Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
24 participants
INTERVENTIONAL
2025-02-01
2025-05-28
Brief Summary
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Detailed Description
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Following the Obesity-Related Behavioral Intervention Trials (ORBIT) Model of intervention development, the proposed study seeks to design and refine a behavioral intervention to address unmet fertility-related information needs and fertility-related distress among female adult survivors of childhood cancer (aged 18-44). The intervention is organized into six remotely delivered sessions integrating patient activation theory and Acceptance and Commitment Therapy (ACT) strategies, and evidence-based reproductive health information and help to empower empower survivors to make informed decisions that align with their personal values. Intervention content will be delivered to a small sample of the target population (N=30). Feasibility and acceptability, as well as examination of pre- to post-intervention patterns of change in intervention targets (primary: fertility health knowledge, fertility-related distress; secondary: psychological flexibility, patient activation, and self-efficacy), will be assessed and utilized to further refine the intervention (e.g., intervention strategies, intervention length, and delivery modality).
Although this project is focused on the late effect of impaired fertility, the intervention developed through this study has the potential to produce significant public health benefits: it could be applied to address other late effects in this population, which if left untreated, may lead to greater health complications in this growing population later in life.
Conditions
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Study Design
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NA
SINGLE_GROUP
SUPPORTIVE_CARE
NONE
Study Groups
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AYA SPARK
Participants will receive the AYA SPARK health intervention which includes six sessions delivered remotely (i.e., videoconferencing) by a clinical psychologist.
AYA SPARK
Intervention includes video conferencing based sessions to cover topics related to fertility-related information needs and concerns among female adult survivors of childhood cancer over a 6-8 week period.
Interventions
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AYA SPARK
Intervention includes video conferencing based sessions to cover topics related to fertility-related information needs and concerns among female adult survivors of childhood cancer over a 6-8 week period.
Eligibility Criteria
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Inclusion Criteria
* Diagnosed with cancer at \<18 years old
* Female sex
* Uncertain fertility status
Exclusion Criteria
* Currently under the care of a fertility specialist
* Having a major/serious psychiatric concern (e.g., schizophrenia) as indicated by medical chart/medical provider
* Inability to provide consent.
18 Years
44 Years
FEMALE
No
Sponsors
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National Cancer Institute (NCI)
NIH
Duke University
OTHER
Responsible Party
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Locations
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Duke University
Durham, North Carolina, United States
Countries
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Other Identifiers
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Pro00109631
Identifier Type: -
Identifier Source: org_study_id
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