Serious Game Intervention for Breast and Gynecologic Cancers

Overseen By Teresa H Thomas, PhD, RN

Age: 18+

Sex: Female

Trial Phase: Phase 3

Sponsor: University of Pittsburgh

Disqualifiers: Hospice, Impaired cognition, Unstable mental health

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 6 months

336 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to help women with advanced breast and gynecologic cancers enhance their quality of life by teaching self-advocacy skills through a video game. The game, called Strong Together, allows users to make decisions for characters with similar cancer experiences, demonstrating the effects of self-advocacy. Participants will use the game to develop skills that can help manage symptoms and improve care. Women diagnosed with advanced cancer in the past six months and currently receiving non-curative treatment might be suitable for this trial. As a Phase 3 trial, it represents the final step before FDA approval, offering participants a chance to contribute to a potentially groundbreaking treatment.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It seems focused on using a video game to teach self-advocacy skills, so it's unlikely to require changes to your medication.

What prior data suggests that this serious game intervention is safe for women with advanced cancer?

Research has shown that the Strong Together game is practical and well-received by women with advanced breast or gynecologic cancer. Studies have found that participants generally respond positively to the game, which teaches self-advocacy skills. Players learn to better manage their symptoms and improve their quality of life. No major reports of negative effects have emerged from using the game, suggesting that Strong Together is a safe and well-tolerated option for those considering joining a trial. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Strong Together serious game because it offers a unique, interactive approach to supporting patients with breast and gynecologic cancers. Unlike traditional methods that often involve medication or paper-based resources, this game is delivered on a tablet and aims to engage patients through gameplay, potentially enhancing emotional well-being and self-advocacy in a more engaging and relatable way. This digital intervention could complement existing treatments by providing an innovative, user-friendly tool for patient empowerment and education.

What evidence suggests that the Strong Together serious game is effective for teaching self-advocacy skills to women with advanced cancer?

Research has shown that the Strong Together game, which participants in this trial may receive, could benefit women with advanced breast or gynecologic cancer. Studies have found that participants find the game easy to use and well-received. It teaches self-advocacy skills, which can enhance quality of life and reduce symptoms. The game places users in situations where they make choices and see the results of speaking up for themselves. It also provides feedback to help users learn and apply these skills in real life. Overall, early evidence suggests it could be a useful tool for managing the challenges of living with cancer. ^{1 2 3 6 7}

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

I am female.

I was diagnosed with late-stage gynecological or breast cancer recently and am not being treated for a cure.

Your doctor believes you will live for at least 6 more months.

Exclusion Criteria

Impaired cognition (per health record)

You have a mental health disorder that is not stable or controlled.

I am currently receiving hospice care.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants engage with the Strong Together serious game intervention to learn self-advocacy skills

6 months

Sessions are conducted virtually through a tablet computer

Follow-up

Participants are monitored for changes in self-advocacy, symptom burden, and quality of life

6 months

What Are the Treatments Tested in This Trial?

Interventions

• Enhanced Care as Usual
• Strong Together serious game

Trial Overview 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.

How Is the Trial Designed?

Group I: Serious game intervention Experimental Treatment 1 Intervention

Participants receive the Strong Together serious game program on a tablet computer.

Group II: Enhanced care as usual Active Control 1 Intervention

Participants receive a paper-based self-advocacy guide.

Who Is Running the Clinical Trial?

University of Pittsburgh

Lead Sponsor

Trials

1,820

Recruited

16,360,000+

National Institutes of Health (NIH)

Collaborator

Trials

2,896

Recruited

8,053,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Published Research Related to This Trial

Out of 2,569 eligible women, only 995 (38.7%) participated in the trial, indicating a significant gap in engagement despite efforts to communicate risk using plain language materials.

Participation was influenced by education level, with women who had some college education or a college degree being more likely to participate, while race/ethnicity also played a role, highlighting the need for targeted outreach to ensure equitable representation in breast cancer prevention trials.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Characteristics Associated with Participation in ENGAGED 2 - A Web-based Breast Cancer Risk Communication and Decision Support Trial. Wernli, KJ., Bowles, EA., Knerr, S., et al.[2022]

The iPEHOC intervention, which integrates patient-reported outcomes (PROs) into cancer care, resulted in a significant reduction in emergency department visits among patients compared to controls, indicating potential benefits in managing cancer-related distress.

Patients exposed to the intervention showed lower rates of palliative care and psychosocial oncology visits, as well as fewer prescriptions for antidepressants, suggesting that PROs may help streamline care, although there was an increase in opioid prescriptions that warrants further investigation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Integration of patient-reported outcomes (PROs) for personalized symptom management in "real-world" oncology practices: a population-based cohort comparison study of impact on healthcare utilization. Howell, D., Li, M., Sutradhar, R., et al.[2021]

In a study involving 80 adults aged 60 and older with newly diagnosed cancer, those using an electronic serious game reported more preventive behaviors against chemotherapy-induced nausea and vomiting (CINV) compared to a control group, who focused more on self-management strategies.

Participants found the serious game highly usable and acceptable, suggesting it could be an effective tool for oncology providers to help older adults manage treatment-related side effects at home.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Using Serious Games to Increase Prevention and Self-Management of Chemotherapy-Induced Nausea and Vomiting in Older Adults With Cancer. Wochna Loerzel, V., Clochesy, JM., Geddie, PI.[2021]

The ICOnnecta't digital ecosystem was successfully implemented for women recently diagnosed with breast cancer, showing high acceptance (57.62%) and satisfaction rates (76.19%), which indicates its potential to improve access to psychosocial support.

