Addressing Fertility Information Needs and Fertility-related Distress Among Female Adult Survivors of Childhood Cancer
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Feasibility as measured by treatment attrition
研究概览
简要总结
The purpose of this study is to develop and refine a behavioral intervention to address fertility-related information needs and fertility-related distress among female adult survivors of childhood cancer.
详细描述
Adult survivors of childhood cancer are a growing population who face a number of long-term and late effects secondary to their cancer treatment, which have the potential to profoundly impact their future health, quality of life, and achievement of life goals. This project will examine the feasibility, acceptability of a novel behavioral intervention aiming to address fertility-related information needs and fertility-related distress among adult survivors of childhood cancer.
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 44 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Currently aged 18-44
- •Diagnosed with cancer at <18 years old
- •Female sex
- •Uncertain fertility status
排除标准
- •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.
研究组 & 干预措施
AYA SPARK
Participants will receive the AYA SPARK health intervention which includes six sessions delivered remotely (i.e., videoconferencing) by a clinical psychologist.
干预措施: AYA SPARK (Behavioral)
结局指标
主要结局
Feasibility as measured by treatment attrition
时间窗: Post-treatment, approximately 16 months
A treatment attrition rate of ≤ 20% will be indicative of preliminary intervention feasibility.
Feasibility as measured by session attendance
时间窗: Post-treatment, approximately 16 months
A session attendance rate of ≥80% will be indicative of preliminary intervention feasibility.
Treatment acceptability as measured by Treatment Acceptability Questionnaire (TAQ)
时间窗: Post-treatment, approximately 16 months
Acceptability will be measured by the Treatment Acceptability Questionnaire (TAQ), a six-item measure assessing perceptions of an interventions acceptability, ethics, and effectiveness. Items are rated on a 7-point Likert scale, from "very unacceptable" to "very acceptable". An average score of ≥5 will be indicative of treatment acceptability.
次要结局
- Patient activation as measured by Short Form of the Patient Activation Measure(Pre-treatment and post-treatment, approximately 16 months)
- Fertility health knowledge as measured by Modified Fertility and Infertility Treatment Knowledge Score (FIT-KS)(Pre-treatment and post-treatment, approximately 16 months)
- Self-efficacy for communicating with medical providers as measured by a modified version of the Ask, Understand, Remember Assessment (AURA)(Pre-treatment and post-treatment, approximately 16 months)
- Psychological flexibility as measured by the Acceptance and Action Questionnaire-II (AAQ-II)(Pre-treatment and post-treatment, approximately 16 months)
- Fertility-related distress will be measured by the Reproductive Concerns after Cancer (RCAC)scale(Pre-treatment and post-treatment, approximately 16 months)