Study to Improve Survivorship Care Related to Fertility and Family-building After Cancer

NCT04200287 | Completed

• 2 other identifiers: IRB-52372VAR0192
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this research is to explore how a patient decision aid tool (website) given to patients prior to their survivorship care visits, may impact patient-provider communication about fertility and family-building after cancer; and assess the impact of using the tool on patient reported outcomes. The overall purpose of this research is to improve survivorship care by establishing a multi-disciplinary approach to managing cancer and fertility issues and prompt early referral to supportive and medical care resources.

Conditions

Cancer

Outcome Measures

Primary Outcomes (1)

• Decisional Conflict Scale (DCS)

  The Decisional Conflict Scale (DCS) is a validated survey that assesses personal uncertainty in making healthcare decisions; modifiable factors contributing to uncertainty; and the quality of the decision made. It is reliable and responsive to change, and the most widely used measure of decision-making quality. 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). The outcome will be reported as the mean difference from baseline to 4-week and 6-week follow-up time points, with standard deviation.

  6 weeks

Secondary Outcomes (3)

• Unmet Fertility Information

  6 weeks

• Reproductive Concerns After Cancer (RCAC) Scale

  6 weeks

• COMRADE

  6 weeks

Study Arms (1)

Young adult female (YA-F) cancer survivors

EXPERIMENTAL

YA-F cancer survivors will complete a baseline survey (T1) of sociodemographic and patient reported outcomes (PRO) and then will be sent a link to access the decision aid tool (website) with instructions to review the website before their upcoming visit. A follow-up survey (T2) will be emailed 4-weeks post-baseline, prior to their clinic visit, to evaluate website access and PROs. A post-visit survey (T3) will be emailed 6- weeks post-baseline (after their survivorship care visit) to assess PROs.

Behavioral: Online decision aid tool

Interventions

Online decision aid tool BEHAVIORAL

The decision aid intervention will be presented via a website

Young adult female (YA-F) cancer survivors

Eligibility Criteria

• Age: 18 Years - 45 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• completed cancer treatment at least 6-months prior, excluding long-term adjuvant or maintenance therapies
• report an interest in discussing fertility/family-building with a provider
• understands verbal and written English
• access to the Internet and use of a computer, tablet, or smartphone
• has a scheduled cancer survivorship visit within the study time frame

You may not qualify if:

• Prior hospitalization for a mental disorder or history of psychosis
• Note: Survivors on adjuvant maintenance or endocrine treatment, such as tamoxifen, will not be excluded because clinical guidelines allow treatment delay or hiatus to accommodate fertility

Sponsors & Collaborators

• Stanford University: lead

Study Sites (1)

Stanford Medical Center

Stanford, California, 94304, United States

Location

MeSH Terms

Conditions

Neoplasms

Study Officials

• Catherine Benedict

  Stanford University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 12, 2019
• First Posted: December 16, 2019
• Study Start: January 6, 2020
• Primary Completion: September 11, 2021
• Study Completion: September 11, 2021
• Last Updated: May 13, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)