NCT06336642

Brief Summary

To learn about the effect of Structured Personalized Oxygen and Supportive Therapies for Dyspnea in Oncology (SPOT-ON) treatment on the severity of shortness of breath in patients with cancer.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
150

participants targeted

Target at P75+ for phase_2

Timeline
71mo left

Started Jun 2024

Longer than P75 for phase_2

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 Progress26%
Jun 2024Mar 2032

First Submitted

Initial submission to the registry

March 20, 2024

Completed
9 days until next milestone

First Posted

Study publicly available on registry

March 29, 2024

Completed
2 months until next milestone

Study Start

First participant enrolled

June 11, 2024

Completed
5.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2030

Expected
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2032

Last Updated

March 10, 2026

Status Verified

March 1, 2026

Enrollment Period

5.8 years

First QC Date

March 20, 2024

Last Update Submit

March 9, 2026

Conditions

Dyspnea

Outcome Measures

Primary Outcomes (1)

  • Primary Outcome Measure: 1.Safety and adverse events (AEs)

    Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE)

    [Time Frame: Through study completion; an average of 1 year.]

Study Arms (2)

Group 1: SPOT-ON

EXPERIMENTAL

Participants will work with the healthcare team to find the best ways to reduce your shortness of breath by finding what combination of treatments work for participant. Participants will receive education about shortness of breath by the research staff in addition to information about standard treatments or medications for your shortness of breath that would be offered by your medical team.

Behavioral: SPOT-ON Early StartBehavioral: SPOT-ON Delayed Start

Group 2: SPOT-ON Waitlist

EXPERIMENTAL

Participants will work with the healthcare team to find the best ways to reduce your shortness of breath by finding what combination of treatments work for participant. Participants will receive education about shortness of breath by the research staff in addition to information about standard treatments or medications for your shortness of breath that would be offered by your medical team.

Behavioral: SPOT-ON Early StartBehavioral: SPOT-ON Delayed Start

Interventions

SPOT-ON Early StartBEHAVIORAL

Participants will start treatment within 3 days of enrollment, which may include: receiving information on breathing techniques, relaxation techniques, posture techniques, and distraction techniques, and/or trying different oxygen-based therapies, such as high-flow nasal cannula, low-flow supplemental oxygen, and non-invasive ventilation with a respiratory therapist.

Group 1: SPOT-ONGroup 2: SPOT-ON Waitlist
SPOT-ON Delayed StartBEHAVIORAL

Participants will start treatment within 3 days of enrollment, which may include: receiving information on breathing techniques, relaxation techniques, posture techniques, and distraction techniques, and/or trying different oxygen-based therapies, such as high-flow nasal cannula, low-flow supplemental oxygen, and non-invasive ventilation with a respiratory therapist.

Group 1: SPOT-ONGroup 2: SPOT-ON Waitlist

Eligibility Criteria

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

You may qualify if:

  • Diagnosis of cancer
  • Age 18 or older.
  • Admitted to a medical floor.
  • Dyspnea intensity at rest of at least 4 on a 0-10-point NRS (where 0 = none, 10 = worst).
  • Speak English or Spanish.

You may not qualify if:

  • Hemodynamic instability requiring active Merit Team or ICU team involvement.
  • Delirium as per clinical team's assessment in the Electronic Health Record (EHR).
  • Severe hypoxemia (SpO2 \< 90% despite supplemental oxygen of up to 6 L/min).
  • Continuous positive airway pressure (CPAP) use for obstructive sleep apnea, actively using \>10 hours a day.
  • Respiratory failure necessitating mechanical ventilation (i.e., HFNC or NIV), and planned thoracentesis within 72 hours of enrollment.
  • Patients with known pregnancy.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

MD Anderson Cancer Center

Houston, Texas, 77030, United States

RECRUITING

Related Publications (1)

  • Hui D, Kim MJ, Thomas S, Sachdev G, Shete S, Rathi N, Hensch N, De La Cruz V, Ontai A, Mahler DA, Li J, Bruera E. Structured Personalized Oxygen and Supportive Therapies for Dyspnea in Oncology (SPOT-ON): A personalized randomized clinical trial protocol. PLoS One. 2025 Dec 2;20(12):e0336691. doi: 10.1371/journal.pone.0336691. eCollection 2025.

    PMID: 41329762DERIVED

Related Links

MeSH Terms

Conditions

Dyspnea

Condition Hierarchy (Ancestors)

Respiration DisordersRespiratory Tract DiseasesSigns and Symptoms, RespiratorySigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • David Hui, MD

    M.D. Anderson Cancer Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

David Hui, MD

CONTACT

(713) 792-6258dhui@mdanderson.org

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 20, 2024

First Posted

March 29, 2024

Study Start

June 11, 2024

Primary Completion (Estimated)

March 31, 2030

Study Completion (Estimated)

March 31, 2032

Last Updated

March 10, 2026

Record last verified: 2026-03

Locations

US(1)