Clinical trial · Interventional
Project Persist: mHealth for Cancer Survivorship
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Many studies have shown that anxiety and depression are associated with reduced treatment adherence and poor treatment outcomes among patients undergoing cancer treatments. Given the negative consequences of psychological symptoms for cancer patients, it is important to effectively identify and address emotional distress among cancer patients. However, many barriers exist that limit access to effective treatments. Mobile health (mHealth) technologies offer the potential for remote monitoring and on demand management of psychological needs among cancer patients. This pilot randomized controlled trial (RCT) will assess the initial feasibility of a phone-delivered intervention for anxiety and depressive symptoms among cancer patients that are receiving active radiation treatments. A total of 60 participants will be randomized to in-person and smartphone-based assessment only (n=30) or assessment plus smartphone-based intervention (n=30). Both groups will be followed for 8 weeks (6 weeks while undergoing radiation therapy for breast or gynecological cancer + 2 weeks following radiation therapy). It is expected that patients who are randomized to the intervention group will report that the smartphone app is easy to use, app content is useful, and will show greater improvements in reported anxiety, depression, and quality of life compared with the assessment only group. Data from this pilot study will be used to inform the development of mHealth interventions that will be tested in future fully powered RCTs.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Reduce Treatment Non-adherence | — | UNRESOLVED | — |
| Symptom Management | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Assessment only group | Behavioral | — | UNRESOLVED |
| Intervention group | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- OTHER
- label
- Assessment only group
- description
- Standard care + Daily ecological momentary assessments (EMAs)
- interventionNames
- Behavioral: Assessment only group
- type
- EXPERIMENTAL
- label
- Intervention group
- description
- Intervention group will receive same measures and interventions as the assessment only group AND will receive messaging that is tailored to patient responses on EMAs. When participants provide a pattern of responses that are suggestive of heightened emotional distress, they will receive feedback and/or a prompt to complete one of the self-management exercise. The app will prompt participants to complete a brief educational video on relaxation strategies and guided relaxation exercises. Participants will have access to: 1) a "Help me Cope" button in the app that contains links to evidenced-based self-management techniques, and 2) a "Contact Counselor" button that will send a secure email to a study psychologist requesting a call. Participants will receive a coping focused message at the completion of the "Report Distress" EMAs. Participants can access these on demand intervention components and review them at any time in addition to receiving the tailored intervention messages.
- interventionNames
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 99 Years
Show eligibility criteria text
Inclusion Criteria: Eligible participants include adults 18+ who are: 1. community dwelling 2. diagnosed with a primary breast or gynecological or head and neck cancer 3. ordered to receive radiation treatments during a minimum of 5-6 consecutive weeks 4. able to read at the 7th grade level, speak, and write English. 5. scheduled for 5-6 weeks of radiation therapy Exclusion Criteria: 1. radiation treatment with primary palliative intent 2. radiation treatment protocol occurring in a time period of less than 6 weeks 3. severe visual impairment that limits mobile technology use (e.g, partial or full blindness) 4. history of dementia or other major neurocognitive disorder. There are no early termination criteria; however, individuals can elect to stop participation in mobile monitoring at any time.
References
Publications (0)
Data not yet available