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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to improve care for cancer patients with heart-related conditions such as high blood pressure, diabetes, or high cholesterol. It tests various methods to involve primary care doctors in the cancer treatment process, enhancing communication and managing chronic diseases more effectively. Patients diagnosed with early-stage breast, prostate, colorectal, endometrial, or lung cancer who also take medication for one of these heart-related conditions may find this trial suitable. Participants should have recently started cancer treatment and visited their primary care doctor within the last year. As an unphased trial, this study offers a unique opportunity to contribute to innovative care strategies that could benefit future patients with similar health profiles.

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.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that both the iGuide 2 Intervention (customized) and the iGuide Intervention (self-guided) are generally well-tolerated. Customized interventions, such as iGuide 2, have improved patients' quality of life without causing major side effects. A review found that these interventions help by tailoring care to individual needs, reducing negative effects.

Similarly, self-guided interventions, like the original iGuide, are designed to be easy to use and safe. Past research on digital health tools similar to iGuide has demonstrated improved health outcomes for cancer patients. These tools aim to enhance the treatment experience without adding significant risks.

Overall, current evidence suggests these interventions are safe, focusing on improving care with minimal risk. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the TEAM-based Care for Cancer trial because it explores innovative ways to enhance cancer care through tailored interventions. Unlike traditional methods, which often rely on a one-size-fits-all approach, the iGuide 2 Intervention offers personalized guidance, potentially improving patient outcomes by addressing individual needs. Additionally, the self-guided iGuide Intervention empowers patients to take control of their care, promoting active participation in their treatment journey. This trial aims to uncover whether these tailored and self-guided approaches can lead to better patient engagement and outcomes compared to standard care.

What evidence suggests that this trial's treatments could be effective for cancer patients with cardiovascular comorbidities?

This trial will compare the iGuide 2 Intervention, customized for each patient, with the self-guided iGuide Intervention. Research has shown that the iGuide 2 Intervention may help cancer patients manage their illness and communicate better with healthcare teams. This program aims to enhance how patients use healthcare services and support caregivers, which is crucial for those dealing with both cancer and heart issues. Studies have found that personalized care can significantly improve patient outcomes by tailoring treatment to individual needs.

The iGuide Intervention is self-guided, and research suggests it boosts patient satisfaction and confidence in managing health. It uses patient feedback to track symptoms, making it easier for patients to receive necessary care. Both interventions in this trial aim to improve care, which could benefit people managing cancer and heart conditions simultaneously. ^{6 7 8 9 10}

Are You a Good Fit for This Trial?

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.

I am having surgery at Duke but won't return for follow-up.

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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 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]

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 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]

Citations

1. cancer.gov cancer.gov/research/participate/clinical-trials-search/v?id=NCI-2022-04339

A Self-Guided Multi-Level Intervention for Improving the ... This clinical trial evaluates the iGuide and iGuide 2 interventions for their ability to optimize disease management and communication among cancer patients and ...

2. grants.nih.gov grants.nih.gov/grants/guide/pa-files/par-18-247.html

Expired PAR-18-247: Intervening with Cancer Caregivers ... Outcomes of such interventions are expected to (1) optimize patient health care utilization, (2) improve caregiver well-being, and (3) ...

3. nature.com nature.com/articles/s41388-025-03424-x

A targeted literature review on the impact of tailored ... A targeted literature review identified published studies evaluating the impact of tailored (customized based on individual patient characteristics) non- ...

4. ascopubs.org ascopubs.org/doi/10.1200/CCI.20.00015

Electronic Patient-Reported Outcome–Based Interventions ... We performed a systematic and mapping review of the scientific literature on the current ePRO-based approaches used for palliative cancer care.

5. grants.nih.gov grants.nih.gov/grants/guide/pa-files/par-19-355.html

Expired PAR-19-355: Intervening with Cancer Caregivers ... A description of how the intervention will balance improvements targeted in all 3 outcome areas identified in Section I as targeted by this FOA, ...

6. withpower.com withpower.com/trial/phase-prostatic-neoplasms-4-2021-bd50c

TEAM-based Care for Cancer (ONE TEAM Trial) It involves two interventions: iGuide 2 Intervention (tailored/targeted) and iGuide Intervention (self-guided), compared to standard care. The study aims to ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12074991/

A targeted literature review on the impact of tailored ... A targeted literature review identified published studies evaluating the impact of tailored (customized based on individual patient characteristics) non- ...

8. clinicaltrials.gov clinicaltrials.gov/study/NCT05332561

Study Details | NCT05332561 | Genomics Guided Targeted ... The study aims to show an overall benefit of the precision medicine approach in high-risk eBC patients and to allow for secondary exploratory evaluation of ...

9. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0738399125000412

Effectiveness of tailored interventions on quality of life in ... This systematic review aimed to identify effective components and assess the statistical, practical, and clinical significance of tailored interventions for ...

10. sciencedirect.com sciencedirect.com/science/article/pii/S2950247024000914

Virtual multimodal hub for patients undergoing major ... The secondary aim is to obtain pilot data on the likely difference in key outcomes—postoperative complications within 30 days after surgery, quality of life, ...