Stage I Lung Cancer, Stage II Lung Cancer, Stage III Lung Cancer, Stage IV Lung Cancer
Conditions
Brief summary
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.
Detailed description
Primary Objective: Pilot and qualitatively assess the acceptability of SHAREDCare through semi- structured interviews Secondary Objectives: * Describe quantitative assessments of intervention acceptability, appropriateness, and feasibility. * Describe survivor level of unmet needs13 using a validated measure to collect data before and/or after completion of the SHAREDCare intervention. * Track clinical referrals and other actions made as a result of patient responses on the Electronic Distress Screening (EDS) and the percentage of referrals that have been "completed" (i.e. those referrals where a patient completed the relevant medical or social needs-related visit). * Track recruitment, assessment completion, and any related adverse events. 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.
Interventions
BEHAVIORALTelephone based interview
Receive SHAREDCare navigator calls
OTHERSurvey using a questionnaire.
Ancillary studies
OTHERElectronic health record review
Ancillary studies
OTHERReferral
Receive standard of care automated referrals
Sponsors
Wake Forest University Health Sciences
National Cancer Institute (NCI)
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients must have histologically or cytologically confirmed study disease. A pathology report should be referenced/available (stages I-IV lung cancer) * Ability to understand and the willingness to sign an institutional review board (IRB)-approved informed consent document * ≥ 18 years of age * Within two years of lung cancer diagnosis * Able to understand, read and write English
Exclusion criteria
Does not meet the above inclusion criteria
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| SHAREDCare's Qualitative Acceptability | At 4 weeks post-initial call | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| SHAREDCare's Quantitative Acceptability | At 4 weeks post-initial call | 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. |
| SHAREDCare's Quantitative Appropriateness | At 4 weeks post-initial call | 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. |
| SHAREDCare's Quantitative Feasibility | At 4 weeks post-initial call | 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 |
| Number of Survivors With Unmet Needs | At baseline and at 4 weeks post-initial call | 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. |
| Number of Clinical Referrals Made | At 4 weeks post-initial call | Quantitative analyses will include descriptive statistics of quantitative data on level of clinical and demographic characteristics and referrals. |
| Percentage of Referrals Completed | At 4 weeks post-initial call | 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. |
| Number of Participants Enrolled/Eligible | At 4 weeks post-initial call | 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. |
| Percentage of Assessments Completed | At 4 weeks post-initial call | 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. |
| Number of Adverse Events Reported | At baseline (initial call) up to 4 weeks post-initial call | The frequency of any adverse events will be reported. |
Countries
United States
Outcome results
None listed