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Lung CancerFOCUSNCT07102212

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

A study testing mHealth Intervention in people with Lung Cancer and Breast Cancer, run by Ohio State University Comprehensive Cancer Center at 1 site in United States.

Suspended

Paused. Enrolment is on hold for now and may resume.

Official record
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Trial 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). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Lung Cancer, Breast Cancer, Prostate Cancer
What is being tested?
mHealth Intervention
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
120 participants
Where
1 siteUnited States
Study dates
15 Nov 2026to 30 Sep 2029
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

  • 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)

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Ohio State University Comprehensive Cancer Center

    Columbus, Ohio, 43210

Other trials in United States

About this study

Official title: Randomized Clinical Trial of a Telemedicine-mHealth Symptom Cluster Intervention for Advanced Cancer Patients: Increasing Access in Rural Areas

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.

Read the detailed description

The investigators will deliver an evidence-based intervention for a common cancer symptom cluster, with clinically significant pilot findings, to rural, underserved people with advanced cancer. The investigators will improve access via a telemedicine- mHealth approach, developed and refined based on the needs and evaluative feedback of people with advanced cancer. The investigators aim to reduce symptom severity and interference via an integrated CBT-ACT intervention. In addition, the investigators will examine the behavioral, hormonal, and inflammatory mechanisms of symptom change including several novel biomarkers identified in the pilot trial (e.g., IL-12, IL-1alpha, TNFbeta). An effective, accessible, brief alternative to medication-based symptom cluster management is essential given the limited availability of palliative and psychosocial care for this population and impact of these symptoms on patient functional status, quality of life, treatment adherence, and survival. The study aligns with NCI's goal to enhance access to clinical trials via telemedicine and mobile applications to better meet the survivorship needs of underserved populations and the goal of RFA CA-22-027 to test interventions to improve delivery of comprehensive survivorship care for individuals with advanced cancer.

SPECIFIC AIMS:

Aim 1: Evaluate the effectiveness of a telemedicine-mHealth symptom management intervention (FOCUS) targeting a common symptom cluster for people with advanced cancer

Aim 2: Determine the impact of FOCUS dose on symptom severity and interference and examine usage by patient geographic location and other demographics

Aim 3 (Exploratory): Examine biobehavioral mediators of treatment effects

PRIMARY OBJECTIVES:

  1. Evaluate the effectiveness of a telemedicine-mHealth symptom management intervention (FOCUS) targeting a common symptom cluster for people with advanced cancer.

II. Determine the impact of FOCUS dose on symptom severity and interference and examine usage by patient geographic location and gender.

EXPLORATORY OBJECTIVE:

  1. Examine biobehavioral mediators of treatment effects.

OUTLINE: Patients are randomized to 1 of 2 arms.

ARM I: Patients complete four FOCUS modules covering symptoms of insomnia, worry-anxiety, fatigue, and mood over 2-2.5 hours each over 6 weeks. Patients also receive professional support via telemedicine over 20-30 minutes per week for 6 weeks. Additionally, patients undergo blood sample collection throughout the study.

ARM II: Patients complete four standardized National Cancer Institute (NCI) modules covering symptoms of sleep, worry, fatigue, and mood over 6 weeks. Patients also receive standardized support via telemedicine over 20-30 minutes per week for 6 weeks. Additionally, patients undergo blood sample collection throughout the study.

After completion of study intervention, patients are followed up at 12 weeks and 6 and 12 months.

Being tested
mHealth Intervention
Keywords
symptom management, cancer, rural, sleep, anxiety, worry, fatigue, mood, depression, mHealth, telemedicine, app, advanced cancer, Appalachian
Medical subject headings
Lung Neoplasms, Breast Neoplasms, Prostatic Neoplasms, Multiple Myeloma, Melanoma, Neoplasms, Anxiety Disorders, Fatigue

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • mHealth InterventionBehavioural

    Participants are randomized to the FOCUS app or Information Control section of the app and will have six weeks to complete the app. Randomization, via the app, is stratified by geographic location (rural vs other), cancer type, and demographics so experimental arms are equivalent. Participants will complete 5 assessments online over a 12-mo period. The participants will have weekly telehealth professional support during the six-week intervention. Participants wear GeneActiv watches for sleep/activity recording for 7 days and provide blood and saliva samples at baseline, 6 and 12 weeks, and 6 and 12 months.

Study groups in NCT07102212
Study groupRoleWhat they receive
FOCUS Intervention ArmExperimentalFOCUS is a standardized mHealth-integrated CBT-ACT biobehavioral intervention divided into four modules. FOCUS includes an introductory video, sleep diary, app overview and a sleep module, worry-uncertainty module, fatigue module, and a mood module (each 1.5 hours spread over a week), for a total of 6 hrs of direct mHealth intervention (not including home practice time) spaced across 6 wks. All modules include behavioral and values-based exercises. The app also features motivational features/rewards for skill-based home practice activities. FOCUS Telemedicine Component. Psychosocial Oncology Fellows (Ph.D. clinical psychologists) will provide minimal contact professional support, connecting with participants via telemedicine for 15-20 min each week to answer questions about skills and home practice after each module. Our project coordinator will respond to any technical or study issues with Moby support, our mobile app design team.
Receives: Behavioral: mHealth Intervention
Information Control ArmSham comparatorParticipants will be randomly assigned to an area of the mHealth app specific for control participants. This section of the app will contain a similar video introduction and instructions for use of the app followed by four symptom modules - sleep, worry, fatigue, and mood containing standardized patient information from NCI for each symptom. Control Group Telemedicine Component. Participants will receive weekly minimal contact with a postdoctoral fellow who will assess understanding of NCI symptom management materials with standardized questions focused on that week's material, note information to be reviewed the following week, answer any study-related questions, and record any symptom management practices initiated since reviewing these materials.
Receives: Behavioral: mHealth Intervention

