Cancer SurvivorshipNCT06181643
Innovating CBT-I for Cancer Survivors: An Optimization Trial
A study testing Survivorship Sleep Program with Individual Delivery + No Booster Sessions, Survivorship Sleep Program with Group Delivery + No Booster Sessions and Survivorship Sleep Program with Individual Delivery + 3 Booster Sessions in people with Cancer Survivorship and Insomnia, run by Massachusetts General Hospital at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer Survivorship, Insomnia
- What is being tested?
- Survivorship Sleep Program with Individual Delivery + No Booster Sessions, Survivorship Sleep Program with Group Delivery + No Booster Sessions and Survivorship Sleep Program with Individual Delivery + 3 Booster Sessions
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Sep 2024to 31 May 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- History of nonmetastatic, localized, or regional solid or blood malignancy(ies)
- Completion of primary cancer treatment (radiation, surgery, and/or chemotherapy). Use of hormonal, maintenance, oral, and immunotherapies is permitted.
- Chronic insomnia (DSM-5 criteria)
- 18 years of age or older
Who cannot join
- Self-reported inability to speak and write in English
- Undertreated noninsomnia 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Massachusetts General Hospital
Boston, Massachusetts, 02114
About this study
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.
Read the detailed description
Insomnia is a significant issue in 30-50% of cancer survivors. Our pilot randomized controlled trial of synchronous, virtual cognitive behavioral therapy for insomnia (CBT-I) for cancer survivors suggested that a group format or booster sessions may optimize effects on insomnia and daytime functioning. The goal of this project is to conduct a factorial, randomized controlled trial to optimize synchronous, virtual delivery of CBT-I for cancer survivors. We will conduct a 2×2 factorial trial (N=80) to evaluate the optimal combination of two intervention design components: delivery (individual vs. group) and booster sessions (0 vs 3). The primary outcome is change in insomnia severity (insomnia severity index) from T0 (week 0) to T2 (week 8). The secondary outcomes are acute (T0-T1, week 4) and sustained (T0-T3, week 16) changes in insomnia severity, emotional distress, work-related functioning, use of sleep medications, and subjective and objective sleep metrics (measured with sleep diaries and Fitbit). Exploratory aim 1 is to characterize study participation and sleep outcomes among cancer survivors with insomnia. Exploratory aim 2 is to characterize the acceptability of design components using Likert ratings (very low=1 to very high=5, benchmarks=4 or higher) and exit interviews with open-ended responses with probes. This 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 among the steadily increasing number of cancer survivors.
- Conditions
- Cancer Survivorship, Insomnia
- Being tested
- Survivorship Sleep Program with Individual Delivery + No Booster Sessions, Survivorship Sleep Program with Group Delivery + No Booster Sessions, Survivorship Sleep Program with Individual Delivery + 3 Booster Sessions, Survivorship Sleep Program with Group Delivery + 3 Booster Sessions
- Medical subject headings
- Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Survivorship Sleep Program with Individual Delivery + No Booster SessionsBehavioural
4 weekly SSP sessions delivered to individual participants (session durations approximately 45 min/session). No booster sessions.
Survivorship Sleep Program with Group Delivery + No Booster SessionsBehavioural
4 weekly SSP sessions delivered to groups of participants (session durations approximately 90 min/session). No booster sessions.
Survivorship Sleep Program with Individual Delivery + 3 Booster SessionsBehavioural
4 weekly SSP sessions delivered to individual participants (session durations approximately 45 min/session). 3 monthly booster sessions.
Survivorship Sleep Program with Group Delivery + 3 Booster SessionsBehavioural
4 weekly SSP sessions delivered to groups of participants (session durations approximately 90 min/session). 3 monthly booster sessions.
| Study group | Role | What they receive |
|---|---|---|
| Group 1: Survivorship Sleep Program with Individual Delivery + No Booster Sessions | Experimental | 4 weekly SSP sessions delivered to individual participants (session durations approximately 45 min/session). No booster sessions. Receives: Behavioral: Survivorship Sleep Program with Individual Delivery + No Booster Sessions |
| Group 2: Survivorship Sleep Program with Group Delivery + No Booster Sessions | Experimental | 4 weekly SSP sessions delivered to groups of participants (session durations approximately 90 min/session). No booster sessions. Receives: Behavioral: Survivorship Sleep Program with Group Delivery + No Booster Sessions |
| Group 3: Survivorship Sleep Program with Individual Delivery + 3 Booster Sessions | Experimental | 4 weekly SSP sessions delivered to individual participants (session durations approximately 45 min/session), followed by 3 monthly booster sessions. Receives: Behavioral: Survivorship Sleep Program with Individual Delivery + 3 Booster Sessions |
| Group 4: Survivorship Sleep Program with Group Delivery + 3 Booster Sessions | Experimental | 4 weekly SSP sessions delivered to groups of participants (session durations approximately 90 min/session), followed by 3 monthly booster sessions. Receives: Behavioral: Survivorship Sleep Program with Group Delivery + 3 Booster Sessions |
What is being measured
The primary outcome is the main question the study is designed to answer.
