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| ID | Type | Description | Link |
|---|---|---|---|
| 1R21CA267857 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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The purpose of the study is to learn if single session online education programs can help improve cancer survivors' sleep.
This study is a randomized controlled trial of cancer survivors with clinically significant symptoms of insomnia to evaluate the efficacy of the cognitive-behavioral intervention Sleep Treatment Education Program-1 (STEP-1).
Participants in this study will be randomized to either the behavioral education session, Sleep Treatment Education Program-1 (STEP-1), which will instruct them on how to make changes to their sleep habits and behaviors or an enhanced usual care control program which will provides them with access to online relaxation programs and instruct them about how these programs can help improve sleep.
Participation in the study involves:
It expected that about 70 people will take part in this study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sleep Treatment Education Program (STEP-1) | Experimental | Prior to being randomized, all participants will complete health questionnaires. Participants assigned to the Sleep Treatment Education Program (STEP-1) group will receive online instruction on making changes to sleep habits and health behaviors. Participants will be contacted at 1 month and 2 months after the education session to complete follow up online questionnaires. |
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| Enhanced Usual Care: Relaxation Education | Active Comparator | Prior to being randomized, all participants will complete health questionnaires. Participants assigned to the Enhanced Usual Care group will receive information on relaxation techniques to improve sleep Participants will be contacted at 1 month and 2 months after the education session to complete follow up online questionnaires. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sleep Treatment Education Program (STEP-1) | Behavioral | Video conference instruction on behavioral changes to improve sleep. |
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| Measure | Description | Time Frame |
|---|---|---|
| Insomnia Severity Change at 8 Weeks | The Insomnia Severity Index (ISI) is a 7-item measure used to evaluate insomnia severity (e.g. dissatisfaction with sleep and worry about sleep problems). Item response values are totaled to calculate a total ISI score ranging from 0-28, with higher scores indicating more insomnia symptom burden. | Baseline to 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Profile of Mood States Change at 8 Weeks | The Profile of Mood States-Short Form (POMS-SF) is a 35-item measure of mood. Items responses are totaled to calculate scores on 7 subscales: Anger-Hostility, Confusion-Bewilderment, Depression-Dejection, Fatigue-Inertia, Tension-Anxiety, Vigor-Activity, and Friendliness. The Total Mood Disturbance (TMD) score used in the study is calculated by adding together the scores of 5 subscales, Anger-Hostility, Confusion-Bewilderment, Depression-Dejection, Fatigue-Inertia, Tension-Anxiety, then subtracting the score from the Vigor-Activity subscale. TMD scores range from -20 to 100 with higher scores indicating greater impairment. |
| Measure | Description | Time Frame |
|---|---|---|
| Intervention Session Usability & Satisfaction | Study specific participant checklist describing ease of use, acceptability and credibility of intervention | Up to 4 weeks post-intervention |
| Intervention Satisfaction Summary |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Christopher Recklitis, PhD, MPH | Dana-Farber Cancer Insitute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dana Farber Cancer Institute | Boston | Massachusetts | 02115 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39608001 | Derived | Bice BL, Michaud AL, McCormick KG, Miklos EM, Descombes ID, Medeiros-Nancarrow C, Zhou ES, Recklitis CJ. Sleep Treatment Education Program for Cancer Survivors: Protocol for an Efficacy Trial. JMIR Res Protoc. 2024 Nov 28;13:e60762. doi: 10.2196/60762. |
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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: [contact information for 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.
Data can be shared no earlier than 1 year following the date of publication
Contact the Belfer Office for Dana-Farber Innovations (BODFI) at innovation@dfci.harvard.edu
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| ID | Title | Description |
|---|---|---|
| FG000 | STEP-1 | Participants received a single 75-minute synchronous videoconference intervention session based on cognitive behavioral therapy components of sleep hygiene, stimulus control, and cognitive restructuring |
| FG001 | Relaxation (Control) | Participants received a single 60-minute synchronous videoconference education session based on relaxation exercises such as progressive muscle relaxation, paced breathing, and guided imagery |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Intervention Session and Evaluation |
| |||||||||||||
| Required Follow-up |
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| Optional Extended Follow-up |
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From the original 70 participants who began the study and completed the Baseline questionnaire, two participants were lost to follow-up and one withdrew following the education session (reflected in the Participant Flow chart). Those three participants were not included in the analyzed sample reported here (n=67).
