Social Network Coaching for Cancer

(SONATA Trial)

Overseen By Kah Poh Loh, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Rochester

Disqualifiers: Psychiatric, Cognitive impairments

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

Compensation: Varies

Number of Visits: 6

220 Participants Needed

Trial Summary

What is the purpose of this trial?

The purpose of this study is to see if a social network support program (SOcial Networks to Activate Trust \& Adherence or SONATA) is helpful for older individuals receiving cancer treatment. The SONATA program will last for about 4 months. There are a total of 6 coaching sessions. The first 5 sessions will be held approximately every 1 to 2 weeks. Session 6 or the final session will be held approximately 1 to 2 months after session 5. Each session will last for about 1 to 2 hours.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It seems to focus on social support rather than medication changes.

What data supports the effectiveness of the treatment SONATA for cancer patients?

The study on improving adherence to endocrine hormonal therapy among breast cancer patients shows that support from a patient navigator and personalized communication can enhance treatment adherence, which is a key component of the SONATA approach. This suggests that similar strategies in SONATA could improve adherence and outcomes for cancer patients. ^{1 2 3 4 5}

What makes the SONATA treatment unique for cancer patients?

The SONATA treatment is unique because it focuses on enhancing social networks to build trust and improve adherence to cancer therapy, rather than relying solely on medication. This approach emphasizes the importance of the patient-physician relationship and the patient's support system, which can significantly impact treatment compliance and overall quality of life. ^{1 5 6 7 8}

Research Team

Kah Poh Loh, MD

Principal Investigator

University of Rochester

Eligibility Criteria

This trial is for individuals aged 65 or older who have been diagnosed with cancer and are starting or within the first three months of oral cancer treatments. They must be able to consent, speak English, and identify at least one person from their social network to join them in the program.

Inclusion Criteria

I am 65 years old or older.

I have been diagnosed with cancer.

I am starting or have recently started oral cancer treatment.

Exclusion Criteria

Patient with any psychiatric or cognitive impairments interfering with participation as determined by the treating oncology team

Patient enrolled on oral anticancer therapeutic trials

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

SONATA Intervention

Participants engage in the SONATA social network support program, consisting of 6 coaching sessions over approximately 4 months

16 weeks

6 sessions (in-person or virtual)

Follow-up

Participants are monitored for adherence to oral anticancer treatments and other outcomes

4 weeks

Treatment Details

Interventions

• SONATA

Trial Overview The SONATA program is being tested to see if it helps older adults with cancer by providing social support through coaching sessions. Participants will engage in six sessions over approximately four months aimed at enhancing trust and adherence to treatment.

Participant Groups

Group I: Arm 1 - SONATA Intervention Experimental Treatment 1 Intervention

Who Is Running the Clinical Trial?

University of Rochester

Lead Sponsor

Trials

883

Recruited

555,000+

Findings from Research

In a study of 577 cancer patients, breast cancer patients showed significantly higher rates of non-adherence to adjuvant chemotherapy guidelines compared to colon cancer patients, with rates of 69% for primary non-adherence and 89% for non-persistence at 6 months.

Patient-centered communication (PCCM) was found to be a critical factor influencing adherence, with lower communication scores linked to higher non-adherence, particularly among older patients and those diagnosed with breast cancer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adjuvant chemotherapy non-adherence, patient-centered communication, and patient-level factors in elderly breast and colon cancer patients. Mitchell, KR., Boyle, JR., Juricekova, L., et al.[2023]

In a study of 7371 patients with operable IIIAN2 non-small-cell lung cancer, only 33.7% received all four recommended best treatment practices, highlighting a significant gap in adherence to guidelines.

Collective adherence to these best practices, including anatomic resection and induction therapy, was linked to improved survival rates, indicating that following these guidelines can lead to better patient outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Social determinants and facility type impact adherence to best practices in operable IIIAN2 lung cancer. Muslim, Z., Stroever, S., Baig, MZ., et al.[2023]

The study found significant variation in prostate cancer treatment rates, specifically prostatectomy, among different urologist subgroups based on their social networks, indicating that physician connections can influence treatment decisions.

