CancerNCT04059237
Pilot Study of a Decision Aid Intervention for Family-building After Cancer
A study testing Web based decision aid intervention in people with Cancer, run by Stanford University at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Cancer
- What is being tested?
- Web based decision aid intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 102 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Jan 2020to 11 Dec 2022
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Cancer
- Being tested
- Web based decision aid intervention
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Web based decision aid interventionBehavioural
Decision aid tool (website) to assist young adult female cancer survivors in making decisions and preparing for family-building after cancer.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Web based decision aid intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Baseline, 1 month, 3 months
Secondary outcomes (8)
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.
Measured: 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.
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: Baseline, 1 month, 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2019
- Study start6 Jan 2020
- Primary completion11 Dec 2022
- Study completion11 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for CancerStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 102 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Principal investigator, Catherine Benedict, Stanford University
- Investigators
- Catherine Benedict, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04059237
- Sponsor's protocol ID
- IRB-52143
- Other IDs
- VAR0190, IRB-52143, K07CA229186
- Status last verified
- Mar 2024
- First submitted
- 14 Aug 2019
- Last updated
- 9 Apr 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 31888941
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study of a Decision Aid Intervention for Family-building After Cancer
- ClinicalTrials.gov ID
- NCT04059237
- Acronym / sponsor ID
- IRB-52143
- Conditions
- Cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 102 participants (actual)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 6 Jan 2020 (actual)
- Primary completion
- 11 Dec 2022 (actual)
- Study completion
- 11 Dec 2022 (actual)
- First posted
- 16 Aug 2019 (actual)
- Results
- Posted 9 Apr 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Online Decision Aid | Experimental | Behavioral: Web based decision aid interventionweb-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. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Web based decision aid interventionDecision aid tool (website) to assist young adult female cancer survivors in making decisions and preparing for family-building after cancer. | Behavioural | Online Decision Aid |
Primary outcome
Measure Decision Conflict Scale
Time frame: 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).
8 secondary outcomes
Fertility Information Needs
Time frame: Baseline, 1 month, 3 months
Measure Illness Perceptions Questionnaire-Revised (IPQ-R)
Time frame: Baseline, 1 month, 3 month
Measure Reproductive Concerns After Cancer (RCAC) Scale
Time frame: Baseline, 1 month, 3 months
Measure Impact of Events Scale-Revised (IES-R)
Time frame: Baseline, 1 month, 3 month
Measure PROMIS Self-Efficacy (PROMIS-SE) - General Self-Efficacy Subscale
Time frame: Baseline, 1 month, 3 months
Measure PROMIS Self-Efficacy (PROMIS-SE) - Managing Fertility/Family-Building Issues Subscale
Time frame: Baseline, 1 month, 3 months
Measure PROMIS Self-Efficacy (PROMIS-SE) - Managing Difficult Emotions Subscale
Time frame: Baseline, 1 month, 3 months
Measure PROMIS Self-Efficacy (PROMIS-SE) - Managing Difficult Emotions Related to Fertility/Family-Building Subscale
Time frame: Baseline, 1 month, 3 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 31888941Benedict 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Catherine Benedict principal investigator
Stanford University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Web based decision aid intervention in people with Cancer, run by Stanford University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 9 Apr 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measure Decision Conflict Scale (time frame: Baseline, 1 month, 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04059237, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Apr 2024; AzTrials last refreshed its copy on 6 Nov 2026.