Stage I Lung CancerSHAREDCareNCT06654245
Assessing and Addressing Follow-up Care Needs That Will Facilitate Care Transitions for Cancer Survivors
A study testing Telephone based interview, Survey using a questionnaire. and Electronic health record review in people with Stage I Lung Cancer and Stage II Lung Cancer, run by Wake Forest University Health Sciences at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stage I Lung Cancer, Stage II Lung Cancer, Stage III Lung Cancer
- What is being tested?
- Telephone based interview, Survey using a questionnaire. and Electronic health record review
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Jun 2025to 12 Jan 2026
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
Atrium Health Wake Forest Baptist Comprehensive Cancer Center (AH-WFBCCC)
Winston-Salem, North Carolina, 27157
About this study
Official title: Toward an Integrated Approach to Assessing and Addressing Follow-Up Care Needs That Will Facilitate Care Transitions for Cancer Survivors: A Pilot Study
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.
Read the 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.
- Being tested
- Telephone based interview, Survey using a questionnaire., Electronic health record review, Referral
- Medical subject headings
- Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Telephone based interviewBehavioural
Receive SHAREDCare navigator calls
Survey using a questionnaire.Other
Ancillary studies
Electronic health record reviewOther
Ancillary studies
ReferralOther
Receive standard of care automated referrals
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Telephone based interview; Other: Survey using a questionnaire.; Other: Electronic health record review; Other: Referral |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: At 4 weeks post-initial call
Secondary outcomes (8)
SHAREDCare's Quantitative Acceptability
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.
Measured: At 4 weeks post-initial call
SHAREDCare's Quantitative Feasibility
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.
Measured: At 4 weeks post-initial call
SHAREDCare's Quantitative Appropriateness
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.
Measured: At 4 weeks post-initial call
Total Survivor Unmet Needs Survey Score
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
Measured: At baseline and at 4 weeks post-initial call
Number of Clinical Referrals Made
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.
Measured: At 4 weeks post-initial call
Number of Referrals Completed
Defined as those referrals where a patient self-reported completing visit through 4 weeks post-initial call.
Measured: At 4 weeks post-initial call
Number of Participants Enrolled
The number of eligible participants enrolled in the study was assessed. Reasons for non-enrollment among eligible participants were recorded and summarized descriptively.
Measured: During study recruitment over 5 months
Percentage of Participants With Completion of All Follow-up Visits
Retention was assessed as the percentage of enrolled participants who completed all planned follow-up assessments through the end of study participation.
Measured: Through 4 weeks post-initial call
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2024
- Study start11 Jun 2025
- Primary completion12 Jan 2026
- Study completion12 Jan 2026
Why it stopped: Low accruals, PI decision
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Stage I Lung CancerStudies of the same condition, open and under way.
- More trials run by Wake Forest University Health SciencesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wake Forest University Health Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Sarah Birken, PhD, Principal investigator, Wake Forest University Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06654245
- Sponsor's protocol ID
- IRB00119287
- Other IDs
- P30CA012197, ONC-LUN-2403
- Acronym
- SHAREDCare
- Status last verified
- Aug 2026
- First submitted
- 21 Oct 2024
- Last updated
- 22 Oct 2026
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Toward an Integrated Approach to Assessing and Addressing Follow-Up Care Needs That Will Facilitate Care Transitions for Cancer Survivors: A Pilot Study
- ClinicalTrials.gov ID
- NCT06654245
- Acronym / sponsor ID
- SHAREDCare / IRB00119287
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Low accruals, PI decision
- Enrolment
- 5 participants (actual)
- Lead sponsor
- Wake Forest University Health SciencesUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 11 Jun 2025 (actual)
- Primary completion
- 12 Jan 2026 (actual)
- Study completion
- 12 Jan 2026 (actual)
- First posted
- 23 Oct 2024 (actual)
- Results
- Posted 22 Oct 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SHAREDCare Supportive care arm | Experimental | Behavioral: Telephone based interview, Other: Survey using a questionnaire., Other: Electronic health record review, Other: ReferralPatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Telephone based interviewReceive SHAREDCare navigator calls | Behavioural | SHAREDCare Supportive care arm |
| Survey using a questionnaire.Ancillary studies | Other | SHAREDCare Supportive care arm |
| Electronic health record reviewAncillary studies | Other | SHAREDCare Supportive care arm |
| ReferralReceive standard of care automated referrals | Other | SHAREDCare Supportive care arm |
Primary outcome
SHAREDCare's Qualitative Acceptability
Time frame: 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).
8 secondary outcomes
SHAREDCare's Quantitative Acceptability
Time frame: At 4 weeks post-initial call
SHAREDCare's Quantitative Feasibility
Time frame: At 4 weeks post-initial call
SHAREDCare's Quantitative Appropriateness
Time frame: At 4 weeks post-initial call
Total Survivor Unmet Needs Survey Score
Time frame: At baseline and at 4 weeks post-initial call
Number of Clinical Referrals Made
Time frame: At 4 weeks post-initial call
Number of Referrals Completed
Time frame: At 4 weeks post-initial call
Number of Participants Enrolled
Time frame: During study recruitment over 5 months
Percentage of Participants With Completion of All Follow-up Visits
Time frame: Through 4 weeks post-initial call
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Oct 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sarah Birken, PhD principal investigator
Wake Forest University Health Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Telephone based interview, Survey using a questionnaire. and Electronic health record review in people with Stage I Lung Cancer and Stage II Lung Cancer, run by Wake Forest University Health Sciences at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 22 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 22 Oct 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
SHAREDCare's Qualitative Acceptability (time frame: At 4 weeks post-initial call). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Oct 2026.