Survivorship & Cancer Care Delivery Research & Clinical Trials

IMPACT Trial: NIH Reporter
IMPACT Trial: ClinicalTrials.gov

PIs: Jennifer Dahne, Ph.D., and Evan Graboyes, M.D., MPH

Individuals living with advanced and metastatic cancer that is likely incurable cancer are a growing subpopulation of cancer survivors with unique care needs. Although depression is one of the most critical issues for these patients, current approaches for delivering care are limited and strategies for scalable identification of these patients are unknown.

To address these gaps, SCOR researchers launched the IMPACT trial. This NCI-funded randomized clinical trial will evaluate the effectiveness and implementation of a proactive identification plus digital mental health intervention approach to treating depression among 279 people living with likely incurable cancer. The study will also aim to develop an electronic health record-derived phenotype of likely incurable cancer to enhance efficient identification of these individuals for referral to a range of supportive care services and clinical trials. Results from this research have the potential to expand evidence-based psychosocial treatment access in a manner that is scalable across oncology settings for individuals living with likely incurable cancer.

Geriatric Oncology
SOLACE Trial: NIH Reporter

PIs: Ashish Deshmukh, Ph.D., MPH, and Evan Graboyes, M.D., MPH

Human papillomavirus-associated oropharyngeal cancer (OPC) is one of the fastest rising causes of cancer incidence in the US, particularly among older adults. To date, ongoing de-intensification clinical trials have not considered the evolving OPC epidemiology and the unique considerations of treating older adults with cancer.

To address these gaps, SCOR researchers launched the SOLACE study. This NCI-funded study will leverage disease simulation modeling to generate in-silico trials to compare harms vs benefits of different treatment paradigms over the patient’s lifetime in the context of aging and multimorbidity. Study findings could transform clinical decision-making for OPC, maximize benefits and reduce harms, and inform evidence-based, patient-centered, and preference-concordant decision-making for this rapidly growing patient population.

Shared Decision-Making

PI: Kathryn Engelhardt, M.D.

Shared decision-making (SDM) is a critical component to determining the optimal treatment of lung cancer. However, most interventions to enhance SDM target the provider. As a result, SDM-based interventions often shift decision-making responsibility to the overwhelmed patient.

This project aims to evaluate the implementation of a previously developed decision grid in the thoracic oncology clinics of Hollings Cancer Center and to engage patients and family members to understand what information patients want to share and how we can support transfer of this knowledge from patients to providers. Study findings will enhance the dissemination and implementation of SDM tools into clinical care for patients with lung cancer.

BRIGHT Trial: NIH Reporter
BRIGHT Multi-Site Trial: ClinicalTrials.gov

PI: Evan Graboyes, M.D., MPH

Head and neck cancer survivors suffer high rates of body image-related distress which results in significant psychosocial morbidity and decreased quality of life. However, effective therapies to manage this disorder among head and neck cancer survivors are lacking.

To address this gap, SCOR researchers launched the BRIGHT (Building a Renewed ImaGe after Head and neck cancer Treatment) trial. This NCI-funded multisite randomized clinical trial will randomize head and neck cancer survivors (N=180) to a brief tele-cognitive behavioral therapy intervention or a dose- and delivery-matched tele-survivorship education control condition. Results could provide evidence supporting the first effective treatment in this population, thereby minimizing psychosocial morbidity, improving quality of life and developing new standards of clinical care.

ENDURE Trial: NIH Reporter
ENDURE Trial: ClinicalTrials.gov

PI: Evan Graboyes, M.D., MPH

For patients with locally advanced head and neck cancer, clinical practice guidelines recommend initiating adjuvant radiation therapy within six weeks of surgery. Despite its oncologic importance, delays starting adjuvant therapy are common, disproportionately burden non-majority populations, and contribute to poor survival and disparities in mortality.

To improve the delivery of timely adjuvant therapy for all patient groups, SCOR researchers launched the ENDURE (Enhanced Navigation for Disparities and Untimely Radiation thErapy) trial. This NCI-funded multisite hybrid effectiveness-implementation clinical trial will evaluate an enhanced patient navigation intervention versus usual care for decreasing delays and disparities starting adjuvant therapy among patients with head and neck cancer. Results may help improve survival and decrease disparities in mortality for patients with head and neck cancer while improving our understanding of the delivery of effective interprofessional team-based cancer care.

The OASIS Program

PIs: Evan Graboyes, M.D., MPH and Jennifer Dahne, Ph.D.

Cancer survivors have a 2- to 5-fold higher risk of depression than the general population with downstream negative health consequences including lower adherence to cancer treatment, decreased physical and social functioning, impaired immunity, and increased mortality. Unfortunately, barriers to screening, referral, and treatment prevent the growing population of cancer survivors with depression from receiving the mental health care they need.

In the Hollings Cancer Center-funded OASIS study, SCOR researchers will conduct a multi-project program comprised of three highly synergistic and integrated projects related to depression screening, referral, and treatment supported by four shared cores (behavioral immunology, administrative, implementation science and economic evaluation, data science) organized around a central theme of developing a scalable, technology-based care delivery model for the growing population of cancer survivors with depression.

