Connect Oncology Needs Evaluation Tool (CONNECT-LC)

July 11, 2023 updated by: Wake Forest University Health Sciences

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
78

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • North Carolina
      • Winston-Salem, North Carolina, United States, 27157
        • Wake Forest Baptist Comprehensive Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Other: CONNECT Intervention Group
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
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.
Other: 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
Behavioral: CONTROL Group
Participants will receive a generic printed list of hospital, community, and national supportive care resources.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Number of Eligible Participants
Time Frame: Approximately 3 months
The number of eligible participants who agreed to participate in this study
Approximately 3 months
Accrual
Time Frame: Approximately 3 months
Number of caregivers who agreed to participate divided by the number of months of recruitment.
Approximately 3 months
Retention of Participants
Time Frame: Approximately 3 months
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
Time Frame: Approximately 3 months
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
Time Frame: 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.
Approximately 3 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Supportive Care Service Utilization Survey for Caregivers
Time Frame: Baseline to 3 months
Survey developed for the purpose of this study to query participants about utilization of supportive care services assessed as part of the CONNECT Preferences Survey. Survey instructions will reflect current assessment (T0, T1, T2 - T0 since your loved one's diagnosis and T1 and T2 since using the online CONNECT program). Caregivers will be asked to think about services or resources from any places they may have gone to for supportive care using the T0, T1, T2 timeframe. Rating scales consists of (Yes, I used this, No, I did not need this, No, I wish this had been available to me and I do not know what this is or if is was available).
Baseline to 3 months
PROMIS Emotional Distress-Anxiety-Short Form 8a for Caregivers
Time Frame: Baseline to 3 months
An 8-item instrument that assesses fear, anxious misery, hyperarousal, and somatic symptoms related to arousal; widely used in oncology populations. Response options range from NEVER to ALWAYS.
Baseline to 3 months
PROMIS Emotional Distress- Depression Short Form 8a for Caregivers
Time Frame: Baseline to 3 months
An 8-item instrument that assesses sadness, guilt, self-criticism, worthlessness, loneliness, interpersonal alienation, as well as loss of Interest, meaning, and purpose. Response options range from NEVER to ALWAYS
Baseline to 3 months
Caregiver Reaction Assessment (Burden) for Caregivers
Time Frame: Baseline to 3 months
A 24-item instrument assessing positive and negative aspects of caregiving (esteem, lack of family support, finances, schedule, and health). Rating scale is based on participants' responses that best describe how they currently feel (Strongly disagree to strongly agree).
Baseline to 3 months
Caregiver Quality of Life Index-Cancer (CqoL-Canc) for Caregivers
Time Frame: Baseline to 3 months
A 35-item instrument assessing dimensions of caregiver quality of life (burden, disruptiveness, positive adaptation, financial concerns). Response options are based on how true each statement has been for the caregiver during the PAST WEEK. Options (not at all, a little bit, somewhat, quite a bit or very much).
Baseline to 3 months
FAMCARE (Perceived care quality) Questionnaire for Caregivers
Time Frame: Baseline to 3 months
A 20-item instrument to assess family caregiver satisfaction with information giving, availability of care, physical patient care, and symptom control. Rating scale options are very satisfied to very dissatisfied.
Baseline to 3 months
FAMCARE (Perceived care quality) Questionnaire for Participants
Time Frame: Baseline to 3 months
A 20-item instrument to assess participant satisfaction with information giving, availability of care, physical patient care, and symptom control. Rating scale options are very satisfied to very dissatisfied.
Baseline to 3 months
SF-1247 (Mental and physical well-being) Survey for Participants
Time Frame: Baseline to 3 months
A 12-item instrument measuring physical and mental well-being of the participants (particularly in the past four weeks). Participants will answer from a scale of 1 = excellent to 5 = poor.
Baseline to 3 months
Proportion of Unplanned Hospitalizations
Time Frame: Baseline to 3 months
Survey designed for the purpose of the study to capture patient self-reported unplanned healthcare utilization. Total score will reflect number of unplanned visits to the emergency room, urgent care, or healthcare provider.
Baseline to 3 months
Interventionist Notes - E-Tool Preference Survey
Time Frame: Baseline to 3 months
A 17-item survey consisting of various resources that participants and their caregivers would like more information on and accessibility of these resources. Response options are YES or NO with the option to select multiple options for obtaining access.
Baseline to 3 months
MD Anderson Symptom Inventory for Lung Cancer Questionnaire
Time Frame: Baseline to 3 months
A 16-item instrument to assess lung cancer specific and general symptoms and the impact on daily functioning. Participants will rate the severity of their symptoms in the last 24 hours based on a scale of 0 = not present to 10 - as bad as you can imagine.
Baseline to 3 months
Caregiver Risk Scale
Time Frame: Baseline to 3 months
A 7-item measure to assess caregiver behaviors for managing self-care. This scale consists of questions that can be answered YES or NO.
Baseline to 3 months
Caregiver Barriers Survey
Time Frame: Baseline to 3 months
A 16-item survey developed for the purpose of this study to assess caregiver barriers to accessing supportive care. Response options: Always, very often, sometimes, rarely, never.
Baseline to 3 months
Snyder State Hope Scale for Participants
Time Frame: Baseline to 3 months.
6-item instrument to assess hope of participants. Score on an 8-point Likert scale with anchor scores of 1 (definitely true) to 8 (definitely false). Higher scores reflect greater state of hope.
Baseline to 3 months.