In cities A, B, and C, certain urologist subgroups had notably lower odds of performing prostatectomies compared to others, even after accounting for patient characteristics, suggesting that physician networks play a crucial role in treatment variability.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Physician social networks and variation in prostate cancer treatment in three cities. Pollack, CE., Weissman, G., Bekelman, J., et al.[2022]

In a study of 107 women with breast cancer over 26 weeks, 52% experienced unjustified changes to their chemotherapy regimens, indicating significant physician nonadherence that could impact treatment efficacy.

Factors such as older patient age, the treatment setting, and disease stage were linked to higher rates of nonadherence, while psychological factors specifically influenced the prescribing of vincristine, suggesting that understanding these influences could help reduce unnecessary treatment modifications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Predictors of physician nonadherence to chemotherapy regimens. Schleifer, SJ., Bhardwaj, S., Lebovits, A., et al.[2019]

Adjuvant endocrine hormonal therapy (EHT) is crucial for nearly all breast cancer patients with hormone receptor-positive tumors, significantly reducing recurrence rates and the risk of death, yet about 33% of patients do not adhere to their prescribed medication.

This study aims to improve adherence to EHT through a bilingual, culturally tailored smartphone app and support from a patient navigator, with the goal of enhancing patient education, self-management, and ultimately improving survival and quality of life for breast cancer patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Improving adherence to endocrine hormonal therapy among breast cancer patients: Study protocol for a randomized controlled trial. Chalela, P., Munoz, E., Inupakutika, D., et al.[2020]

In a study of 131 colon cancer patients, trust in oncologists was linked to improved physical functioning over time, highlighting the importance of a strong patient-physician relationship.

Patient enablement, which involves helping patients understand their diagnosis and treatment, was found to significantly influence changes in physical functioning, suggesting that empowering patients can enhance their quality of life during cancer care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patients' Trust in Physician, Patient Enablement, and Health-Related Quality of Life During Colon Cancer Treatment. Ernstmann, N., Wirtz, M., Nitzsche, A., et al.[2018]

There is a significant lack of quantitative data on treatment compliance among cancer patients, highlighting a gap in understanding how well patients follow their prescribed medical regimens.

Compliance is influenced not only by patient behavior but also by factors such as physician behavior, the quality of the patient-physician relationship, and the support systems available to patients, suggesting a need for a more holistic approach to improving compliance in cancer care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Compliance with cancer therapy by patients and physicians. Lewis, C., Linet, MS., Abeloff, MD.[2019]

A study involving 82 estrogen receptor-positive breast cancer patients developed predictive models to understand the complex reasons behind early discontinuation of adjuvant endocrine treatment, highlighting the need for tailored interventions.

Three effective strategies were identified to improve treatment adherence: reducing general anxiety, reinforcing pill-taking routines, and increasing trust in healthcare providers, particularly benefiting patients with lower health literacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Network Modeling of Complex Time-Dependent Changes in Patient Adherence to Adjuvant Endocrine Treatment in ER+ Breast Cancer. Shinn, EH., Busch, BE., Jasemi, N., et al.[2022]

References

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

Adjuvant chemotherapy non-adherence, patient-centered communication, and patient-level factors in elderly breast and colon cancer patients. [2023]

2. England pubmed.ncbi.nlm.nih.gov

Social determinants and facility type impact adherence to best practices in operable IIIAN2 lung cancer. [2023]

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

Physician social networks and variation in prostate cancer treatment in three cities. [2022]

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

Predictors of physician nonadherence to chemotherapy regimens. [2019]

5. Netherlands pubmed.ncbi.nlm.nih.gov

Improving adherence to endocrine hormonal therapy among breast cancer patients: Study protocol for a randomized controlled trial. [2020]

6. England pubmed.ncbi.nlm.nih.gov

Patients' Trust in Physician, Patient Enablement, and Health-Related Quality of Life During Colon Cancer Treatment. [2018]

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

Compliance with cancer therapy by patients and physicians. [2019]

8. Switzerland pubmed.ncbi.nlm.nih.gov

Network Modeling of Complex Time-Dependent Changes in Patient Adherence to Adjuvant Endocrine Treatment in ER+ Breast Cancer. [2022]