LiveWell Study: NIH Reporter
LiveWell Study: ClinicalTrials.gov

PI: Kelly Hyland, Ph.D.

Patients with metastatic lung cancer are living longer, but experience high rates of psychological distress (i.e., depression, anxiety), persistent symptom burden, and decrements in psychological well-being and overall quality of life. Given that existing psychosocial intervention paradigms are not designed to help patients navigate the emotional turbulence of living with life-limiting illness, SCOR researchers developed LiveWell, an 8-session telehealth-delivered adapted Dialectical Behavioral Therapy Skills Training protocol that teaches patients transdiagnostic skills (e.g., mindfulness, distress tolerance, emotion regulation, interpersonal effectiveness) to live as well as possible, with metastatic lung cancer.

This NCI-funded randomized clinical trial will evaluate the feasibility, acceptability, and preliminary efficacy of LiveWell to reduce psychological distress in people living with metastatic lung cancer compared to usual care (N=80). Results may support LiveWell’s ability to reduce psychological distress and improve quality of life in this population, thereby providing a promising psychosocial intervention paradigm for patients living with advanced cancer and other chronic illnesses.

PI: Kelly Hyland, Ph.D.

Long-term cancer survivors (>5 years since diagnosis) living with likely incurable disease are a difficult to identify and access population at high risk for cancer-related morbidity that can negatively impact their quality of life.

In this National Cancer Institute-funded supplement study, SCOR researchers will leverage the infrastructure of the parent grant (R01CA281740) to conduct formative research with long-term cancer survivors who are individuals living with likely incurable cancer (LTSC-ILLIC). Patients will complete self-report assessments about emotional concerns and symptoms, including fear of cancer progression, insomnia, and fatigue. A subset of patients (N=up to 30) will participate in a one-time, in-depth semi-structured interview about their emotional needs, symptoms, and experiences as LTCS-ILLIC. This study will inform the rapid development of a modular digital health intervention to deliver evidence-based treatment to address patients’ specific emotional health and symptom burden needs. This line of research has the potential to develop new standards of care and improve quality of life in the growing population of LTCS-ILLIC.

PI: Kelly Hyland, Ph.D.

Women with metastatic breast cancer (mBC) are living longer because of better treatments, but longer survival often comes with ongoing emotional distress, physical symptoms, and uncertainty about the future. Many patients experience depression, anxiety, and reduced quality of life, and current support programs are not always designed to meet patients’ changing emotional needs. With support from an American Cancer Society Institutional Research Grant, this study will test a new skills training program called LiveWell mBC, which is designed to help women live well, with metastatic breast cancer.

LiveWell mBC teaches skills adapted from Dialectical Behavioral Therapy, an evidence-based psychotherapy. Women learn practical tools to manage emotions, cope with stress, live in the present moment (mindfulness), and communicate effectively. The program includes nine small-group sessions with other women with mBC and two skills trainers, delivered by telehealth. This study will enroll 48 women receiving care at Hollings Cancer Center and randomly assign them to either LiveWell mBC or usual care. Researchers will evaluate participation, satisfaction, and changes in distress, well-being, symptoms, and quality of life. Results may improve supportive care for people living with metastatic cancer.

PIs: Kelly Hyland, Ph.D. & Amanda Kastrinos, Ph.D.

Half of cancer caregivers in the U.S. are young adults (YA) (age 18-35) caring for a parent with cancer. YA child caregivers experience distressing emotional, social, and financial burdens given their place in the lifespan, including a significant shift in family roles. Caregiving for a parent with metastatic cancer (e.g., metavivor) is further complicated by significant uncertainty and variability in prognosis, goals of care, and caregiving needs over time.

Open communication within the survivor-caregiver dyad is associated with better physical and psychological outcomes for both parties. However, YA child caregivers and metavivor parents face unique communication challenges, such as parents withholding medical information to shield children from distress and children withdrawing from their parent as a strategy to cope. These communication patterns can increase anxiety, uncertainty, and distress in the dyad.

This study will characterize communication challenges and support needs in the YA child caregiver-parent metavivor dyad to inform the development of a dyadic behavioral intervention specifically tailored to this unit and their needs. Metavivors and caregivers will participate in in-depth interviews and complete an online questionnaire. Findings will provide critical pilot data to inform the development of a tailored dyadic intervention to improve dyadic communication and quality of life.”

NIH Reporter

PI: Amanda Kastrinos, Ph.D.

Cancer caregivers between the ages of 18 and 35 are known as the “hidden” generation of caregivers – they make up a quarter of all U.S. caregivers, and yet they are largely absent from caregiving scholarship and supports. Due to their age and developmental stage, emerging and young adults who provide care to a parent with cancer are particularly vulnerable to developing psychological and behavioral problems as a result of their caregiving experience, and previous studies show they want guidance in navigating the interpersonal challenges that arise with their diagnosed parent and within their family during their parent’s cancer.

This project aims to fill this critical resource gap for emerging and young adult caregivers (EYACs) by developing the first communication support intervention that addresses the age-specific needs of EYACs who care for a parent with cancer, improving their communication skills and reducing their risks of psychological distress.

