Cancer SurvivorshipNCT07471685
Family Building Decision Support for Female Adolescent and Young Adult Cancer Survivors
A study testing Nurse Navigator-Delivered Family Building Decision Support and Survivorship Education in people with Cancer Survivorship and Family Planning, run by Duke University at 1 site in United States.
Trial summary
This study aims to develop and pilot-test a nurse navigator-delivered behavioral program to support female adolescent and young adult (AYA) cancer survivors in making informed, values-driven family-building decisions after completion of cancer treatment. Read more about this study
- Who is it for?
- Ages 18 to 39 years, women only
- Conditions the study is for
- Cancer Survivorship, Family Planning, Adolescent and Young Adult Cancer
- What is being tested?
- Nurse Navigator-Delivered Family Building Decision Support and Survivorship Education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteUnited States
- Study dates
- 11 May 2026to Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 39 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Female (biological sex) AYA cancer survivor age 15-39 at original diagnosis and 18-39 at enrollment.
- Completed cancer treatment with curative intent.
- Prior exposure to treatments posing gonadotoxic risk (e.g., alkylating agents, total body irradiation) and/or treatments increasing obstetric risk (e.g., chest radiation, radiation to uterus, anthracycline exposure).
- Has not completed family building.
- Able to speak/read English.
- Willing and able to complete videoconference sessions and REDCap surveys.
Who cannot join
- Visual, hearing, or cognitive impairment or severe mental illness that would interfere with participation as determined by study staff.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Duke Cancer Institute
Durham, North Carolina, 27710
Smrithi Divakaran, MBBS, MSPH, 919-681-7695, smrithi.divakaran@duke.edu
Michael W Willis, BA, 919-681-8437, michael.w.willis@duke.edu
About this study
Official title: Development and Pilot Testing of a Family Building Decision Support Intervention for Female Adolescent and Young Adult Cancer Survivors
This study aims to develop and pilot-test a nurse navigator-delivered behavioral program to support female adolescent and young adult (AYA) cancer survivors in making informed, values-driven family-building decisions after completion of cancer treatment. Female AYA survivors often face fertility impairments, uncertainty about reproductive potential, elevated obstetric risks during pregnancy, and significant emotional distress related to parenthood planning. Currently, few interventions address these post-treatment decision-making needs.
The intervention consists of four videoconference sessions that combine personalized, risk-based reproductive health education with coping strategies derived from Acceptance and Commitment Therapy and Patient Activation Theory. A pilot randomized controlled trial will evaluate feasibility, acceptability, and preliminary changes in knowledge, decisional conflict, self-efficacy, and reproductive-health-related distress among 48 participants randomized to the intervention or a survivorship-education control condition. Findings will inform future testing of the intervention's efficacy in a larger clinical trial.
- Being tested
- Nurse Navigator-Delivered Family Building Decision Support, Survivorship Education
- Keywords
- AYA, oncofertility, fertility after cancer, survivorship
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nurse Navigator-Delivered Family Building Decision SupportBehavioural
Four ~60-minute, weekly or biweekly videoconference sessions over 4-6 weeks. Components include:
Personalized, risk-based reproductive health education based on cancer type and treatment exposures (e.g., gonadotoxic chemotherapy, chest or uterine radiation, anthracyclines); review of fertility potential evaluation, assisted reproductive technologies, adoption pathways, and pregnancy health considerations (maternal/fetal risks, surveillance, co-management).
ACT-derived coping skills (values clarification, cognitive defusion, acceptance, committed action) to align decisions with personal values and reduce avoidance.
Patient activation strategies to promote engagement in risk-based reproductive care and informed decision-making.
Includes between-session practice and brief home exercises.
Survivorship EducationBehavioural
NCI booklet "Facing Forward: Life After Cancer Treatment" provided at baseline; participants may receive referrals to survivorship supportive services as needed.
| Study group | Role | What they receive |
|---|---|---|
| Nurse Navigator-Delivered Family Building Decision Support | Experimental | Four ~60-minute, weekly or biweekly videoconference sessions over 4-6 weeks. Components include:
1. Personalized, risk-based reproductive health education based on cancer type and treatment exposures (e.g., gonadotoxic chemotherapy, chest or uterine radiation, anthracyclines); review of fertility potential evaluation, assisted reproductive technologies, adoption pathways, and pregnancy health considerations (maternal/fetal risks, surveillance, co-management).
2. ACT-derived coping skills (values clarification, cognitive defusion, acceptance, committed action) to align decisions with personal values and reduce avoidance.
