NeoplasmseNightfallNCT07876661
Effectiveness of a Guided, Web-based, Stepped-care-approach to Cognitive Behavioral Therapy for Insomnia in Cancer Survivors
A study testing Stepped-care Cognitive Behavioral Therapy for Insomnia and Standard web-based Cognitive Behavioral Therapy for Insomnia in people with Neoplasms and Cancer Survivorship, run by Vrije Universiteit Brussel at 1 site in Belgium.
Trial summary
The goal of this multicenter randomized clinical trial is to develop and evaluate a web-based stepped-care approach to Cognitive Behavioral Therapy for Insomnia (CBT-I), specifically tailored to adult cancer survivors experiencing insomnia. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Neoplasms, Cancer Survivorship, Insomnia
- What is being tested?
- Stepped-care Cognitive Behavioral Therapy for Insomnia and Standard web-based Cognitive Behavioral Therapy for Insomnia
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- 1 siteBelgium
- Study dates
- 15 Oct 2026to 1 Apr 2030
- Phase
- Interventional
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
- Adult cancer survivors (all cancer types), who are cancer-free and have completed primary cancer treatment (radiotherapy, chemotherapy, and surgery) ≥ 3 months prior.
- Age ≥ 18 years
- Sufficient proficiency in Dutch reading and comprehension.
- Insomnia Severity Index (ISI) score ≥ 12
- Co-occurring sleep disorders permitted, provided they are adequately treated (e.g., obstructive sleep apnea managed with CPAP)
- Concurrent use of (sleep) medication permitted.
Who cannot join
- Presence of active cancer or ongoing cancer treatment (except immunotherapy or hormonal therapy).
- Severe psychiatric disorders (e.g., diagnosis of bipolar disorder or schizophrenia), or significant indication as identified via the MINI-screen, that would impede trial participation
- Significant indication of cognitive impairment (score of 11 or more on the 6-CIT), rendering trial participation difficult.
- Prior receipt of psychological treatment targeting insomnia (CBT-I)
- Other untreated sleep disorders, as determined through a sleep interview and the SLAAP-50.
- Engagement in shift work during the past 3 months or planned shift work within the upcoming 15 months
- Current pregnancy or being a parent/primary caregiver of an infant aged ≤ 6 months
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Belgium1 site
Vrije Universiteit Brussel
Brussels
Astrid Lahousse, PhD, +32 2 477 44 20, astrid.lucie.lahousse@vub.be
Anneleen Malfliet, PhD
About this study
Official title: eNightfall-project: Effectiveness of a Guided, Web-based, Stepped-care-approach to Cognitive Behavioral Therapy for Insomnia in Cancer Survivors: a Multicenter Randomized Controlled Clinical Trial.
The goal of this multicenter randomized clinical trial is to develop and evaluate a web-based stepped-care approach to Cognitive Behavioral Therapy for Insomnia (CBT-I), specifically tailored to adult cancer survivors experiencing insomnia. Participants will be randomly assigned to one of three study arms: stepped-care web-based CBT-I (eSTEPCBT-I), standardized web-based CBT-I (eSTANDCBT-I), or care as usual (CAU). The study aims to determine whether a stepped-care approach can improve access to effective insomnia treatment while maintaining clinical effectiveness and cost-effectiveness.
Read the detailed description
The primary questions this clinical trial aims to answer are:
- Does a stepped-care web-based CBT-I intervention (eSTEPCBT-I) lead to greater reductions in insomnia severity and higher remission rates than care as usual (CAU) among adult cancer survivors?
- Is eSTEPCBT-I non-inferior to a standardized web-based CBT-I intervention (eSTANDCBT-I) in reducing insomnia severity and increasing remission rates among adult cancer survivors?
The secondary questions this clinical trial aims to answer are:
- Does eSTEPCBT-I improve therapy adherence and satisfaction compared with eSTANDCBT-I?
- Does eSTEPCBT-I reduce the use of additional therapies (e.g., medication use) compared with CAU, or is it equivalent to eSTANDCBT-I?
- Does eSTEPCBT-I improve psychological functioning, physical complaints (e.g., pain), and health-related quality of life compared with CAU, or is it equivalent to eSTANDCBT-I?
- Are the effects of eSTEPCBT-I on the use of additional therapies, psychological functioning, physical complaints, and health-related quality of life maintained during long-term follow-up?
- What is the cost-effectiveness of eSTEPCBT-I compared with eSTANDCBT-I and CAU?
Participants will:
- Be randomly assigned to one of three study arms: eSTEPCBT-I, eSTANDCBT-I, or care as usual.
