Pilot Study of a Decision Aid Intervention for Family-building After Cancer

Stanford University

Status: Completed

Conditions: Cancer

Treatments: Behavioral: Web based decision aid intervention

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT04059237

K07CA229186 (U.S. NIH Grant/Contract)

IRB-52143 (Other Identifier)

VAR0190 (Other Identifier)

Details and patient eligibility

About

This study tests a web-based decision aid and planning too to help young female cancer survivors manage fertility and family-building issues in post treatment survivorship.

Full description

The overall goal of this work is to pilot test a single-arm intervention of a decision aid and planning tool (website) to assist young adult female cancer survivors in making decisions and preparing for family-building after cancer.

Primary Objective: Examine feasibility and acceptability of a decision aid intervention in a single-arm pilot trial.

Secondary Objective: Obtain preliminary effect sizes of the decision aid intervention using a pre-post study design.

Enrollment: 102 patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Female
• Completed cancer treatment known to have gonadotoxic effects (e.g., systemic chemotherapy, surgery affecting reproductive organs or hormone regulation, and/or pelvic radiation)
• Understands verbal and written English
• Desires future children or uncertainty regarding family-building plans
• Access to the Internet and use of a computer, tablet, or smartphone

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

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 preservation, egg extraction for surrogacy, or pregnancy for some patients, and because patients may be interested in alternative family-building options such as surrogacy or adopting.

Trial design

Primary purpose: Supportive Care

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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102 participants in 1 patient group

Online Decision Aid

Experimental group

Description:

web-based psychosocial assessment questionnaires will be administered at baseline (T1; pre-intervention) and at one-month (T2) and three-month (T3) follow-up time points.

Treatment:

Behavioral: Web based decision aid intervention