Insomnia Severity Index (ISI) total score
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.
Measured: T0 (Baseline) to T2 (week 8)
Secondary outcomes (6)
Emotional distress: PROMIS Anxiety Symptoms
PROMIS anxiety short form. Acute (T0-T1; week 4) and 3-month (T0-T3; week 16) changes will be examined as secondary outcomes.
Measured: T0 (week 0) to T3 (week 16)
Emotional distress: PROMIS Depression Symptoms
PROMIS depression short form. Acute (T0-T1; week 4) and T0-T3 (week 16) changes will be examined as secondary outcomes.
Measured: T0 (week 0) to T3 (week 16)
Daytime fatigue: PROMIS Fatigue
PROMIS fatigue short form. Acute (T0-T1; week 4) and T0-T3 (week 16) changes will be examined as secondary outcomes.
Measured: T0 (week 0) to T3 (week 16)
Work-related functioning
Work-related functioning will be measured using the six-item Work Productivity and Activity Impairment: General Health (WPAI:GH), which includes scores for absenteeism, presenteeism, and total work impairment. Acute (T0-T1; week 4) and T0-T3 (week 16) changes will be examined as secondary outcomes.
Measured: T0 (week 0) to T3 (week 16)
Use of sleep aid medications
Use of sleep aid medications (frequency, dose) will be evaluated via self-report surveys and electronic medical records (when possible). Acute (T0-T1; week 4) and T0-T3 (week 16) changes will be examined as secondary outcomes.
Measured: T0 (week 0) to T3 (week 16)
Sleep diaries and actigraphy
Sleep diaries and actigraphy will be collected during SSP Sessions 1-4 and for 7 days at each timepoint (T0-T3) to derive sleep efficiency, sleep onset latency, and wake after sleep onset. Discrepancy scores between subjective and objective sleep metrics (e.g., sleep onset latency) will be examined. Acute (T0-T1; week 4) and T0-T3 (week 16) changes will be examined as secondary outcomes.
Measured: T0 (week 0) to T3 (week 16)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Dec 2023
- Study start6 Sep 2024
- Primary completion15 Nov 2026 (estimated)
- Study completion31 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cancer SurvivorshipStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Principal investigator, Daniel L Hall, PhD, Massachusetts General Hospital
- Investigators
- Daniel Hall, PhD, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06181643
- Sponsor's protocol ID
- 23-681
- Other IDs
- 5R21CA279248-02
- Status last verified
- Oct 2026
- First submitted
- 13 Dec 2023
- Last updated
- 28 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Innovating CBT-I for Cancer Survivors: An Optimization Trial
- ClinicalTrials.gov ID
- NCT06181643
- Acronym / sponsor ID
- 23-681
- Conditions
- Cancer Survivorship, Insomnia
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 6 Sep 2024 (actual)
- Primary completion
- 15 Nov 2026 (estimated)
- Study completion
- 31 May 2027 (estimated)
- First posted
- 26 Dec 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Insomnia is a significant issue in 30-50% of cancer survivors. Our pilot randomized controlled trial of synchronous, virtual cognitive behavioral therapy for insomnia (CBT-I) for cancer survivors suggested that a group format or booster sessions may optimize effects on insomnia and daytime functioning. The goal of this project is to conduct a factorial, randomized controlled trial to optimize synchronous, virtual delivery of CBT-I for cancer survivors. We will conduct a 2×2 factorial trial (N=80) to evaluate the optimal combination of two intervention design components: delivery (individual vs. group) and booster sessions (0 vs 3). The primary outcome is change in insomnia severity (insomnia severity index) from T0 (week 0) to T2 (week 8). The secondary outcomes are acute (T0-T1, week 4) and sustained (T0-T3, week 16) changes in insomnia severity, emotional distress, work-related functioning, use of sleep medications, and subjective and objective sleep metrics (measured with sleep diaries and Fitbit). Exploratory aim 1 is to characterize study participation and sleep outcomes among cancer survivors with insomnia. Exploratory aim 2 is to characterize the acceptability of design components using Likert ratings (very low=1 to very high=5, benchmarks=4 or higher) and exit interviews with open-ended responses with probes. This 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 among the steadily increasing number of cancer survivors.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Group 1: Survivorship Sleep Program with Individual Delivery + No Booster Sessions | Experimental | Behavioral: Survivorship Sleep Program with Individual Delivery + No Booster Sessions4 weekly SSP sessions delivered to individual participants (session durations approximately 45 min/session). No booster sessions. |
| Group 2: Survivorship Sleep Program with Group Delivery + No Booster Sessions | Experimental | Behavioral: Survivorship Sleep Program with Group Delivery + No Booster Sessions4 weekly SSP sessions delivered to groups of participants (session durations approximately 90 min/session). No booster sessions. |
| Group 3: Survivorship Sleep Program with Individual Delivery + 3 Booster Sessions | Experimental | Behavioral: Survivorship Sleep Program with Individual Delivery + 3 Booster Sessions4 weekly SSP sessions delivered to individual participants (session durations approximately 45 min/session), followed by 3 monthly booster sessions. |
| Group 4: Survivorship Sleep Program with Group Delivery + 3 Booster Sessions | Experimental | Behavioral: Survivorship Sleep Program with Group Delivery + 3 Booster Sessions4 weekly SSP sessions delivered to groups of participants (session durations approximately 90 min/session), followed by 3 monthly booster sessions. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- History of nonmetastatic, localized, or regional solid or blood malignancy(ies)
- Completion of primary cancer treatment (radiation, surgery, and/or chemotherapy). Use of hormonal, maintenance, oral, and immunotherapies is permitted.
