PainPsyMINTNCT07332377
mHealth Intervention for Pain Self Management
A study testing Mobile Health (mHealth) Intervention in people with Pain and Pain Management, run by Virginia Commonwealth University at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pain, Pain Management, Symptom Monitoring
- What is being tested?
- Mobile Health (mHealth) Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Feb 2026to 8 Jun 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
United States1 site
Virginia Commonwealth University
Richmond, Virginia, 23298
About this study
Official title: PsyMINT: Mobile Health (mHealth) Intervention to Support Self-Management of Pain and Symptoms for Cancer Survivors
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.
Read the 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.
- Being tested
- Mobile Health (mHealth) Intervention
- Keywords
- cancer survivorship, pain management, mHealth, behavioral intervention, nonpharmacologic intervention, app, digital health
- Medical subject headings
- Pain, Agnosia, Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mobile Health (mHealth) InterventionBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Mobile Health (mHealth) Intervention | Experimental | Implement a bank of 60 mHealth intervention messages, ecological momentary assessments (EMAs), and e-diary entries to PiLR to deliver a 1-week mHealth intervention to cancer survivors experiencing pain Receives: Behavioral: Mobile Health (mHealth) Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Baseline and end of one week intervention
Secondary outcomes (3)
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.
Measured: Baseline and end of one week intervention
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.
Measured: 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)
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.
Measured: Baseline and end of one week intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2026
- Study start23 Feb 2026
- Primary completion8 Jun 2026
- Study completion8 Jun 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PainStudies of the same condition, open and under way.
- More trials run by Virginia Commonwealth UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Virginia Commonwealth University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Minority Health and Health Disparities (NIMHD)
- Responsible party
- Sponsor
- Investigators
- Sun Jung Kim, Ph.D, Principal investigator, Virginia Commonwealth University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07332377
- Sponsor's protocol ID
- MCC-25-22625
- Other IDs
- HM300000094, P50MD017319
- Acronym
- PsyMINT
- Status last verified
- Sep 2026
- First submitted
- 8 Jan 2026
- Last updated
- 14 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There are no plans to share individual data, but a de-identified aggregated form of self-report data may be available to share when the study is complete and findings are published.
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PsyMINT: Mobile Health (mHealth) Intervention to Support Self-Management of Pain and Symptoms for Cancer Survivors
- ClinicalTrials.gov ID
- NCT07332377
- Acronym / sponsor ID
- PsyMINT / MCC-25-22625
- Keywords
- cancer survivorship, pain management, mHealth, behavioral intervention, nonpharmacologic intervention, app, digital health
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Virginia Commonwealth UniversityUniversity, hospital or other
- Collaborators
- National Institute on Minority Health and Health Disparities (NIMHD)
- Study start
- 23 Feb 2026 (actual)
- Primary completion
- 8 Jun 2026 (actual)
- Study completion
- 8 Jun 2026 (actual)
- First posted
- 12 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Mobile Health (mHealth) Intervention | Experimental | Behavioral: Mobile Health (mHealth) InterventionImplement a bank of 60 mHealth intervention messages, ecological momentary assessments (EMAs), and e-diary entries to PiLR to deliver a 1-week mHealth intervention to cancer survivors experiencing pain |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mobile Health (mHealth) InterventionIndividuals 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. | Behavioural | Mobile Health (mHealth) Intervention |
Primary outcome
Feasibility and acceptability of the mobile health (mHealth) intervention
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: * 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).
3 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 2026.
- Individual participant dataSharing planned: No. There are no plans to share individual data, but a de-identified aggregated form of self-report data may be available to share when the study is complete and findings are published.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sun Jung Kim, Ph.D principal investigator
Virginia Commonwealth University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mobile Health (mHealth) Intervention in people with Pain and Pain Management, run by Virginia Commonwealth University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility and acceptability of the mobile health (mHealth) intervention (time frame: Baseline and end of one week intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Sep 2026.