Symptom Management for YA Cancer Survivors

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Brief Title

Symptom Management for YA Cancer Survivors

Official Title

Improving Symptom Management for Survivors of Young Adult Cancer

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=30) 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.
    


Study Type

Interventional


Primary Outcome

Intervention Satistfaction: SSTS-R

Secondary Outcome

 Group Therapy Experiences Scale

Condition

Cancer

Intervention

Behavioral Symptom Management for Young Adult Cancer Survivors

Study Arms / Comparison Groups

 Behavioral Symptom Management for Young Adult Cancer Survivors
Description:  The proposed intervention will provide systematic training in cognitive and behavioral coping skills (e.g., activity-rest cycling, cognitive restructuring, relaxation training) delivered over the course of 8 sessions (10 therapy hours). By employing these strategies, participants learn to adjust their thoughts, behaviors, and emotions in the service of better managing symptoms.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Behavioral

Estimated Enrollment

60

Start Date

January 22, 2020

Completion Date

October 1, 2025

Primary Completion Date

October 1, 2025

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)
      

Gender

All

Ages

18 Years - 39 Years

Accepts Healthy Volunteers

No

Contacts

Caroline S Dorfman, 919-416-3473, [email protected]

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT04035447

Organization ID

Pro00103249


Responsible Party

Sponsor

Study Sponsor

Duke University

Collaborators

 National Cancer Institute (NCI)

Study Sponsor

Caroline S Dorfman, Principal Investigator, Duke University


Verification Date

July 2020