Supportive Care Models for Cancer

Recruiting at 16 trial locations

Overseen By Manali I Patel, MD MPH MS

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Stanford University

Disqualifiers: Inability to consent, Moving, others

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

Compensation: Varies

Number of Visits: 5

Duration: 12 months

2996 Participants Needed

Trial Summary

What is the purpose of this trial?

This cluster-randomized comparative effectiveness trial compares a technology-based supportive cancer care (SCC) approach with a redesigned team-based supportive cancer care (SCC) approach.

Do I need to stop my current medications to join the trial?

The trial information does not specify whether you need to stop taking your current medications.

What data supports the effectiveness of the treatment Redesigned team-based supportive cancer care?

Research shows that digital supportive cancer care, which includes symptom monitoring and educational materials, can improve patient outcomes. E-health solutions in oncology have been found to enhance communication and symptom management, making patients more involved in their care. ^{1 2 3 4 5}

Is supportive cancer care safe for humans?

Many studies report high satisfaction rates and suggest that supportive cancer care, including teleoncology and digital health interventions, is generally safe for patients. However, more research is needed to fully understand the safety aspects of these models. ^{1 3 4 6 7}

How is the Redesigned team-based supportive cancer care treatment different from other cancer treatments?

This treatment is unique because it combines team-based care with digital health tools, like online portals and telehealth, to provide comprehensive support for cancer patients, addressing not just physical symptoms but also emotional and social needs, which is not typically the focus of standard cancer treatments. ^{1 2 3 4 8}

Eligibility Criteria

This trial is for English or Spanish-speaking adults newly diagnosed with solid tumor cancers or blood malignancies. They must understand and agree to participate in the study, plan to keep their current oncologist for at least a year, and not be moving from the area soon.

Inclusion Criteria

I speak English or Spanish.

I have been recently diagnosed with cancer.

I can understand and am willing to consent to participate.

Exclusion Criteria

Patients who anticipate moving from the area within 12 months

I plan to change my cancer doctor within the next year.

Employed by the practice site

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Assessment

Participants complete a baseline interview upon enrollment during the initial consent phone contact

1 week

1 visit (virtual)

Treatment

Participants receive supportive cancer care through either a technology-based approach or a team-based approach with weekly sessions during months 1-4 and bi-weekly sessions during months 5-12

12 months

Weekly visits (in-person or virtual) during months 1-4, bi-weekly visits during months 5-12

Follow-up

Participants are monitored for health-related quality of life, patient activation, satisfaction with care, and other outcomes at 3, 6, and 12 months post enrollment

12 months

3 visits (virtual) at 3, 6, and 12 months

Treatment Details

Interventions

• Redesigned team-based supportive cancer care
• Technology-based supportive cancer care

Trial Overview The study compares two types of supportive care for cancer patients: one uses technology like apps or online tools, while the other relies on a redesigned team approach involving healthcare professionals.

Participant Groups

Group I: Redesigned team-based supportive cancer care Experimental Treatment 1 Intervention

Patients are paired with a health educator who will discuss the same educational materials from ARM A either in person or by telephone discussions weekly during months 1-4 and every other week during months 5-12.

Group II: Technology-based supportive cancer care Active Control 1 Intervention

Patients receive educational materials to assist with advance care planning and symptom management through a technology-based supportive cancer care weekly during months 1-4 and every other week during months 5-12.

Who Is Running the Clinical Trial?

Stanford University

Lead Sponsor

Trials

2,527

Recruited

17,430,000+

Patient-Centered Outcomes Research Institute

Collaborator

Trials

592

Recruited

27,110,000+

Findings from Research

The digital supportive cancer care portal was adopted by 72% of patients undergoing chemotherapy, with a high usability score of 72.3, indicating that patients found it easy to use and engage with the platform.

Patients reported significant improvements in symptom distress, quality of life, and health engagement after using the portal, suggesting that it may positively impact patient outcomes during cancer treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Supportive digital health service during cancer chemotherapy: A single arm before and after feasibility study. Fridriksdottir, N., Ingadottir, B., Skuladottir, K., et al.[2023]

Supportive care in oncology focuses on managing symptoms and improving quality of life throughout the entire cancer journey, from diagnosis to end-of-life care, emphasizing a patient-centered approach that includes communication with families and caregivers.

