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

NCT ID: NCT04200287

Last Updated: 2022-05-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-01-06
• Study Completion Date: 2021-09-11

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.

Detailed Description

Objective 1: Establish feasibility and acceptability of conducting research with YA-F cancer survivors at the Stanford Cancer Institute (SCI) and Lucile Packard Children's Hospital (LPCH).

Hypothesis 1: Study procedures will be feasible in the given timeframe and acceptable to patients, as evidence by recruitment, enrollment, and completion rates and participant feedback.

Objective 2: Evaluate the impact of using the tool as a part of survivorship care on patient reported outcomes (PROs; i.e., information needs, fertility distress, decision-making uncertainty, and satisfaction with care).

Hypothesis 2: In a single-arm pilot study (N=20), use of the decision aid tool will lead to improvements in fertility distress, decision-making uncertainty, and satisfaction with care.

Conditions

Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Young adult female (YA-F) cancer survivors

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.

Group Type: EXPERIMENTAL

Online decision aid tool

Intervention Type: BEHAVIORAL

The decision aid intervention will be presented via a website

Interventions

Online decision aid tool

The decision aid intervention will be presented via a website

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Stanford University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Catherine Benedict

Role: PRINCIPAL_INVESTIGATOR

Stanford University

Locations

Stanford Medical Center

Stanford, California, United States

Countries

United States

Provided Documents

Document Type: Informed Consent Form

View Document

Other Identifiers

VAR0192

Identifier Type: OTHER

Identifier Source: secondary_id

IRB-52372

Identifier Type: -

Identifier Source: org_study_id