mHealth Intervention for Pain Self Management
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorVirginia Commonwealth University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
In a post-treatment stage with no evidence of disease (complete remission)
Diagnosed with cancer in the past three years
Experiencing cancer/treatment-related pain
≥ 18 years of age at the time of first diagnosis
Disqualifiers
Individuals who currently use any medication for psychiatric reasons (including stimulants, and mood stabilizers)
Patients with major psychotic disorders (bipolar disorder or schizophrenia) and/or substance use disorders.
Those who are currently pregnant or plan to become pregnant in the next three months
Trial design
Design model
Single group
Treatments tested in this trial
Mobile Health (mHealth) Intervention
BehavioralIndividuals 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.
Treatment groups
25 Participants
are divided into 1 treatment groupGroup A: Mobile Health (mHealth) InterventionExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Feasibility and acceptability of the mobile health (mHealth) 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: * Proportion of participants retained, * Proportion who complete at least 80% of EMAs, * 19-item Post-Study System Usability Questionnaire (PSSUQ) mean scores to be greater than 5 (as indicators of feasibility and acceptability).
Time frame
Baseline and end of one week interventionSecondary outcomes
1
Self-efficacy for pain management
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 intervention2
Improved quality of life using a brief version of the Functional Assessment of Cancer Therapy (FACT-G)
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 intervention3
Improved Quality of Life using the European Organization for Research and Treatment of Cancer (EORTC)'s Quality of Life Questionnaire (QLQ-C30)
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.
Time frame
Baseline and end of one week interventionSponsors and contacts
Click on the lead sponsor to view all of their trials.
Virginia Commonwealth University
Lead sponsor
National Institute on Minority Health and Health Disparities (NIMHD)
Collaborator
Source ClinicalTrials.gov