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| ID | Title | Description |
|---|---|---|
| BG000 | STEP-1 | Participants received a single 75-minute synchronous videoconference intervention session based on cognitive behavioral therapy components of sleep hygiene, stimulus control, and cognitive restructuring |
| BG001 | Relaxation (Control) |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Insomnia Severity Change at 8 Weeks | The Insomnia Severity Index (ISI) is a 7-item measure used to evaluate insomnia severity (e.g. dissatisfaction with sleep and worry about sleep problems). Item response values are totaled to calculate a total ISI score ranging from 0-28, with higher scores indicating more insomnia symptom burden. | Posted | Mean | Standard Deviation | Units on a scale | Baseline to 8 weeks |
|
From enrollment to 8 weeks for all participants, additional follow-up to 12 weeks for participants in optional coaching session
This was a minimal risk educational intervention. Participants self-report on significant health changes in their own words.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | STEP-1 | Participants received a single 75-minute synchronous videoconference intervention session based on cognitive behavioral therapy components of sleep hygiene, stimulus control, and cognitive restructuring |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Christopher Recklitis | Dana-Farber Cancer Institute | 617-632-5124 | crecklitis@partners.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Oct 2, 2023 | Dec 11, 2025 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D007319 | Sleep Initiation and Maintenance Disorders |
| ID | Term |
|---|---|
| D020919 | Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
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| Enhanced Usual Care | Behavioral | Video conference instruction on relaxation techniques to improve sleep. |
|
| Baseline to 8 weeks |
| Profile of Mood States Change at 4 Weeks | The Profile of Mood States-Short Form (POMS-SF) is a 35-item measure of mood. Items responses are totaled to calculate scores on 7 subscales: Anger-Hostility, Confusion-Bewilderment, Depression-Dejection, Fatigue-Inertia, Tension-Anxiety, Vigor-Activity, and Friendliness. The Total Mood Disturbance (TMD) score used in the study is calculated by adding together the scores of 5 subscales, Anger-Hostility, Confusion-Bewilderment, Depression-Dejection, Fatigue-Inertia, Tension-Anxiety, then subtracting the score from the Vigor-Activity subscale. TMD scores range from -20 to 100 with higher scores indicating greater impairment. | Baseline to 4 weeks |
| Change in Sleep Quality | The PROMIS Sleep Disturbance Short Form 8b (PROMIS-SD) is an 8 item scale used to assess sleep disturbances and their impact on overall sleep quality. Items include specific sleep problems (e.g., restless sleep) as well as satisfaction with sleep quality and amount of sleep. Item responses are summed to calculate a Total score, with raw scores (range 8-40) translated into t-scores (mean = 50, SD= 10). Higher PROMIS-SD Total t-scores indicate greater levels of sleep disturbance. | Baseline to 8 Weeks |
| Sleep Duration | Total sleep time in hours per night calculated from the Consensus Sleep Diary-Morning | Administered at 8 week follow-up |
| Insomnia Severity Change at 4 Weeks | The Insomnia Severity Index (ISI) is a 7-item measure used to evaluate insomnia severity (e.g. dissatisfaction with sleep and worry about sleep problems). Item response values are totaled to calculate a total ISI score ranging from 0-28, with higher scores indicating more insomnia symptom burden. | Baseline to 4 Weeks |
Brief participant questionnaire to provide feedback about the intervention and how it could be improved.
| Completed at the 8-week post-intervention timepoint |
| Coaching Satisfaction Summary | Brief participant questionnaire to provide feedback about coaching session. could be improved. | Up to 13 weeks post-intervention |
| Insomnia Symptoms at 16 Weeks (Optional) | After completing 8-week follow-up, participants will be asked if they are willing to complete one additional Insomnia Severity Scale 8 weeks later. | At 16 weeks post-intervention |
| NOT COMPLETED |
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| NOT COMPLETED |
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Participants received a single 60-minute synchronous videoconference education session based on relaxation exercises such as progressive muscle relaxation, paced breathing, and guided imagery |
| BG002 | Total | Total of all reporting groups |
| Years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Insomnia Severity Index | The Insomnia Severity Index (ISI) is a 7-item measure used to evaluate insomnia severity (e.g. dissatisfaction with sleep and worry about sleep problems). Item response values are totaled to calculate a total ISI score ranging from 0-28, with higher scores indicating more insomnia symptom burden. | Mean | Standard Deviation | Units on a scale |
|
