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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Cancer

Intervention / Treatment
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* Behavioral: Web based decision aid intervention


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

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

What is the study measuring?
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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). The outcome will be reported as the mean difference from baseline to 1 and 3 months, with standard deviation. | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Measure Fertility Information | 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. The outcome will be reported as the mean difference from baseline to 1 and 3 months, with standard deviation | 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). Total 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. | 3 months | 
| 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). The outcome will be reported as the mean difference from baseline to 1 and 3 months, with standard deviation | 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). Total scores range from 15 to 75, with higher scores indicating greater distress (worse outcome). The outcome will be reported as the mean difference from baseline to 1 and 3 months, with standard deviation. | 3 months | 
| Measure PROMIS Self-Efficacy (PROMIS-SE) | The PROMIS General Self-Efficacy and Self-Efficacy for Managing Emotions subscales measure the degree to which people feel confident in managing various situations, problems, and events and confidence in managing difficult emotions. Questions will assess general self-efficacy in these domains and self-efficacy in managing fertility and family-building issues and emotions. The survey has 16 questions, intended to collect the participant's assessment of general self-efficacy (4 items), self-efficacy for managing fertility/family-building issues (4 items), self-efficacy for managing difficulty emotions (4 items), and self-efficacy for managing difficult emotions related to fertility/family-building (4 items). The questions are answered on a 5 point scale ranging from I am not at all confident (1) to I am very confident (5). The outcome will be reported as the mean difference from baseline to 1 and 3 months, with standard deviation | 3 months |