Clinical trial NCT03339765: Self-Advocacy Serious Game in Advanced Cancer
Official title: Piloting a Serious Game to Improve Self-Advocacy Among Women With Advanced Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
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
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
First posted: 2017-11-13
Enrollment: 78
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Detailed description: 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 Aims:

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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

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

Primary outcomes:
measure: Number of participants who engage in at least 8 out of the 12 serious game sessions
timeFrame: 3 months
measure: Number of participants who find the intervention acceptable based on ratings of the Post Study System Usability Questionnaire and qualitative interviews.
timeFrame: 3 months
Secondary outcomes:
measure: Change in patient self-advocacy as assessed by the Female Self-Advocacy in Cancer Survivorship Scale.
timeFrame: Baseline, 3 months, and 6 months
measure: Change in symptom burden as assessed by the MD Anderson Symptom Inventory scale.
timeFrame: Baseline, 3 months, and 6 months
measure: Change in healthcare utilization as assessed by participants' number of hospital admissions, emergency room visits, and primary care visits in the past three months.
timeFrame: Baseline, 3 months, and 6 months
measure: Change in quality of life as assessed by the Functional Assessment of Cancer Therapy-General scale.
timeFrame: Baseline, 3 months, and 6 months
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: University of Pittsburgh Medical Center
state: Pennsylvania
Study officials:
affiliation: University of Pittsburgh School of Nursing
name: Teresa H Thomas, PhD, RN
role: PRINCIPAL_INVESTIGATOR
References: