Connect Oncology Needs Evaluation Tool (CONNECT-LC)

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: Completed
• Conditions: Lung Cancer
• Intervention / Treatment: Behavioral: CONNECT Intervention; Behavioral: CONTROL Group

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: Interventional
• Enrollment (Actual): 78
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Supportive Care Service Utilization Survey for Caregivers	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	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	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	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	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	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	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	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	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	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	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	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	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	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

Outcome Measure	Measure Description	Time Frame
Supportive Care Service Utilization Survey for Caregivers	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	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	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	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	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	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	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	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	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	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	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	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	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	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

• Sponsor: Wake Forest University Health Sciences
• Collaborators: Lung Cancer Research Foundation
• Investigators: Principal Investigator: Chandylen Nightingale, Ph.D, Wake Forest University Health Sciences

Study record dates

Study Major Dates

• Study Start (Actual): July 18, 2019
• Primary Completion (Actual): July 24, 2020
• Study Completion (Actual): July 24, 2020

Study Registration Dates

• First Submitted: April 12, 2019
• First Submitted That Met QC Criteria: April 15, 2019
• First Posted (Actual): April 18, 2019

Study Record Updates

• Last Update Posted (Actual): July 13, 2023
• Last Update Submitted That Met QC Criteria: July 11, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Keywords: Lung cancer caregivers
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Neoplasms
• Other Study ID 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