CancerNCT04566068
Survivorship Sleep Program
A study testing Intervention- Adapted Virtual Insomnia Program in people with Cancer and Insomnia, run by Massachusetts General Hospital at 1 site in United States.
Trial summary
This is a randomized pilot trial to test the feasibility and acceptability (primary outcomes) of a virtual cognitive behavioral program for insomnia for survivors of various cancer types. Secondary outcomes are to examine the preliminary effects on reducing insomnia severity from baseline to post-intervention. Read more about this study
- Who is it for?
- Ages 18 years and older
- What is being tested?
- Intervention- Adapted Virtual Insomnia Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Oct 2020to 16 Jun 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 (i.e., radiation, surgery, and/or chemotherapy)
- Chronic insomnia
- Age ≥18 years
Who cannot join
- Self-reported inability to speak and write in English
- Undertreated noninsomnia sleep disorder (e.g., sleep apnea)
- Undertreated epilepsy, serious mental illness, or 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, 02115
About this study
Official title: Adapted Telehealth Intervention for Insomnia Among Cancer Survivors
This is a randomized pilot trial to test the feasibility and acceptability (primary outcomes) of a virtual cognitive behavioral program for insomnia for survivors of various cancer types. Secondary outcomes are to examine the preliminary effects on reducing insomnia severity from baseline to post-intervention.
Read the detailed description
Cognitive Behavioral Therapy for insomnia (CBT-I), is an evidenced-based insomnia program that is recommended by the American College of Physicians and can be delivered using session-by-session treatment manuals.
Among cancer survivors, CBT-I has only yielded small-to-moderate sized improvements in several aspects of sleep, including sleep efficiency, sleep onset latency, and wake after sleep onset as compared with inactive control conditions. Moreover, systematic reviews of CBT-I with cancer survivors have found high rates of attrition and low attendance. Thus, while CBT-I for cancer survivors is promising, further adaptation is needed to demonstrate greater feasibility and larger effects. Additionally, CBT-I is traditionally delivered in-person, which is not feasible for many cancer survivors. Barriers include time limitations, travel, and illness burden constraints, as well as a paucity of trained CBT-I providers. Telehealth delivery of CBT-I is an innovative approach to address these barriers to care and enhance uptake.
The intervention being tested in this study was informed by a 4-10 session CBT-I protocol and adapted based on interviews the investigators conducted with cancer survivors with insomnia to learn about their sleep-related challenges, suggestions, and preferences for intervention delivery, as well as a systematic review and meta-analysis the investigators published in Sleep Medicine Reviews in 2020.
The research study procedures include screening for eligibility and randomization into 1 of 2 study arms: the Adapted Virtual Intervention Group or a Control Group (Enhanced Usual Care; referral for behavioral sleep medicine and sleep hygiene handout). Participants will be in this research study for approximately 2 months. It is expected that about 40 people will take part in this research study.
- Being tested
- Intervention- Adapted Virtual Insomnia Program, Control- Enhanced usual care
- Keywords
- Insomnia, Cancer Survivors
- Medical subject headings
- Neoplasms, Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intervention- Adapted Virtual Insomnia ProgramBehavioural
4 sessions (approximately 45 min/each, weekly) plus 3 check-ins (approximately 15 min/each, between-sessions) delivered virtually. Sessions are modeled after a published, evidence-based CBT-I protocol and adapted to target needs and preferences identified by cancer survivors.
Control- Enhanced usual careBehavioural
Enhanced usual care. Referral to the Massachusetts General Hospital Behavioral Sleep Medicine service plus an educational handout on the topic of sleep hygiene.
| Study group | Role | What they receive |
|---|---|---|
| Intervention- Adapted Virtual Insomnia Program | Experimental | 4 sessions (approximately 45 min/each, weekly) plus 3 check-ins (approximately 15 min/each, between-sessions) delivered virtually. Sessions are modeled after a published, evidence-based CBT-I protocol and adapted to target needs and preferences identified by cancer survivors. Interventionists will participate in weekly supervision. Approximately half of participants will be asked to wear sleep trackers for one-week prior to starting the intervention (T0) and one-week after completing the intervention (T1). Receives: Behavioral: Intervention- Adapted Virtual Insomnia Program |
| Control- Enhanced usual care | Placebo comparator | Enhanced usual care. Referral to the Massachusetts General Hospital Behavioral Sleep Medicine service plus an educational handout on the topic of sleep hygiene. Receives: Behavioral: Control- Enhanced usual care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility: Enrollment rate of those screened and eligible
Percent of those screened and eligible who enroll (i.e., sign consent and complete baseline). Reasons for ineligibility, refusal, or drop out, will also be measured along with session attendance.