PI: Michelle A. Mollica, Ph.D., MPH, RN, OCN, FAAN

Care for people with chronic and complex conditions is often shared across multiple medical specialties, yet poor communication, unclear roles, and fragmented workflows frequently undermine effective care delivery. These coordination failures create a major barrier to translating evidence‑based guidelines into routine clinical practice. This SCTR-funded study addresses this challenge by focusing on cancer survivorship as a high‑complexity use case where quality care should be shared between oncology and primary care. This project engages breast, prostate, lung, and colorectal cancer survivors, oncology clinicians, and primary care clinicians to identify where coordination breaks down and what strategies are most feasible in real‑world settings. Using these insights, we will develop Advancing Coordination for Translation (ACT), a scalable, technology‑enabled intervention blueprint to clarify roles, improve communication, and support coordinated, guideline‑concordant care across specialties. The ultimate goal is to generate scalable and adaptable intervention strategies that accelerate the translation of evidence into routine care across cancer and other chronic conditions.

PI: Michelle Mollica, Ph.D., MPH, RN, OCN, FAAN

After a cancer diagnosis, survivors often face ongoing physical and emotional challenges, yet follow up care is frequently fragmented between oncology teams and primary care providers. Survivors may be unsure who to contact for their healthcare concerns, while clinicians lack clear roles and effective ways to communicate, leading to unmet needs, duplicated services, and poor health outcomes.

To address these challenges, SCOR researchers are conducting a mixed methods study to develop a practical, technology supported intervention blueprint for shared survivorship care: PRIMary care Engagement in Survivorship (PRIMES). This study will seek perspectives of colorectal cancer survivors, oncology clinicians, and primary care providers to better understand current gaps and identify solutions that fit real world clinical settings. Through surveys, interviews, and focus group discussions, the research team will clarify care responsibilities and design the PRIMES intervention blueprint to improve communication and coordination across primary care and oncology.

The long term goal of PRIMES is to support a sustainable, team based model of survivorship care that improves patient experiences, care quality, and health outcomes. By strengthening connections between oncology and primary care, PRIMES aims to ensure survivors receive coordinated and comprehensive follow-up care to address their needs.

SNAP Trial: NIH Reporter
SNAP Trial: ClinicalTrials.gov

PI: Katherine Sterba, Ph.D., MPH

Cancer caregivers face unique and overwhelming burdens as they care for survivors with life-altering changes in physical and social functioning, devastating late and long-term treatment effects and extremely demanding follow-up care. There is a significant gap in knowledge about effective care transition interventions to address caregiver burden and survivor toxicities and improve supportive care and health care utilization (HCU).

SCOR researchers are leading a study to improve post-treatment recovery outcomes in head and neck cancer survivors and their caregivers through the delivery of a tablet-based, dyadic survivorship needs assessment planning (SNAP) tool implemented into clinic workflow at the end of treatment. Results from this NCI-funded randomized clinical trial of 176 cancer survivor-caregiver dyads may provide critical evidence supporting this sustainable, technology-enabled care planning system.

Hearing Loss Prevention

PI: Brent A. Wilkerson, Ph.D.

Many cancer survivors experience hearing loss and tinnitus associated with cisplatin chemotherapy. Hearing loss has implications for language, education and social development in young people as well as employment and mental well-being throughout life. Sodium thiosulfate therapy offers some protection against cisplatin-induced hearing loss in eligible patients, but can counteract the anti-tumor activity of cisplatin. Safer, targeted otoprotective strategies are needed.

As a step toward this goal, our research seeks to better define the therapeutic window and cellular targets for otoprotective therapies in the cochlea. Our approach studies the relationship between DNA damage, cochlear pathology and hearing loss following cisplatin exposure in model systems. Our hope is that understanding the effects of cisplatin on the ear could inform new targeted therapeutic approaches.

Pranayama Trial

PI: Sundar Balasubramanian, Ph.D.

Cancer survivorship is associated with many long-term chronic health issues that arise as a result of cancer treatment protocols. Non-pharmacological lifestyle and mind-body interventions have been shown to be effective and critical components of a total-health strategy for cancer survivors.

In this NCI-funded Small Business Technology Transfer (STTR) Grant, PranaScience Institute seeks to develop and test a novel group video app for home-based delivery of a yogic breathing intervention that reduces symptoms of cancer treatment survival and supports total-health. Results could provide a scalable platform for a mind-body intervention to manage chronic health concerns among cancer survivors.

Palliative Care Implementation

PI: Suparna Qanungo, Ph.D.

The extremely limited use of palliative care in low resource settings exacerbates suffering in patients with life-limiting illnesses such as cancer. This is particularly a problem for patients living in rural areas where barriers to care are even more pronounced.

The goal of this NCI-funded pragmatic clinical trial is to test and evaluate a home-based palliative care intervention for utilizing community health workers to facilitate the delivery of palliative care to cancer patients in rural India. Results from this trial may enhance the implementation of palliative care for patients with cancer in low-resource settings, thereby minimizing symptom burden and enhancing quality of life for cancer survivors.