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| ID | Type | Description | Link |
|---|---|---|---|
| P30CA012197 | U.S. NIH Grant/Contract | View source | |
| ONC-LUN-2403 | Other Identifier | AHWFBCCC |
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Low accruals, PI decision
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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This clinical trial evaluates whether a shared response plan (SHAREDCare) improves follow-up care for lung cancer survivors. As the number of cancer survivors increases, there is a new need for high-quality chronic illness care. High-quality chronic illness care can be difficult to deliver and involves working with the patient to be certain they have what they need to be actively involved with their care to meet their needs. SHAREDCare allows the patient to work with a navigator to review identified distress and social needs. The patient and navigator discuss the needs and develop a shared response plan to address the needs in ways that consider the patient's current behaviors, beliefs, and motivation. The plan also establishes specific patient goals, anticipates barriers, and establishes how the navigator will follow-up on the needs and adjust care and assistance when needed. Using a shared response plan may improve follow-up care for lung cancer survivors.
Primary Objective: Pilot and qualitatively assess the acceptability of SHAREDCare through semi- structured interviews
Secondary Objectives:
OUTLINE:
Patients receive a SHAREDCare call with a navigator to discuss identified distress and social needs and develop/deploy a shared response plan to address identified needs on study. Patients also receive standard of care automated referrals on study. Two weeks following the initial call, patients receive a second SHAREDCare call with a navigator to follow-up on the shared response plan.
After completion of study intervention, patients are followed up 4 weeks after initial call.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SHAREDCare Supportive care arm | Experimental | Patients receive a SHAREDCare call with a navigator to discuss identified distress and social needs and develop/deploy a shared response plan to address identified needs on study. Patients also receive standard of care automated referrals on study. Two weeks following the initial call, patients receive a second SHAREDCare call with a navigator to follow-up on the shared response plan. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Telephone based interview | Behavioral | Receive SHAREDCare navigator calls |
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| Measure | Description | Time Frame |
|---|---|---|
| SHAREDCare's Qualitative Acceptability | Will be assessed with semi-structured interviews. These methods will be guided by Grounded Theory, a process using inductive coding to develop theory from data (e.g., themes relating to components, timing, or delivery of the intervention). | At 4 weeks post-initial call |
| Measure | Description | Time Frame |
|---|---|---|
| SHAREDCare's Quantitative Acceptability | Will be measured with the Acceptability of Intervention Measure. Quantitative analyses will include descriptive statistics of quantitative data on level of clinical and demographic characteristics and acceptability. Distributions of continuous variables (acceptability) will be examined for estimation of standard deviations (SD) that will be used to inform power analysis for future studies. |
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Inclusion Criteria:
Exclusion Criteria: Does not meet the above inclusion criteria
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Atrium Health Wake Forest Baptist Comprehensive Cancer Center (AH-WFBCCC) | Winston-Salem | North Carolina | 27157 | United States |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| ICF | No | No | Yes | Informed Consent Form | Jul 23, 2025 | Jan 28, 2026 |
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| Survey using a questionnaire. | Other | Ancillary studies |
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| Electronic health record review | Other | Ancillary studies |
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| Referral | Other | Receive standard of care automated referrals |
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| At 4 weeks post-initial call |
| SHAREDCare's Quantitative Appropriateness | Will be measured with the Intervention Appropriateness Measure. Quantitative analyses will include descriptive statistics of quantitative data on level of clinical and demographic characteristics and appropriateness. Distributions of continuous variables (acceptability) will be examined for estimation of SD that will be used to inform power analysis for future studies. | At 4 weeks post-initial call |
| SHAREDCare's Quantitative Feasibility | Will be measured with the Feasibility Intervention Measure. Quantitative analyses will include descriptive statistics of quantitative data on level of clinical and demographic characteristics and feasibility. Distributions of continuous variables (acceptability) will be examined for estimation of SD that will be used to inform power analysis for future studies | At 4 weeks post-initial call |
| Number of Survivors With Unmet Needs | Will be assessed before and/or after completion of the SHAREDCare intervention using a validated measure called the Survivor Unmet Needs Survey. This measure will be used to determine the prevalence and predictors of cancer survivors' unmet needs. Scores at baseline and follow-up will be summarized as median (interquartile range, range). Changes will be tested by Wilcoxon signed-rank test. | At baseline and at 4 weeks post-initial call |
| Number of Clinical Referrals Made | Quantitative analyses will include descriptive statistics of quantitative data on level of clinical and demographic characteristics and referrals. | At 4 weeks post-initial call |
| Percentage of Referrals Completed | Will be defined as those referrals where a patient self-reported completing the relevant visit documented in a format adapted from another study. Quantitative analyses will include descriptive statistics of quantitative data on level of clinical and demographic characteristics and referrals. | At 4 weeks post-initial call |
| Number of Participants Enrolled/Eligible | The number of eligible participants will be tracked and for those not enrolled, reasons will be summarized. Will calculate the percent of participants who complete the follow-up visit to assess retention. Will also compare demographic characteristics and baseline scores of participants who complete the follow-up visit to those who do not via Fisher's exact tests or Wilcoxon rank sum tests as appropriate. | At 4 weeks post-initial call |
| Percentage of Assessments Completed | The percent of participants who complete the follow-up visit to assess retention. Will also compare demographic characteristics and baseline scores of participants who complete the follow-up visit to those who do not via Fisher's exact tests or Wilcoxon rank sum tests as appropriate. | At 4 weeks post-initial call |
| Number of Adverse Events Reported | The frequency of any adverse events will be reported. | At baseline (initial call) up to 4 weeks post-initial call |
| ICF_000.pdf |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Jul 6, 2026 |
| ID | Term |
|---|---|
| D008175 | Lung Neoplasms |
| ID | Term |
|---|---|
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| D012017 | Referral and Consultation |
| ID | Term |
|---|---|
| D011364 | Professional Practice |
| D009934 | Organization and Administration |
| D006298 | Health Services Administration |
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