- Chronic insomnia (DSM-5 criteria)
- 18 years of age or older
Key exclusion criteria (4 listed)
- Self-reported inability to speak and write in English
- Undertreated noninsomnia 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Survivorship Sleep Program with Individual Delivery + No Booster Sessions4 weekly SSP sessions delivered to individual participants (session durations approximately 45 min/session). No booster sessions. | Behavioural | Group 1: Survivorship Sleep Program with Individual Delivery + No Booster Sessions |
| Survivorship Sleep Program with Group Delivery + No Booster Sessions4 weekly SSP sessions delivered to groups of participants (session durations approximately 90 min/session). No booster sessions. | Behavioural | Group 2: Survivorship Sleep Program with Group Delivery + No Booster Sessions |
| Survivorship Sleep Program with Individual Delivery + 3 Booster Sessions4 weekly SSP sessions delivered to individual participants (session durations approximately 45 min/session). 3 monthly booster sessions. | Behavioural | Group 3: Survivorship Sleep Program with Individual Delivery + 3 Booster Sessions |
| Survivorship Sleep Program with Group Delivery + 3 Booster Sessions4 weekly SSP sessions delivered to groups of participants (session durations approximately 90 min/session). 3 monthly booster sessions. | Behavioural | Group 4: Survivorship Sleep Program with Group Delivery + 3 Booster Sessions |
Primary outcome
Insomnia Severity Index (ISI) total score
Time frame: T0 (Baseline) to T2 (week 8)
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.
6 secondary outcomes
Emotional distress: PROMIS Anxiety Symptoms
Time frame: T0 (week 0) to T3 (week 16)
Emotional distress: PROMIS Depression Symptoms
Time frame: T0 (week 0) to T3 (week 16)
Daytime fatigue: PROMIS Fatigue
Time frame: T0 (week 0) to T3 (week 16)
Work-related functioning
Time frame: T0 (week 0) to T3 (week 16)
Use of sleep aid medications
Time frame: T0 (week 0) to T3 (week 16)
Sleep diaries and actigraphy
Time frame: T0 (week 0) to T3 (week 16)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2026.
Related trials for Cancer Survivorship
Recruiting
Study of a Support Program for Quality of Life in Chinese Cancer Patients and Survivors
Cancer, Survivorship
Not yet recruiting
Patient-reported Outcomes-driven Supportive Care Navigation Among Hispanic/Latinx Cancer Patients
Cancer
Not yet recruitingPhase 2
Obesity Treatment With Phentermine-Topiramate ER in AYA Surviving Leukemia and Lymphoma
Acute Lymphoblastic Leukemia in Remission, Hodgkin Lymphoma in Remission
RecruitingPhase 1
Study of Preoperative Radiation Therapy in Participants With Resectable Recurrent Abdominal Adrenocortical Carcinoma
Adrenocortical Carcinoma (ACC), Recurrent Adrenocortical Carcinoma (ACC)
Recruiting
Facial Expression Awareness Training to Understand and Recognize Emotions
Survivors of Pediatric Brain Tumors, Pediatric Cancer
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Daniel Hall, PhD principal investigator
Massachusetts General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Survivorship Sleep Program with Individual Delivery + No Booster Sessions, Survivorship Sleep Program with Group Delivery + No Booster Sessions and Survivorship Sleep Program with Individual Delivery + 3 Booster Sessions in people with Cancer Survivorship and Insomnia, run by Massachusetts General Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 28 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Insomnia Severity Index (ISI) total score (time frame: T0 (Baseline) to T2 (week 8)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Oct 2026.