Cancer
Conditions
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.
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.
Interventions
BEHAVIORALWeb 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.
Sponsors
National Cancer Institute (NCI)
Stanford University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Measure Decision Conflict Scale | Baseline, 1 month, 3 months | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Measure Illness Perceptions Questionnaire-Revised (IPQ-R) | Baseline, 1 month, 3 month | 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. |
| Measure Reproductive Concerns After Cancer (RCAC) Scale | Baseline, 1 month, 3 months | 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). |
| Measure Impact of Events Scale-Revised (IES-R) | Baseline, 1 month, 3 month | 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). |
| Fertility Information Needs | Baseline, 1 month, 3 months | 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. |
| Measure PROMIS Self-Efficacy (PROMIS-SE) - Managing Fertility/Family-Building Issues Subscale | Baseline, 1 month, 3 months | 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). |
| Measure PROMIS Self-Efficacy (PROMIS-SE) - Managing Difficult Emotions Subscale | Baseline, 1 month, 3 months | 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). |
| Measure PROMIS Self-Efficacy (PROMIS-SE) - Managing Difficult Emotions Related to Fertility/Family-Building Subscale | Baseline, 1 month, 3 months | 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). |
| Measure PROMIS Self-Efficacy (PROMIS-SE) - General Self-Efficacy Subscale | Baseline, 1 month, 3 months | 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). |
Countries
United States
Participant flow
Pre-assignment details
102 participants signed informed consent; 98 participants started the study.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 98 |
| Total | 98 |
Baseline characteristics
| Characteristic | Online Decision Aid |
|---|---|
| Age, Continuous | 30.98 years STANDARD_DEVIATION 5.61 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 14 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 84 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race/Ethnicity, Customized Asian or Pacific Islander | 6 Participants |
| Race/Ethnicity, Customized Black | 4 Participants |
| Race/Ethnicity, Customized Other | 3 Participants |
| Race/Ethnicity, Customized Prefer not to answer | 1 Participants |
| Race/Ethnicity, Customized White | 84 Participants |
| Region of Enrollment United States | 98 Participants |
| Sex: Female, Male Female | 98 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 98 |
| other Total, other adverse events | 0 / 98 |
| serious Total, serious adverse events | 0 / 98 |
Outcome results
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).
Time frame: Baseline, 1 month, 3 months
Population: Participants with available data at each respective timepoint
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Online Decision Aid | Measure Decision Conflict Scale | Baseline | 52.25 score on a scale | Standard Deviation 24.26 |
| Online Decision Aid | Measure Decision Conflict Scale | 1 month | 36.86 score on a scale | Standard Deviation 26.03 |
| Online Decision Aid | Measure Decision Conflict Scale | 3 months | 34.55 score on a scale | Standard Deviation 16.96 |
p-value: <0.001ANOVA
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.
Time frame: Baseline, 1 month, 3 months
Population: Participants with available data at each respective timepoint
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Online Decision Aid | Fertility Information Needs | Baseline | 3.39 score on a scale | Standard Deviation 1.81 |
| Online Decision Aid | Fertility Information Needs | 1 month | 2.02 score on a scale | Standard Deviation 1.56 |
| Online Decision Aid | Fertility Information Needs | 3 months | 2.09 score on a scale | Standard Deviation 1.67 |
p-value: <0.001ANOVA
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.
Time frame: Baseline, 1 month, 3 month
Population: Participants with available data at each respective timepoint
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Online Decision Aid | Measure Illness Perceptions Questionnaire-Revised (IPQ-R) | Baseline | 85.66 score on a scale | Standard Deviation 10.62 |
| Online Decision Aid | Measure Illness Perceptions Questionnaire-Revised (IPQ-R) | 1 month | 81.48 score on a scale | Standard Deviation 9.94 |
| Online Decision Aid | Measure Illness Perceptions Questionnaire-Revised (IPQ-R) | 3 months | 81.64 score on a scale | Standard Deviation 10.64 |
p-value: <0.001ANOVA
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).
Time frame: Baseline, 1 month, 3 month
Population: Participants with available data at each respective timepoint
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Online Decision Aid | Measure Impact of Events Scale-Revised (IES-R) | Baseline | 1.34 score on a scale | Standard Deviation 1.04 |
| Online Decision Aid | Measure Impact of Events Scale-Revised (IES-R) | 1 month | 1.10 score on a scale | Standard Deviation 0.91 |
| Online Decision Aid | Measure Impact of Events Scale-Revised (IES-R) | 3 months | 1.03 score on a scale | Standard Deviation 0.92 |
p-value: 0.01ANOVA
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).
Time frame: Baseline, 1 month, 3 months
Population: Participants with available data at each respective timepoint
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Online Decision Aid | Measure PROMIS Self-Efficacy (PROMIS-SE) - General Self-Efficacy Subscale | Baseline | 3.83 score on a scale | Standard Deviation 0.87 |
| Online Decision Aid | Measure PROMIS Self-Efficacy (PROMIS-SE) - General Self-Efficacy Subscale | 1 month | 3.91 score on a scale | Standard Deviation 0.88 |
| Online Decision Aid | Measure PROMIS Self-Efficacy (PROMIS-SE) - General Self-Efficacy Subscale | 3 months | 3.89 score on a scale | Standard Deviation 0.75 |
p-value: 0.59ANOVA
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).
Time frame: Baseline, 1 month, 3 months
Population: Participants with available data at each respective timepoint
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Online Decision Aid | 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 |
| Online Decision Aid | 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 |
| Online Decision Aid | 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 |
p-value: 0.08ANOVA
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).
Time frame: Baseline, 1 month, 3 months
Population: Participants with available data at each respective timepoint
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Online Decision Aid | Measure PROMIS Self-Efficacy (PROMIS-SE) - Managing Difficult Emotions Subscale | Baseline | 3.23 score on a scale | Standard Deviation 0.95 |
| Online Decision Aid | Measure PROMIS Self-Efficacy (PROMIS-SE) - Managing Difficult Emotions Subscale | 1 month | 3.32 score on a scale | Standard Deviation 0.9 |
| Online Decision Aid | Measure PROMIS Self-Efficacy (PROMIS-SE) - Managing Difficult Emotions Subscale | 3 months | 3.27 score on a scale | Standard Deviation 0.94 |
p-value: 0.52ANOVA
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).
Time frame: Baseline, 1 month, 3 months
Population: Participants with available data at each respective timepoint
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Online Decision Aid | Measure PROMIS Self-Efficacy (PROMIS-SE) - Managing Fertility/Family-Building Issues Subscale | Baseline | 2.95 score on a scale | Standard Deviation 1.07 |
| Online Decision Aid | Measure PROMIS Self-Efficacy (PROMIS-SE) - Managing Fertility/Family-Building Issues Subscale | 1 month | 3.31 score on a scale | Standard Deviation 0.94 |
| Online Decision Aid | Measure PROMIS Self-Efficacy (PROMIS-SE) - Managing Fertility/Family-Building Issues Subscale | 3 months | 3.26 score on a scale | Standard Deviation 0.1 |
p-value: 0.02ANOVA
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).
Time frame: Baseline, 1 month, 3 months
Population: Participants with available data at each respective timepoint
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Online Decision Aid | Measure Reproductive Concerns After Cancer (RCAC) Scale | Baseline | 64.14 score on a scale | Standard Deviation 11.03 |
| Online Decision Aid | Measure Reproductive Concerns After Cancer (RCAC) Scale | 1 month | 61.55 score on a scale | Standard Deviation 12.3 |
| Online Decision Aid | Measure Reproductive Concerns After Cancer (RCAC) Scale | 3 months | 60.94 score on a scale | Standard Deviation 11.19 |
p-value: 0.1ANOVA