Strong Together serious game for Quality of Life (QOL)

1
Effectiveness
1
Safety
UPMC Hillman Cancer Center, Pittsburgh, PA
+1 More
Strong Together serious game - Behavioral
Eligibility
18+
Female
Eligible conditions
Quality of Life (QOL)

Study Summary

Efficacy of a Self-advocacy Serious Game Intervention

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Eligible Conditions

  • Quality of Life (QOL)
  • Self-Management

Treatment Effectiveness

Effectiveness Estimate

1 of 3

Compared to trials

Study Objectives

This trial is evaluating whether Strong Together serious game will improve 2 primary outcomes, 6 secondary outcomes, and 4 other outcomes in patients with Quality of Life (QOL). Measurement will happen over the course of Baseline and 3 months.

Baseline and 3 months
Changes from baseline in use of healthcare service utilization defined as hospital admissions, emergency room visits, and (un)planned clinic visits at 3 months
Intervention receipt
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 quality of life scores on the Functional Assessment of Cancer Therapy - General (FACT-G) Scale at 3 months
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 symptom burden scores on the M.D. Anderson Symptom Inventory (MDASI) at 3 months
Baseline and 6 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
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 6 months
Mean change from baseline in self-advocacy scores on the Female Self-Advocacy in Cancer Survivorship (FSACS) Scale at 6 months
Mean change from baseline in symptom burden scores on the M.D. Anderson Symptom Inventory (MDASI) at 6 months
Baseline and v6 months
Intervention mechanism usage

Trial Safety

Safety Estimate

1 of 3

Compared to trials

Trial Design

2 Treatment Groups

Enhanced care as usual
Serious game intervention

This trial requires 336 total participants across 2 different treatment groups

This trial involves 2 different treatments. Strong Together Serious Game is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are not being studied for commercial purposes.

Serious game intervention
Behavioral
Participants receive the Strong Together serious game program on a tablet computer.
Enhanced care as usual
Behavioral
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

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: baseline and 6 months
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly baseline and 6 months for reporting.

Who is running the study

Principal Investigator
T. T. R.
Prof. Teresa Thomas, RN, PhD
University of Pittsburgh

Closest Location

UPMC Hillman Cancer Center - Pittsburgh, PA

Eligibility Criteria

This trial is for female patients aged 18 and older. You must have received newly diagnosed for Quality of Life (QOL) or the other condition listed above. There are 6 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
Female
≥18 years
Diagnosed with Stage III or IV gynecological or Stage IV breast cancer within the past 3 months being treated with non-curative intent
Have at least a 6-month life expectancy (as determined by their oncologist)
Eastern Cooperative Oncology Group performance score of 0 to 2 (per health record or oncologist)
Able to read and write in English

Patient Q&A Section

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

How many people get self-management a year in the United States?

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More than 60% of those diagnosed with arthritis, diabetes, COPD and/or asthma still continue not getting their treatment as prescribed by a physician. Those chronically ill with arthritis in the US still will face their symptoms and medication requirements without medical support.

Unverified Answer

What are common treatments for self-management?

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Self-management interventions with both behavioral and pharmacotherapeutic elements are effective and appear to be equally effective for common chronic medical conditions. The self-management treatments for diabetes, hypertension, and chronic obstructive pulmonary disease can apply across multiple disease domains.

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What is self-management?

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The need for self-management is significant in the care of [osteoarthritis](https://www.withpower.com/clinical-trials/osteoarthritis). Recent findings, we have not found evidence that interventions that include a clinical or biomedical component and/or self-management support have better outcomes in terms of pain or function than standard care. Nevertheless, our results add to the growing literature highlighting the need for further research into the use of self-management as a treatment or intervention for OA.

Unverified Answer

What are the signs of self-management?

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Self-management of chronic disease (such as schizophrenia) should include lifestyle-related lifestyle modifications. The most significant factors in self-management are self-efficacy and motivation. Further study of self-management skills may lead to improved outcomes of the disease, especially if this knowledge is embedded in an integrated health care model.

Unverified Answer

What causes self-management?

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The term self-management is likely to be misleading. To identify the determinants of self-management, this paper suggests five types of self-managers. There are differences between primary and secondary care practitioners. A 'whole' approach, based on patient needs, is required.

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Can self-management be cured?

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Most people with chronic conditions are able to reduce their symptoms, however they have a strong emotional response to what they are seeing. There is an inverse relationship between the intensity of the emotional intensity reaction and the ability to do self-management. Results from a recent paper has implications for the design of the self-management skills and strategies that will be most effective to increase self-management skills in chronic disease.

Unverified Answer

Does strong together serious game improve quality of life for those with self-management?

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Those with good self-management had a significantly better experience with SSC than those with poor self-management. Improvement in health knowledge through the game is a promising area for future development.

Unverified Answer

Does self-management run in families?

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Knowledge of family history was a significant predictor of self-management behaviors. Families are encouraged to be familiar with both the disease process and ways of self-management.

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What is strong together serious game?

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Serious games, in particular the MMOG were extremely effective at improving [health care knowledge and self-esteem]]. Findings from a recent study demonstrates the positive impact of serious games in a real life setting.

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Has strong together serious game proven to be more effective than a placebo?

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Data from a recent study suggests that players who are more committed to the game have more positive effects than players who are more neutral about the game. As of now, it seems that the game has no detrimental effects to the cardiovascular benefits. It would be nice to replicate these results with more patients, and with longer study periods, because the findings are so preliminary and might not come out in a favourable manner. As a game seems as a complementary therapy that should be included to all treatments.

Unverified Answer

What are the latest developments in strong together serious game for therapeutic use?

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This new approach is a promising research tool to enhance the effectiveness of serious games by promoting self-management as well as decreasing fatigue and decreasing stress levels. Also, this approach encourages players to take advantage of different game elements as opposed to the monolithic method with which video games are usually designed.

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How serious can self-management be?

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In a study population of stable, asymptomatic Type 2 diabetes patients, less serious adverse events can result from using diabetes treatment algorithms as self-management guidelines than can result from using an "alternative" treatment approach that may include use of more severe treatment regimens or that may be more expensive.

Unverified Answer
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