Measured: T0 (Baseline)- T2(1 Month Post-Intervention Follow Up): 2 Months
Acceptability: 5 item measure of enjoyableness, convenience, helpfulness, odds of future use, and overall satisfaction
Participants will be asked to rate the enjoyableness, convenience, helpfulness, odds of future use, and overall satisfaction (1=very low to 5=very high) of the program in exit interviews, which will use open-ended questions and response probes to explicate each rating.
Measured: T0 (Baseline)- T1 (Post-Intervention): 1 Month
Secondary outcomes (1)
Change in Insomnia Severity
Change in insomnia severity (T0-T1) will be assessed using the validated Insomnia Severity Index (ISI). Scores of 15 or higher on the ISI indicate clinically significant insomnia.
Measured: T0 (Baseline)- T1(Post-Intervention): 1 Month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2020
- Study start1 Oct 2020
- Primary completion16 Jun 2021
- Study completion16 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for CancerStudies 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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- American Cancer Society, Inc.
- Responsible party
- Principal investigator, Daniel Hall, Massachusetts General Hospital
- Investigators
- Daniel L Hall, Ph.D, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04566068
- Sponsor's protocol ID
- 20-170
- Status last verified
- Apr 2022
- First submitted
- 14 Sep 2020
- Last updated
- 11 Apr 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to Sponsor Investigator or designee. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.
Publications
Hall DL, Arditte Hall KA, Gorman MJ, Comander A, Goldstein MR, Cunningham TJ, Wieman S, Mizrach HR, Juhel BC, Li R, Markowitz A, Grandner M, Park ER. The Survivorship Sleep Program (SSP): A synchronous, virtual cognitive behavioral therapy for insomnia pilot program among cancer survivors. Cancer. 2022 Apr 1;128(7):1532-1544. doi: 10.1002/cncr.34066. Epub 2021 Dec 16.
PubMed 34914845Cai Z, Tang Y, Liu C, Li H, Zhao G, Zhao Z, Zhang B. Cognitive behavioural therapy for insomnia in people with cancer. Cochrane Database Syst Rev. 2025 Oct 31;10(10):CD015176. doi: 10.1002/14651858.CD015176.pub2.
PubMed 41170811
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adapted Telehealth Intervention for Insomnia Among Cancer Survivors
- ClinicalTrials.gov ID
- NCT04566068
- Acronym / sponsor ID
- 20-170
- Keywords
- Insomnia, Cancer Survivors
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Collaborators
- American Cancer Society, Inc.
- Study start
- 1 Oct 2020 (actual)
- Primary completion
- 16 Jun 2021 (actual)
- Study completion
- 16 Jun 2021 (actual)
- First posted
- 28 Sep 2020 (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.
This is a randomized pilot trial to test the feasibility and acceptability (primary outcomes) of a virtual cognitive behavioral program for insomnia for survivors of various cancer types. Secondary outcomes are to examine the preliminary effects on reducing insomnia severity from baseline to post-intervention.
Detailed description
Cognitive Behavioral Therapy for insomnia (CBT-I), is an evidenced-based insomnia program that is recommended by the American College of Physicians and can be delivered using session-by-session treatment manuals.
Among cancer survivors, CBT-I has only yielded small-to-moderate sized improvements in several aspects of sleep, including sleep efficiency, sleep onset latency, and wake after sleep onset as compared with inactive control conditions. Moreover, systematic reviews of CBT-I with cancer survivors have found high rates of attrition and low attendance. Thus, while CBT-I for cancer survivors is promising, further adaptation is needed to demonstrate greater feasibility and larger effects. Additionally, CBT-I is traditionally delivered in-person, which is not feasible for many cancer survivors. Barriers include time limitations, travel, and illness burden constraints, as well as a paucity of trained CBT-I providers. Telehealth delivery of CBT-I is an innovative approach to address these barriers to care and enhance uptake.
The intervention being tested in this study was informed by a 4-10 session CBT-I protocol and adapted based on interviews the investigators conducted with cancer survivors with insomnia to learn about their sleep-related challenges, suggestions, and preferences for intervention delivery, as well as a systematic review and meta-analysis the investigators published in Sleep Medicine Reviews in 2020.
