Cancer Survivorship, Pain, Pain Management, Symptom Management, Symptom Monitoring
Conditions
Keywords
cancer survivorship, pain management, mHealth, behavioral intervention, nonpharmacologic intervention, app, digital health
Brief summary
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.
Detailed description
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.
Interventions
BEHAVIORALMobile Health (mHealth) Intervention
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.
Sponsors
Virginia Commonwealth University
National Institute on Minority Health and Health Disparities (NIMHD)
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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 * Cognitively able to actively participate in an online-based study * Able to read, write, and understand English
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Feasibility and acceptability of the mobile health (mHealth) intervention | 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: * 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Self-efficacy for pain management | 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. |
| Improved quality of life using a brief version of the Functional Assessment of Cancer Therapy (FACT-G) | 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. |
| Improved Quality of Life using the European Organization for Research and Treatment of Cancer (EORTC)'s Quality of Life Questionnaire (QLQ-C30) | 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. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORSun Jung Kim, Ph.D
Virginia Commonwealth University
Outcome results
None listed