Addressing Fertility Information Needs and Distress

NCT06834945 | Completed DMC

• 2 other identifiers: Pro001096315F32CA265054-03
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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.

Conditions

Childhood Cancer; Fertility Issues

Keywords

Fertility Concerns; Fertility Distress

Outcome Measures

Primary Outcomes (3)

• Feasibility as measured by treatment attrition

  A treatment attrition rate of ≤ 20% will be indicative of preliminary intervention feasibility.

  Post-treatment, approximately 16 months

• Feasibility as measured by session attendance

  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)

  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 Outcomes (5)

• Fertility health knowledge as measured by Modified Fertility and Infertility Treatment Knowledge Score (FIT-KS)

  Pre-treatment and post-treatment, approximately 16 months

• Patient activation as measured by Short Form of the Patient Activation Measure

  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

Study Arms (1)

AYA SPARK

EXPERIMENTAL

Participants will receive the AYA SPARK health intervention which includes six sessions delivered remotely (i.e., videoconferencing) by a clinical psychologist.

Behavioral: AYA SPARK

Interventions

AYA SPARK BEHAVIORAL

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.

AYA SPARK

Eligibility Criteria

• Age: 18 Years - 44 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Duke University: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Duke University

Durham, North Carolina, 27705, United States

Location

MeSH Terms

Conditions

Neoplasms; Infertility

Condition Hierarchy (Ancestors)

Genital Diseases; Urogenital Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 10, 2025
• First Posted: February 19, 2025
• Study Start: February 1, 2025
• Primary Completion: May 28, 2025
• Study Completion: May 28, 2025
• Last Updated: July 20, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)