3. Patient activation strategies to promote engagement in risk-based reproductive care and informed decision-making. Includes between-session practice and brief home exercises. Receives: Behavioral: Nurse Navigator-Delivered Family Building Decision Support |
| Survivorship Educational Materials | Active comparator | NCI booklet "Facing Forward: Life After Cancer Treatment" provided at baseline; participants may receive referrals to survivorship supportive services as needed. Receives: Behavioral: Survivorship Education |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility as measured by number of adolescents and young adults (AYAs) enrolled
Feasibility will be assessed by study enrollment. The intervention will be considered feasible if N=48 AYAs enroll during the 10-month study period.
Measured: up to 10 months
Feasibility as measured by the number of participants who complete all four sessions
The intervention will be considered feasible if >80% of participants complete all four sessions.
Measured: Post-treatment (4-6 weeks)
Feasibility as measured by frequency of program skills use
Feasibility will be assessed by a novel questionnaire designed to assess use of program skills (intervention strategies). Participants will be asked to evaluate the frequency with which they used skills or ideas presented in the intervention program, on a scale from 1 (not at all) to 6 (every day), since their last study session.
Measured: Post-treatment (4-6 weeks), follow-up (8-10 weeks)
Feasibility as measured by frequency of specific program skills use
Feasibility will be assessed by a novel questionnaire designed to assess use of program skills (intervention strategies). Participants will be asked to evaluate use of 16 specific program skills or strategies since their last study session, on a scale of 1 (not at all) to 5 (6 or more days per week).
Measured: Post-treatment (4-6 weeks), follow-up (8-10 weeks)
Acceptability as measured by the Client Satisfaction Questionnaire
The Client Satisfaction Questionnaire is an 8-item scale assessing participants' views of an intervention as acceptable and satisfactory. Items are rated on a 4-point scale (e.g., 1 "very dissatisfied" to 4 "very satisfied") and averaged. The intervention will be considered acceptable if >80% of intervention arm participants rate it as >3 out of 4.
Measured: Post-treatment (4-6 weeks)
Acceptability as measured by the Treatment Acceptability Questionnaire
The Treatment Acceptability Questionnaire is a six-item scale assessing participants' views of an intervention as acceptable, ethical, and effective. Items are rated on a 7-point Likert scale (e.g., 1 "very unacceptable" to 7 "very acceptable") and averaged. The intervention will be acceptable if >80% of intervention arm participants rate it as >5 out of 7 on the TAQ.
Measured: Post-treatment (4-6 weeks)
Acceptability as measured by the Satisfaction with Therapy and Therapist Scale-Revised (STTS-R)
Participants will complete the 13-item Satisfaction with Therapy and Therapist Scale-Revised specific to the program they received. The first 12 items ask participants to rate their agreement with statements related to intervention satisfaction on a 5-point scale ranging from "strongly disagree" (1) to "strongly agree" (5). The 13th item asks "How much did the intervention help with your symptoms?" with 5 answer choices ranging from "made things a lot better" to "made things a lot worse."
Measured: Post-treatment (4-6 weeks)
Secondary outcomes (5)
Decisional conflict as measured by the Decisional Conflict Scale
Decisional conflict related to family building options will be assessed using the Decisional Conflict Scale. Participants will respond to 16 questions about decisional conflict related to family building from 0 (strongly agree) to 4 (strongly disagree). The total scores ranges from 0 to 64, with higher scores indicating greater conflict.
Measured: Baseline, follow-up (8-10 weeks)
Self-efficacy as measured by the Decision Self-Efficacy Scale
Self-efficacy will be assessed using the Decision Self-Efficacy Scale; items will be worded to assess self-efficacy for family building decision-making. Participants will respond to 11 items assessing decision self-efficacy from 0 (not at all confident) to 4 (very confident). The total score ranges from 0 to 44, with higher scores indicating greater self-efficacy.
Measured: Baseline, follow-up (8-10 weeks)
Distress as measured by the Reproductive Concerns after Cancer Scale
Distress will be assessed using the 18-item Reproductive Concerns after Cancer Scale. Participants will respond to statements with ratings from 1 (strongly disagree) to 5 (strongly agree) about concerns related to having (more) biological children. The total score ranges from 18 to 90, with higher scores indicating greater reproductive-related concerns.
