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Active, Not Recruiting

NCT Number: NCT06050135

Roadmap to Parenthood: Testing the Efficacy of a Decision Aid and Planning Tool for Family Building After Cancer

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Quality of Life Parenthood Status

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Stanford Universtiy

Palo Alto, California, 94305, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

Roadmap to Parenthood

Other

web-based decision support

Informational Booklet

Other

web-based informational booklet about young adult cancer survivorship

Primary outcomes

  1. 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)

Secondary outcomes

  1. Planning Behaviors for Future Family Building

    Time frame: 12 months

    Yes and No (Y/N) question of whether participants completed "next step" planning behaviors aligned with their family-building goals

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

    Time frame: 12 months

    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

Other outcomes

  1. Unmet Fertility Information Needs

    Time frame: 12 months

    The survey has 5 questions, each answered by a Yes / No response. Yes is scored as 1, and no is scored as 0. Total scores range from 0 to 5, with higher scores indicating greater perceived knowledge.

  2. Patient-Reported Outcomes Measure (PROMIS) General Self Efficacy

    Time frame: 12 months

    Questions measures the degree to which people feel confident in managing various situations, problems, and events and confidence in managing negative emotions. 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

  3. Reproductive Concerns After Cancer (RCAC) Scale

    Time frame: 12 months

    The survey has 18 questions, answered on a 5 point scale ranging from "strongly disagree" (1) to "strongly agree" (5). Total scores range from 18 to 90, with higher scores indicating greater distress (worse outcome).

  4. COMRADE subscale

    Time frame: 12 months

    Items are answered on a 5-point scale from "Strongly Disagree" to "Strongly Agree," with high scores indicating better outcomes

  5. Patient-Reported Outcomes Measure (PROMIS) General Self-Efficacy and Self-Efficacy for Managing Emotions

    Time frame: 12 months

    The PROMIS General Self-Efficacy and Self-Efficacy for Managing Emotions subscales measure the degree to which people feel confident in managing various situations, problems, and events and confidence in managing negative emotions. 21 Questions will assess general self-efficacy in these domains and self-efficacy in managing fertility and family-building issues and emotions. The outcome will be reported as the mean difference from baseline to 1, 6, and 12 months, with standard deviation. Items are answered on a 5-point scale from "Strongly Disagree" to "Strongly Agree," with high scores indicating better outcomes

Sponsors and collaborators

Lead sponsor

Stanford University

Other

Collaborators

  • National Cancer Institute (NCI)
  • National Institutes of Health (NIH)

Registry information

Important dates

Study start
2024
Primary completion
2026
Study completion
2027
First posted
Sep 22, 2023
Registry last updated
Feb 25, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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