Survivorship Care for Lung Cancer
(KYLEADSII Trial)
Recruiting in Palo Alto (17 mi)
Overseen byJerod L Stapleton, PhD
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Jerod L Stapleton, PhD
Disqualifiers: Psychiatric disturbance, Substance abuse, others
No Placebo Group
Approved in 1 Jurisdiction
Trial Summary
What is the purpose of this trial?The overarching goal of the Kentucky LEADS Collaborative Lung Cancer Survivorship Care program is to reduce the burden of lung cancer by offering an innovative survivorship care approach that improves lung cancer quality of life, overcomes lung cancer stigma, and helps survivors engage with care. The project involves a two-group parallel randomized clinical trial comparing the impact of the Kentucky LEADS Collaborative Lung Cancer Survivorship Care program (KLCLCSC) among lung cancer survivors (N=300) against an enhanced usual care condition (bibliotherapy+assessment) on quality of life outcomes.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications.
What data supports the effectiveness of the treatment Enhanced Usual Care, Duphalac, Kristalose, Kentucky LEADS Collaborative Lung Cancer Survivorship Care Program, KLCLCSC, Kentucky LEADS Collaborative Lung Cancer Survivorship Care Program for lung cancer?
Research shows that survivorship care planning (SCP) can improve health outcomes for cancer survivors, including those with lung cancer. The implementation of SCPs has been supported by both clinicians and patients, indicating their potential effectiveness in improving long-term care and follow-up compliance.
12345How is the Kentucky LEADS Collaborative Lung Cancer Survivorship Care Program treatment different from other treatments for lung cancer?
The Kentucky LEADS Collaborative Lung Cancer Survivorship Care Program is unique because it focuses on survivorship care planning, which includes creating personalized care plans for patients who have completed primary cancer treatment. This approach emphasizes long-term follow-up and management of both physical and psychosocial effects of cancer, aiming to improve overall quality of life for lung cancer survivors.
12367Eligibility Criteria
This trial is for adults over 18 who have been diagnosed with lung cancer and live in a rural area (RUC code of 4+). They must be able to communicate in English. There's no mention of specific exclusions, so it seems open to many lung cancer survivors.Inclusion Criteria
I am 18 years old or older.
Be able to communicate effectively in English
I have been diagnosed with lung cancer.
+1 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Treatment
Participants receive the Kentucky LEADS Collaborative Lung Cancer Survivorship Care Program (KLCLCSC) or Enhanced Usual Care (EUC) for 6 months
6 months
Follow-up
Participants are monitored for changes in quality of life, engagement, and other outcomes after treatment
6 months
Participant Groups
The study compares the Kentucky LEADS Collaborative Lung Cancer Survivorship Care program, which aims to improve quality of life and engagement with care, against enhanced usual care involving bibliotherapy and assessment.
2Treatment groups
Experimental Treatment
Active Control
Group I: Kentucky LEADS Collaborative Lung Cancer Survivorship Care Program (KLCLCSC)Experimental Treatment1 Intervention
The Kentucky LEADS Collaborative Lung Cancer Survivorship Care Program (KLCLCSC) is a targeted and tailored lung cancer survivorship care intervention built on principles of patient-centered care, shared decision making, and motivational interviewing to build survivor engagement and improve lung cancer outcomes.
Group II: Enhanced Usual Care (EUC)Active Control1 Intervention
The enhanced usual care condition involves usual care plus bibliotherapy and assessment.
Kentucky LEADS Collaborative Lung Cancer Survivorship Care Program is already approved in United States for the following indications:
🇺🇸 Approved in United States as Kentucky LEADS Collaborative Lung Cancer Survivorship Care Program for:
- Lung cancer survivorship care
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Markey Cancer CenterLexington, KY
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Who Is Running the Clinical Trial?
Jerod L Stapleton, PhDLead Sponsor
University of Colorado, DenverLead Sponsor
G02 for Lung CancerCollaborator
National Cancer Institute (NCI)Collaborator
University of KentuckyCollaborator
University of LouisvilleCollaborator
References
Long-term assessment of efficacy with a novel Thoracic Survivorship Program for patients with lung cancer. [2023]We developed a novel, nurse practitioner-run Thoracic Survivorship Program to aid in long-term follow-up. Patients with non-small cell lung cancer who were disease-free at least 1 year after resection could be referred to the Thoracic Survivorship Program by their surgeon. Our objectives were to summarize follow-up compliance and assess long-term outcomes between Thoracic Survivorship Program enrollment and non-Thoracic Survivorship Program.
