SuspendedNot applicableNCT07102212
Official study title

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

Study 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.

Ask AI to explain this study
Start here

Key things to know

Main goalSupportive Care

This describes the study’s primary purpose.

What is being studiedmHealth Intervention

The study team can explain what participation involves.

Who it may be forLung Cancer · Breast Cancer

These are broad labels—not an eligibility decision.

Checked against the public recordLast updated Aug 17, 2026 · Source: ClinicalTrials.gov

Is enrollment open?Suspended

Ask the study team to confirm whether enrollment is open.

What kind of study?Not applicable

Interventional

Where is it offered?1 U.S. location

Locations may change over time.

Who runs it?Ohio State University Comprehensive Cancer Center

Study sponsor

01
Study overview

What this study is about

Purpose
Supportive Care
Study type
Interventional
Phase
Not applicable
Sponsor
Ohio State University Comprehensive Cancer Center
Interventions being studied
Behavioral: mHealth Intervention
02
Explore related studies

How this study is categorized

These labels come from structured fields and exact terms in the public record.

03
Public criteria

Who may be able to participate

The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.

Requirements people may need to meetInclusion criteria
  • Participants will include 120 people with advanced cancer who are ≥ 18 yrs old
  • Able to read and write in English
  • Who use internet and e-mail as determined by Computer \& Mobile Device Proficiency Questionnaire.
  • People with stage IIIb\&c/IV lung cancer, stage IV breast cancer, stage IV prostate cancer, advanced (on active treatment) multiple myeloma, and stage IIIb \& IV melanoma (24 of each cancer type)
  • meet clinical cut-offs on any two symptoms in this cluster (i.e., ≥ 8 on Insomnia Severity Index (ISI), ≥ 3 on Patient Health Questionnaire-2 for depression, ≥ 2 on Generalized Anxiety Disorder-2, ≥ 3 on Fatigue Symptom Inventory Severity)
Reasons someone may not be able to joinExclusion criteria
  • Night-shift work
  • Untreated bipolar disorder
  • Substance use disorder
  • Cognitive impairment per Brief Screen for Cognitive Impairment
  • Eastern Cooperative Oncology Group performance status of 3 or greater (in bed 50% or more of day), or \<6 mos predicted survival per oncology team.
  • Prior participation in cognitive behavior therapy will not be an exclusion criterion if individuals meet symptom severity threshold for at least two symptoms.

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

04
Study sites

U.S. locations

  • Ohio State University Comprehensive Cancer CenterColumbus, Ohio

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Aug 17, 2026. Always confirm current availability with the study team.

View original record ↗