Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT03339765 |
| Other study ID # |
PRO17070414 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
December 13, 2018 |
| Est. completion date |
March 18, 2021 |
Study information
| Verified date |
July 2023 |
| Source |
University of Pittsburgh |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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.
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.
