Clinical trial NCT04035447: Symptom Management for YA Cancer Survivors
Official title: Improving Symptom Management for Survivors of Young Adult Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cancer
Young Adult
Pain
Psychological Distress
Fatigue
Breast Cancer
Melanoma
Hematologic Cancer
Germ Cell Tumor
Endocrine Cancer
Keywords: Cancer
Young Adult
Behavioral Symptom Management
Lead sponsor: Duke University
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2019-07-29
Enrollment: 109
Sex: ALL
Minimum age (years): 18
Maximum age (years): 39
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: A two-arm, cluster RCT employing a wait-list control arm will be used. Six cohorts of YA survivors (n=10/cohort) will be randomized with equal allocation to the intervention or control arms.
Primary purpose: SUPPORTIVE_CARE

Brief 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.

Detailed 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)

Primary outcomes:
measure: Intervention Satisfaction: Satisfaction with Therapy and Therapist Scale-Revised (SSTS-R)
timeFrame: Following completion of the intervention, up to 12 months
measure: Open-Ended Questions About the Program
timeFrame: Following completion of the intervention, up to 12 months
measure: Session attendance
timeFrame: Following completion of the intervention, up to 12 months
measure: Treatment Acceptability Questionnaire
timeFrame: Following completion of the intervention, up to 12 months
measure: Use of Intervention Strategies
timeFrame: Following completion of the intervention, up to 12 months
measure: Self-reported use of the Mobile Application
timeFrame: Following completion of the intervention, up to 12 months
Secondary outcomes:
measure: Change in Depressive Symptoms: PROMIS Depression Short Form
timeFrame: Baseline and again 3, 6, 9, and 12 months following the baseline assessment
measure: Change in Anxiety: PROMIS Anxiety Short Form
timeFrame: Baseline and again 3, 6, 9, and 12 months following the baseline assessment
measure: Change in Symptom Interference: Illness intrusiveness rating scale
timeFrame: Baseline and again 3, 6, 9, and 12 months following the baseline assessment
measure: Change in Pain: Brief Pain Inventory
timeFrame: Baseline and again 3, 6, 9, and 12 months following the baseline assessment
measure: Change in Fatigue: PROMIS Fatigue Short Form
timeFrame: Baseline and again 3, 6, 9, and 12 months following the baseline assessment
Other outcomes:
measure: Sociodemographics
timeFrame: Baseline
measure: Disease Characteristics
timeFrame: Baseline
measure: Change in Activity: International Physical Activity Questionnaire
timeFrame: Baseline and again 3, 6, 9, and 12 months following the baseline assessment
measure: Change in Activity: Stanford Leisure-Time Activity Categorical Item (LCAT)
timeFrame: Baseline and again 3, 6, 9, and 12 months following the baseline assessment
measure: Change in Spritual Well-Being: Functional Assessment of Chronic Illness Therapy (FACIT)
timeFrame: Baseline and again 3, 6, 9, and 12 months following the baseline assessment
measure: Changes in Cancer Experience: Acceptance and Action Questionnaires for Cancer (AAQ)
timeFrame: Baseline and again 3, 6, 9, and 12 months following the baseline assessment
measure: Changes in Living in Alignment with Values: The Valuing Questionnaire (VQ)
timeFrame: Baseline and again 3, 6, 9, and 12 months following the baseline assessment
measure: Group Therapy Experiences Scale
timeFrame: Following completion of the intervention, up to 12 months
measure: Change in Social Isolation: PROMIS Social Isolation Scale
timeFrame: Baseline and again 3, 6, 9, and 12 months following the baseline assessment
measure: Change in Self-Efficacy: The Self-Efficacy for Managing Chronic Disease Scale
timeFrame: Baseline and again 3, 6, 9, and 12 months following the baseline assessment
measure: Change in Self-Efficacy: PROMIS Self-Efficacy for Managing Chronic Conditions - Managing Symptoms - Short Form 4a
timeFrame: Baseline and again 3, 6, 9, and 12 months following the baseline assessment
measure: Change in Emotional Support: PROMIS Emotional Support-Short Form
timeFrame: Baseline and again 3, 6, 9, and 12 months following the baseline assessment
measure: Change in Instrumental Support: PROMIS Instrumental Support-Short Form
timeFrame: Baseline and again 3, 6, 9, and 12 months following the baseline assessment
measure: Change in Informational Support: PROMIS Informational Support-Short Form
timeFrame: Baseline and again 3, 6, 9, and 12 months following the baseline assessment
Locations:
city: Durham
country: United States
facility: Duke Cancer Institute
state: North Carolina
Study officials:
affiliation: Duke University
name: Caroline S Dorfman
role: PRINCIPAL_INVESTIGATOR
References:
citation: Dorfman CS, Shelby RA, Stalls JM, Somers TJ, Keefe FJ, Vilardaga JP, Winger JG, Mitchell K, Ehren C, Oeffinger KC. Improving Symptom Management for Survivors of Young Adult Cancer: Development of a Novel Intervention. J Adolesc Young Adult Oncol. 2023 Aug;12(4):472-487. doi: 10.1089/jayao.2022.0100. Epub 2022 Sep 30.