SHAREDCare Plan for Lung Cancer Survivors

(SHAREDCare Trial)

Overseen By Sarah Birken, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Wake Forest University Health Sciences

Disqualifiers: Non-English speakers, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 3

15 Participants Needed

Trial Summary

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}

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.

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

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

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.

Who Is Running the Clinical Trial?

Wake Forest University Health Sciences

Lead Sponsor

Trials

1,432

Recruited

2,506,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Findings from Research

A systematic review of 11 studies, including 8 randomized controlled trials, found that the shared care model for cancer survivors is as effective as usual care in terms of quality of life and clinical outcomes, while also being highly acceptable to patients and practitioners.

Patient satisfaction with shared care was reported to be higher than with usual care, suggesting that improved communication between primary and hospital care can enhance follow-up for cancer survivors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Effectiveness of Shared Care in Cancer Survivors-A Systematic Review. Zhao, Y., Brettle, A., Qiu, L.[2022]

The shared care model (SCM) during chemotherapy did not significantly improve overall emotional well-being, empowerment, or symptom prevalence among cancer patients, based on a study with 97 participants.

However, the SCM was effective in reducing clinical anxiety over time in the intervention group, suggesting that targeted approaches may be beneficial for specific patient subgroups.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Randomized Controlled Trial of Shared Care for Patients With Cancer Involving General Practitioners and Cancer Specialists. Johnson, CE., Saunders, CM., Phillips, M., et al.[2022]

The Partnership Study explored the effectiveness of video consultations involving patients, general practitioners (GPs), and oncologists, revealing that while the concept is seen as useful, addressing technical and organizational challenges is crucial for successful implementation.

Interviews with oncologists highlighted the need for better structuring of consultations and communication, as well as careful case selection to enhance the collaborative care model between GPs and oncologists in cancer treatment.

NCBI (Pubmed)

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. Hansen, DG., Trabjerg, TB., Sisler, JJ., et al.[2021]

In a study of 10,132 cancer survivors aged 65 and older, those receiving shared care reported similar experiences of care compared to those receiving oncologist-led, PCP-led, or other care patterns, indicating that shared care may not offer distinct advantages.

The only notable difference was that survivors in PCP-led and other care patterns reported lower satisfaction in getting needed medications compared to those in shared care, suggesting that medication access may be a concern in certain care models.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Associations between shared care and patient experiences among older cancer survivors. Halpern, MT., Cohen, J., Lines, LM., et al.[2022]

Survivors of lung and colorectal cancer often face significant post-treatment challenges, including poor quality of life and greater health complications, yet they are underrepresented in research, leading to disparities in care.

This study outlines a new telehealth intervention designed to enhance care coordination between oncology and primary care, aiming to empower cancer survivors through self-management skills and improve their post-treatment outcomes, which will be tested in a randomized controlled trial.

NCBI (Pubmed)

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. Sun, V., Reb, A., Debay, M., et al.[2023]

A retrospective analysis of 724 adverse events (AEs) after primary cancer treatment revealed that 46% of these events resulted in physical harm, with 4% leading to severe harm or death, highlighting significant safety concerns in post-treatment care.

The study found that 50% of AEs were related to care transitions, indicating that improvements in administrative practices, communication, and clarity in patient responsibility could greatly reduce these adverse events and enhance patient safety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Attention to cancer patients' safety after primary treatment is needed. Christiansen, AH., Lipczak, H., Knudsen, JL.[2015]

In a study of 1,371 patients with advanced-stage non-small-cell lung cancer, 58% received chemotherapy, with younger patients (under 55) more likely to be treated compared to older patients (47% for those 75 and older).

