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NCT06181643 · ClinicalTrials.gov registry record · NA

Innovating CBT-I for Cancer Survivors: An Optimization Trial

A NA study of Insomnia and Cancer Survivorship, sponsored by Massachusetts General Hospital.

Recruiting
Registry status
NA
Development phase
80
Enrollment target
1
Study location

NCT06181643: Recruiting NA study of Insomnia and Cancer Survivorship, sponsored by Massachusetts General Hospital.

NCT06181643 is a NA study of Insomnia and Cancer Survivorship that is actively recruiting participants, run by Massachusetts General Hospital. The registered enrollment target is 80 participants, below the 170-participant average among 151 other Insomnia trials with a reported enrollment target (53% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT06181643, a NA study of Insomnia and Cancer Survivorship, is actively recruiting participants, sponsored by Massachusetts General Hospital.

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

Study Summary

The overall goal of this project is to conduct a factorial, randomized controlled trial to optimize synchronous, virtual delivery of CBT-I for cancer survivors. The proposed project will yield multiple deliverables to innovate cancer survivorship care, chiefly an optimized, scalable, virtually-delivered intervention that addresses chronic insomnia, one of the most deleterious concerns among the growing demographic of cancer survivors in the U.S. Findings will inform future considerations for delivering CBT-I to cancer survivors.

Primary Outcome

Changes in insomnia severity will be assessed using the validated Insomnia Severity Index (ISI). Scores of 15 or higher on the ISI indicate clinically significant insomnia, and reductions of \>8 points are considered clinically meaningful. Changes from T0-T2 are the primary outcome. Acute (T0-T1; post-SSP) and 3-month (T0-T3; 3 Month Surveillance/Booster 3) changes will be examined as secondary outcomes.

Interventions

  • BEHAVIORAL Survivorship Sleep Program with Individual Delivery + No Booster Sessions
  • BEHAVIORAL Survivorship Sleep Program with Group Delivery + No Booster Sessions
  • BEHAVIORAL Survivorship Sleep Program with Individual Delivery + 3 Booster Sessions
  • BEHAVIORAL Survivorship Sleep Program with Group Delivery + 3 Booster Sessions

Study Locations (1)

Massachusetts

  • Massachusetts General Hospital - Boston

Trial Details

FieldValue
Enrollment Target 80 participants
Start Date 2024-09-06
Est. Completion 2026-05-31
Phase NA
Massachusetts General Hospital

2,032 total trials

What NCT06181643 shows while recruiting

NCT06181643 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 80 participants, a relatively small participant target, below the 170-participant average among 151 other Insomnia trials with a reported enrollment target (53% lower).

The record links to 2 conditions, with Insomnia appearing as the primary indexed condition, and to 4 interventions - of which Survivorship Sleep Program with Individual Delivery + No Booster Sessions is the first listed.

NCT06181643 reports a single indexed study location in Massachusetts.

Frequently Asked Questions

What is clinical trial NCT06181643 about?

NCT06181643 is a clinical study titled "Innovating CBT-I for Cancer Survivors: An Optimization Trial". The overall goal of this project is to conduct a factorial, randomized controlled trial to optimize synchronous, virtual delivery of CBT-I for cancer survivors. The proposed project will yield multiple deliverables to innovate cancer survivorship care, chiefly an optimized, scalable, virtually-deliv...

What is the current status of trial NCT06181643?

This trial is currently recruiting. It is a NA study. The enrollment target is 80 participants. The study started on 2024-09-06. Estimated completion is 2026-05-31.

What conditions does trial NCT06181643 study?

This clinical trial studies the following conditions: Insomnia, Cancer Survivorship.

What interventions are being tested in trial NCT06181643?

The interventions under investigation include: Survivorship Sleep Program with Individual Delivery + No Booster Sessions (BEHAVIORAL), Survivorship Sleep Program with Group Delivery + No Booster Sessions (BEHAVIORAL), Survivorship Sleep Program with Individual Delivery + 3 Booster Sessions (BEHAVIORAL), Survivorship Sleep Program with Group Delivery + 3 Booster Sessions (BEHAVIORAL).

Who is sponsoring clinical trial NCT06181643?

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

Where is trial NCT06181643 being conducted?

This trial has 1 study location across Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Similar trials for Insomnia

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT06181643's enrollment target sits among peer trials

80 74th of 151 higher than 73 of 151 other Insomnia trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Insomnia trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT06181643, the US trial registry maintained by the National Library of Medicine. NCT06181643 (small enrollment · single site footprint · recruiting) retrieved and formatted by PlainTrial, see methodology.