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Supportive Care Service Utilization Survey for Caregivers
Time Frame: Baseline to 3 months
Survey developed for the purpose of this study to query participants about utilization of supportive care services assessed as part of the CONNECT Preferences Survey. Survey instructions will reflect current assessment (T0, T1, T2 - T0 since your loved one's diagnosis and T1 and T2 since using the online CONNECT program). Caregivers will be asked to think about services or resources from any places they may have gone to for supportive care using the T0, T1, T2 timeframe. Rating scales consists of (Yes, I used this, No, I did not need this, No, I wish this had been available to me and I do not know what this is or if is was available).
Baseline to 3 months
PROMIS Emotional Distress-Anxiety-Short Form 8a for Caregivers
Time Frame: Baseline to 3 months
An 8-item instrument that assesses fear, anxious misery, hyperarousal, and somatic symptoms related to arousal; widely used in oncology populations. Response options range from NEVER to ALWAYS.
Baseline to 3 months
PROMIS Emotional Distress- Depression Short Form 8a for Caregivers
Time Frame: Baseline to 3 months
An 8-item instrument that assesses sadness, guilt, self-criticism, worthlessness, loneliness, interpersonal alienation, as well as loss of Interest, meaning, and purpose. Response options range from NEVER to ALWAYS
Baseline to 3 months
Caregiver Reaction Assessment (Burden) for Caregivers
Time Frame: Baseline to 3 months
A 24-item instrument assessing positive and negative aspects of caregiving (esteem, lack of family support, finances, schedule, and health). Rating scale is based on participants' responses that best describe how they currently feel (Strongly disagree to strongly agree).
Baseline to 3 months
Caregiver Quality of Life Index-Cancer (CqoL-Canc) for Caregivers
Time Frame: Baseline to 3 months
A 35-item instrument assessing dimensions of caregiver quality of life (burden, disruptiveness, positive adaptation, financial concerns). Response options are based on how true each statement has been for the caregiver during the PAST WEEK. Options (not at all, a little bit, somewhat, quite a bit or very much).
Baseline to 3 months
FAMCARE (Perceived care quality) Questionnaire for Caregivers
Time Frame: Baseline to 3 months
A 20-item instrument to assess family caregiver satisfaction with information giving, availability of care, physical patient care, and symptom control. Rating scale options are very satisfied to very dissatisfied.
Baseline to 3 months
FAMCARE (Perceived care quality) Questionnaire for Participants
Time Frame: Baseline to 3 months
A 20-item instrument to assess participant satisfaction with information giving, availability of care, physical patient care, and symptom control. Rating scale options are very satisfied to very dissatisfied.
Baseline to 3 months
SF-1247 (Mental and physical well-being) Survey for Participants
Time Frame: Baseline to 3 months
A 12-item instrument measuring physical and mental well-being of the participants (particularly in the past four weeks). Participants will answer from a scale of 1 = excellent to 5 = poor.
Baseline to 3 months
Proportion of Unplanned Hospitalizations
Time Frame: Baseline to 3 months
Survey designed for the purpose of the study to capture patient self-reported unplanned healthcare utilization. Total score will reflect number of unplanned visits to the emergency room, urgent care, or healthcare provider.
Baseline to 3 months
Interventionist Notes - E-Tool Preference Survey
Time Frame: Baseline to 3 months
A 17-item survey consisting of various resources that participants and their caregivers would like more information on and accessibility of these resources. Response options are YES or NO with the option to select multiple options for obtaining access.
Baseline to 3 months
MD Anderson Symptom Inventory for Lung Cancer Questionnaire
Time Frame: Baseline to 3 months
A 16-item instrument to assess lung cancer specific and general symptoms and the impact on daily functioning. Participants will rate the severity of their symptoms in the last 24 hours based on a scale of 0 = not present to 10 - as bad as you can imagine.
Baseline to 3 months
Caregiver Risk Scale
Time Frame: Baseline to 3 months
A 7-item measure to assess caregiver behaviors for managing self-care. This scale consists of questions that can be answered YES or NO.
Baseline to 3 months
Caregiver Barriers Survey
Time Frame: Baseline to 3 months
A 16-item survey developed for the purpose of this study to assess caregiver barriers to accessing supportive care. Response options: Always, very often, sometimes, rarely, never.
Baseline to 3 months
Snyder State Hope Scale for Participants
Time Frame: Baseline to 3 months.
6-item instrument to assess hope of participants. Score on an 8-point Likert scale with anchor scores of 1 (definitely true) to 8 (definitely false). Higher scores reflect greater state of hope.
Baseline to 3 months.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Wake Forest University Health Sciences

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Lung Cancer Research Foundation

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Chandylen Nightingale, Ph.D, Wake Forest University Health Sciences

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 18, 2019

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 24, 2020

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 24, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 12, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 15, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 18, 2019

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 13, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 11, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • IRB00054952
  • WFBCCC 04319 (Other Identifier: Wake Forest Baptist Comprehensive Cancer Center)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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