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Tests a online sleep program for insomnia in people who have had cancer

Tests a virtual sleep therapy program for chronic insomnia in cancer survivors.

Key facts

Who runs it
Massachusetts General Hospital
Where
Boston, United StatesSee the site
Trial code
Registry title
Efficacy of Synchronous, Virtual Cognitive Behavioral Therapy for Insomnia Across Phases of Cancer Survivorship
Status
Recruiting
People taking part
198 people, planned
Started
1 Jan 2025
Expected to end
28 Dec 2028
Type of study
Interventional, 2 groupsOne group gets an existing treatment, for comparison.
Treatments tested
  • Cognitive Behavioral Therapy - Insomnia
  • Enhanced Usual Care
Record updated
13 March 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults who have had cancer and have long-lasting insomnia. They can be finished with treatment, still in treatment, or living with metastatic cancer.

Age
18 years or older
Sex
All sexes can join
Disease stage
Cancer survivors in one of three phases: finished primary treatment of non-metastatic, localized or regional cancer; currently in primary treatment of such cancer; or metastatic cancer treated with hormonal, maintenance, oral or immunotherapies. Chronic insomnia (DSM-5 criteria) is also needed.
Earlier treatment
Hormonal, maintenance, oral and immunotherapies are allowed in every phase.

Main reasons for not taking part

  • Cannot speak and write in English
  • Sleep disorder other than insomnia that is undertreated, such as sleep apnea
  • Undertreated epilepsy, serious mental illness or suicidality
  • Psychiatric hospital stay in the past year
  • Unwilling or unable to stop night shift work

The registry criteria, word for word

Show all 7 criteriaShow less

Who can take part

  • Cancer survivor, defined as:; (A) history of nonmetastatic, localized or regional, solid or blood malignancy(ies) and completion of primary cancer treatment (i.e., radiation, surgery, and/or chemotherapy). Use of hormonal, maintenance, oral, and immunotherapies is permitted; or; (B) history of nonmetastatic, localized or regional, solid or blood malignancy(ies) and current primary cancer treatment (i.e., radiation, surgery, and/or chemotherapy); Use of hormonal, maintenance, oral, and immunotherapies is permitted; or; (C) history of metastatic sold or blood malignancy (ies) taking hormonal, maintenance, oral, or immunotherapies to prevent further disease progression
  • Chronic insomnia (DSM-5 criteria)
  • Age 18 years or older

Who cannot take part

  • Undertreated non-insomnia sleep disorder (e.g., sleep apnea)
  • Undertreated epilepsy, undertreated serious mental illness, undertreated suicidality, and/or psychiatric hospitalization in the past year
  • Self-reported inability to speak and write in English
  • Unwilling or unable to discontinue night shift work

Where in United States

  • Massachusetts General HospitalBoston, United StatesContact: Daniel Hall, PhDTaking people

About the trial

What the trial wants to find out

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.

Read full original descriptionShow less

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.

The 2 groups in the trial

  • Enhance Usual CareExisting treatment, for comparison

    A sleep hygiene handout and a referral for CBT-I offered through MGH or community partners.

    Treatment: Enhanced Usual Care

  • Survivorship Sleep ProgramTreatment being tested

    4, weekly virtual sessions of the Survivorship Sleep Program plus 1 booster session

    Treatment: Cognitive Behavioral Therapy - Insomnia

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
Efficacy of Synchronous, Virtual Cognitive Behavioral Therapy for Insomnia Across Phases of Cancer Survivorship
Plain-language title
Tests a online sleep program for insomnia in people who have had cancerGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 12 November 2026.
Record updated
13 March 2026