CompletedNot applicableNCT03919864
Official study title

Connect Oncology Needs Evaluation Tool

Study 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.

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Key things to know

Main goalSupportive Care

This describes the study’s primary purpose.

What is being studiedCONNECT Intervention and CONTROL Group

The study team can explain what participation involves.

Who it may be forLung Cancer

These are broad labels—not an eligibility decision.

Checked against the public recordLast updated Jul 13, 2023 · Source: ClinicalTrials.gov

Is enrollment open?Completed

Ask the study team to confirm whether enrollment is open.

What kind of study?Not applicable

Interventional

Where is it offered?1 U.S. location

Locations may change over time.

Who runs it?Wake Forest University Health Sciences

Study sponsor

01
Study overview

What this study is about

Purpose
Supportive Care
Study type
Interventional
Phase
Not applicable
Sponsor
Wake Forest University Health Sciences
Interventions being studied
Behavioral: CONNECT Intervention; Behavioral: CONTROL Group
02
Explore related studies

How this study is categorized

These labels come from structured fields and exact terms in the public record.

03
Public criteria

Who may be able to participate

The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.

Requirements people may need to meetInclusion 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.
Reasons someone may not be able to joinExclusion 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.

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

04
Study sites

U.S. locations

  • Wake Forest Baptist Comprehensive Cancer CenterWinston-Salem, North Carolina

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Jul 13, 2023. Always confirm current availability with the study team.

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