Virtual Cognitive Behavioral Therapy for Insomnia in Cancer Survivors

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This project evaluates the effectiveness of a virtual Cognitive Behavioral Therapy for Insomnia (CBT-I) program, known as the Survivorship Sleep Program, compared to Enhanced Usual Care in reducing insomnia severity among cancer survivors. The trial will include 198 participants and assess both subjective and objective sleep measures, emotional distress, fatigue, and medication use. It aims to include a diverse group of cancer survivors, including those currently in treatment and those living with metastatic cancer, to enhance the generalizability of the findings. The study will utilize both quantitative and qualitative methods to gather comprehensive data on the impact of the intervention.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Cancer survivor, defined as:

   1. (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
   2. (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
   3. (C) history of metastatic sold or blood malignancy (ies) taking hormonal, maintenance, oral, or immunotherapies to prevent further disease progression.
2. Chronic insomnia (DSM-5 criteria)
3. Age 18 years or older

Exclusion Criteria:

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

Where it's running

• Massachusetts General Hospital
  Boston, Massachusetts, United States Recruiting

Study contacts

• Study coordinator: Daniel L Hall, PhD
• Email: hall@mgh.harvard.edu
• Phone: 617-724-6300

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.