Virtual Cognitive Behavioral Therapy for Insomnia in Cancer Survivors
Efficacy of Synchronous, Virtual Cognitive Behavioral Therapy for Insomnia Across Phases of Cancer Survivorship
This study is testing a virtual therapy program for insomnia to see if it helps cancer survivors sleep better compared to regular care.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 198 (estimated) |
| Sex | All |
| Sponsor | Massachusetts General Hospital Academic / other |
| Drugs / interventions | chemotherapy, radiation |
| Locations | 1 site (Boston, Massachusetts) |
| Trial ID | NCT06807086 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates include cancer survivors aged 18 and older who experience chronic insomnia and are either in treatment or have completed primary cancer treatment.
Not a fit: Patients with untreated non-insomnia sleep disorders or serious mental illnesses may not benefit from this intervention.
Why it matters
Potential benefit: If successful, this program could significantly improve sleep quality and overall well-being for cancer survivors suffering from insomnia.
How similar studies have performed: Previous pilot studies have shown the feasibility and preliminary efficacy of similar CBT-I approaches for cancer survivors, indicating potential for success in this larger trial.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Boston, Massachusetts
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.