Self-Advocacy Serious Game in Advanced Cancer

NCT03339765 | Completed DMC

• 1 other identifier: PRO17070414
• Study Type: interventional
• Target: 78
• Locations: 1 country
• Sites: 1

Brief Summary

Self-advocacy, defined as the ability of a patient to get her needs and priorities met in the face of a challenge, is an essential skill but not all women with advanced cancer are able to do it. We want to instruct women with advanced cancer who have low self-advocacy to self-advocate for their health and well-being. We will test a new "serious game" or video program that teaches self-advocacy skills through interactive, situation-based activities. 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 self-advocate or not, and directly show them the health and social benefits of self-advocating and the negative consequences of not self-advocating. Through engaging in the Strong Together program, participants vicariously learn the essential skills of self-advocacy, understand the downstream effects of using or not using these skills, and learn distinct behaviors that they can then use to address their own challenges.

Conditions

Ovarian Cancer Stage III; Ovarian Cancer Stage IV; Breast Cancer Stage IV; Cervical Cancer Stage IIIB; Cervical Cancer Stage IVA; Cervical Cancer Stage IVB; Endometrial Cancer Stage III; Endometrial Cancer Stage IV; Vulvar Cancer, Stage III; Vulvar Cancer, Stage IV; Vaginal Cancer Stage III; Vaginal Cancer Stage IVA; Vaginal Cancer Stage IVB

Keywords

Self-advocacy; Advanced cancer; Serious games; Self-management

Outcome Measures

Primary Outcomes (2)

• Number of participants who engage in at least 8 out of the 12 serious game sessions

  We will calculate the number of participants in the intervention group who complete two-thirds (66.7%) of the intervention sessions as a measure of intervention feasibility. We will accept that we achieved adequate feasibility if at least 75% of participants engage in at least eight out of the twelve serious game sessions.

  3 months

• Number of participants who find the intervention acceptable based on ratings of the Post Study System Usability Questionnaire and qualitative interviews.

  We will accept that we achieved adequate acceptability if at least 80% of participants find the intervention acceptable based on the Post Study System Usability Questionnaire scores and if no issues are raised during the qualitative interviews and feedback that cannot be revised prior to the future trial.

  3 months

Secondary Outcomes (4)

• Change in patient self-advocacy as assessed by the Female Self-Advocacy in Cancer Survivorship Scale.

  Baseline, 3 months, and 6 months

• Change in symptom burden as assessed by the MD Anderson Symptom Inventory scale.

  Baseline, 3 months, and 6 months

• Change in healthcare utilization as assessed by participants' number of hospital admissions, emergency room visits, and primary care visits in the past three months.

  Baseline, 3 months, and 6 months

• Change in quality of life as assessed by the Functional Assessment of Cancer Therapy-General scale.

  Baseline, 3 months, and 6 months

Study Arms (2)

Serious game intervention

EXPERIMENTAL

Participants randomized to the intervention will receive the Strong Together serious game program on a tablet computer. The goal of this serious game is to teach the participant how to advocate for her needs relate to her cancer and treatment. The research team will send participants weekly notifications for 12 weeks to alert them that a new serious game session is available and encourage them to complete one session per week.

Behavioral: Strong Together serious game

Enhanced care as usual

NO INTERVENTION

If randomized to the enhanced care as usual arm, the research team will give participants a paper-based self-advocacy patient brochure published by the National Coalition for Cancer Survivorship. This guide is not a part of usual care, but is freely available on the Internet.

Interventions

Strong Together serious game BEHAVIORAL

The Strong Together serious game program is an interactive, immersive education program in which participants quickly learn the behaviors of self-advocacy and the potential consequences of self-advocating or not. Participants will receive weekly game sessions to play at home for three months.

Serious game intervention

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Inclusion criteria are based on cancer diagnoses which primarily occur in women (gynecological and breast cancer).
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• On hospice at the time of recruitment
• Impaired cognition (per health record)
• Other active, unstable mental health disorder

Sponsors & Collaborators

• University of Pittsburgh: lead

Study Sites (1)

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, 15261, United States

Location

MeSH Terms

Conditions

Ovarian Neoplasms; Breast Neoplasms; Uterine Cervical Neoplasms; Endometrial Neoplasms; Vulvar Neoplasms; Vaginal Neoplasms

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Uterine Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Vulvar Diseases; Vaginal Diseases

Study Officials

• Teresa H Thomas, PhD, RN

  University of Pittsburgh School of Nursing

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: November 3, 2017
• First Posted: November 13, 2017
• Study Start: December 13, 2018
• Primary Completion: March 18, 2021
• Study Completion: March 18, 2021
• Last Updated: July 5, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)