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

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.

Study Overview

• Status: Completed
• Conditions: Cancer
• Intervention / Treatment: Behavioral: Web based decision aid intervention

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 102
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Stanford, California, United States, 94304
      • Stanford Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Online Decision Aid; 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; Decision aid tool (website) to assist young adult female cancer survivors in making decisions and preparing for family-building after cancer.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Fertility Information Needs	This investigator-designed survey assesses perceived information needs about fertility topics such as the risk of infertility; risk of early menopause; options to assess fertility status; options to preserve fertility; and options for alternative family-building. The survey has 5 questions, each answered by a Yes / No response. Yes is scored as 1, and no is scored as 0. Total scores range from 0 to 5, with higher scores indicating greater perceived knowledge.	Baseline, 1 month, 3 months
Measure Illness Perceptions Questionnaire-Revised (IPQ-R)	The Illness Perceptions Questionnaire-Revised (IPQ-R) is a survey that assesses cognitive and emotional representations of illness, and is validated in cancer populations. The survey has 28 questions, answered on a 5-point scale ranging from "strongly disagree" (1) to "strongly agree" (5). Mean scores range from 28 to 140, with higher scores indicating worse outcomes. The outcome will be reported as the mean difference from baseline to 1 and 3 months, with standard deviation.	Baseline, 1 month, 3 month
Measure Reproductive Concerns After Cancer (RCAC) Scale	The Reproductive Concerns After Cancer (RCAC) Scale is a validated survey of cancer survivors' fertility and health concerns. The survey has 18 questions, answered on a 5-point scale ranging from "strongly disagree" (1) to "strongly agree" (5). Total scores range from 18 to 90, with higher scores indicating greater distress (worse outcome).	Baseline, 1 month, 3 months
Measure Impact of Events Scale-Revised (IES-R)	Impact of Events Scale-Revised (IES-R) is a validated measure of distress in reaction to negative life events that has been adapted to measure current subjective distress related to infertility risk. The survey has 15 questions, intended to collect the participant's assessment of intrusive thoughts (7 questions) and effortful avoidance of reminders about a distressing event (8 questions). The questions are answered on a 5-point scale ranging from "not at all" (1) to "extremely" (5). Mean scores range from 15 to 75, with higher scores indicating greater distress (worse outcome).	Baseline, 1 month, 3 month
Measure PROMIS Self-Efficacy (PROMIS-SE) - General Self-Efficacy Subscale	The PROMIS Self-Efficacy - General Self Efficacy subscale measures the degree to which people feel confident in managing various situations, problems, and events. The survey has 4 questions intended to collect the participant's assessment of general self-efficacy The questions are answered on a 5 point scale ranging from "I am not at all confident" (1) to "I am very confident" (5).	Baseline, 1 month, 3 months
Measure PROMIS Self-Efficacy (PROMIS-SE) - Managing Fertility/Family-Building Issues Subscale	The PROMIS Self-Efficacy - General Self-Efficacy subscale measures the degree to which people feel confident in managing various situations, problems, and events and confidence in managing difficult emotions. Questions were adapted to assess self-efficacy in managing fertility and family-building issues. The survey has 4 questions, intended to collect the participant's assessment of self-efficacy for managing fertility/family-building issues. The questions are answered on a 5 point scale ranging from "I am not at all confident" (1) to "I am very confident" (5).	Baseline, 1 month, 3 months
Measure PROMIS Self-Efficacy (PROMIS-SE) - Managing Difficult Emotions Subscale	The PROMIS Self-Efficacy - Managing Difficult Emotions subscale measures the degree to which people feel confident in managing difficult emotions. The survey has 4 questions, intended to collect the participant's assessment of self-efficacy for managing difficult emotions. The questions are answered on a 5 point scale ranging from "I am not at all confident" (1) to "I am very confident" (5).	Baseline, 1 month, 3 months
Measure PROMIS Self-Efficacy (PROMIS-SE) - Managing Difficult Emotions Related to Fertility/Family-Building Subscale	The PROMIS Self-Efficacy - Managing Difficult Emotions subscale measures the degree to which people feel confident in managing difficult emotions. Questions were adapted to assess self-efficacy in managing emotions related to fertility and family-building. The survey has 4 questions, intended to collect the participant's assessment of self-efficacy for managing difficult emotions related to fertility/family-building. The questions are answered on a 5 point scale ranging from "I am not at all confident" (1) to "I am very confident" (5).	Baseline, 1 month, 3 months

Collaborators and Investigators

• Sponsor: Stanford University
• Collaborators: National Cancer Institute (NCI)
• Investigators: Principal Investigator: Catherine Benedict, Stanford University

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): January 6, 2020
• Primary Completion (Actual): December 11, 2022
• Study Completion (Actual): December 11, 2022

Study Registration Dates

• First Submitted: August 14, 2019
• First Submitted That Met QC Criteria: August 14, 2019
• First Posted (Actual): August 16, 2019

Study Record Updates

• Last Update Posted (Actual): April 9, 2024
• Last Update Submitted That Met QC Criteria: March 11, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: IRB-52143 (Other Identifier: Stanford IRB); VAR0190 (Other Identifier: OnCore); K07CA229186 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No