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Connect Oncology Needs Evaluation Tool

  • Clinicaltrials.gov identifier

    NCT03919864

  • Recruitment Status

    Completed

  • First Posted

    April 18, 2019

  • Last update posted

    August 3, 2020

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.

  • Condition or Disease:Lung Cancer
  • Intervention/Treatment: Behavioral: CONNECT Intervention
    Behavioral: CONTROL Group
  • Phase: N/A

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 Design

  • Study Type: Interventional
  • Actual Enrollment: 78 participants
  • Allocation: Randomized
  • Intervention Model: Parallel Assignment
  • Masking: None (Open Label) ()
  • Primary Purpose: Supportive Care
  • Official Title: Caregiver Oncology Needs Evaluation Tool (CONNECT): A Technology-Based Intervention to Connect Lung Cancer Caregivers With Supportive Care Resources
  • Actual Study Start Date: July 2019
  • Actual Primary Completion Date: July 2020
  • Actual Study Completion Date: July 2020

Arms and interventions

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.

Outcome Measures

  • Primary Outcome Measures: 1. Number of Eligible Participants [ Time Frame: Approximately 3 months ]
    The number of eligible participants who agreed to participate in this study
  • 2. Accrual [ Time Frame: Approximately 3 months ]
    Number of caregivers who agreed to participate divided by the number of months of recruitment.
  • 3. Retention of Participants [ Time Frame: Approximately 3 months ]
    Number of participants who completed the T2 assessment divided by the number who agreed to participate
  • 4. 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.
  • 5. 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.
  • Secondary Outcome Measures: 1. 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).
  • 2. 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.
  • 3. 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
  • 4. 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).
  • 5. 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).
  • 6. 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.
  • 7. 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.
  • 8. 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.
  • 9. 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.
  • 10. 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.
  • 11. 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.
  • 12. 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.
  • 13. 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.
  • 14. 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.

Eligibility Criteria

  • Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
  • Sexes Eligible for Study: All
  • Accepts Healthy Volunteers: No

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.

Contacts and Locations

Contacts

Locations

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

Sponsors and Collaborators

Wake Forest University Health Sciences

Lung Cancer Research Foundation

Investigators

Principal Investigator: Chandylen Nighingale, Ph.D Wake Forest University Health Sciences

More Information

  • Responsible Party: Wake Forest University Health Sciences
  • ClinicalTrials.gov Identifier: NCT03919864 History of Changes
  • Other Study ID Numbers: IRB00054952, WFBCCC 04319
  • First Posted: April 18, 2019 Key Record Dates
  • Last Update Posted: August 3, 2020
  • Last Verified: July 2020
  • Individual Participant
    Data (IPD) Sharing
    Statement:

  • Plan to Share IPD: No
  • Studies a U.S. FDA-regulated Drug Product: No
  • Studies a U.S. FDA-regulated Device Product: No
  • Keywords provided by Wake Forest University Health Sciences: Lung cancer caregivers
  • Additional relevant MeSH terms: Lung Neoplasms