Connect Oncology Needs Evaluation Tool

NCT03919864 | Completed DMC

• 2 other identifiers: IRB00054952WFBCCC 04319
• Study Type: interventional
• Target: 78
• Locations: 1 country
• Sites: 1

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.

Conditions

Lung Cancer

Keywords

Lung cancer caregivers

Outcome Measures

Primary Outcomes (5)

• 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

Other Outcomes (14)

• Supportive Care Service Utilization Survey for Caregivers

  Baseline to 3 months

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

  Baseline to 3 months

• PROMIS Emotional Distress- Depression Short Form 8a for Caregivers

  Baseline to 3 months

Study Arms (2)

CONNECT Intervention Group

OTHER

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

CONTROL Group

OTHER

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

Interventions

CONNECT Intervention BEHAVIORAL

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.

CONNECT Intervention Group

CONTROL Group BEHAVIORAL

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

CONTROL Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Wake Forest University Health Sciences: lead
• Lung Cancer Research Foundation: collaborator

Study Sites (1)

Wake Forest Baptist Comprehensive Cancer Center

Winston-Salem, North Carolina, 27157, United States

Location

MeSH Terms

Conditions

Lung Neoplasms

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Officials

• Chandylen Nightingale, Ph.D

  Wake Forest University Health Sciences

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 12, 2019
• First Posted: April 18, 2019
• Study Start: July 18, 2019
• Primary Completion: July 24, 2020
• Study Completion: July 24, 2020
• Last Updated: July 13, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)