Addressing Fertility Information Needs and Distress

July 18, 2025 updated by: Duke University

Addressing Fertility Information Needs and Fertility-related Distress Among Female Adult Survivors of Childhood Cancer

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

24

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • North Carolina
      • Durham, North Carolina, United States, 27705
        • Duke University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: AYA SPARK
Participants will receive the AYA SPARK health intervention which includes six sessions delivered remotely (i.e., videoconferencing) by a clinical psychologist.
Behavioral: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Feasibility as measured by treatment attrition
Time Frame: Post-treatment, approximately 16 months
A treatment attrition rate of ≤ 20% will be indicative of preliminary intervention feasibility.
Post-treatment, approximately 16 months
Feasibility as measured by session attendance
Time Frame: Post-treatment, approximately 16 months
A session attendance rate of ≥80% will be indicative of preliminary intervention feasibility.
Post-treatment, approximately 16 months
Treatment acceptability as measured by Treatment Acceptability Questionnaire (TAQ)
Time Frame: 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.
Post-treatment, approximately 16 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Fertility health knowledge as measured by Modified Fertility and Infertility Treatment Knowledge Score (FIT-KS)
Time Frame: Pre-treatment and post-treatment, approximately 16 months
Fertility health knowledge will be assessed via modified items from the FIT-KS, a measure examining knowledge of normal reproductive function, general fertility information, treatment factors affecting fertility, infertility information, and alternative parenting options. The total score ranges from 0 to 29, where a higher score indicates greater knowledge.
Pre-treatment and post-treatment, approximately 16 months
Patient activation as measured by Short Form of the Patient Activation Measure
Time Frame: Pre-treatment and post-treatment, approximately 16 months
The PAM is a 13-item measure used to assess survivors' knowledge, skills, and confidence that are central to managing their health and health care. Patients are asked to rate their agreement with statements about their health and health care on a 4 point scale from "strongly disagree" to "strongly agree." From these response a total PAM score is calculated on a scale of 0-100, with higher scores indicating higher levels of activation.
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)
Time Frame: Pre-treatment and post-treatment, approximately 16 months
A 6-item measure assessing self-efficacy for communication in clinical encounters. Patients are asked to rate their agreement with statements related to their confidence in asking questions, understanding explanations, and remembering information on a 4 point scale from "Disagree a lot" to "agree a lot" with higher scores indicating greater confidence in patient communication abilities within a healthcare setting.
Pre-treatment and post-treatment, approximately 16 months
Psychological flexibility as measured by the Acceptance and Action Questionnaire-II (AAQ-II)
Time Frame: Pre-treatment and post-treatment, approximately 16 months
7-item questionnaire designed to measure psychological inflexibility rated on 7-point Likert scale (1 = never true, 7 = always true); higher total scores indicate greater levels of psychological inflexibility or experiential avoidance
Pre-treatment and post-treatment, approximately 16 months
Fertility-related distress will be measured by the Reproductive Concerns after Cancer (RCAC)scale
Time Frame: Pre-treatment and post-treatment, approximately 16 months
RCAC an 18-item scale that assesses concerns about: fertility potential, partner disclosure, child's health, personal health, acceptance, and becoming pregnant. The RCAC has been used to assess fertility-related distress among female cancer survivors. Items are rated on a five-point Likert scale ranging from 1= "Strongly disagree" to 5= "Strongly agree." with higher scores indicating greater concerns.
Pre-treatment and post-treatment, approximately 16 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Duke University

Collaborators

National Cancer Institute (NCI)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2025

Primary Completion (Actual)

May 28, 2025

Study Completion (Actual)

May 28, 2025

Study Registration Dates

First Submitted

February 10, 2025

First Submitted That Met QC Criteria

February 18, 2025

First Posted (Actual)

February 19, 2025

Study Record Updates

Last Update Posted (Actual)

July 20, 2025

Last Update Submitted That Met QC Criteria

July 18, 2025

Last Verified

May 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Pro00109631
  • 5F32CA265054-03 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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