Trial Outcomes & Findings for Pilot Study of a Decision Aid Intervention for Family-building After Cancer (NCT NCT04059237)

NCT ID: NCT04059237

Last Updated: 2024-04-09

Results Overview

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).

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 102 participants
• Primary outcome timeframe: Baseline, 1 month, 3 months
• Results posted on: 2024-04-09

Participant Flow

102 participants signed informed consent; 98 participants started the study.

Participant milestones

Measure	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. 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.
Overall Study STARTED	98
Overall Study Completed Baseline Assessment	98
Overall Study Completed 1-month Assessment	78
Overall Study Completed 3-month Assessment	55
Overall Study COMPLETED	55
Overall Study NOT COMPLETED	43

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	Online Decision Aid n=98 Participants 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. 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.
Age, Continuous	30.98 years STANDARD_DEVIATION 5.61 • n=5 Participants
Sex: Female, Male Female	98 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	14 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	84 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race/Ethnicity, Customized White	84 Participants n=5 Participants
Race/Ethnicity, Customized Black	4 Participants n=5 Participants
Race/Ethnicity, Customized Asian or Pacific Islander	6 Participants n=5 Participants
Race/Ethnicity, Customized Other	3 Participants n=5 Participants
Race/Ethnicity, Customized Prefer not to answer	1 Participants n=5 Participants
Region of Enrollment United States	98 Participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline, 1 month, 3 months

Population: Participants with available data at each respective timepoint

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).

Outcome measures

Measure	Online Decision Aid n=98 Participants 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. 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.
Measure Decision Conflict Scale Baseline	52.25 score on a scale Standard Deviation 24.26
Measure Decision Conflict Scale 1 month	36.86 score on a scale Standard Deviation 26.03
Measure Decision Conflict Scale 3 months	34.55 score on a scale Standard Deviation 16.96

SECONDARY outcome

Timeframe: Baseline, 1 month, 3 months

Population: Participants with available data at each respective timepoint

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.

Outcome measures

Measure	Online Decision Aid n=98 Participants 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. 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.
Fertility Information Needs Baseline	3.39 score on a scale Standard Deviation 1.81
Fertility Information Needs 1 month	2.02 score on a scale Standard Deviation 1.56
Fertility Information Needs 3 months	2.09 score on a scale Standard Deviation 1.67

SECONDARY outcome

Timeframe: Baseline, 1 month, 3 month

Population: Participants with available data at each respective timepoint

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.

Outcome measures

Measure	Online Decision Aid n=98 Participants 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. 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.
Measure Illness Perceptions Questionnaire-Revised (IPQ-R) Baseline	85.66 score on a scale Standard Deviation 10.62
Measure Illness Perceptions Questionnaire-Revised (IPQ-R) 1 month	81.48 score on a scale Standard Deviation 9.94
Measure Illness Perceptions Questionnaire-Revised (IPQ-R) 3 months	81.64 score on a scale Standard Deviation 10.64

SECONDARY outcome

Timeframe: Baseline, 1 month, 3 months

Population: Participants with available data at each respective timepoint

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).

Outcome measures

Measure	Online Decision Aid n=98 Participants 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. 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.
Measure Reproductive Concerns After Cancer (RCAC) Scale Baseline	64.14 score on a scale Standard Deviation 11.03
Measure Reproductive Concerns After Cancer (RCAC) Scale 1 month	61.55 score on a scale Standard Deviation 12.30
Measure Reproductive Concerns After Cancer (RCAC) Scale 3 months	60.94 score on a scale Standard Deviation 11.19

SECONDARY outcome

Timeframe: Baseline, 1 month, 3 month

Population: Participants with available data at each respective timepoint

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).

Outcome measures

Measure	Online Decision Aid n=98 Participants 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. 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.
Measure Impact of Events Scale-Revised (IES-R) Baseline	1.34 score on a scale Standard Deviation 1.04
Measure Impact of Events Scale-Revised (IES-R) 1 month	1.10 score on a scale Standard Deviation .91
Measure Impact of Events Scale-Revised (IES-R) 3 months	1.03 score on a scale Standard Deviation .92

SECONDARY outcome

Timeframe: Baseline, 1 month, 3 months

Population: Participants with available data at each respective timepoint

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).

Outcome measures

Measure	Online Decision Aid n=98 Participants 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. 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.
Measure PROMIS Self-Efficacy (PROMIS-SE) - General Self-Efficacy Subscale Baseline	3.83 score on a scale Standard Deviation 0.87
Measure PROMIS Self-Efficacy (PROMIS-SE) - General Self-Efficacy Subscale 1 month	3.91 score on a scale Standard Deviation 0.88
Measure PROMIS Self-Efficacy (PROMIS-SE) - General Self-Efficacy Subscale 3 months	3.89 score on a scale Standard Deviation 0.75

SECONDARY outcome

Timeframe: Baseline, 1 month, 3 months

Population: Participants with available data at each respective timepoint

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).

Outcome measures

Measure	Online Decision Aid n=98 Participants 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. 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.
Measure PROMIS Self-Efficacy (PROMIS-SE) - Managing Fertility/Family-Building Issues Subscale Baseline	2.95 score on a scale Standard Deviation 1.07
Measure PROMIS Self-Efficacy (PROMIS-SE) - Managing Fertility/Family-Building Issues Subscale 1 month	3.31 score on a scale Standard Deviation 0.94
Measure PROMIS Self-Efficacy (PROMIS-SE) - Managing Fertility/Family-Building Issues Subscale 3 months	3.26 score on a scale Standard Deviation 0.10

SECONDARY outcome

Timeframe: Baseline, 1 month, 3 months

Population: Participants with available data at each respective timepoint

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).

Outcome measures

Measure	Online Decision Aid n=98 Participants 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. 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.
Measure PROMIS Self-Efficacy (PROMIS-SE) - Managing Difficult Emotions Subscale 1 month	3.32 score on a scale Standard Deviation 0.90
Measure PROMIS Self-Efficacy (PROMIS-SE) - Managing Difficult Emotions Subscale Baseline	3.23 score on a scale Standard Deviation 0.95
Measure PROMIS Self-Efficacy (PROMIS-SE) - Managing Difficult Emotions Subscale 3 months	3.27 score on a scale Standard Deviation 0.94

SECONDARY outcome

Timeframe: Baseline, 1 month, 3 months

Population: Participants with available data at each respective timepoint

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).

Outcome measures

Measure	Online Decision Aid n=98 Participants 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. 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.
Measure PROMIS Self-Efficacy (PROMIS-SE) - Managing Difficult Emotions Related to Fertility/Family-Building Subscale Baseline	2.70 score on a scale Standard Deviation 0.93
Measure PROMIS Self-Efficacy (PROMIS-SE) - Managing Difficult Emotions Related to Fertility/Family-Building Subscale 1 month	2.92 score on a scale Standard Deviation 1.05
Measure PROMIS Self-Efficacy (PROMIS-SE) - Managing Difficult Emotions Related to Fertility/Family-Building Subscale 3 months	2.92 score on a scale Standard Deviation 1.05

Adverse Events

Online Decision Aid

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Catherine Benedict, PhD

Stanford University

Phone: 650-498-9111

Email: cbenedict@stanford.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place