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Connect Oncology Needs Evaluation Tool (CONNECT-LC)

Primary Purpose

Lung Cancer

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

CONNECT Intervention

CONTROL Group

About this trial

This is an interventional supportive care trial for Lung Cancer focused on measuring Lung cancer caregivers

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Wake Forest Baptist Comprehensive Cancer Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Arm Label

CONNECT Intervention Group

CONTROL Group

Arm Description

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 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

Outcomes

Primary Outcome Measures

Number of Eligible Participants

The number of eligible participants who agreed to participate in this study

Accrual

Number of caregivers who agreed to participate divided by the number of months of recruitment.

Retention of Participants

Number of participants who completed the T2 assessment divided by the number who agreed to participate

Participants Acceptability of the CONNECT Program Survey

A 10-item survey developed for study to assess how much caregivers liked different aspects of CONNECT.

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.

Secondary Outcome Measures

Full Information

NCT ID

NCT03919864

First Posted

April 12, 2019

Last Updated

July 11, 2023

Sponsor

Wake Forest University Health Sciences

Collaborators

Lung Cancer Research Foundation

1. Study Identification

Unique Protocol Identification Number

NCT03919864

Brief Title

Connect Oncology Needs Evaluation Tool

Acronym

CONNECT-LC

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

July 2023

Overall Recruitment Status

Completed

Study Start Date

July 18, 2019 (Actual)

Primary Completion Date

July 24, 2020 (Actual)

Study Completion Date

July 24, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Wake Forest University Health Sciences

Collaborators

Lung Cancer Research Foundation

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Lung Cancer

Keywords

Lung cancer caregivers

7. Study Design

Primary Purpose

Supportive Care

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

78 (Actual)

8. Arms, Groups, and Interventions

Arm Title

CONNECT Intervention Group

Arm Type

Other

Arm Description

Arm Title

CONTROL Group

Arm Type

Other

Arm Description

Intervention Type

Behavioral

Intervention Name(s)

CONNECT Intervention

Intervention Description

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.

Intervention Type

Behavioral

Intervention Name(s)

CONTROL Group

Intervention Description

Participants will receive a generic printed list of hospital, community, and national supportive care resources.

Primary Outcome Measure Information:

Title

Number of Eligible Participants

Description

The number of eligible participants who agreed to participate in this study

Time Frame

Approximately 3 months

Title

Accrual

Description

Number of caregivers who agreed to participate divided by the number of months of recruitment.

Time Frame

Approximately 3 months

Title

Retention of Participants

Description

Number of participants who completed the T2 assessment divided by the number who agreed to participate

Time Frame

Approximately 3 months

Title

Participants Acceptability of the CONNECT Program Survey

Description

A 10-item survey developed for study to assess how much caregivers liked different aspects of CONNECT.

Time Frame

Approximately 3 months

Title

Acceptability of CONNECT Program Interview

Description

Time Frame

Approximately 3 months

Other Pre-specified Outcome Measures:

Title

Supportive Care Service Utilization Survey for Caregivers

Description

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).

Time Frame

Baseline to 3 months

Title

PROMIS Emotional Distress-Anxiety-Short Form 8a for Caregivers

Description

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.

Time Frame

Baseline to 3 months

Title

PROMIS Emotional Distress- Depression Short Form 8a for Caregivers

Description

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

Time Frame

Baseline to 3 months

Title

Caregiver Reaction Assessment (Burden) for Caregivers

Description

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).

Time Frame

Baseline to 3 months

Title

Caregiver Quality of Life Index-Cancer (CqoL-Canc) for Caregivers

Description

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).

Time Frame

Baseline to 3 months

Title

FAMCARE (Perceived care quality) Questionnaire for Caregivers

Description

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.

Time Frame

Baseline to 3 months

Title

FAMCARE (Perceived care quality) Questionnaire for Participants

Description

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.

Time Frame

Baseline to 3 months

Title

SF-1247 (Mental and physical well-being) Survey for Participants

Description

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.

Time Frame

Baseline to 3 months

Title

Proportion of Unplanned Hospitalizations

Description

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.

Time Frame

Baseline to 3 months

Title

Interventionist Notes - E-Tool Preference Survey

Description

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.

Time Frame

Baseline to 3 months

Title

MD Anderson Symptom Inventory for Lung Cancer Questionnaire

Description

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.

Time Frame

Baseline to 3 months

Title

Caregiver Risk Scale

Description

A 7-item measure to assess caregiver behaviors for managing self-care. This scale consists of questions that can be answered YES or NO.

Time Frame

Baseline to 3 months

Title

Caregiver Barriers Survey

Description

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.

Time Frame

Baseline to 3 months

Title

Snyder State Hope Scale for Participants

Description

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.

Time Frame

Baseline to 3 months.

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Chandylen Nightingale, Ph.D

Organizational Affiliation

Wake Forest University Health Sciences

Official's Role

Principal Investigator

Facility Information:

Facility Name

Wake Forest Baptist Comprehensive Cancer Center

City

Winston-Salem

State/Province

North Carolina

ZIP/Postal Code

27157

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

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