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

Stanford University

Status: Completed

Conditions: Cancer

Treatments: Behavioral: Online decision aid tool

Study type: Interventional

Funder types: Other

Identifiers

NCT04200287

VAR0192 (Other Identifier)

IRB-52372

Details and patient eligibility

About

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.

Full 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.

Enrollment: 20 patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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20 participants in 1 patient group

Young adult female (YA-F) cancer survivors

Experimental group

Description:

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.

Treatment:

Behavioral: Online decision aid tool