Measured: Baseline, follow-up (8-10 weeks)
Distress as measured by the Fertility Problem Inventory
Distress will be assessed using the Fertility Problem Inventory, which asks participants to rate their agreement with 38 statements across 4 domains (social concerns, relationship concerns, rejection of childfree lifestyle, need for parenthood). Participants will rate each statement from 1 (strongly disagree) to 6 (strongly agree). The total score ranges from 38 to 228, with higher scores indicating greater fertility-related distress.
Measured: Baseline, follow-up (8-10 weeks)
Family building knowledge as measured by knowledge item pool
Knowledge will be assessed using an item pool developed for the study. Each participant will respond true (1) or false (0) to 10 items, with the specific items being dependent on the risk-based education provided and associated family building options discussed during the intervention sessions. Knowledge will be calculated as the percent of correct items.
Measured: Baseline, follow-up (8-10 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2026
- Study start11 May 2026
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cancer SurvivorshipStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Caroline S Dorfman, PhD, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07471685
- Sponsor's protocol ID
- Pro00113254
- Status last verified
- May 2026
- First submitted
- 10 Mar 2026
- Last updated
- 14 May 2026
- Results posted
- No
- Data monitoring committee
- No
- 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 14 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development and Pilot Testing of a Family Building Decision Support Intervention for Female Adolescent and Young Adult Cancer Survivors
- ClinicalTrials.gov ID
- NCT07471685
- Acronym / sponsor ID
- Pro00113254
- Keywords
- AYA, oncofertility, fertility after cancer, survivorship
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Study start
- 11 May 2026 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 13 Mar 2026 (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.
This study aims to develop and pilot-test a nurse navigator-delivered behavioral program to support female adolescent and young adult (AYA) cancer survivors in making informed, values-driven family-building decisions after completion of cancer treatment. Female AYA survivors often face fertility impairments, uncertainty about reproductive potential, elevated obstetric risks during pregnancy, and significant emotional distress related to parenthood planning. Currently, few interventions address these post-treatment decision-making needs.
The intervention consists of four videoconference sessions that combine personalized, risk-based reproductive health education with coping strategies derived from Acceptance and Commitment Therapy and Patient Activation Theory. A pilot randomized controlled trial will evaluate feasibility, acceptability, and preliminary changes in knowledge, decisional conflict, self-efficacy, and reproductive-health-related distress among 48 participants randomized to the intervention or a survivorship-education control condition. Findings will inform future testing of the intervention's efficacy in a larger clinical trial.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Nurse Navigator-Delivered Family Building Decision Support | Experimental | Behavioral: Nurse Navigator-Delivered Family Building Decision SupportFour ~60-minute, weekly or biweekly videoconference sessions over 4-6 weeks. Components include: 1. Personalized, risk-based reproductive health education based on cancer type and treatment exposures (e.g., gonadotoxic chemotherapy, chest or uterine radiation, anthracyclines); review of fertility potential evaluation, assisted reproductive technologies, adoption pathways, and pregnancy health considerations (maternal/fetal risks, surveillance, co-management). 2. ACT-derived coping skills (values clarification, cognitive defusion, acceptance, committed action) to align decisions with personal values and reduce avoidance. 3. Patient activation strategies to promote engagement in risk-based reproductive care and informed decision-making. Includes between-session practice and brief home exercises. |
| Survivorship Educational Materials | Active comparator | Behavioral: Survivorship EducationNCI booklet "Facing Forward: Life After Cancer Treatment" provided at baseline; participants may receive referrals to survivorship supportive services as needed. |
Who may qualify
- Ages
- 18 to 39 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Female (biological sex) AYA cancer survivor age 15-39 at original diagnosis and 18-39 at enrollment.
- Completed cancer treatment with curative intent.
- Prior exposure to treatments posing gonadotoxic risk (e.g., alkylating agents, total body irradiation) and/or treatments increasing obstetric risk (e.g., chest radiation, radiation to uterus, anthracycline exposure).
- Has not completed family building.
- Able to speak/read English.
Key exclusion criteria (1 listed)
- Visual, hearing, or cognitive impairment or severe mental illness that would interfere with participation as determined by study staff.
