-tool Preference survey, or have an option for an automated referral to a caregiver navigator

Primary Outcome Measures

Name	Time	Method
Accrual	Approximately 3 months	Number of caregivers who agreed to participate divided by the number of months of recruitment.
Participants Acceptability of the CONNECT Program Survey	Approximately 3 months	A 10-item survey developed for study to assess how much caregivers liked different aspects of CONNECT.
Number of Eligible Participants	Approximately 3 months	The number of eligible participants who agreed to participate in this study
Acceptability of CONNECT Program Interview	Approximately 3 months	A 20-minute qualitative interview to explore factors associated with acceptability. During interviews, CONNECT elements will be reviewed and open-ended questions will be used to elicit feedback on functionality, strengths, and weaknesses of the e-tool. Interview recordings will be transcribed verbatim.
Retention of Participants	Approximately 3 months	Number of participants who completed the T2 assessment divided by the number who agreed to participate

Secondary Outcome Measures

Name	Time	Method

Locations (1): Wake Forest Baptist Comprehensive Cancer Center
🇺🇸
Winston-Salem, North Carolina, United States