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 | Measured using the Acceptability of Intervention Measure (AIM), a 4-item instrument assessing perceived acceptability of an intervention. Each item is rated on a 1-5 Likert scale, with higher scores indicating greater acceptability. The overall AIM score is calculated as the mean of the four items and ranges from 1 to 5. |
| SHAREDCare's Quantitative Feasibility | At 4 weeks post-initial call | Measured using the Feasibility of Intervention Measure (FIM), a 4-item instrument assessing the perceived feasibility of an intervention. Each item is rated on a 1-5 Likert scale, with higher scores indicating greater feasibility. The overall FIM score is calculated as the mean of the four items and ranges from 1 to 5. |
| SHAREDCare's Quantitative Appropriateness | At 4 weeks post-initial call | Measured using the Intervention Appropriateness Measure (IAM), a 4-item instrument assessing perceived appropriateness of an intervention. Each item is rated on a 1-5 Likert scale, with higher scores indicating greater appropriateness. The overall IAM score is calculated as the mean of the four items and ranges from 1 to 5. |
| Total Survivor Unmet Needs Survey Score | At baseline and at 4 weeks post-initial call | Measured using the Survivor Unmet Needs Survey, a 30-item instrument assessing cancer survivors' unmet supportive care needs. Each item is scored from 0 (no unmet need) to 4 (very high unmet need). Item scores are summed to create a total score ranging from 0 to 120, with higher scores indicating greater unmet needs and a worse outcome. Total scores were assessed at baseline and 4 weeks post-initial call |
| Number of Clinical Referrals Made | At 4 weeks post-initial call | Total number of referrals generated during the SHAREDCare intervention, including referrals to supportive care services such as tobacco cessation, nutrition, health coaching, financial navigation, and palliative care. |
| Number of Referrals Completed | At 4 weeks post-initial call | Defined as those referrals where a patient self-reported completing visit through 4 weeks post-initial call. |
| Number of Participants Enrolled | During study recruitment over 5 months | The number of eligible participants enrolled in the study was assessed. Reasons for non-enrollment among eligible participants were recorded and summarized descriptively. |
| Percentage of Participants With Completion of All Follow-up Visits | Through 4 weeks post-initial call | Retention was assessed as the percentage of enrolled participants who completed all planned follow-up assessments through the end of study participation. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORSarah Birken, PhD
Wake Forest University Health Sciences
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Customized Mean age in years | 70.8 Age in Years STANDARD_DEVIATION 9.1 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 5 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 2 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 3 Participants |
| Sex: Female, Male Female | 4 Participants |
| Sex: Female, Male Male | 1 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 5 |
| other Total, other adverse events | 0 / 5 |
| serious Total, serious adverse events | 0 / 5 |
Outcome results
None listed