CancerNCT04200287
Study to Improve Survivorship Care Related to Fertility and Family-building After Cancer
A study testing Online decision aid tool in people with Cancer, run by Stanford University at 1 site in United States.
Trial summary
The goal of this research is to explore how a patient decision aid tool (website) given to patients prior to their survivorship care visits, may impact patient-provider communication about fertility and family-building after cancer; and assess the impact of using the tool on patient reported outcomes. 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?
- Online decision aid tool
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Jan 2020to 11 Sep 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- completed cancer treatment at least 6-months prior, excluding long-term adjuvant or maintenance therapies
- report an interest in discussing fertility/family-building with a provider
- understands verbal and written English
- access to the Internet and use of a computer, tablet, or smartphone
- has a scheduled cancer survivorship visit within the study time frame
Who cannot join
- Prior hospitalization for a mental disorder or history of psychosis
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Pilot Study to Improve Survivorship Care Related to Fertility and Family-building After Cancer
The goal of this research is to explore how a patient decision aid tool (website) given to patients prior to their survivorship care visits, may impact patient-provider communication about fertility and family-building after cancer; and assess the impact of using the tool on patient reported outcomes. The overall purpose of this research is to improve survivorship care by establishing a multi-disciplinary approach to managing cancer and fertility issues and prompt early referral to supportive and medical care resources.
Read the detailed description
Objective 1: Establish feasibility and acceptability of conducting research with YA-F cancer survivors at the Stanford Cancer Institute (SCI) and Lucile Packard Children's Hospital (LPCH).
Hypothesis 1: Study procedures will be feasible in the given timeframe and acceptable to patients, as evidence by recruitment, enrollment, and completion rates and participant feedback.
Objective 2: Evaluate the impact of using the tool as a part of survivorship care on patient reported outcomes (PROs; i.e., information needs, fertility distress, decision-making uncertainty, and satisfaction with care).
Hypothesis 2: In a single-arm pilot study (N=20), use of the decision aid tool will lead to improvements in fertility distress, decision-making uncertainty, and satisfaction with care.
- Conditions
- Cancer
- Being tested
- Online decision aid tool
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Online decision aid toolBehavioural
The decision aid intervention will be presented via a website
| Study group | Role | What they receive |
|---|---|---|
| Young adult female (YA-F) cancer survivors | Experimental | YA-F cancer survivors will complete a baseline survey (T1) of sociodemographic and patient reported outcomes (PRO) and then will be sent a link to access the decision aid tool (website) with instructions to review the website before their upcoming visit. A follow-up survey (T2) will be emailed 4-weeks post-baseline, prior to their clinic visit, to evaluate website access and PROs. A post-visit survey (T3) will be emailed 6- weeks post-baseline (after their survivorship care visit) to assess PROs. Receives: Behavioral: Online decision aid tool |
What is being measured
The primary outcome is the main question the study is designed to answer.
Decisional Conflict Scale (DCS)
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 4-week and 6-week follow-up time points, with standard deviation.
Measured: 6 weeks
Secondary outcomes (3)
Unmet 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 4-week and 6-week follow-up time points, with standard deviation.
Measured: 6 weeks
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 4-week and 6-week followup time points, with standard deviation.
Measured: 6 weeks
COMRADE
The COMRADE is a measure of patient-based outcomes of risk communication within patient-provider interactions and treatment decision-making effectiveness. It consists of two subscales: Satisfaction with Communication \& Confidence in Decision-making. Items were adapted to refer to fertility and reproductive health care options. The measure has 20 questions. Items are answered on a 5-point scale from "Strongly Disagree" to "Strongly Agree," with high scores indicating better outcomes.
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2019
- Study start6 Jan 2020
- Primary completion11 Sep 2021
- Study completion11 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Catherine Benedict, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04200287
- Sponsor's protocol ID
- IRB-52372
- Other IDs
- VAR0192
- Status last verified
- May 2022
- First submitted
- 12 Dec 2019
- Last updated
- 13 May 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study to Improve Survivorship Care Related to Fertility and Family-building After Cancer
- ClinicalTrials.gov ID
- NCT04200287
- Acronym / sponsor ID
- IRB-52372
- Conditions
- Cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Study start
- 6 Jan 2020 (actual)
- Primary completion
- 11 Sep 2021 (actual)
- Study completion
- 11 Sep 2021 (actual)
- First posted
- 16 Dec 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this research is to explore how a patient decision aid tool (website) given to patients prior to their survivorship care visits, may impact patient-provider communication about fertility and family-building after cancer; and assess the impact of using the tool on patient reported outcomes. The overall purpose of this research is to improve survivorship care by establishing a multi-disciplinary approach to managing cancer and fertility issues and prompt early referral to supportive and medical care resources.
Detailed description
Objective 1: Establish feasibility and acceptability of conducting research with YA-F cancer survivors at the Stanford Cancer Institute (SCI) and Lucile Packard Children's Hospital (LPCH).
Hypothesis 1: Study procedures will be feasible in the given timeframe and acceptable to patients, as evidence by recruitment, enrollment, and completion rates and participant feedback.
Objective 2: Evaluate the impact of using the tool as a part of survivorship care on patient reported outcomes (PROs; i.e., information needs, fertility distress, decision-making uncertainty, and satisfaction with care).
Hypothesis 2: In a single-arm pilot study (N=20), use of the decision aid tool will lead to improvements in fertility distress, decision-making uncertainty, and satisfaction with care.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Young adult female (YA-F) cancer survivors | Experimental | Behavioral: Online decision aid toolYA-F cancer survivors will complete a baseline survey (T1) of sociodemographic and patient reported outcomes (PRO) and then will be sent a link to access the decision aid tool (website) with instructions to review the website before their upcoming visit. A follow-up survey (T2) will be emailed 4-weeks post-baseline, prior to their clinic visit, to evaluate website access and PROs. A post-visit survey (T3) will be emailed 6- weeks post-baseline (after their survivorship care visit) to assess PROs. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- completed cancer treatment at least 6-months prior, excluding long-term adjuvant or maintenance therapies
- report an interest in discussing fertility/family-building with a provider
- understands verbal and written English
- access to the Internet and use of a computer, tablet, or smartphone
- has a scheduled cancer survivorship visit within the study time frame
Key exclusion criteria (2 listed)
- Prior hospitalization for a mental disorder or history of psychosis
- 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
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 |
|---|---|---|
| Online decision aid toolThe decision aid intervention will be presented via a website | Behavioural | Young adult female (YA-F) cancer survivors |
Primary outcome
Decisional Conflict Scale (DCS)
Time frame: 6 weeks
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 4-week and 6-week follow-up time points, with standard deviation.
3 secondary outcomes
Unmet Fertility Information
Time frame: 6 weeks
Reproductive Concerns After Cancer (RCAC) Scale
Time frame: 6 weeks
COMRADE
Time frame: 6 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2022.
- 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 Online decision aid tool 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 2 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 13 May 2022. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Decisional Conflict Scale (DCS) (time frame: 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 13 May 2022.