NCT06050135

Brief 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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
260

participants targeted

Target at P75+ for not_applicable quality-of-life

Timeline
9mo left

Started May 2024

Typical duration for not_applicable quality-of-life

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress72%
May 2024Feb 2027

First Submitted

Initial submission to the registry

September 15, 2023

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 22, 2023

Completed
8 months until next milestone

Study Start

First participant enrolled

May 20, 2024

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 23, 2026

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

February 10, 2027

Expected
Last Updated

February 25, 2026

Status Verified

February 1, 2026

Enrollment Period

1.7 years

First QC Date

September 15, 2023

Last Update Submit

February 23, 2026

Conditions

Quality of LifeParenthood Status

Keywords

Roadmap to ParenthoodDecision aidPlanning tool

Outcome Measures

Primary Outcomes (1)

  • 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)

    12 months

Secondary Outcomes (2)

  • Planning Behaviors for Future Family Building

    12 months

  • Patient-Reported Outcomes Measure-29 (PROMIS-29) Quality of Life

    12 months

Other Outcomes (5)

  • Unmet Fertility Information Needs

    12 months

  • Patient-Reported Outcomes Measure (PROMIS) General Self Efficacy

    12 months

  • Reproductive Concerns After Cancer (RCAC) Scale

    12 months

  • +2 more other outcomes

Study Arms (2)

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.

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).

Other: Informational Booklet

Interventions

Roadmap to ParenthoodOTHER

web-based decision support

Web-based decision support (Roadmap to Parenthood)
Informational BookletOTHER

web-based informational booklet about young adult cancer survivorship

Informational booklet

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsFemale cancer survivors
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Stanford Universtiy

Palo Alto, California, 94305, United States

Location

Study Officials

  • Catherine Benedict, PhD

    Stanford University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 15, 2023

First Posted

September 22, 2023

Study Start

May 20, 2024

Primary Completion

January 23, 2026

Study Completion (Estimated)

February 10, 2027

Last Updated

February 25, 2026

Record last verified: 2026-02

Locations

US(1)