| Profile of Mood States - Short Form (Total Mood Disturbance) | The Profile of Mood States-Short Form (POMS-SF) is a 35-item measure of mood. Item responses are totaled to calculate scores on 7 subscales. The Total Mood Disturbance (TMD) score used in the study is calculated by adding together the scores of 5 subscales, Anger-Hostility, Confusion-Bewilderment, Depression-Dejection, Fatigue-Inertia, Tension-Anxiety, then subtracting the score from the Vigor-Activity subscale. TMD scores range from -20 to 100 higher scores indicating greater impairment. | Mean | Standard Deviation | Units on a scale |
|
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| Secondary | Profile of Mood States Change at 8 Weeks | The Profile of Mood States-Short Form (POMS-SF) is a 35-item measure of mood. Items responses are totaled to calculate scores on 7 subscales: Anger-Hostility, Confusion-Bewilderment, Depression-Dejection, Fatigue-Inertia, Tension-Anxiety, Vigor-Activity, and Friendliness. The Total Mood Disturbance (TMD) score used in the study is calculated by adding together the scores of 5 subscales, Anger-Hostility, Confusion-Bewilderment, Depression-Dejection, Fatigue-Inertia, Tension-Anxiety, then subtracting the score from the Vigor-Activity subscale. TMD scores range from -20 to 100 with higher scores indicating greater impairment. | Posted | Mean | Standard Deviation | Units on a scale | Baseline to 8 weeks |
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|
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| Secondary | Profile of Mood States Change at 4 Weeks | The Profile of Mood States-Short Form (POMS-SF) is a 35-item measure of mood. Items responses are totaled to calculate scores on 7 subscales: Anger-Hostility, Confusion-Bewilderment, Depression-Dejection, Fatigue-Inertia, Tension-Anxiety, Vigor-Activity, and Friendliness. The Total Mood Disturbance (TMD) score used in the study is calculated by adding together the scores of 5 subscales, Anger-Hostility, Confusion-Bewilderment, Depression-Dejection, Fatigue-Inertia, Tension-Anxiety, then subtracting the score from the Vigor-Activity subscale. TMD scores range from -20 to 100 with higher scores indicating greater impairment. | Posted | Mean | Standard Deviation | Units on a scale | Baseline to 4 weeks |
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| Secondary | Change in Sleep Quality | The PROMIS Sleep Disturbance Short Form 8b (PROMIS-SD) is an 8 item scale used to assess sleep disturbances and their impact on overall sleep quality. Items include specific sleep problems (e.g., restless sleep) as well as satisfaction with sleep quality and amount of sleep. Item responses are summed to calculate a Total score, with raw scores (range 8-40) translated into t-scores (mean = 50, SD= 10). Higher PROMIS-SD Total t-scores indicate greater levels of sleep disturbance. | Posted | Mean | Standard Deviation | Units on a scale | Baseline to 8 Weeks |
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| Secondary | Sleep Duration | Total sleep time in hours per night calculated from the Consensus Sleep Diary-Morning | Posted | Median | Inter-Quartile Range | Time (in hours per night) | Administered at 8 week follow-up |
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| Secondary | Insomnia Severity Change at 4 Weeks | The Insomnia Severity Index (ISI) is a 7-item measure used to evaluate insomnia severity (e.g. dissatisfaction with sleep and worry about sleep problems). Item response values are totaled to calculate a total ISI score ranging from 0-28, with higher scores indicating more insomnia symptom burden. | Posted | Mean | Standard Deviation | Units on a scale | Baseline to 4 Weeks |
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| Other Pre-specified | Intervention Session Usability & Satisfaction | Study specific participant checklist describing ease of use, acceptability and credibility of intervention | Not Posted | Jul 2026 | Up to 4 weeks post-intervention | Participants |
| Other Pre-specified | Intervention Satisfaction Summary | Brief participant questionnaire to provide feedback about the intervention and how it could be improved. | Not Posted | Jul 2026 | Completed at the 8-week post-intervention timepoint | Participants |
| Other Pre-specified | Coaching Satisfaction Summary | Brief participant questionnaire to provide feedback about coaching session. could be improved. | Not Posted | Jul 2026 | Up to 13 weeks post-intervention | Participants |
| Other Pre-specified | Insomnia Symptoms at 16 Weeks (Optional) | After completing 8-week follow-up, participants will be asked if they are willing to complete one additional Insomnia Severity Scale 8 weeks later. | Not Posted | Jul 2026 | At 16 weeks post-intervention | Participants |
| 0 |
| 34 |
| 0 |
| 34 |
| 0 |
| 34 |
| EG001 | Relaxation (Control) | Participants received a single 60-minute synchronous videoconference education session based on relaxation exercises such as progressive muscle relaxation, paced breathing, and guided imagery | 0 | 33 | 0 | 33 | 0 | 33 |
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| D001523 |
| Mental Disorders |