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NCT04829539 · ClinicalTrials.gov registry record · Phase 3

Comparing Brief Behavioral Therapy (BBT-CI) and Healthy Eating Education Learning (HEAL) for Cancer-Related Sleep Problems While Receiving Cancer Treatment

A Phase 3 study of Malignant Solid Neoplasm and Hematopoietic and Lymphoid Cell Neoplasm, sponsored by University of Rochester NCORP Research Base.

Recruiting
Registry status
Phase 3
Development phase
400
Enrollment target
20
Study locations

NCT04829539 is a Phase 3 study of Malignant Solid Neoplasm and Hematopoietic and Lymphoid Cell Neoplasm that is actively recruiting participants, run by University of Rochester NCORP Research Base. The registered enrollment target is 400 participants, below the 1,139-participant average among 176 other Malignant Solid Neoplasm trials with a reported enrollment target (65% lower). The trial reports 20 study locations across 6 states.

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The verdict

NCT04829539, a Phase 3 study of Malignant Solid Neoplasm and Hematopoietic and Lymphoid Cell Neoplasm, is actively recruiting participants, sponsored by University of Rochester NCORP Research Base.

RECRUITING
Registry status
Phase 3
Development phase
400 participants
Enrollment target
20
Study locations

Study Summary

This phase III trial compares BBT-CI to HEAL for the reduction of insomnia in patients with stage I-IV cancer who are receiving cancer treatment. Cancer treatment can cause side effects such as sleep problems. Sleep problems such as insomnia, are common for cancer patients. Insomnia can be described as difficulty falling asleep, waking up many times during the night or waking up earlier than patient would like. Insomnia can increase fatigue and worsen quality of life. This trial may help researchers determine which treatment works better in reducing insomnia, BBT-CI or HEAL.

Interventions

  • OTHER Quality-of-Life Assessment
  • OTHER Questionnaire Administration
  • BEHAVIORAL Behavioral Intervention
  • OTHER Electronic Health Record Review

Study Locations (20)

Hawaii

  • Hawaii Cancer Care Inc - Waterfront Plaza - Honolulu
  • Queen's Cancer Cenrer - POB I - Honolulu
  • Queen's Medical Center - Honolulu
  • Straub Clinic and Hospital - Honolulu
  • University of Hawaii Cancer Center - Honolulu
  • Queen's Cancer Center - Kuakini - Honolulu
  • The Cancer Center of Hawaii-Liliha - Honolulu
  • Kapiolani Medical Center for Women and Children - Honolulu
  • Tripler Army Medical Center - Honolulu
  • Hawaii Cancer Care - Westridge - ‘Aiea

Delaware

  • Beebe South Coastal Health Campus - Millville
  • Helen F Graham Cancer Center - Newark
  • Medical Oncology Hematology Consultants PA - Newark
  • Beebe Health Campus - Rehoboth Beach

Colorado

  • Kaiser Permanente-Franklin - Denver
  • Kaiser Permanente-Rock Creek - Lafayette
  • Kaiser Permanente-Lone Tree - Lone Tree

Arizona

  • Kingman Regional Medical Center - Kingman

Arkansas

  • Mercy Hospital Fort Smith - Fort Smith

Georgia

  • Memorial Health University Medical Center - Savannah

Trial Details

FieldValue
Enrollment Target 400 participants
Start Date 2021-06-24
Est. Completion 2026-12-16
Phase Phase 3

What the Registry Record Tells You About NCT04829539

The ClinicalTrials.gov registry entry for NCT04829539 describes a study currently listed as recruiting, categorized as Phase 3. The registered enrollment target is 400 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 1,139-participant average among 176 other Malignant Solid Neoplasm trials with a reported enrollment target (65% lower). The listed sponsor is University of Rochester NCORP Research Base, which has 11 total studies on file at ClinicalTrials.gov.

The record links to 2 conditions, with Malignant Solid Neoplasm appearing as the primary indexed condition, and to 4 interventions - of which Quality-of-Life Assessment is the first listed.

NCT04829539 reports 20 study locations spanning 6 distinct geographic areas - top geographies include Hawaii, Delaware, Colorado.

Frequently Asked Questions

What is clinical trial NCT04829539 about?

NCT04829539 is a clinical study titled "Comparing Brief Behavioral Therapy (BBT-CI) and Healthy Eating Education Learning (HEAL) for Cancer-Related Sleep Problems While Receiving Cancer Treatment". This phase III trial compares BBT-CI to HEAL for the reduction of insomnia in patients with stage I-IV cancer who are receiving cancer treatment. Cancer treatment can cause side effects such as sleep problems. Sleep problems such as insomnia, are common for cancer patients. Insomnia can be described...

What is the current status of trial NCT04829539?

This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 400 participants. The study started on 2021-06-24. Estimated completion is 2026-12-16.

What conditions does trial NCT04829539 study?

This clinical trial studies the following conditions: Malignant Solid Neoplasm, Hematopoietic and Lymphoid Cell Neoplasm.

What interventions are being tested in trial NCT04829539?

The interventions under investigation include: Quality-of-Life Assessment (OTHER), Questionnaire Administration (OTHER), Behavioral Intervention (BEHAVIORAL), Electronic Health Record Review (OTHER).

Who is sponsoring clinical trial NCT04829539?

This trial is sponsored by University of Rochester NCORP Research Base, which has 11 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT04829539 being conducted?

This trial has 20 study locations across Arizona, Arkansas, Colorado, Delaware, Georgia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

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