mHealth Intervention / Breast Cancer / Lung Cancer · Interventional Study

Telemedicine-mHealth Symptom Cluster Intervention for Advanced Cancer Patients: Finding Our Center Under Stress (FOCUS)

ClinicalTrials.gov · August 17, 2026

Preliminary Why this matters to you Expert discussion

Early or partial results. Treat as a signal, not a conclusion.

AI Summary

This is a planned telemedicine-mHealth behavioral intervention trial (FOCUS) targeting symptom clusters in advanced cancer patients. The trial is suspended and has not yet reported results, so no efficacy or safety evidence is available. The registration describes the intended primary endpoints (insomnia, depression, fatigue, anxiety, symptom interference, and app engagement) but no outcome data.

What was studied

Interventional, Randomized, Parallel, Double masking, Supportive Care purpose. Lung Cancer, Breast Cancer, Prostate Cancer, Multiple Myeloma, Melanoma; age from 18 Years. Intervention: FOCUS Intervention Arm. Compared with: Information Control Arm — Sham Comparator. n = 120. 1 site: United States.

Key findings

Safety

Safety was not reported in the material analysed. Check the source before drawing any conclusion about harm.

Who this may help

No clinical impact can be assessed at this stage, as no results are reported. Clinicians should await completion and publication of this trial before considering FOCUS for clinical use.

Plain-language summary

This is a suspended trial registration with no results posted; the study design and population are sound but the evidence base is absent, making this a planning document rather than a report of outcomes.

Study design

As stated by the source record.

MethodsPrimary outcome measures: Insomnia Severity Index (assessed at Baseline, 6 and 12 weeks, and 6 and 12 months); Center for Epidemiological Studies Depression Scale (assessed at Baseline, 6 and 12 weeks, and 6 and 12 months); Fatigue Severity Index (assessed at Baseline, 6 and 12 weeks, and 6 and 12 months); Generalized Anxiety Disorder (assessed at Baseline, 6 and 12 weeks, and 6 and 12 months); App Dose and Use (assessed at Up to 12 months); Symptom Interference/Quality of Life (assessed at Baseline, 6 and 12 weeks, 6 and 12 months)

DesignInterventional, Randomized, Parallel, Double masking, Supportive Care purpose

PopulationLung Cancer, Breast Cancer, Prostate Cancer, Multiple Myeloma, Melanoma; age from 18 Years

Sample size120

InterventionFOCUS Intervention Arm

ComparatorInformation Control Arm — Sham Comparator

Setting1 site: United States

Reported figures

Quoted from the source exactly as published.

Planned enrollment120

Primary endpoint: Insomnia Severity IndexBaseline, 6 and 12 weeks, and 6 and 12 months

Primary endpoint: Center for Epidemiological Studies Depression ScaleBaseline, 6 and 12 weeks, and 6 and 12 months

Primary endpoint: Fatigue Severity IndexBaseline, 6 and 12 weeks, and 6 and 12 months

Primary endpoint: Generalized Anxiety DisorderBaseline, 6 and 12 weeks, and 6 and 12 months

Primary endpoint: App Dose and UseUp to 12 months

Primary endpoint: Symptom Interference/Quality of LifeBaseline, 6 and 12 weeks, 6 and 12 months

Clinical bottom line

No clinical impact can be assessed at this stage, as no results are reported. Clinicians should await completion and publication of this trial before considering FOCUS for clinical use.

Caveats

Trial recruitment is suspended; no results or outcome data have been reported in this registry record.
No comparator group is specified; control or comparison arm design is not described.
No information on blinding, randomization method, or study site locations is provided.
Phase designation is listed as 'NA', limiting classification of study stage and sample size adequacy.

Evidence assessment

Graded across the dimensions that decide whether you should act, each from what the source actually supports. There is no single score, and where a dimension was not assessed it says so.

Study design

moderate

Interventional behavioral study with planned longitudinal outcome measurement at multiple timepoints.

Directness

strong

Directly addresses symptom clusters (insomnia, depression, fatigue, anxiety) in advanced cancer patients.

Consistency

insufficient

No results reported; cannot assess consistency with other trials or existing evidence.

Risk of bias

insufficient

No blinding, allocation concealment, or outcome ascertainment methods described in registry record.

Sample adequacy

moderate

Planned enrollment 120 participants across five cancer types; recruitment currently suspended.

What is missing. This record has no key findings. That is a gap in the analysis, not a judgement about the study.

Source abstract

Registry record from ClinicalTrials.gov (NCT07102212). This is a study registration, not published results. Lead sponsor: Ohio State University Comprehensive Cancer Center. Recruitment status: SUSPENDED. Phase: NA. Study type: INTERVENTIONAL. Enrollment: 120 participants (ESTIMATED). Conditions: Lung Cancer, Breast Cancer, Prostate Cancer, Multiple Myeloma, Melanoma. Interventions: BEHAVIORAL: mHealth Intervention. Primary outcome measures: Insomnia Severity Index , Baseline, 6 and 12 weeks, and 6 and 12 months; Center for Epidemiological Studies Depression Scale , Baseline, 6 and 12 weeks, and 6 and 12 months; Fatigue Severity Index , Baseline, 6 and 12 weeks, and 6 and 12 months; Generalized Anxiety Disorder , Baseline, 6 and 12 weeks, and 6 and 12 months; App Dose and Use , Up to 12 months; Symptom Interference/Quality of Life , Baseline, 6 and 12 weeks, 6 and 12 months. Brief summary: This clinical trial studies whether a telemedicine-mobile health (mHealth) intervention, Finding Our Center Under Stress (FOCUS), improves symptom management in patients with cancer that may have spread from where it first started to nearby tissue, lymph nodes, or distant parts of the body (advanced). Patients with advanced cancer often experience difficulties with sleep, worry, fatigue, and sometimes mood. FOCUS uses cognitive-behavioral and acceptance and commitment therapy strategies designed to improve these symptoms. Cognitive-behavioral therapy is a type of counseling focused on how the ways that people think (cognitive) and what they do (behavioral) can change the way they feel. Acceptance and commitment therapy is an intervention which has demonstrated success in treating symptoms by teaching strategies to focus time and energy on valued activities despite symptoms. This may be an effective way for patients with advanced cancer to manage their symptoms.

Follow from this

Taken from the source record, never inferred. Follow any of these and new work involving them reaches your briefing.

mHealth InterventionOhio State University Comprehensive Cancer CenterBreast CancerLung CancerNCT07102212Prostate Cancer