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.

Study Overview

• Status: Not yet recruiting
• Conditions: Quality of Life; Parenthood Status
• Intervention / Treatment: Other: Roadmap to Parenthood; Other: Informational Booklet

• Study Type: Interventional
• Enrollment (Estimated): 256
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Catherine Benedict, PhD; Phone Number: 650-498-5566; Email: cbenedict@stanford.edu

Study Locations

• United States
  • California
    • Palo Alto, California, United States, 94305
      • Stanford Universtiy
      • Contact: Catherine Benedict, PhD; Phone Number: 650-498-5566; Email: cbenedict@stanford.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Web-based decision support (Roadmap to Parenthood); 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; web-based decision support
Active Comparator: Informational booklet; 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; web-based informational booklet about young adult cancer survivorship

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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	12 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Unmet Fertility Information Needs	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.	12 months
Reproductive Concerns After Cancer (RCAC) Scale	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).	12 months
COMRADE subscale	Items are answered on a 5-point scale from "Strongly Disagree" to "Strongly Agree," with high scores indicating better outcomes	12 months
Patient-Reported Outcomes Measure (PROMIS) General Self Efficacy	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	12 months
Patient-Reported Outcomes Measure (PROMIS) General Self-Efficacy and Self-Efficacy for Managing Emotions	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	12 months

Collaborators and Investigators

• Sponsor: Stanford University
• Collaborators: National Cancer Institute (NCI); National Institutes of Health (NIH)
• Investigators: Principal Investigator: Catherine Benedict, PhD, Stanford University

Study record dates

Study Major Dates

• Study Start (Estimated): May 1, 2024
• Primary Completion (Estimated): July 31, 2028
• Study Completion (Estimated): July 31, 2028

Study Registration Dates

• First Submitted: September 15, 2023
• First Submitted That Met QC Criteria: September 15, 2023
• First Posted (Actual): September 22, 2023

Study Record Updates

• Last Update Posted (Actual): April 4, 2024
• Last Update Submitted That Met QC Criteria: April 2, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: Decision aid; Roadmap to Parenthood; Planning tool
• Other Study ID Numbers: IRB-71534; PS0027 (Other Identifier: OnCore); 1R37CA282148-01 (U.S. NIH Grant/Contract)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No