SHAREDCare Plan for Lung Cancer Survivors

(SHAREDCare Trial)

Recruiting in Palo Alto (17 mi)

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Wake Forest University Health Sciences

Disqualifiers: Non-English speakers, others

No Placebo Group

Trial Summary

What is the purpose of this trial?

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.

Do I have to stop taking my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications. It seems focused on improving follow-up care rather than changing medication regimens.

What data supports the effectiveness of the treatment SHAREDCare for lung cancer survivors?

Research shows that shared care models, which involve both cancer specialists and general practitioners, can improve emotional well-being and patient satisfaction for cancer survivors. These models help coordinate care and address the unique needs of survivors, potentially leading to better outcomes. ^{1 2 3 4 5}

Is the SHAREDCare Plan for Lung Cancer Survivors safe for humans?

The research articles discuss adverse events (unwanted side effects) related to cancer treatments, highlighting the importance of monitoring and reducing these events to ensure patient safety. While specific safety data for SHAREDCare is not provided, the focus on minimizing adverse events suggests a general concern for safety in cancer treatment trials. ^{6 7 8 9 10}

How is the SHAREDCare Plan for Lung Cancer Survivors treatment different from other treatments?

The SHAREDCare Plan is unique because it involves a collaborative approach where both cancer specialists and primary care providers work together to manage the care of lung cancer survivors. This shared care model aims to improve the continuity of care and address the unique needs of survivors, which may not be as effectively managed by a single type of healthcare provider. ^{1 4 11 12 13}

Eligibility Criteria

This trial is for lung cancer survivors who need help with follow-up care. Participants will work with a navigator to address their distress and social needs, set goals, and overcome barriers. There's no specific exclusion criteria provided.

Inclusion Criteria

Ability to understand and the willingness to sign an institutional review board (IRB)-approved informed consent document

Able to understand, read and write English

I was diagnosed with lung cancer less than two years ago.

Exclusion Criteria

Does not meet the above inclusion criteria

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Participants receive a SHAREDCare call with a navigator to discuss identified distress and social needs and develop a shared response plan. Two weeks following the initial call, patients receive a second SHAREDCare call to follow-up on the shared response plan.

2 weeks

2 calls (virtual)

Follow-up

Participants are monitored for safety and effectiveness after the intervention, including assessment of SHAREDCare's acceptability, feasibility, and appropriateness.

4 weeks

1 follow-up call (virtual)

Treatment Details

Interventions

• SHAREDCare (Behavioural Intervention)

Trial Overview The trial tests SHAREDCare, which includes telephone interviews, electronic health record reviews, referrals, and surveys via questionnaires to improve chronic illness care among lung cancer survivors.

Participant Groups

Group I: SHAREDCare Supportive care arm Experimental Treatment 4 Interventions

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.

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

Atrium Health Wake Forest Baptist Comprehensive Cancer Center (AH-WFBCCC) Winston-Salem, NC

Who Is Running the Clinical Trial?

Wake Forest University Health Sciences Lead Sponsor

National Cancer Institute (NCI) Collaborator

References

1. England pubmed.ncbi.nlm.nih.gov

The Effectiveness of Shared Care in Cancer Survivors-A Systematic Review. [2022] To determine whether the shared care model during the follow-up of cancer survivors is effective in terms of patient-reported outcomes, clinical outcomes, and continuity of care.

2. United States pubmed.ncbi.nlm.nih.gov

Randomized Controlled Trial of Shared Care for Patients With Cancer Involving General Practitioners and Cancer Specialists. [2022] We aimed to determine whether a shared care model (SCM) during chemotherapy treatment improved emotional well-being, empowerment, and prevalence of symptoms for people being treated for cancer.

3. England pubmed.ncbi.nlm.nih.gov

Cross-sectoral communication by bringing together patient with cancer, general practitioner and oncologist in a video-based consultation: a qualitative study of oncologists' and nurse specialists' perspectives. [2021] Shared care models in the field of cancer aim to improve care coordination, role clarification and patient satisfaction. Cross-sectoral communication is pivotal. Involvement of patients may add to intended mechanisms.A randomised controlled trial 'The Partnership Study' tested the effect of bringing together patient, general practitioner (GP) and oncologist for a consultation conducted by video.

4. United States pubmed.ncbi.nlm.nih.gov

Associations between shared care and patient experiences among older cancer survivors. [2022] Cancer survivors have unique medical care needs. "Shared care," delivered by both oncologists and primary care providers (PCPs), may better address these needs. Little information is available on differences in outcomes among survivors receiving shared care versus oncologist-led or PCP-led care. This study compared experiences of care for survivors receiving shared care, oncologist-led, PCP-led, or other care patterns.

