Virginia Commonwealth University
Richmond, Virginia, 23298, United States
Location status: Recruiting
NCT Number: NCT07332377
This is a feasibility pilot test of a single-arm intervention to evaluate the beta version of an mHealth app-based behavioral intervention prior to scaling for a randomized controlled trial (RCT). This mHealth intervention is designed to enhance self-efficacy and support pain and symptom self-management among post-treatment cancer survivors.
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Not applicable
Richmond, Virginia, 23298, United States
Location status: Recruiting
The intervention involves a set of tested intervention messages, ecological momentary assessments (EMAs), and e-diary entries to our PsyMINT mobile app. A 1-week mHealth intervention to cancer survivors who experience pain will be delivered. The feasibility of an mHealth app platform (PsyMINT) as a message presentation environment will be delivered and evaluated. The app messages will target five topics/modules, including psychoeducational materials related to pain management; positive psychology; opioid literacy; skill building for patient-provider communication and trust; and quality of life.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Individuals will use the mHealth app for 1 week. Participants will interact with evidence-based messages and will complete ecological momentary assessments (EMA's) (two times per day) and electronic diaries (e-diaries) daily.
Time frame: Baseline and end of one week intervention
The feasibility and acceptability of the behavioral intervention will be assessed using a pre-validated measure, the 19-item Post-Study System Usability Questionnaire (PSSUQ)87 (e.g., "It was simple to use this app") on a 7-point Likert scale. Acceptability and feasibility outcomes will be evaluated through analysis of mean scores and proportions, including:
Time frame: Baseline and end of one week intervention
Determine preliminary evidence for efficacy, using the 10-item Pain Self-Efficacy Questionnaire (PSEQ) at baseline and at post-intervention.
Time frame: Baseline and end of one week intervention
Determine preliminary evidence of efficacy using a modified version (shortened) of the Functional Assessment of Cancer Therapy (FACT-G) at baseline and post-intervention. The 26-item FACT-G questionnaire is designed to assess 4 domains of health related quality of life in cancer patients: Physical, social, emotional, and functional well-being using a 5-point Likert scale (1 = Not at all through 5=Very much).
For the FACT-G questionnaire, difference scores will be calculated for the four subscales and the total score using measurements obtained at baseline and post-intervention. The scoring is designed so that a lower score reflects an improved state of well-being and functioning.
Time frame: Baseline and end of one week intervention
Determine preliminary evidence of efficacy using the European Organization for Research and Treatment of Cancer (EORTC)'s Quality of Life Questionnaire (QLQ-C30) at baseline and at post-intervention. The 30-item EORTC is designed to measure health-related quality of life, including global health status, functional domains (physical, role, emotional, cognitive, and social functioning), and common cancer-related symptoms. We will compute mean scores of these sub-domains which will be reported on a 4 point Likert scale (1= Not at all 4 = Very much). Mean scores for global health status, symptom scales, and functional scales will be computed for measurements assessed at baseline and post-intervention, and difference scores for each subscale will be calculated. Low scores indicate better functioning and improved symptoms.
Contact information is provided by the study sponsor or research team.
Virginia Commonwealth University
Other
PsyMINT: Mobile Health (mHealth) Intervention to Support Self-Management of Pain and Symptoms for Cancer Survivors
Acronym: PsyMINT
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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