This care must be evidence-based and involve a multidisciplinary team, including various specialists, to address physical, emotional, and financial challenges, while also integrating new technologies like eHealth to enhance patient support.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Supportive care in cancer-a MASCC perspective. Olver, I., Keefe, D., Herrstedt, J., et al.[2022]

Cancer clinicians recognize the value of telephone follow-ups for providing reassurance and answering patient questions, which could potentially reduce hospital visits and ensure equitable care, especially for those in rural areas.

Despite acknowledging the cost-effectiveness of a centralized telephone support model, most clinicians preferred a local delivery system, believing that local nurses have better knowledge of their community's needs and emphasizing the importance of some face-to-face interactions with patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Localized versus centralized nurse-delivered telephone services for people in follow up for cancer: opinions of cancer clinicians. Harrison, JD., Durcinoska, I., Butow, PN., et al.[2015]

A study involving 154 cancer patients and 36 clinicians in rural Victoria, Australia, found that both groups highly accepted a supportive care screening and referral process, which effectively identified 90% of relevant patient problems.

The process not only helped patients realize that support was available (87% reported this) but also improved the rapport between patients and clinicians (72%), indicating its potential to enhance patient-centered care in rural settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cancer patient and clinician acceptability and feasibility of a supportive care screening and referral process. Ristevski, E., Regan, M., Jones, R., et al.[2022]

E-health technologies are transforming supportive care in oncology by enabling real-time assessments and interventions, which can enhance communication between patients and healthcare professionals.

These technologies not only improve symptom management and patient engagement but also represent a shift towards patient-centered care, allowing patients to take a more active role in their treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[E-health, digitalization, or digital transformation: Impact on cancer supportive care]. Seguin, L., Tassy, L.[2022]

The D-SCAN app was found to be feasible and satisfactory for patients with advanced cancer, with 76% of participants meeting the criteria for successful symptom survey completion, which exceeded the target of 75%.

While the app increased awareness of supportive care resources among patients and caregivers, and showed high usability satisfaction, further research is needed to evaluate its actual impact on quality of life and resource utilization.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A single-site pilot feasibility randomized trial of a supportive care mobile application intervention for patients with advanced cancer and caregivers. Merz, A., Mohamed, A., Corbett, C., et al.[2022]

Teleoncology has been successfully implemented to provide cancer care closer to home for rural and disadvantaged communities, with many patients and health professionals reporting high satisfaction rates.

A single center study indicates that it is safe to supervise chemotherapy delivery remotely, and overall, teleoncology models have shown cost savings for health systems, although further research on safety is needed.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Medical models of teleoncology: current status and future directions. Sabesan, S.[2014]

Supportive cancer care encompasses comprehensive assistance for patients, including pain management, psychological support, and access to therapies, which is crucial for improving quality of life during treatment.

In France, the establishment of supportive care centers in hospitals aims to enhance coordination among multidisciplinary teams, particularly benefiting patients with bone metastasis through tailored interventions like bisphosphonates and physiotherapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Supportive care for urological metastatic patients]. Lebret, T., Di Palma, M., Ripoll, J., et al.[2008]

References

1. Canada pubmed.ncbi.nlm.nih.gov

Supportive digital health service during cancer chemotherapy: A single arm before and after feasibility study. [2023]

2. Germany pubmed.ncbi.nlm.nih.gov

Supportive care in cancer-a MASCC perspective. [2022]

3. Australia pubmed.ncbi.nlm.nih.gov

Localized versus centralized nurse-delivered telephone services for people in follow up for cancer: opinions of cancer clinicians. [2015]

4. England pubmed.ncbi.nlm.nih.gov

Cancer patient and clinician acceptability and feasibility of a supportive care screening and referral process. [2022]

5. France pubmed.ncbi.nlm.nih.gov

[E-health, digitalization, or digital transformation: Impact on cancer supportive care]. [2022]

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

A single-site pilot feasibility randomized trial of a supportive care mobile application intervention for patients with advanced cancer and caregivers. [2022]

7. Australia pubmed.ncbi.nlm.nih.gov

Medical models of teleoncology: current status and future directions. [2014]

8. France pubmed.ncbi.nlm.nih.gov

[Supportive care for urological metastatic patients]. [2008]