Quality of LifeNCT06050135
Roadmap to Parenthood: Testing the Efficacy of a Decision Aid and Planning Tool for Family Building After Cancer
A study testing Roadmap to Parenthood and Informational Booklet in people with Quality of Life and Parenthood Status, run by Stanford University at 1 site in United States.
Trial summary
This study will test a decision support intervention that consists of a web-based 'decision aid and planning tool' for family building after cancer in a randomized controlled trial. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Quality of Life, Parenthood Status
- What is being tested?
- Roadmap to Parenthood and Informational Booklet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 260 participants
- Where
- 1 siteUnited States
- Study dates
- 20 May 2024to 10 Feb 2027
- 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 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Assigned female at birth
- Aged 18 to 45 years old
- Understands verbal and written English
- History of a cancer diagnosis.
- Completed cancer treatment(s) with known or uncertain gonadotoxic effects (e.g., systemic chemotherapy, surgery or radiation affecting reproductive organs or hormone regulation, stem cell or bone marrow transplant, and/or immunotherapy)
- Interested in having a future child (or more children) or uncertain about family building plans
- Access to the Internet and use of a computer, tablet, or smartphone
- Ability to understand and the willingness to personally sign the written IRB-approved informed consent document
Who cannot join
- Currently undergoing cancer treatment excluding long term adjuvant or maintenance therapies, such as tamoxifen
- Significant physical or mental disability that prevents completion of study activities
Trial locations and contacts
1 site in 1 country.
About this study
This study will test a decision support intervention that consists of a web-based 'decision aid and planning tool' for family building after cancer in a randomized controlled trial.
- Conditions
- Quality of Life, Parenthood Status
- Being tested
- Roadmap to Parenthood, Informational Booklet
- Keywords
- Roadmap to Parenthood, Decision aid, Planning tool
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Roadmap to ParenthoodOther
web-based decision support
Informational BookletOther
web-based informational booklet about young adult cancer survivorship
| Study group | Role | What they receive |
|---|---|---|
| Web-based decision support (Roadmap to Parenthood) | Experimental | Patients will receive access to the Roadmap to Parenthood tool (website). The goal of the Roadmap tool is to encourage young adult females (YA-Fs) to be informed about family-building options, set realistic expectations about potential difficulties, and plan ahead to avoid or mitigate barriers, while also inspiring hope and confidence that parenthood may be achieved, despite their cancer histories. Receives: Other: Roadmap to Parenthood |
| Informational booklet | Active comparator | Patients will receive the web-based Livestrong 'Planning for Life After Cancer: A Guide to Survivorship for Teens and Young Adults' informational booklet, covering many topics (e.g., physical symptoms, emotional concerns, day-to-day needs). Receives: Other: Informational Booklet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Decision Conflict Scale
Decisional Conflict Scale is a validated survey that assesses personal uncertainty in making healthcare decisions; modifiable factors contributing to uncertainty; and the quality of the decision made. The survey has 16 questions, with responses on a 5 point scale ranging from "strongly agree" (1) to "strongly disagree" (5). Total scores range from 16 to 80, with higher scores indicating greater uncertainty (worse outcome)
Measured: 12 months
Secondary outcomes (2)
Planning Behaviors for Future Family Building
Yes and No (Y/N) question of whether participants completed "next step" planning behaviors aligned with their family-building goals
Measured: 12 months
Patient-Reported Outcomes Measure-29 (PROMIS-29) Quality of Life
PROMIS-29 assesses seven domains of health-related quality of life including physical function, anxiety, depression, ability to participate in social roles and activities (social participation), fatigue, pain interference, and pain intensity. Items are scored on a 5-point scale (range 1-5). From the sum of the answers to each question in the domain, the total raw score for each domain is calculated, resulting in seven domain scores, each between 4 and 20
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2023
- Study start20 May 2024
- Primary completion23 Jan 2026
- Study completion10 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Quality of LifeStudies of the same condition, open and under way.
- More trials run by Stanford 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
- 260 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Catherine Benedict, PhD, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06050135
- Sponsor's protocol ID
- IRB-71534
- Other IDs
- 1R37CA282148-01, NCI-2024-06041
- Status last verified
- Feb 2026
- First submitted
- 15 Sep 2023
- Last updated
- 25 Feb 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Roadmap to Parenthood: Testing the Efficacy of a Decision Aid and Planning Tool for Family Building After Cancer
- ClinicalTrials.gov ID
- NCT06050135
- Acronym / sponsor ID
- IRB-71534
- Conditions
- Quality of Life, Parenthood Status
- Keywords
- Roadmap to Parenthood, Decision aid, Planning tool
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 260 participants (actual)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Cancer Institute (NCI)
- Study start
- 20 May 2024 (actual)
- Primary completion
- 23 Jan 2026 (actual)
- Study completion
- 10 Feb 2027 (estimated)
- First posted
- 22 Sep 2023 (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 will test a decision support intervention that consists of a web-based 'decision aid and planning tool' for family building after cancer in a randomized controlled trial.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Web-based decision support (Roadmap to Parenthood) | Experimental | Other: Roadmap to ParenthoodPatients will receive access to the Roadmap to Parenthood tool (website). The goal of the Roadmap tool is to encourage young adult females (YA-Fs) to be informed about family-building options, set realistic expectations about potential difficulties, and plan ahead to avoid or mitigate barriers, while also inspiring hope and confidence that parenthood may be achieved, despite their cancer histories. |
| Informational booklet | Active comparator | Other: Informational BookletPatients will receive the web-based Livestrong 'Planning for Life After Cancer: A Guide to Survivorship for Teens and Young Adults' informational booklet, covering many topics (e.g., physical symptoms, emotional concerns, day-to-day needs). |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Assigned female at birth
- Aged 18 to 45 years old
- Understands verbal and written English
- History of a cancer diagnosis.
- Completed cancer treatment(s) with known or uncertain gonadotoxic effects (e.g., systemic chemotherapy, surgery or radiation affecting reproductive organs or hormone regulation, stem cell or bone marrow transplant, and/or immunotherapy)
Key exclusion criteria (2 listed)
- Currently undergoing cancer treatment excluding long term adjuvant or maintenance therapies, such as tamoxifen
- Significant physical or mental disability that prevents completion of study activities
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 |
|---|---|---|
| Roadmap to Parenthoodweb-based decision support | Other | Web-based decision support (Roadmap to Parenthood) |
| Informational Bookletweb-based informational booklet about young adult cancer survivorship | Other | Informational booklet |
Primary outcome
Decision Conflict Scale
Time frame: 12 months
Decisional Conflict Scale is a validated survey that assesses personal uncertainty in making healthcare decisions; modifiable factors contributing to uncertainty; and the quality of the decision made. The survey has 16 questions, with responses on a 5 point scale ranging from "strongly agree" (1) to "strongly disagree" (5). Total scores range from 16 to 80, with higher scores indicating greater uncertainty (worse outcome)
2 secondary outcomes
Planning Behaviors for Future Family Building
Time frame: 12 months
Patient-Reported Outcomes Measure-29 (PROMIS-29) Quality of Life
Time frame: 12 months
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 25 Feb 2026.
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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.
Catherine Benedict, PhD principal investigator
Stanford 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 Roadmap to Parenthood and Informational Booklet in people with Quality of Life and Parenthood Status, run by Stanford 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 8 inclusion and 2 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: under way, not looking for participants, as of the sponsor's last update on 25 Feb 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?
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?
Decision Conflict Scale (time frame: 12 months). 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 25 Feb 2026; AzTrials last refreshed its copy on 6 Nov 2026.