Breast Cancer Clinical Trial
Symptom Management for YA Cancer Survivors
Summary
Symptom interference is common for survivors of young adult cancer (aged 18-39 at diagnosis) and impacts their abilities to achieve normative life goals (e.g., education, careers, independence, romantic/social relationships) as well as adhere to recommended follow-up care. Assistance with symptom management has been rated by young adult survivors as an important and unmet healthcare need; however, skill-based symptom management interventions have typically been tested among older cancer survivors and have not targeted the unique developmental needs of those diagnosed as young adults. The proposed research advances the health and wellbeing of young adult cancer survivors by creating a developmentally appropriate hybrid in-person/mHealth behavioral symptom management intervention which addresses variables (i.e., symptoms and symptom interference) consistently linked to significant social, economic, and health burden.
Full Description
More than 60,000 young adults (YAs) aged 18-39 are diagnosed with cancer in the US each year. Advances in treatment have yielded five year survival rates >70% suggesting that the majority of YAs will become long-term cancer survivors. Symptom (e.g., pain, fatigue, distress) interference is common for YA cancer survivors and impacts their abilities to achieve normative life goals (e.g., returning to work/school, achieving autonomy, pursuing social/romantic relationships) and adhere to recommended follow-up care. Symptom management has been identified as a significant issue in the transition to survivorship for YAs by the Institute of Medicine and National Cancer Institute, and assistance with symptom management is rated as an important and unmet need by YA survivors. Yet, behavioral symptom management interventions have not targeted the needs of those diagnosed as YAs. The proposed study aims to develop and test the feasibility and acceptability of a novel behavioral symptom management intervention designed for survivors of YA cancer (cancer types: hematologic, breast, or gastrointestinal cancers, melanoma, or germ cell tumors). The hybrid intervention will include inperson, group sessions and an integrated mobile application. The intervention will provide peer support while also teaching skills to improve symptoms, symptom interference, and self-efficacy for symptom management. The mobile application will assist with symptom monitoring, home skills practice, and connecting with group members. The preliminary version of the intervention will be guided by the research team's prior work developing and testing symptom management interventions for cancer survivors, national guidelines for YA oncology, consultation with an expert advisory board, and input from patient (n=20) and provider N=10) stakeholders. The intervention will be further refined following review by patient user testers (n=10). Next, feasibility, acceptability, and distributions of change over time as well as relationships between outcome variables will be examined through a pilot randomized clinical trial of the developed intervention. Participants (N=60) will be randomized to intervention or wait-list control arms. Primary study outcomes are symptom (pain, fatigue, distress) severity and symptom interference. Self-efficacy and support will also be examined as mediators of change in outcome variables. The proposed study has the potential to make several significant contributions by targeting an underserved group of cancer survivors, addressing a critical gap in care, and addressing variables consistently linked to social, economic, and health burden for YAs. It will also provide important information about approaches to identify, recruit, and retain YA cancer survivors in research and provide pilot data for a larger trial.
Eligibility Criteria
Young Adult Cancer Survivors Participating in Intervention Development Interviews
Eligibility Criteria
Diagnosed with hematologic, breast, gastrointestinal, or endocrine cancers, melanoma, or germ cell tumors
Diagnosed with cancer as a young adult
Under the care of a medical provider at the Duke Cancer Institute
Completed curative treatment involving multimodal therapy within the last five years
Able to speak and read English
Able to give informed consent
Exclusion Criteria
Nonambulatory
Major mental illness, i.e., schizophrenia
Untreated or uncontrolled mental illness, i.e., bipolar
Residence greater than 100 miles from the research site
Medical Providers Participating in Intervention Development Interviews Eligibility criteria
o Provide care to young adult cancer survivors at the Duke Cancer Institute
Young Adult Cancer Survivor User Testers
Eligibility Criteria
Diagnosed with hematologic, breast, gastrointestinal cancers, or endocrine cancers, melanoma, or germ cell tumors
Diagnosed with cancer as a young adult
Under the care of a medical provider at the Duke Cancer Institute
Completed curative treatment involving multimodal therapy within the last five years
Able to speak and read English
Able to give informed consent
Exclusion Criteria
Nonambulatory
Major mental illness, i.e., schizophrenia
Untreated or uncontrolled mental illness, i.e., bipolar
Residence great than 100 miles from the research site
RCT Participants
Eligibility Criteria:
diagnosed with cancer as a YA (aged 18-39)
diagnosis of hematologic, breast, endocrine or gastrointestinal cancer, melanoma, or germ cell tumor
receiving care at the Duke Cancer Institute
completed curative treatment involving multimodal therapy within the last 2 years
able to speak/read English; and able to give informed consent.
Exclusion Criteria:
non-ambulatory
major mental illness (i.e., schizophrenia)
untreated or uncontrolled mental illness (i.e., bipolar disorder)
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There is 1 Location for this study
Durham North Carolina, 27710, United States
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