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

NCT04059237 | Completed Results DMC

• 3 other identifiers: IRB-52143VAR0190K07CA229186
• Study Type: interventional
• Target: 102
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Cancer

Outcome Measures

Primary Outcomes (1)

• Measure Decision Conflict Scale

  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).

  Baseline, 1 month, 3 months

Secondary Outcomes (8)

• Fertility Information Needs

  Baseline, 1 month, 3 months

• Measure Illness Perceptions Questionnaire-Revised (IPQ-R)

  Baseline, 1 month, 3 month

• Measure Reproductive Concerns After Cancer (RCAC) Scale

  Baseline, 1 month, 3 months

• Measure Impact of Events Scale-Revised (IES-R)

  Baseline, 1 month, 3 month

• Measure PROMIS Self-Efficacy (PROMIS-SE) - General Self-Efficacy Subscale

  Baseline, 1 month, 3 months

Study Arms (1)

Online Decision Aid

EXPERIMENTAL

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.

Behavioral: Web based decision aid intervention

Interventions

Web based decision aid intervention BEHAVIORAL

Decision aid tool (website) to assist young adult female cancer survivors in making decisions and preparing for family-building after cancer.

Online Decision Aid

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Stanford University: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Stanford Cancer Center

Stanford, California, 94304, United States

Location

Related Publications (1)

• Benedict C, Ford JS, Schapira L, Simon P, Spiegel D, Diefenbach M. Family-building decision aid and planning tool for young adult women after cancer treatment: protocol for preliminary testing of a web-based decision support intervention in a single-arm pilot study. BMJ Open. 2019 Dec 29;9(12):e033630. doi: 10.1136/bmjopen-2019-033630.

  PMID: 31888941 DERIVED

MeSH Terms

Conditions

Neoplasms

Results Point of Contact

• Title: Catherine Benedict, PhD
• Organization: Stanford University

cbenedict@stanford.edu

650-498-9111

Study Officials

• Catherine Benedict

  Stanford University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Associate Professor, Psychiatry and Behavioral Sciences- Medical Psychiatry

Study Record Dates

• First Submitted: August 14, 2019
• First Posted: August 16, 2019
• Study Start: January 6, 2020
• Primary Completion: December 11, 2022
• Study Completion: December 11, 2022
• Last Updated: April 9, 2024
• Results First Posted: April 9, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)