Childhood CancerNCT06834945
Addressing Fertility Information Needs and Distress
A study testing AYA SPARK in people with Childhood Cancer and Fertility Issues, run by Duke University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 44 years, women only
- Conditions the study is for
- Childhood Cancer, Fertility Issues
- What is being tested?
- AYA SPARK
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Feb 2025to 28 May 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 44 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Currently aged 18-44
- Diagnosed with cancer at <18 years old
- Female sex
- Uncertain fertility status
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Childhood Cancer, Fertility Issues
- Being tested
- AYA SPARK
- Keywords
- Fertility Concerns, Fertility Distress
- Medical subject headings
- Neoplasms, Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AYA SPARKBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| AYA SPARK | Experimental | Participants will receive the AYA SPARK health intervention which includes six sessions delivered remotely (i.e., videoconferencing) by a clinical psychologist. Receives: Behavioral: AYA SPARK |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility as measured by treatment attrition
A treatment attrition rate of ≤ 20% will be indicative of preliminary intervention feasibility.
Measured: Post-treatment, approximately 16 months
Feasibility as measured by session attendance
A session attendance rate of ≥80% will be indicative of preliminary intervention feasibility.
Measured: 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.
Measured: Post-treatment, approximately 16 months
Secondary outcomes (5)
Fertility health knowledge as measured by Modified Fertility and Infertility Treatment Knowledge Score (FIT-KS)
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.
Measured: Pre-treatment and post-treatment, approximately 16 months
Patient activation as measured by Short Form of the Patient Activation Measure
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.
Measured: 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)
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.
Measured: Pre-treatment and post-treatment, approximately 16 months
Psychological flexibility as measured by the Acceptance and Action Questionnaire-II (AAQ-II)
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
Measured: Pre-treatment and post-treatment, approximately 16 months
Fertility-related distress will be measured by the Reproductive Concerns after Cancer (RCAC)scale
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.
Measured: Pre-treatment and post-treatment, approximately 16 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2025
- Study start1 Feb 2025
- Primary completion28 May 2025
- Study completion28 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Childhood CancerStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06834945
- Sponsor's protocol ID
- Pro00109631
- Other IDs
- 5F32CA265054-03
- Status last verified
- May 2025
- First submitted
- 10 Feb 2025
- Last updated
- 20 Jul 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Addressing Fertility Information Needs and Fertility-related Distress Among Female Adult Survivors of Childhood Cancer
- ClinicalTrials.gov ID
- NCT06834945
- Acronym / sponsor ID
- Pro00109631
- Conditions
- Childhood Cancer, Fertility Issues
- Keywords
- Fertility Concerns, Fertility Distress
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 1 Feb 2025 (actual)
- Primary completion
- 28 May 2025 (actual)
- Study completion
- 28 May 2025 (actual)
- First posted
- 19 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| AYA SPARK | Experimental | Behavioral: AYA SPARKParticipants will receive the AYA SPARK health intervention which includes six sessions delivered remotely (i.e., videoconferencing) by a clinical psychologist. |
Who may qualify
- Ages
- 18 to 44 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Currently aged 18-44
- Diagnosed with cancer at <18 years old
- Female sex
- Uncertain fertility status
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AYA SPARKIntervention 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. | Behavioural | AYA SPARK |
Primary outcome
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.
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.
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.
5 secondary outcomes
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
Patient activation as measured by Short Form of the Patient Activation Measure
Time frame: 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
Psychological flexibility as measured by the Acceptance and Action Questionnaire-II (AAQ-II)
Time frame: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing AYA SPARK in people with Childhood Cancer and Fertility Issues, run by Duke University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility as measured by treatment attrition (time frame: Post-treatment, approximately 16 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jul 2025.