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.
(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)
Self-reported inability to speak and write in English
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
Unwilling or unable to discontinue night shift work
Parallel
Cognitive Behavioral Therapy - Insomnia
BehavioralThe Survivorship Sleep Program is a virtual program based on cognitive behavioral therapy for insomnia (CBT-I), which teaches evidence based skills to improve sleep-related behaviors, expectations, and environment, to promote relaxation, and to reduce worry. It also involves reducing the time spent in bed in order to improve the quantity and quality of sleep over time. The Survivorship Sleep Program is delivered in 4 weekly sessions by a trained facilitator and includes considerations specific to managing insomnia after cancer diagnosis and treatment. Additionally, 1 booster session is offered at week 6.
Enhanced Usual Care
BehavioralA sleep hygiene handout and a referral for CBT-I offered through MGH or community partners.
Insomnia Severity Index
A 7-item self-report questionnaire measuring changes in insomnia severity. Response options range from 0 (None) to 4 (Very severe). Items include "How NOTICEABLE to others do you think your sleep problem is in terms of impairing the quality of your life?"
PROMIS anxiety short form
A 4-iem self-report questionnaire measuring anxiety levels. Response options range from 1 (Never characteristic of me in the past seven days) to 5 (Always as it applies within the past seven days). Items include "In the past seven days I felt fearful" and "In the past seven days I felt anxious."
PROMIS depression short form
A 4-iem self-report questionnaire measuring depression levels. Response options range from 1 (Never characteristic of me in the past seven days) to 5 (Always as it applies within the past seven days). Items include "In the past seven days I felt worthless" and "In the past seven days I felt unhappy."
PROMIS fatigue short form
A 7-iem self-report questionnaire measuring fatigue levels. Response options range from 1 (Never characteristic of me in the past seven days) to 5 (Always as it applies within the past seven days). Items include "In the past seven days, how often did you feel tired?" and "In the past seven days, how often did you run out of energy?"
Use of sleep aid meditations
Use of sleep aid medications (frequency, dose) will be evaluated via self-report surveys and electronic medical records (when possible).
Click on the lead sponsor to view all of their trials.
Massachusetts General Hospital
Lead sponsor
American Cancer Society, Inc.
Collaborator
