mHealth Intervention for Pain Self Management
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Mobile Health (mHealth) Intervention.
- Who it may be relevant to
- Registry conditions: Pain, Pain Management, Symptom Monitoring, Symptom Management. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
PsyMINT: Mobile Health (mHealth) Intervention to Support Self-Management of Pain and Symptoms for Cancer Survivors
Overview
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
- Behavioral Mobile 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.
Primary outcome measures
- Feasibility and acceptability of the mobile health (mHealth) intervention [Time frame: Baseline and end of one week intervention]
Secondary outcome measures (3)
- Self-efficacy for pain management [Time frame: Baseline and end of one week intervention]
- Improved quality of life using a brief version of the Functional Assessment of Cancer Therapy (FACT-G) [Time frame: Baseline and end of one week intervention]
- Improved Quality of Life using the European Organization for Research and Treatment of Cancer (EORTC)'s Quality of Life Questionnaire (QLQ-C30) [Time frame: Baseline and end of one week intervention]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Supportive care
Study locations
United States · 1 center
- Virginia Commonwealth University — Richmond
Identifiers
NCT: NCT07332377 · MCC-25-22625 · HM300000094 · P50MD017319