The platform effectively managed the needs of 443 patients, with 94.33% of users remaining engaged in preventive steps, highlighting the importance of strong social support in improving psychosocial outcomes during the cancer journey.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

ICOnnecta't: Development and Initial Results of a Stepped Psychosocial eHealth Ecosystem to Facilitate Risk Assessment and Prevention of Early Emotional Distress in Breast Cancer Survivors' Journey. Medina, JC., Flix-Valle, A., Rodríguez-Ortega, A., et al.[2022]

A study involving 43 adolescent and young adult cancer patients found that most participants were willing to play an action video game designed to teach them about cancer and self-care during treatment.

The game was generally accepted by participants, with cancer-related content not being a deterrent, suggesting it could be an effective educational tool for improving understanding and self-care among young cancer patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Factors affecting acceptability to young cancer patients of a psychoeducational video game about cancer. Kato, PM., Beale, IL.[2015]

A video-game intervention significantly improved adherence to cancer treatment medications, such as trimethoprim-sulfamethoxazole and 6-mercaptopurine, among 375 adolescents and young adults undergoing therapy.

The intervention also enhanced self-efficacy and knowledge about cancer treatment, indicating that engaging methods like video games can be effective tools for improving health behaviors in young patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A video game improves behavioral outcomes in adolescents and young adults with cancer: a randomized trial. Kato, PM., Cole, SW., Bradlyn, AS., et al.[2022]

A community advisory board of older adults and caregivers was crucial in developing a serious game aimed at helping manage chemotherapy-induced nausea and vomiting (CINV), ensuring the game's content was relevant and reflective of their real experiences.

The formative evaluation process highlighted the importance of older adults' perspectives in creating educational tools, suggesting that serious gaming could effectively enhance symptom self-management education for this age group, which traditional methods may not adequately address.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Using a community advisory board to develop a serious game for older adults undergoing treatment for cancer. Loerzel, V., Clochesy, J., Geddie, P.[2019]

A 9-month trial involving 226 women with early-stage breast cancer found that a computer-based educational program did not significantly improve health self-efficacy, healthcare participation, anxiety, or depression compared to standard care.

Factors such as older age, undergoing axillary dissection, and better physical well-being were associated with higher usage of the program, while post-operative chemotherapy and a sense of meaningfulness were linked to lower usage, suggesting that simply providing information may not be sufficient to enhance outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Challenges of evaluating a computer-based educational programme for women diagnosed with early-stage breast cancer: a randomised controlled trial. Ventura, F., Sawatzky, R., Öhlén, J., et al.[2018]

A nurse-led intervention using a customized prechemotherapy educational virtual reality (VR) video significantly reduced anxiety levels, heart rate, and blood pressure in 35 patients receiving first-time chemotherapy.

The intervention also increased patients' perceived self-efficacy to cope with cancer, suggesting that VR education could be an effective tool for supporting patients during chemotherapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Effects of Virtual Reality on Anxiety and Self-Efficacy Among Patients With Cancer: A Pilot Study. Birkhoff, SD., Waddington, C., Williams, J., et al.[2021]

The study involved 78 women with advanced breast or gynecologic cancer, and the serious game intervention 'Strong Together' was found to be feasible and acceptable, with high engagement rates (84% completed ≥75% of the game).

Participants who used the game showed significant improvements in self-advocacy skills at both 3 and 6 months compared to those receiving standard care, suggesting that this intervention could enhance patient-centered care in cancer treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The feasibility, acceptability, and preliminary efficacy of a self-advocacy serious game for women with advanced breast or gynecologic cancer. Thomas, TH., Bender, C., Donovan, HS., et al.[2023]

The mHealth TLC game was found to be believable and appropriate for clinic use, helping lung cancer patients improve their communication skills with healthcare providers during virtual visits.

Participants reported that the game could potentially reduce lung cancer stigma and enhance patient self-management, highlighting the importance of collaboration between game developers and healthcare experts in creating effective health games.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Development and usability evaluation of the mHealth Tool for Lung Cancer (mHealth TLC): a virtual world health game for lung cancer patients. Brown-Johnson, CG., Berrean, B., Cataldo, JK.[2019]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/37243943/

The feasibility, acceptability, and preliminary efficacy of a self ... Conclusions: Strong Together is feasible and acceptable among women with advanced breast or gynecologic cancer. This intervention demonstrates ...

2. acsjournals.onlinelibrary.wiley.com acsjournals.onlinelibrary.wiley.com/doi/10.1002/cncr.34887

The feasibility, acceptability, and preliminary efficacy of a self ... Strong Together is feasible and acceptable among women with advanced breast or gynecologic cancer. This intervention demonstrates promising ...

3. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1551714422003299

Testing the effects of the Strong Together self-advocacy ... This prospective behavioral randomized clinical trial tests the efficacy of a self-advocacy serious game among women newly diagnosed with advanced breast or ...

4. clinicaltrials.gov clinicaltrials.gov/study/NCT03339765

Self-Advocacy Serious Game in Advanced Cancer | ... The goal of the Strong Together serious game is to engage participants in challenges commonly experienced by women with advanced cancer, offer them choices to ...

5. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/36379436/

Protocol for the STRONG randomized clinical trial - PubMed Our novel serious game, Strong Together, aims to teach women with advanced cancer self-advocacy skills needed to improve their symptom burden, quality of life,

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9839496/

Protocol for the STRONG randomized clinical trial - PMC Our novel serious game, Strong Together, aims to teach women with advanced cancer self-advocacy skills needed to improve their symptom burden, quality of life,

7. acsjournals.onlinelibrary.wiley.com acsjournals.onlinelibrary.wiley.com/doi/abs/10.1002/cncr.34887

The feasibility, acceptability, and preliminary efficacy of a self ... Conclusions. Strong Together is feasible and acceptable among women with advanced breast or gynecologic cancer. This intervention demonstrates ...