Clinical trial NCT06834945: Addressing Fertility Information Needs and Distress
Official title: Addressing Fertility Information Needs and Fertility-related Distress Among Female Adult Survivors of Childhood Cancer
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Childhood Cancer
Fertility Issues
Keywords: Fertility Concerns
Fertility Distress
Lead sponsor: Duke University
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2025-02-19
Enrollment: 30
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 44
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Currently aged 18-44
* Diagnosed with cancer at \<18 years old
* Female sex
* Uncertain fertility status

Exclusion Criteria:

* Age \<18
* 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.

Primary outcomes:
measure: Feasibility as measured by treatment attrition
timeFrame: Post-treatment, approximately 16 months
measure: Feasibility as measured by session attendance
timeFrame: Post-treatment, approximately 16 months
measure: Treatment acceptability as measured by Treatment Acceptability Questionnaire (TAQ)
timeFrame: Post-treatment, approximately 16 months
Secondary outcomes:
measure: Fertility health knowledge as measured by Modified Fertility and Infertility Treatment Knowledge Score (FIT-KS)
timeFrame: Pre-treatment and post-treatment, approximately 16 months
measure: Patient activation as measured by Short Form of the Patient Activation Measure
timeFrame: Pre-treatment and post-treatment, approximately 16 months
measure: Self-efficacy for communicating with medical providers as measured by a modified version of the Ask, Understand, Remember Assessment (AURA)
timeFrame: Pre-treatment and post-treatment, approximately 16 months
measure: Psychological flexibility as measured by the Acceptance and Action Questionnaire-II (AAQ-II)
timeFrame: Pre-treatment and post-treatment, approximately 16 months
measure: Fertility-related distress will be measured by the Reproductive Concerns after Cancer (RCAC)scale
timeFrame: Pre-treatment and post-treatment, approximately 16 months
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke University
state: North Carolina
Study officials:
References: