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| ID | Type | Description | Link |
|---|---|---|---|
| VAR0190 | Other Identifier | OnCore | |
| IRB-52143 | Other Identifier | Stanford IRB | |
| K07CA229186 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| 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 |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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.
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| Name | Affiliation | Role |
|---|---|---|
| Catherine Benedict | Stanford University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Stanford Cancer Center | Stanford | California | 94304 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31888941 | Derived | 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. |
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102 participants signed informed consent; 98 participants started the study.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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). | Participants with available data at each respective timepoint | Posted | Mean | Standard Deviation | score on a scale | Baseline, 1 month, 3 months |
|
3 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Catherine Benedict, PhD | Stanford University | 650-498-9111 | cbenedict@stanford.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Oct 6, 2022 | Feb 8, 2024 | Prot_SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Feb 8, 2021 | Apr 5, 2022 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D009369 | Neoplasms |
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| 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 |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
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| 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. | Participants with available data at each respective timepoint | Posted | Mean | Standard Deviation | score on a scale | 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. | Participants with available data at each respective timepoint | Posted | Mean | Standard Deviation | score on a scale | 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). | Participants with available data at each respective timepoint | Posted | Mean | Standard Deviation | score on a scale | 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). | Participants with available data at each respective timepoint | Posted | Mean | Standard Deviation | score on a scale | 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). | Participants with available data at each respective timepoint | Posted | Mean | Standard Deviation | score on a scale | 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). | Participants with available data at each respective timepoint | Posted | Mean | Standard Deviation | score on a scale | 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). | Participants with available data at each respective timepoint | Posted | Mean | Standard Deviation | score on a scale | Baseline, 1 month, 3 months |
|
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|
|
| 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). | Participants with available data at each respective timepoint | Posted | Mean | Standard Deviation | score on a scale | Baseline, 1 month, 3 months |
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| 0 |
| 98 |
| 0 |
| 98 |
| 0 |
| 98 |
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