Connect Oncology Needs Evaluation Tool

Study Overview
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Brief Summary
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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
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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.

Official Title
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Caregiver Oncology Needs Evaluation Tool (CONNECT): A Technology-Based Intervention to Connect Lung Cancer Caregivers With Supportive Care Resources

Conditions
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Lung Cancer

Intervention / Treatment
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* Behavioral: CONNECT Intervention
* Behavioral: CONTROL Group


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: CONNECT Intervention Group<br>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. | Behavioral: CONNECT Intervention<br>* Participants will be included in a multi-component e-tool with brief educational videos, an assessment of multidimensional supportive care needs, a tailored resource list and an optional automated referral to a caregiver navigator. Two weeks after baseline participants will receive re-education and an optional referral.<br>|
| Other: CONTROL Group<br>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 | Behavioral: CONTROL Group<br>* Participants will receive a generic printed list of hospital, community, and national supportive care resources.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Eligible Participants | The number of eligible participants who agreed to participate in this study | Approximately 3 months | 
| Accrual | Number of caregivers who agreed to participate divided by the number of months of recruitment. | Approximately 3 months | 
| Retention of Participants | Number of participants who completed the T2 assessment divided by the number who agreed to participate | Approximately 3 months | 
| Participants Acceptability of the CONNECT Program Survey | A 10-item survey developed for study to assess how much caregivers liked different aspects of CONNECT. | Approximately 3 months | 
| Acceptability of CONNECT Program Interview | 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. | Approximately 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Lung cancer caregivers