Symptom Management for YA Cancer Survivors
Status
Conditions
Treatments
Study type
Funder types
Identifiers
Details and patient eligibility
About
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.
Enrollment
Sex
Ages
Volunteers
Inclusion and exclusion 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)
Trial design
Primary purpose
Allocation
Interventional model
Masking
65 participants in 2 patient groups
Trial contacts and locations
Loading...
Central trial contact
Caroline S Dorfman, PhD
Data sourced from clinicaltrials.gov
Clinical trials
Research sites
Resources
Legal