5. England pubmed.ncbi.nlm.nih.gov

Rationale and Design of a Telehealth Self-Management, Shared Care Intervention for Post-treatment Survivors of Lung and Colorectal Cancer. [2023] Survivors of lung and colorectal cancer have high post-treatment needs; the majority are older and suffer from greater comorbidities and poor quality of life (QOL). They remain underrepresented in research, leading to significant disparities in post-treatment outcomes. Personalized post-treatment follow-up care and care coordination among healthcare teams is a priority for survivors of lung and colorectal cancer. However, there are few evidence-based interventions that address survivors' post-treatment needs beyond the use of a follow-up care plan. This paper describes the rationale and design of an evidence-informed telehealth intervention that integrates shared care coordination between oncology/primary care and self-management skills building to empower post-treatment survivors of lung and colorectal cancer. The intervention design was informed by (1) contemporary published evidence on cancer survivorship, (2) our previous research in lung and colorectal cancer survivorship, (3) the chronic care self-management model (CCM), and (4) shared post-treatment follow-up care between oncology and primary care. A two-arm, parallel randomized controlled trial will determine the efficacy of the telehealth intervention to improve cancer care delivery and survivor-specific outcomes. ClinicalTrials.gov Identifier: NCT04428905.

6. Denmark pubmed.ncbi.nlm.nih.gov

Attention to cancer patients' safety after primary treatment is needed. [2015] Knowledge about patient safety issues after primary treatment of cancer is sparse.

7. United States pubmed.ncbi.nlm.nih.gov

Adverse events among the elderly receiving chemotherapy for advanced non-small-cell lung cancer. [2021] To describe chemotherapy use and adverse events (AEs) for advanced-stage, non-small-cell lung cancer (NSCLC) in community practice, including descriptions according to variation by age.

8. China pubmed.ncbi.nlm.nih.gov

[Role of Adverse Events Supervision in Clinical Trials in Neoadjuvant Treatment of Operable Stage III NSCLC]. [2023] Programmed cell death protein 1 (PD-1) combined with platinum containing dual drug chemotherapy is a new adjuvant treatment option for operable stage III non-small cell lung cancer (NSCLC), and the quality assurance of clinical trials of related drugs plays a crucial role in the results of the clinical trials. This study aims to explore the impact of adverse events (AEs) supervision on reducing treatment-related AEs in patients.

9. United States pubmed.ncbi.nlm.nih.gov

Developing a cancer-specific trigger tool to identify treatment-related adverse events using administrative data. [2021] As there are few validated tools to identify treatment-related adverse events across cancer care settings, we sought to develop oncology-specific "triggers" to flag potential adverse events among cancer patients using claims data.

10. Canada pubmed.ncbi.nlm.nih.gov

Adverse events in community care: implications for practice, policy and research. [2019] Adverse events in community care constitute a system-wide issue that warrants attention from all healthcare system stakeholders. Improving patient safety and preventing adverse events will require policy at multiple levels that addresses (1) local healthcare system integration, (2) competition and financing, (3) technology and electronic records, (4) collaboration and communication among providers, (5) organizational culture and (6) education for clinicians, patients and caregivers. This article describes the results of a symposium in which 31 healthcare professionals from 18 organizations were asked to discuss adverse events and to identify important implications for practice, policy and research. Results include prioritized lists of what providers can do to prevent adverse events, suggested policy changes and information needed from research.

11. England pubmed.ncbi.nlm.nih.gov

Shared care involving cancer specialists and primary care providers - What do cancer survivors want? [2023] Cancer survivors are living longer, prompting greater focus on managing cancer as a chronic condition. Shared care between primary care providers (PCPs) and cancer specialists, involving explicit partnership in how care is communicated, could ensure effective transitions between services. However, little is known about cancer patients' and survivors' preferences regarding shared care.

12. England pubmed.ncbi.nlm.nih.gov

ProCare Trial: a phase II randomized controlled trial of shared care for follow-up of men with prostate cancer. [2022] To test the feasibility and efficacy of a multifaceted model of shared care for men after completion of treatment for prostate cancer.

13. United States pubmed.ncbi.nlm.nih.gov

Survivorship issues for patients with lung cancer. [2022] Survivorship concerns for patients with lung and bronchus cancers include quality of life and physical and psychological aspects. Recommendations for follow-up care should incorporate a survivorship paradigm and practices for these patients.