NCT07332377

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
25

participants targeted

Target at below P25 for not_applicable pain

Timeline
11mo left

Started Feb 2026

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress18%
Feb 2026Mar 2027

First Submitted

Initial submission to the registry

January 8, 2026

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 12, 2026

Completed
1 month until next milestone

Study Start

First participant enrolled

February 23, 2026

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2027

Last Updated

March 18, 2026

Status Verified

March 1, 2026

Enrollment Period

1.1 years

First QC Date

January 8, 2026

Last Update Submit

March 16, 2026

Conditions

PainPain ManagementSymptom MonitoringSymptom ManagementCancer Survivorship

Keywords

cancer survivorshippain managementmHealthbehavioral interventionnonpharmacologic interventionappdigital health

Outcome Measures

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).

    Baseline and end of one week intervention

Secondary Outcomes (3)

  • Self-efficacy for pain management

    Baseline and end of one week 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

  • 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

Study Arms (1)

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

Behavioral: Mobile Health (mHealth) Intervention

Interventions

Mobile Health (mHealth) InterventionBEHAVIORAL

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.

Mobile Health (mHealth) Intervention

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Virginia Commonwealth University

Richmond, Virginia, 23298, United States

RECRUITING

MeSH Terms

Conditions

PainAgnosiaAlzheimer Disease

Interventions

TelemedicineMethods

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsPerceptual DisordersNeurobehavioral ManifestationsNervous System DiseasesDementiaBrain DiseasesCentral Nervous System DiseasesTauopathiesNeurodegenerative DiseasesNeurocognitive DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Delivery of Health CarePatient Care ManagementHealth Services AdministrationInvestigative Techniques

Study Officials

  • Sun Jung Kim, Ph.D

    Virginia Commonwealth University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Sun Jung Kim, Ph.D

CONTACT

804-628-4688sjkim2@vcu.edu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 8, 2026

First Posted

January 12, 2026

Study Start

February 23, 2026

Primary Completion (Estimated)

March 31, 2027

Study Completion (Estimated)

March 31, 2027

Last Updated

March 18, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

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.

Locations

US(1)