The research study procedures include screening for eligibility and randomization into 1 of 2 study arms: the Adapted Virtual Intervention Group or a Control Group (Enhanced Usual Care; referral for behavioral sleep medicine and sleep hygiene handout). Participants will be in this research study for approximately 2 months. It is expected that about 40 people will take part in this research study.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention- Adapted Virtual Insomnia Program | Experimental | Behavioral: Intervention- Adapted Virtual Insomnia Program4 sessions (approximately 45 min/each, weekly) plus 3 check-ins (approximately 15 min/each, between-sessions) delivered virtually. Sessions are modeled after a published, evidence-based CBT-I protocol and adapted to target needs and preferences identified by cancer survivors. Interventionists will participate in weekly supervision. Approximately half of participants will be asked to wear sleep trackers for one-week prior to starting the intervention (T0) and one-week after completing the intervention (T1). |
| Control- Enhanced usual care | Placebo comparator | Behavioral: Control- Enhanced usual careEnhanced usual care. Referral to the Massachusetts General Hospital Behavioral Sleep Medicine service plus an educational handout on the topic of sleep hygiene. |
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 (i.e., radiation, surgery, and/or chemotherapy)
- Chronic insomnia
- Age ≥18 years
Key exclusion criteria (4 listed)
- Self-reported inability to speak and write in English
- Undertreated noninsomnia sleep disorder (e.g., sleep apnea)
- Undertreated epilepsy, serious mental illness, or 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 |
|---|---|---|
| Intervention- Adapted Virtual Insomnia Program4 sessions (approximately 45 min/each, weekly) plus 3 check-ins (approximately 15 min/each, between-sessions) delivered virtually. Sessions are modeled after a published, evidence-based CBT-I protocol and adapted to target needs and preferences identified by cancer survivors. | Behavioural | Intervention- Adapted Virtual Insomnia Program |
| Control- Enhanced usual careEnhanced usual care. Referral to the Massachusetts General Hospital Behavioral Sleep Medicine service plus an educational handout on the topic of sleep hygiene. | Behavioural | Control- Enhanced usual care |
Primary outcome
Feasibility: Enrollment rate of those screened and eligible
Time frame: T0 (Baseline)- T2(1 Month Post-Intervention Follow Up): 2 Months
Percent of those screened and eligible who enroll (i.e., sign consent and complete baseline). Reasons for ineligibility, refusal, or drop out, will also be measured along with session attendance.
Acceptability: 5 item measure of enjoyableness, convenience, helpfulness, odds of future use, and overall satisfaction
Time frame: T0 (Baseline)- T1 (Post-Intervention): 1 Month
Participants will be asked to rate the enjoyableness, convenience, helpfulness, odds of future use, and overall satisfaction (1=very low to 5=very high) of the program in exit interviews, which will use open-ended questions and response probes to explicate each rating.
1 secondary outcome
Change in Insomnia Severity
Time frame: T0 (Baseline)- T1(Post-Intervention): 1 Month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Apr 2022.
- Results publication: PubMed 34914845Hall DL, Arditte Hall KA, Gorman MJ, Comander A, Goldstein MR, Cunningham TJ, Wieman S, Mizrach HR, Juhel BC, Li R, Markowitz A, Grandner M, Park ER. The Survivorship Sleep Program (SSP): A synchronous, virtual cognitive behavioral therapy for insomnia pilot program among cancer survivors. Cancer. 2022 Apr 1;128(7):1532-1544. doi: 10.1002/cncr.34066. Epub 2021 Dec 16.
- Derived from this study: PubMed 41170811Cai Z, Tang Y, Liu C, Li H, Zhao G, Zhao Z, Zhang B. Cognitive behavioural therapy for insomnia in people with cancer. Cochrane Database Syst Rev. 2025 Oct 31;10(10):CD015176. doi: 10.1002/14651858.CD015176.pub2.
- Individual participant dataSharing planned: Yes. The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to Sponsor Investigator or designee. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.
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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 L Hall, Ph.D 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 Intervention- Adapted Virtual Insomnia Program in people with Cancer 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: finished, as of the sponsor's last update on 11 Apr 2022. 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. Some participants in this study may receive a placebo. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Feasibility: Enrollment rate of those screened and eligible (time frame: T0 (Baseline)- T2(1 Month Post-Intervention Follow Up): 2 Months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04566068, which also lists 2 linked publications.
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 11 Apr 2022.