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Serious Game Intervention for Breast and Gynecologic Cancers

N/A
Recruiting
Research Sponsored by University of Pittsburgh
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Female
Diagnosed with Stage III or IV gynecological or Stage IV breast cancer within the past 3 months being treated with non-curative intent
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline and 6 months
Awards & highlights

Study Summary

This trial is testing whether the game can teach self-advocacy skills to women with metastatic breast or advanced gynecologic cancer, which may help them manage their quality of life concerns and cancer- and treatment-related symptoms.

Who is the study for?
This trial is for women over 18 with advanced breast or gynecologic cancer, who can read and write in English, have a life expectancy of at least 6 months, and are not on hospice care or have unstable mental health disorders. They should be able to perform daily activities with minimal assistance.Check my eligibility
What is being tested?
The study tests the 'Strong Together' serious game designed to teach self-advocacy skills to these women. It's an interactive game that simulates real-life scenarios where players make decisions impacting their care quality and learn from the outcomes.See study design
What are the potential side effects?
Since this intervention involves a serious game application rather than medication, traditional side effects are not expected. However, participants may experience emotional distress or fatigue related to engaging with cancer-related content.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am female.
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I was diagnosed with late-stage gynecological or breast cancer recently and am not being treated for a cure.
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I am 18 years old or older.
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I am mostly active and can care for myself.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline and 6 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline and 6 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Mean change from baseline in self-advocacy scores on the Female Self-Advocacy in Cancer Survivorship (FSACS) Scale at 3 months
Mean change from baseline in self-advocacy scores on the Female Self-Advocacy in Cancer Survivorship (FSACS) Scale at 6 months
Secondary outcome measures
Mean change from baseline in patient-perceived patient-centeredness of care scores on the Patient Centeredness of Care Scale (PCCS) at 3 months
Mean change from baseline in patient-perceived patient-centeredness of care scores on the Patient Centeredness of Care Scale (PCCS) at 6 months
Mean change from baseline in quality of life scores on the Functional Assessment of Cancer Therapy - General (FACT-G) Scale at 3 months
+3 more
Other outcome measures
Changes from baseline in use of healthcare service utilization defined as hospital admissions, emergency room visits, and (un)planned clinic visits at 3 months
Changes from baseline in use of healthcare service utilization defined as hospital admissions, emergency room visits, and (un)planned clinic visits at 6 months
Intervention mechanism usage
+1 more

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Serious game interventionExperimental Treatment1 Intervention
Participants receive the Strong Together serious game program on a tablet computer.
Group II: Enhanced care as usualActive Control1 Intervention
Participants receive a paper-based self-advocacy guide.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Strong Together serious game
2018
N/A
~80

Find a Location

Who is running the clinical trial?

University of PittsburghLead Sponsor
1,716 Previous Clinical Trials
16,346,118 Total Patients Enrolled
National Institutes of Health (NIH)NIH
2,685 Previous Clinical Trials
6,930,622 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,627 Previous Clinical Trials
40,927,005 Total Patients Enrolled

Media Library

Strong Together serious game Clinical Trial Eligibility Overview. Trial Name: NCT04813276 — N/A
Self-Management Research Study Groups: Serious game intervention, Enhanced care as usual
Self-Management Clinical Trial 2023: Strong Together serious game Highlights & Side Effects. Trial Name: NCT04813276 — N/A
Strong Together serious game 2023 Treatment Timeline for Medical Study. Trial Name: NCT04813276 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What objectives is this research attempting to accomplish?

"This trial will assess a variety of objectives over the span of Baseline and 3 months, such as measuring changes in self-advocacy scores on the Female Self-Advocacy in Cancer Survivorship (FSACS) Scale at 6 months. Secondary goals include shifts in patient-perceived patient-centeredness of care ratings registered by the Patient Centeredness of Care Scale (PCCS) at 3 months - which is an 14 item 4 point Likert type scale with a score range from 0 to 42 - and alterations in quality of life indices tracked using the Functional Assessment for Cancer Therapy General (FACT G)"

Answered by AI

Are people still able to enroll in this scientific trial?

"According to the information on clinicaltrials.gov, this research project is actively accepting applicants and has been since August 22nd 2022 when it was first posted. It was last revised on the same date as well."

Answered by AI

How many participants can be admitted to the trial?

"That is correct. In accordance with the information provided on clinicaltrials.gov, this investigation was first announced on August 22nd 2022 and remains open for enrollment today. The trial requires 336 participants from 1 site to participate in order to be completed successfully."

Answered by AI
~184 spots leftby Feb 2026