- Complete a web-based CBT-I intervention lasting between 4 and 10 weeks, depending on the allocated study arm and treatment progression, or receive care as usual.
- Complete a daily sleep diary throughout the intervention period to monitor sleep patterns and treatment progress.
- Complete online questionnaires assessing insomnia severity, sleep quality, fatigue, pain, psychological functioning, health-related quality of life, healthcare utilization, and productivity losses at baseline (T0), (4 weeks after baseline (T1)), post-intervention (T2; 10 weeks after baseline), 6 months post-intervention (T3), and 12 months post-intervention (T4).
- Conditions
- Neoplasms, Cancer Survivorship, Insomnia
- Being tested
- Stepped-care Cognitive Behavioral Therapy for Insomnia, Standard web-based Cognitive Behavioral Therapy for Insomnia, Control arm - Care as usual with sleep hygiene leaflet
- Keywords
- cancer survivorship, insomnia, stepped-care, cognitive-behavioral therapy for insomnia
- 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.
Stepped-care Cognitive Behavioral Therapy for InsomniaBehavioural
Also called eStepCBT-I
Step 1:
Participants receive access to an online self-guided CBT-I module containing educational videos, psychoeducation, and behavioural exercises and 1 online face-to-face sleep coaching session delivered by a trained healthcare provider.
The intervention includes sleep education and sleep hygiene, stimulus control, and individualized behavioural advice to improve sleep.
Step 2:
Participants who do not achieve remission after Step 1 proceed to Step 2, consisting of the eSTANDCBT-I intervention adapted to a 6-week treatment period. Participants receive six online CBT-I modules and two online face-to-face therapy sessions delivered by a CBT-I-certified psychologist. Step 2 incorporates the same evidence-based CBT-I techniques as the eSTANDCBT-I program.
All participants receive Step 1. Only participants with persistent insomnia symptoms after the 4-week assessment proceed to Step 2.
Participants also complete a daily sleep diary throughout the 10-week intervention.
Standard web-based Cognitive Behavioral Therapy for InsomniaBehavioural
Also called eSTANDCBT-I
The eSTANDCBT-I intervention consists of a standard web-based Cognitive Behavioral Therapy for Insomnia (CBT-I) program delivered over a 10-week period. The program includes six online self-guided sessions and two online face-to-face therapy sessions with a CBT-I-certified psychologist.
Participants receive:
access to an online CBT-I platform containing weekly modules with educational videos, interactive exercises, and supporting materials; and two online face-to-face therapy sessions delivered by a CBT-I-certified psychologist.
The intervention incorporates evidence-based CBT-I components commonly used in face-to-face clinical practice, including:
sleep education and sleep hygiene; sleep restriction therapy and stimulus control; cognitive restructuring of maladaptive sleep-related thoughts and beliefs; stress management; relaxation training; and daily-life integration and relapse prevention. Participants are asked to complete a daily sleep diary throughout the 10-week intervention.
Control arm - Care as usual with sleep hygiene leafletOther
Also called Care as Usual with Sleep Hygiene Leaflet
Participants will receive an online sleep hygiene brochure and may seek additional or new sleep support from their usual healthcare providers if needed during the study. No study-specific sleep intervention will be provided, and the care received will be monitored as usual care.
Participants will also complete a logbook and sleep diary throughout the study to enable comparison with the experimental groups. After all data collection has been completed, all intervention materials, including the online eSTANDCBT-I program, will be made available to them.
| Study group | Role | What they receive |
|---|---|---|
| eSTANDCBT-I | Active comparator | An online standard Cognitive Behavioral Therapy for Insomnia (CBT-I) intervention which spans over 10 weeks time. With online modules and two therapist (CBT-I certified psychologist) sessions. Receives: Behavioral: Standard web-based Cognitive Behavioral Therapy for Insomnia |
| eSTEPCBT-I | Experimental | The eSTEPCBT-I intervention is a stepped-care CBT-I program delivered over 10 weeks. All participants begin with Step 1, a 4-week low-intensity sleep coaching intervention. After 4 weeks, insomnia severity is assessed using the Insomnia Severity Index (ISI). Participants who achieve remission (ISI < 11) complete the intervention, whereas those with persistent insomnia symptoms (ISI ≥ 11) proceed to Step 2, the eSTANDCBT-I intervention delivered over the remaining 6 weeks. Receives: Behavioral: Stepped-care Cognitive Behavioral Therapy for Insomnia |
| Care as Usual | Other | Care as usual with online sleep hygiene leaflet Receives: Other: Control arm - Care as usual with sleep hygiene leaflet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Insomnia Severity as assessed by the Insomnia Severity Index (ISI)
Insomnia severity is assessed using the Insomnia Severity Index (ISI), a validated 7-item questionnaire with a total score ranging from 0 to 28. Higher scores indicate greater insomnia severity (worse outcome).
