Self-Advocacy Serious Game in Advanced Cancer
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03339765|
Recruitment Status : Recruiting
First Posted : November 13, 2017
Last Update Posted : March 4, 2020
|Condition or disease||Intervention/treatment||Phase|
|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||Behavioral: Strong Together serious game||Not Applicable|
Background: When faced with the challenges of advanced cancer, women must advocate (or stand up) for their needs and priorities. However, there are no interventions to promote self-advocacy among female patients with advanced cancer. Preliminary work has developed a theoretically-based, psychometrically-strong measure of self-advocacy (the Female Self-Advocacy in Cancer Survivorship (FSACS) Scale) and demonstrated correlations with symptom burden and healthcare utilization. Serious games offer a novel mechanism by which to deliver interactive, engaging health education that links users' choices to consequences so that users learn a desired skill. The fully-automated Strong Together self-advocacy serious game may allow women with advanced cancer to learn self-advocacy skills and therefore improve their health outcomes.
Objective/Hypothesis: The purpose of this pilot randomized controlled trial (RCT) is to evaluate the feasibility, acceptably, and preliminary efficacy of the Strong Together serious game.
Specific Aim 1: To evaluate the feasibility and acceptability of the 3-month Strong Together intervention.
- Benchmark 1: At least 75% of participants will engage in at least 8 out of the 12 serious game sessions.
- Benchmark 2: At least 80% of participants will find the intervention acceptable based on ratings of perceived satisfaction and ease of use, as well as feedback from qualitative exit interviews.
Specific Aim 2: To explore the differences in self-advocacy and symptom burden between groups over time.
• Research Question: Do patients who receive the intervention report improved self-advocacy and lower symptom burden compared to those assigned to enhanced care as usual?
Study Design: This pilot RCT will recruit (N=84) women from cancer clinics at the University of Pittsburgh Medical Center. Eligibility criteria include: female; age ≥ 18 years; diagnosis of Stage III or IV gynecological or Stage IV breast cancer within the past 3 months; 6-month prognosis; Eastern Cooperative Oncology Group score of 0-1; and ability to read and write in English. Measures will be collected at baseline, 3 months, and 6 months. Randomization (2:1) will occur to the 3-month Strong Together intervention group or the enhanced care as usual group. Feasibility will be assessed by calculating percentages of the intervention's dosage, engagement, recruitment, retention, and data completion. Acceptability will be assessed through exit interviews and an acceptability scale. Preliminary efficacy will be measured by exploring differences in self-advocacy and symptom burden scores and calculating point and interval estimates between the groups at 3 and 6 months.
Cancer Relevance: This study represents a unique opportunity to address the lack of self-advocacy interventions, reduce the risks of women with low self-advocacy, and guide an adequately-powered RCT to educate women with advanced cancer to self-advocate.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||81 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Supportive Care|
|Official Title:||Piloting a Serious Game to Improve Self-Advocacy Among Women With Advanced Cancer|
|Actual Study Start Date :||March 9, 2018|
|Estimated Primary Completion Date :||April 30, 2022|
|Estimated Study Completion Date :||December 31, 2023|
Experimental: Serious game intervention
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
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.
No Intervention: Enhanced care as usual
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.
- Number of participants who engage in at least 8 out of the 12 serious game sessions [ Time Frame: 3 months ]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.
- Number of participants who find the intervention acceptable based on ratings of the Post Study System Usability Questionnaire and qualitative interviews. [ Time Frame: 3 months ]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.
- Change in patient self-advocacy as assessed by the Female Self-Advocacy in Cancer Survivorship Scale. [ Time Frame: Baseline, 3 months, and 6 months ]We anticipate that self-advocacy scores will increase (improve) among participants in the intervention group compared to the enhanced care as usual group.
- Change in symptom burden as assessed by the MD Anderson Symptom Inventory scale. [ Time Frame: Baseline, 3 months, and 6 months ]We anticipate that symptom burden scores will decrease (improve) among participants in the intervention group compared to the enhanced care as usual group.
- Change in healthcare utilization as assessed by participants' number of hospital admissions, emergency room visits, and primary care visits in the past three months. [ Time Frame: Baseline, 3 months, and 6 months ]We anticipate that the frequency of healthcare utilization will decrease (improve) among participants in the intervention group compared to the enhanced care as usual group.
- Change in quality of life as assessed by the Functional Assessment of Cancer Therapy-General scale. [ Time Frame: Baseline, 3 months, and 6 months ]We anticipate that quality of life will increase (improve) among participants in the intervention group compared to the enhanced care as usual group.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03339765
|United States, Pennsylvania|
|University of Pittsburgh Medical Center||Recruiting|
|Pittsburgh, Pennsylvania, United States, 15261|
|Contact: Teresa H Thomas, PhD, RN 412-624-3799 email@example.com|
|Principal Investigator: Teresa H Thomas, PhD, RN|
|Principal Investigator:||Teresa H Thomas, PhD, RN||University of Pittsburgh School of Nursing|