Symptom Management for YA Cancer Survivors

Part of paid clinical trials in Durham, North Carolina.

Sponsor
Duke University
Study ID
NCT04035447
Status
Completed

Conditions

  • Breast Cancer
  • Cancer
  • Endocrine Cancer
  • Fatigue
  • Germ Cell Tumor
  • Hematologic Cancer
  • Melanoma
  • Pain
  • Psychological Distress
  • Young Adult

Eligibility Criteria

Sex
ALL
Age
18 Years - 39 Years
Healthy Volunteers
Not accepted

Interventions

  • Behavioral Symptom Management for Young Adult Cancer Survivors — BEHAVIORAL
    The intervention includes group sessions held over Zoom along with an integrated mobile application to provide participants with instruction in cognitive and behavioral strategies for managing symptoms (i.e., pain, fatigue, distress). The developed intervention includes 8 face-to-face group sessions (12 therapy hours). Sessions are delivered using a faded contact approach (i.e., sessions 1-6: weekly, sessions 7-8: biweekly). Participants receive secure access to a study-specific mobile application that includes: 1) audio and video files and brief text-based educational content reviewing strategies discussed during the groups; 2) the ability to self-monitor symptom severity; 3) the ability to connect with group members via a social networking platform; and 4) activity tracking synchronization.

Study Details

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.

Key Dates

Start date
Jan 22, 2020
Status verified
Jun 2025
Primary completion
Jun 15, 2024
Completion
Jun 15, 2024

Study Design

Enrollment
65 participants (actual)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
SUPPORTIVE_CARE

Arms

  • Experimental: Behavioral Symptom Management for Young Adult Cancer Survivors
    The intervention provides systematic training in cognitive and behavioral coping skills (e.g., activity-rest cycling, cognitive defusion, relaxation training) delivered over the course of 8 sessions (12 therapy hours). By employing these strategies, participants learn to adjust their behaviors and emotions as well as interact differently with their thoughts in the service of better managing symptoms.
  • Active Comparator: Waitlist Control
    Waitlist control participants will receive the intervention and receive systematic training in cognitive and behavioral coping skills approximately 6 months into their participation in the study.

Primary Outcome Measure

Intervention Satisfaction: Satisfaction With Therapy and Therapist Scale-Revised (STTS-R) [ Time Frame: Following completion of the intervention, up to 12 months ]

Locations (1)

FacilityCityStateZIPSite coordinators
Duke Cancer InstituteDurhamNorth Carolina27710-

Find similar trials in Durham, NC

By condition
Breast cancerMelanoma
By specialty
OncologyBreast oncologyWomen's healthSkin cancerDermatology
By research site
Duke Cancer Institute· Durham, NC

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