Survivorship care planning and its influence on long-term patient-reported outcomes among colorectal and lung cancer survivors: the CanCORS disease-free survivor follow-up study. [2018]This study aims to evaluate the relationship between survivorship care planning (SCP) and survivorship care and health outcomes reported by long-term lung and colorectal cancer survivors.
Survivorship care planning in a comprehensive cancer center using an implementation framework. [2016]Cancer survivorship care plans (SCPs) have been recommended to improve clinical care and patient outcomes. Research is needed to establish their efficacy and identify best practices. Starting in 2015, centers accredited by the American College of Surgeons Commission on Cancer must deliver SCPs to patients completing primary cancer treatment with curative intent. We describe how we established routine SCP delivery at the Robert H Lurie Comprehensive Cancer Center in Chicago, Illinois, using the Quality Implementation Framework. We evaluated local practices, gathered clinician and patient stakeholder input, developed customized SCP templates within the electronic health record (EHR), and implemented 2 complementary delivery models. Clinician interviews (n = 41) and survey responses (n = 12), along with input from patients (n = 68) and a patient advisory board (n = 15), indicated support for SCPs and survivorship services. To promote feasible implementation and leverage existing workflows, we harmonized 2 SCP delivery models: integrated care within clinics where patients received treatment, and referral to a centralized survivorship clinic. We are implementing SCP delivery with prominent disease sites and will extend services to survivors of other cancers in the future. We developed four electronic disease-specific SCP templates for breast, colorectal, lung, and prostate cancers and a fifth, generic template that can be used for other malignancies. The templates reduced free-text clinician entry by auto-populating 20% of the fields from existing EHR data, and using drop-down menus for another 65%. Mean SCP completion time is 12 minutes (range, 10-15; n = 64). We designed our framework to facilitate ongoing evaluation of implementation and quality improvement. Funding/sponsorship Robert H Lurie Comprehensive Cancer Center, the Coleman Foundation, and the Lynn Sage Cancer Research Foundation.
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.
Breast cancer survivorship care plans: what are they covering and how well do they align with national guidelines? [2020]Survivorship care plans (SCPs) provide key information about cancer treatment history and follow-up recommendations. We describe the completeness of breast cancer SCPs and evaluate guideline concordance of follow-up recommendations.
Advancing survivorship care through the National Cancer Survivorship Resource Center: developing American Cancer Society guidelines for primary care providers. [2022]The National Cancer Survivorship Resource Center (The Survivorship Center) began in 2010 as a collaboration between the American Cancer Society and the George Washington University Cancer Institute and was funded by the Centers for Disease Control and Prevention. The Survivorship Center aims to improve the overall health and quality of life of posttreatment cancer survivors. One key to addressing the needs of this ever-growing population is to develop clinical follow-up care guidelines that emphasize not only the importance of surveillance for cancer recurrence, but also address the assessment and management of the physical and psychosocial long-term and late effects that may result from having cancer and undergoing cancer treatment as well as highlight the importance of healthy behaviors that can reduce the risk of cancer recurrence, second primary cancers, and other chronic diseases. Currently, The Survivorship Center is coordinating the work of experts in oncology, primary care, and other health care professions to develop follow-up care guidelines for 10 priority cancer sites.
Informing the delivery of cancer survivorship care in rural primary care practice. [2022]The cancer survivor population is projected to increase to 22.2 million by 2030, requiring improved collaboration between oncology and primary care practices (PCP). PCPs may feel ill-equipped to provide cancer survivorship care to patients without input from cancer specialists. Compared with nonrural cancer survivors, rural cancer survivors report experiencing worse treatment-related symptoms. The goal of this study was to gain a better understanding of the perspectives of PCP teams towards survivorship care and to develop and test an interdisciplinary training program to improve cancer survivorship care in rural practice.