TEAM-based Care for Cancer

(ONE TEAM Trial)

Overseen By Kevin C Oeffinger, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Duke University

Must be taking: Hypertension, Diabetes, Hypercholesterolemia

Disqualifiers: Myocardial infarction, Heart failure, Kidney disease, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 18 months

313 Participants Needed

Trial Summary

What is the purpose of this trial?

The proposed ONE TEAM Study is an 18-month, cluster randomized controlled trial. This study will use a sequential multiple assignment randomized trial (SMART) design with a second randomization for the intervention group using a dynamic treatment regimen approach. The investigators propose to randomize 800 adults with newly-diagnosed selected cancers treated with curative intent (breast, prostate, colorectal, endometrial, non-small cell lung, and endometrial) and with \>1 selected cardiovascular disease (CVD) comorbidity (hypertension, type 2 diabetes mellitus, hypercholesterolemia). Participants will be enrolled through Duke Cancer Institute and two community-based oncology practices, both settings serving socio-demographically diverse populations. The unit of randomization will be the PCP clinic; there will be \~80 PCP clinics across North Carolina involved in the study. The overarching goals of this study are to improve chronic disease management and communication among cancer survivors by engaging PCPs as active members of the cancer care team and reframing the message to cancer survivors and providers. A diversity supplement with retrospective and qualitative components has been added to abstract older adults with solid tumors who underwent cancer surgery at DUHS. Aims include (1) to estimate the prevalence of cardiovascular complications ≤90 postoperative days among older adults with solid tumors undergoing surgery, and its association with care coordination between surgical providers and PCPs ; (2) to develop a risk index for cardiovascular complications ≤90 days of surgery among older adult patients with a solid tumor; and (3) to Assess experience and perceptions of PCPs on care coordination with surgical providers of older adults with a solid tumor following cancer surgery.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. However, since the study involves managing chronic diseases like hypertension, diabetes, or hypercholesterolemia, it's likely that you will continue your current medications. Please consult with the study team for specific guidance.

What data supports the effectiveness of the TEAM-based Care for Cancer treatment?

Research shows that using electronic tools to assess quality of life can improve communication between patients and doctors, which may enhance care for cancer patients. Additionally, following clinical guidelines and pathways in cancer treatment is linked to better survival rates and lower healthcare costs, suggesting that structured care approaches like TEAM-based Care could be beneficial. ^{1 2 3 4 5}

Is TEAM-based Care for Cancer safe for humans?

The research articles provided do not contain specific safety data for TEAM-based Care for Cancer or its related interventions. Therefore, no relevant safety information is available from these studies. ^{6 7 8 9 10}

How is the TEAM-based Care for Cancer treatment different from other cancer treatments?

The TEAM-based Care for Cancer treatment is unique because it involves a collaborative approach using different levels of guidance, including tailored and self-guided interventions, to support patients. This approach focuses on personalized care and patient involvement, which is different from standard treatments that may not emphasize patient preferences or self-management. ^{11 12 13 14 15}

Eligibility Criteria

Adults aged 18-79 with Stage I-III breast, colorectal, endometrial, head/neck, non-small cell lung cancer or Stage I-IV prostate cancer. They must have visited their PCP in the last year and have at least one CVD comorbidity (hypertension, diabetes, hypercholesterolemia). Exclusions include severe kidney disease (eGFR <30), certain heart conditions (Stage III-IV heart failure or recent myocardial infarction), language barriers, and specific tumor types.

Inclusion Criteria

I am on my first or second treatment for CLL or SLL.

I am a man with prostate cancer currently receiving hormone therapy.

I had an organ transplant, but my kidney function is normal.

Exclusion Criteria

I can stay in the study if my cancer spreads, unless I choose to leave.

I have been diagnosed with uterine sarcoma.

Patients who cannot read, are blind or do not understand/speak English

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive interventions based on a SMART design with two phases, including a self-guided informational strategy and a booster phase for those not meeting targets

18 months

Follow-up

Participants are monitored for safety and effectiveness after treatment, including medication adherence and care coordination

18 months

Postoperative Monitoring

Monitoring of cardiovascular complications within 90 days post-surgery for older adults with solid tumors

90 days

Treatment Details

Interventions

• Control
• iGuide 2 Intervention (Tailored/Targeted)
• iGuide Intervention (Self-guided)

Trial Overview The ONE TEAM Study tests a new care approach for cancer survivors with cardiovascular diseases. It involves two interventions: iGuide 2 Intervention (tailored/targeted) and iGuide Intervention (self-guided), compared to standard care. The study aims to improve chronic disease management by involving primary care physicians more actively in the cancer treatment team.

Participant Groups

Group I: iGuide Intervention Experimental Treatment 2 Interventions

40 PCP clinics; 400 patients

Group II: Control Experimental Treatment 1 Intervention

40 PCP clinics; 400 patients

Who Is Running the Clinical Trial?