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Insomnia Severity Index

    Symptom measures of insomnia will be made using the Insomnia Severity Index, a scale from 0 to 28 with higher scores indicating greater insomnia

    Measured: Baseline, 6 and 12 weeks, and 6 and 12 months

  2. Center for Epidemiological Studies Depression Scale

    Symptom measures of depression will be made using the Center for Epidemiological Studies Depression Scale, a scale from 0 to 60 with higher scores indicating more depressive symptoms/more severe depression

    Measured: Baseline, 6 and 12 weeks, and 6 and 12 months

  3. Fatigue Severity Index

    Symptom measures of fatigue will be made using the Fatigue Severity Index, a scale from 0 to 110 with higher scores indicating more severe fatigue

    Measured: Baseline, 6 and 12 weeks, and 6 and 12 months

  4. Generalized Anxiety Disorder

    Symptom measures of generalized anxiety will be made using the Generalized Anxiety Disorder - 7 (GAD-7), a scale from 0 to 21with higher scores indicating more severe anxiety

    Measured: Baseline, 6 and 12 weeks, and 6 and 12 months

  5. App Dose and Use

    The investigators will analyze usage reports of participant engagement with FOCUS mHealth application to assess time reviewing the four FOCUS modules (sleep, worry, depression, fatigue) and overall time using the application to evaluate dose-response on symptoms. The investigators will compare FOCUS usage by geographic location (rural vs other) and demographics and complete detailed examination of clickmaps, screen recordings, and module usage.

    Measured: Up to 12 months

  6. Symptom Interference/Quality of Life

    The investigators will use the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) five functional sub-scales to assess symptom interference. The subscales will be totaled and the overall scale will range from 0 to 110 with higher scores on functional scales and global health status/quality of life representing better functioning.

    Measured: Baseline, 6 and 12 weeks, 6 and 12 months

Secondary outcomes (3)

  1. Biobehavioral Mediators

    The investigators will test whether symptom severity is mediated by stress hormones (cortisol) and inflammation (IL-12, IL-1alpha, IL-1beta, TNF-alpha, TNFbeta, IL-6, hsCRP, exotaxin) by measuring the levels of each biomarker at various time points throughout the study.

    Measured: Baseline, 6 and 12 weeks, and 6 and 12 months

  2. CAQ-8 (Committed Action Questionnaire)

    The investigators will test whether symptom severity is mediated by behavioral changes (committed action - Committed Action Questionnaire). The CAQ-8 scale ranges from 0 to 48 with higher levels indicating a more committed action.

    Measured: Up to 12 months

  3. AAQ-II (Acceptance and Action Questionnaire)

    The investigators will test whether symptom severity is mediated by behavioral changes (psychological flexibility - Acceptance and Action Questionnaire). The AAQ-II scale ranges from 7 to 49 with higher scores representing greater psychological inflexibility. This measure will be reverse scored so that higher scores represent greater psychological flexibility to test the mediator hypothesis.

    Measured: Up to 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Aug 2025
  2. Study start15 Nov 2026 (estimated)
  3. Primary completion31 Aug 2028 (estimated)
  4. Study completion30 Sep 2029 (estimated)

Why it stopped: pending amendment

Resources

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
Randomised
Intervention model
Parallel groups
Model description
The overall goal of this randomized clinical trial is to evaluate the effectiveness of a telemedicine-mHealth symptom cluster intervention, Finding Our Center Under Stress (FOCUS), with people with advanced cancer. The investigators include a telemedicine-mHealth information control condition for comparison.
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
120 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07102212
Sponsor's protocol ID
OSU-24212
Other IDs
NCI-2025-05185, R01CA281885
Acronym
FOCUS
Status last verified
Aug 2026
First submitted
16 Jul 2025
Last updated
17 Aug 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Per NIH Data Sharing Policy, data from this project, including questionnaire data, de-identified demographics and disease information, as well as biomarker data will be shared at the completion of the study via computerized dataset. The investigators do not plan to release data pertaining to participants' individual web-usage as this data is believed to be private and not essential to the overarching purposes or goals of the project. However, the investigators will release summary statistics pertaining to usage (total app usage, frequency of home practice) so Aim 2 of this study can be evaluated by others interested in the web-usage and descriptive features of the study. A study codebook will be provided outlining the methodology and procedures used to collect the data, variable definitions and labels, scored variable information, and information on the general structure/timepoint labeling of the available data.

Publications

  • Wells-Di Gregorio SM, Marks DR, DeCola J, Peng J, Probst D, Zaleta A, Benson D, Cohn DE, Lustberg M, Carson WE, Magalang U. Pilot randomized controlled trial of a symptom cluster intervention in advanced cancer. Psychooncology. 2019 Jan;28(1):76-84. doi: 10.1002/pon.4912. Epub 2018 Oct 30.

    PubMed 30335211

Questions about this trial

What is this clinical trial studying?

A study testing mHealth Intervention in people with Lung Cancer and Breast Cancer, run by Ohio State University Comprehensive Cancer Center 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 5 inclusion and 6 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: paused, as of the sponsor's last update on 17 Aug 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. Some participants in this study may receive a placebo. 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?

Results are not available in the source record.

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?

Insomnia Severity Index (time frame: Baseline, 6 and 12 weeks, and 6 and 12 months). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07102212, which also lists 1 linked publication.

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 17 Aug 2026.

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