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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04059237
Other study ID # IRB-52143
Secondary ID VAR0190IRB-52143
Status Completed
Phase N/A
First received
Last updated
Start date January 6, 2020
Est. completion date December 11, 2022

Study information

Verified date March 2024
Source Stanford University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 102
Est. completion date December 11, 2022
Est. primary completion date December 11, 2022
Accepts healthy volunteers No
Gender Female
Age group 18 Years to 45 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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.

Locations

Country Name City State
United States Stanford Cancer Center Stanford California

Sponsors (2)

Lead Sponsor Collaborator
Stanford University National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
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