Despite having fewer pre-treatment medical events, older patients experienced more adverse events during chemotherapy, indicating a need to carefully consider the balance between treatment benefits and potential side effects in this age group.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adverse events among the elderly receiving chemotherapy for advanced non-small-cell lung cancer. Chrischilles, EA., Pendergast, JF., Kahn, KL., et al.[2021]

In a study of 66 patients with operable stage III non-small cell lung cancer (NSCLC), the combination of Camrelizumab with Docetaxel and Cisplatin showed good overall safety, with most adverse events (AEs) being mild (grade 1-2) and only 9.1% being severe (grade 3-4).

The supervision of adverse events during neoadjuvant therapy not only helped in managing complications but also led to an improvement in patients' quality of life, indicating that careful monitoring can enhance treatment outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Role of Adverse Events Supervision in Clinical Trials in Neoadjuvant Treatment of Operable Stage III NSCLC]. Zhang, Y., Zhou, S., Tao, W., et al.[2023]

In a study of 322,887 cancer patients undergoing treatment, 19% experienced oncology-specific adverse events, with higher rates in those with metastatic cancers (41% for colorectal and 50% for lung cancer).

The most common triggers for these adverse events included abnormal serum bicarbonate levels and blood transfusions, highlighting the need for targeted monitoring in cancer care to improve patient safety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Developing a cancer-specific trigger tool to identify treatment-related adverse events using administrative data. Weingart, SN., Nelson, J., Koethe, B., et al.[2021]

A symposium with 31 healthcare professionals highlighted that preventing adverse events in community care requires a multi-faceted approach involving policy changes at various levels, including system integration and improved communication among providers.

Key recommendations from the symposium include prioritizing education for clinicians and caregivers, enhancing organizational culture, and leveraging technology to improve patient safety and reduce adverse events.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adverse events in community care: implications for practice, policy and research. Masotti, P., Green, M., McColl, MA.[2019]

Cancer survivors in Australia expressed a strong preference for shared care between primary care providers and cancer specialists, emphasizing the need for accurate communication and patient ownership of their medical records.

Participants identified barriers such as the lack of skills and confidence among primary care providers in managing complex cancer care, highlighting the need for better training and support to facilitate effective shared care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Shared care involving cancer specialists and primary care providers - What do cancer survivors want? Lawn, S., Fallon-Ferguson, J., Koczwara, B.[2023]

A study involving 88 men with low- to moderate-risk prostate cancer showed that a shared care model, which included more primary care visits and a survivorship care plan, produced similar psychological and quality of life outcomes compared to usual hospital care.

Men in the shared care group preferred this model over traditional hospital follow-ups (63% vs 24%), and it was also more cost-effective, saving approximately AUS$323 per patient.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

ProCare Trial: a phase II randomized controlled trial of shared care for follow-up of men with prostate cancer. Emery, JD., Jefford, M., King, M., et al.[2022]

Patients with lung cancer often experience significant physical and psychological distress, which can greatly reduce their quality of life, highlighting the need for effective survivorship care.

A multidisciplinary approach to survivorship care is essential for addressing the long-term effects of lung cancer treatment, and further research is needed to develop evidence-based practices that can improve patient outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Survivorship issues for patients with lung cancer. Pozo, CL., Morgan, MA., Gray, JE.[2022]

References

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

The Effectiveness of Shared Care in Cancer Survivors-A Systematic Review. [2022]

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]

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]

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

Associations between shared care and patient experiences among older cancer survivors. [2022]

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]

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

Attention to cancer patients' safety after primary treatment is needed. [2015]

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

Adverse events among the elderly receiving chemotherapy for advanced non-small-cell lung cancer. [2021]

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

[Role of Adverse Events Supervision in Clinical Trials in Neoadjuvant Treatment of Operable Stage III NSCLC]. [2023]

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

Developing a cancer-specific trigger tool to identify treatment-related adverse events using administrative data. [2021]

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

Adverse events in community care: implications for practice, policy and research. [2019]

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

Shared care involving cancer specialists and primary care providers - What do cancer survivors want? [2023]

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]

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

Survivorship issues for patients with lung cancer. [2022]