Self-Advocacy Serious Game in Advanced Cancer

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Brief Title

Self-Advocacy Serious Game in Advanced Cancer

Official Title

Piloting a Serious Game to Improve Self-Advocacy Among Women With Advanced Cancer

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.
    


Study Type

Interventional


Primary Outcome

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

Secondary Outcome

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

Condition

Ovarian Cancer Stage III

Intervention

Strong Together serious game

Study Arms / Comparison Groups

 Serious game intervention
Description:  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.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Behavioral

Estimated Enrollment

78

Start Date

March 9, 2018

Completion Date

December 31, 2023

Primary Completion Date

April 30, 2022

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
      

Gender

Female

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Teresa H Thomas, PhD, RN, , 

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT03339765

Organization ID

PRO17070414


Responsible Party

Principal Investigator

Study Sponsor

University of Pittsburgh


Study Sponsor

Teresa H Thomas, PhD, RN, Principal Investigator, University of Pittsburgh School of Nursing


Verification Date

September 2020