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 |
|---|---|---|
| Nurse Navigator-Delivered Family Building Decision SupportFour ~60-minute, weekly or biweekly videoconference sessions over 4-6 weeks. Components include: Personalized, risk-based reproductive health education based on cancer type and treatment exposures (e.g., gonadotoxic chemotherapy, chest or uterine radiation, anthracyclines); review of fertility potential evaluation, assisted reproductive technologies, adoption pathways, and pregnancy health considerations (maternal/fetal risks, surveillance, co-management). ACT-derived coping skills (values clarification, cognitive defusion, acceptance, committed action) to align decisions with personal values and reduce avoidance. Patient activation strategies to promote engagement in risk-based reproductive care and informed decision-making. Includes between-session practice and brief home exercises. | Behavioural | Nurse Navigator-Delivered Family Building Decision Support |
| Survivorship EducationNCI booklet "Facing Forward: Life After Cancer Treatment" provided at baseline; participants may receive referrals to survivorship supportive services as needed. | Behavioural | Survivorship Educational Materials |
Primary outcome
Feasibility as measured by number of adolescents and young adults (AYAs) enrolled
Time frame: up to 10 months
Feasibility will be assessed by study enrollment. The intervention will be considered feasible if N=48 AYAs enroll during the 10-month study period.
Feasibility as measured by the number of participants who complete all four sessions
Time frame: Post-treatment (4-6 weeks)
The intervention will be considered feasible if >80% of participants complete all four sessions.
Feasibility as measured by frequency of program skills use
Time frame: Post-treatment (4-6 weeks), follow-up (8-10 weeks)
Feasibility will be assessed by a novel questionnaire designed to assess use of program skills (intervention strategies). Participants will be asked to evaluate the frequency with which they used skills or ideas presented in the intervention program, on a scale from 1 (not at all) to 6 (every day), since their last study session.
Feasibility as measured by frequency of specific program skills use
Time frame: Post-treatment (4-6 weeks), follow-up (8-10 weeks)
Feasibility will be assessed by a novel questionnaire designed to assess use of program skills (intervention strategies). Participants will be asked to evaluate use of 16 specific program skills or strategies since their last study session, on a scale of 1 (not at all) to 5 (6 or more days per week).
Acceptability as measured by the Client Satisfaction Questionnaire
Time frame: Post-treatment (4-6 weeks)
The Client Satisfaction Questionnaire is an 8-item scale assessing participants' views of an intervention as acceptable and satisfactory. Items are rated on a 4-point scale (e.g., 1 "very dissatisfied" to 4 "very satisfied") and averaged. The intervention will be considered acceptable if >80% of intervention arm participants rate it as >3 out of 4.
Acceptability as measured by the Treatment Acceptability Questionnaire
Time frame: Post-treatment (4-6 weeks)
The Treatment Acceptability Questionnaire is a six-item scale assessing participants' views of an intervention as acceptable, ethical, and effective. Items are rated on a 7-point Likert scale (e.g., 1 "very unacceptable" to 7 "very acceptable") and averaged. The intervention will be acceptable if >80% of intervention arm participants rate it as >5 out of 7 on the TAQ.
Acceptability as measured by the Satisfaction with Therapy and Therapist Scale-Revised (STTS-R)
Time frame: Post-treatment (4-6 weeks)
Participants will complete the 13-item Satisfaction with Therapy and Therapist Scale-Revised specific to the program they received. The first 12 items ask participants to rate their agreement with statements related to intervention satisfaction on a 5-point scale ranging from "strongly disagree" (1) to "strongly agree" (5). The 13th item asks "How much did the intervention help with your symptoms?" with 5 answer choices ranging from "made things a lot better" to "made things a lot worse."
5 secondary outcomes
Decisional conflict as measured by the Decisional Conflict Scale
Time frame: Baseline, follow-up (8-10 weeks)
Self-efficacy as measured by the Decision Self-Efficacy Scale
Time frame: Baseline, follow-up (8-10 weeks)
Distress as measured by the Reproductive Concerns after Cancer Scale
Time frame: Baseline, follow-up (8-10 weeks)
Distress as measured by the Fertility Problem Inventory
Time frame: Baseline, follow-up (8-10 weeks)
Family building knowledge as measured by knowledge item pool
Time frame: Baseline, follow-up (8-10 weeks)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2026.
- 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.
Caroline S Dorfman, PhD principal investigator
Duke University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nurse Navigator-Delivered Family Building Decision Support and Survivorship Education in people with Cancer Survivorship and Family Planning, 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 6 inclusion and 1 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: looking for participants now, as of the sponsor's last update on 14 May 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Smrithi Divakaran, MBBS, MSPH (919-681-7695, smrithi.divakaran@duke.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility as measured by number of adolescents and young adults (AYAs) enrolled (time frame: up to 10 months). The study lists 7 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 14 May 2026.