Duke University

Lead Sponsor

Trials

2,495

Recruited

5,912,000+

Findings from Research

Over 6000 patients completed electronic Patient Reported Outcomes (e-PROs), achieving high completion rates (51%-95%) and demonstrating that e-PROs were well-accepted by both patients (76%) and clinicians (80%) for symptom communication and treatment planning.

The implementation of e-PROs led to significant reductions in anxiety levels and hospitalization rates, along with improved patient activation, indicating that integrating e-PROs in oncology practices can enhance patient management and reduce healthcare utilization.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Personalized symptom management: a quality improvement collaborative for implementation of patient reported outcomes (PROs) in 'real-world' oncology multisite practices. Howell, D., Rosberger, Z., Mayer, C., et al.[2020]

The STRIDE intervention, a patient-centered videoconference program, aims to improve adherence to adjuvant endocrine therapy (AET) in breast cancer patients by addressing symptom management and reducing distress, with a feasibility trial involving 75 participants.

This study will objectively monitor medication adherence using electronic pill bottles and assess the intervention's impact on patient satisfaction and symptom distress over 24 weeks, providing valuable insights into effective support strategies for AET adherence.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Study protocol for a randomised controlled feasibility trial of a virtual intervention (STRIDE) for symptom management, distress and adherence to adjuvant endocrine therapy after breast cancer. Jacobs, JM., Rapoport, CS., Horenstein, A., et al.[2021]

The randomized-controlled trial found that using an interactive video disk (IVD) for decision-making did not significantly change treatment choices for women recently diagnosed with breast cancer, indicating that the support from clinical staff is more impactful.

Despite the lack of effect on treatment decisions, participants rated the IVD positively, suggesting it could standardize information delivery, promote evidence-based practices, and serve as a quality assurance tool.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Using an interactive video disk in breast cancer patient support. Maslin, AM., Baum, M., Walker, JS., et al.[2007]

The ConnectedCancerCare (CCC) intervention was found to be feasible and acceptable for women with early-stage breast cancer, with 82% of participants finding it easy to use and 86% willing to recommend it to others.

Women using CCC were more likely to schedule follow-up visits with their primary care provider and had better communication about provider roles, indicating that CCC may enhance patient engagement and knowledge in team-based cancer care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Improving the delivery of team-based survivorship care after primary breast cancer treatment through a multi-level intervention: a pilot randomized controlled trial. Wallner, LP., Abrahamse, P., Gargaro, JG., et al.[2023]

References

1. Germany pubmed.ncbi.nlm.nih.gov

Long-term improvement of quality of life in patients with breast cancer: supporting patient-physician communication by an electronic tool for inpatient and outpatient care. [2022]

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

Evaluation of Guideline Adherence in Colorectal Cancer Treatment in The Netherlands: A Survey Among Medical Oncologists by the Dutch Colorectal Cancer Group. [2019]

3. Netherlands pubmed.ncbi.nlm.nih.gov

Adherence to guidelines and breast cancer patients survival: a population-based cohort study analyzed with a causal inference approach. [2018]

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

Impact of Nonconcordance With NCCN Guidelines on Resource Utilization, Cost, and Mortality in De Novo Metastatic Breast Cancer. [2019]

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

Associations between clinical pathway concordance, cost, and survival outcomes for stage II colon cancer: a population-based study. [2023]

6. Germany pubmed.ncbi.nlm.nih.gov

Improved time to treatment failure and survival in ibrutinib-treated malignancies with a pharmaceutical care program: an observational cohort study. [2021]

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

Investigating the Association Between Advanced Practice Providers and Chemotherapy-Related Adverse Events in Women With Breast Cancer: A Nested Case-Control Study. [2023]

8. Germany pubmed.ncbi.nlm.nih.gov

Can integrative oncology increase adherence to chemotherapy in advanced gynecologic cancer? [2022]

9. Netherlands pubmed.ncbi.nlm.nih.gov

Systematic review of real-world studies evaluating the impact of medication non-adherence to endocrine therapies on hard clinical endpoints in patients with non-metastatic breast cancer. [2021]

10. Germany pubmed.ncbi.nlm.nih.gov

Personalized symptom management: a quality improvement collaborative for implementation of patient reported outcomes (PROs) in 'real-world' oncology multisite practices. [2020]

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

Study protocol for a randomised controlled feasibility trial of a virtual intervention (STRIDE) for symptom management, distress and adherence to adjuvant endocrine therapy after breast cancer. [2021]

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

Using an interactive video disk in breast cancer patient support. [2007]

13. Canada pubmed.ncbi.nlm.nih.gov

The care continuum with interprofessional oncology teams: Perspectives of patients and family. [2015]

14. England pubmed.ncbi.nlm.nih.gov

DeImplementing Ineffective and Low-Value Clinical Practices: Research and Practice Opportunities in Community Oncology Settings. [2022]

15. Netherlands pubmed.ncbi.nlm.nih.gov

Improving the delivery of team-based survivorship care after primary breast cancer treatment through a multi-level intervention: a pilot randomized controlled trial. [2023]