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NCT06807086 · ClinicalTrials.gov registry record · NA

Efficacy of Synchronous, Virtual Cognitive Behavioral Therapy for Insomnia Across Phases of Cancer Survivorship

A NA study of Insomnia Chronic, sponsored by Massachusetts General Hospital.

Recruiting
Registry status
NA
Development phase
198
Enrollment target
1
Study location

NCT06807086 is a NA study of Insomnia Chronic that is actively recruiting participants, run by Massachusetts General Hospital. The registered enrollment target is 198 participants, above the 106-participant average among 16 other Insomnia Chronic trials with a reported enrollment target (87% higher). The trial reports 1 study location across 1 state.

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The verdict

NCT06807086, a NA study of Insomnia Chronic, is actively recruiting participants, sponsored by Massachusetts General Hospital.

RECRUITING
Registry status
NA
Development phase
198 participants
Enrollment target
1
Study location

Study Summary

This project is a single center, prospective randomized controlled trial (N=198) primarily evaluating the efficacy of the Survivorship Sleep Program vs. Enhanced Usual Care on insomnia severity among cancer survivors. The investigators will also examine secondary outcomes associated with cancer-related insomnia including subjective and objective sleep measures (i.e., sleep diaries, actigraphy), emotional distress, fatigue, and use of sleep medications. Notably, most CBT-I trials with cancer survivors who have completed primary treatment with curative intent (i.e., curvivors) but not those in treatment or living with metastatic cancer (i.e., metavivors). To enhance generalizability, this RCT will stratify enrollment by survivorship phase (1:1:1). This project in strengthened by partnerships with community organizations (SurvivorJourneys and Ellie Fund) and use of both quantitative (i.e., surveys, actigraphy) and qualitative methods (i.e., interviews) to inform considerations for future implementation. Collectively, the proposed project will yield multiple deliverables to innovate cancer survivorship care, namely an efficacious, virtually delivered intervention addressing chronic insomnia, one of the most deleterious concerns among the growing population of cancer survivors in the US. Findings will inform a future effectiveness trial and the expansion of the synchronous delivery of CBT-I to survivors across different phases of cancer survivorship.

Conditions Studied

Interventions

  • BEHAVIORAL Enhanced Usual Care
  • BEHAVIORAL Cognitive Behavioral Therapy - Insomnia

Study Locations (1)

Massachusetts

  • Massachusetts General Hospital - Boston

Trial Details

FieldValue
Enrollment Target 198 participants
Start Date 2025-01-01
Est. Completion 2028-12-28
Phase NA

Sponsor

Massachusetts General Hospital

2,032 total trials

What the Registry Record Tells You About NCT06807086

The ClinicalTrials.gov registry entry for NCT06807086 describes a study currently listed as recruiting, categorized as NA. The registered enrollment target is 198 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 106-participant average among 16 other Insomnia Chronic trials with a reported enrollment target (87% higher). The listed sponsor is Massachusetts General Hospital, which has 2,032 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Insomnia Chronic appearing as the primary indexed condition, and to 2 interventions - of which Enhanced Usual Care is the first listed.

NCT06807086 reports 1 study location spanning 1 distinct geographic area - top geographies include Massachusetts.

Frequently Asked Questions

What is clinical trial NCT06807086 about?

NCT06807086 is a clinical study titled "Efficacy of Synchronous, Virtual Cognitive Behavioral Therapy for Insomnia Across Phases of Cancer Survivorship". This project is a single center, prospective randomized controlled trial (N=198) primarily evaluating the efficacy of the Survivorship Sleep Program vs. Enhanced Usual Care on insomnia severity among cancer survivors. The investigators will also examine secondary outcomes associated with cancer-rela...

What is the current status of trial NCT06807086?

This trial is currently recruiting. It is a NA study. The enrollment target is 198 participants. The study started on 2025-01-01. Estimated completion is 2028-12-28.

What conditions does trial NCT06807086 study?

This clinical trial studies the following conditions: Insomnia Chronic.

What interventions are being tested in trial NCT06807086?

The interventions under investigation include: Enhanced Usual Care (BEHAVIORAL), Cognitive Behavioral Therapy - Insomnia (BEHAVIORAL).

Who is sponsoring clinical trial NCT06807086?

This trial is sponsored by Massachusetts General Hospital, which has 2,032 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT06807086 being conducted?

This trial has 1 study location across Massachusetts. 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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