Measured: Baseline before the intervention (T0), within 4 weeks after the start of the intervention (T1), after 10 weeks of intervention (post intervention)(T2), and at 6 months post-intervention (T3) and 12 months post-intervention (T4).
Insomnia Remission Rate assesed by use of the Insomnia Severity Index (ISI)
Insomnia remission is defined as an ISI total score of 11 or lower (≤11). The remission rate is expressed as the percentage of participants achieving remission, with higher percentages indicating a better outcome.
Measured: Baseline before the intervention (T0), within 4 weeks after the start of the intervention (T1), after 10 weeks of intervention (post-intervention, T2), and at 6 months (T3) and 12 months (T4) post-intervention.
Secondary outcomes (26)
Use of additional (sleep-related) healthcare measured by the Medical Consumption Questionnaire (MCQ)
Healthcare use is assessed using the Medical Consumption Questionnaire (MCQ), which records the frequency and type of healthcare services used by participants, including sleep-related healthcare consumption. Outcomes are expressed as the number of healthcare contacts or services used during the specified recall period. Higher values indicate greater healthcare use.
Measured: Baseline before the intervention (T0), after 10 weeks of intervention (post intervention)(T2), and at 6 months post-intervention (T3) and 12 months post-intervention (T4).
Productivity (loss) measured by use of the Productivity Cost Questionnaire (PCQ)
Productivity loss is assessed using the Productivity Cost Questionnaire (PCQ), which measures productivity loss due to absenteeism and presenteeism. Outcomes are expressed as the number of hours of productivity loss, with higher values indicating greater productivity loss (worse outcome).
Measured: Baseline before the intervention (T0), after 10 weeks of intervention (post intervention)(T2), and at 6 months post-intervention (T3) and 12 months post-intervention (T4).
Sleep quality as assesed by the Pittsburgh Sleep Quality Index (PSQI)
Sleep quality is assessed using the Pittsburgh Sleep Quality Index (PSQI), which evaluates subjective sleep quality and sleep disturbances over the past month. The PSQI global score ranges from 0 to 21, with higher scores indicating poorer sleep quality (worse outcome)
Measured: Baseline before the intervention (T0), within 4 weeks after the start of the intervention (T1), after 10 weeks of intervention (post intervention)(T2), and at 6 months post-intervention (T3) and 12 months post-intervention (T4).
Health-Related Quality of Life (Utility) as assessed by the EuroQol 5-Dimension 5-Level Questionnaire (EQ-5D-5L)
Health-related quality of life is assessed using the EuroQol 5-Dimension 5-Level Questionnaire (EQ-5D-5L), which evaluates health status across five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. The health utility score ranges from -0.532 to 1, with higher scores indicating better health-related quality of life. A score of 1 represents full health, while 0 represents death; negative values represent health states valued as worse than death, based on the Belgian EQ-5D-5L value set developed by Bouckaert et al.
Measured: Baseline before the intervention (T0), after 10 weeks of intervention (post intervention)(T2), and at 6 months post-intervention (T3) and 12 months post-intervention (T4).
Pain Intensity as Assessed by the Pain Visual Analogue Scale (VAS)
Pain intensity is assessed using the Pain Visual Analogue Scale (VAS). Participants rate their pain over the past 2 weeks on a scale ranging from 0 to 10, with 0 indicating no pain and 10 indicating the worst pain imaginable. The minimum score is 0 and the maximum score is 10, with higher scores indicating greater pain intensity (worse outcome).y.
Measured: Baseline before the intervention (T0), within 4 weeks after the start of the intervention (T1), after 10 weeks of intervention (post intervention)(T2), and at 6 months post-intervention (T3) and 12 months post-intervention (T4).
Symptoms of Central Sensitization as Assessed by the Central Sensitization Inventory (CSI)
Symptoms of central sensitization are assessed using the Central Sensitization Inventory (CSI), a validated 25-item questionnaire. The total score ranges from 0 to 100, with higher scores indicating greater severity of central sensitization-related symptoms (worse outcome).
Measured: Baseline before the intervention (T0), after 10 weeks of intervention (post intervention)(T2), and at 6 months post-intervention (T3) and 12 months post-intervention (T4).
Fatigue as assesed by the Brugmann Fatigue Scale (BFS)
Fatigue is assessed using the Brugmann Fatigue Scale (BFS), an 8-item questionnaire assessing mental and physical fatigue. Each item is scored from 0 to 3. The Mental Fatigue subscale and Physical Fatigue subscale each range from 0 to 12, with higher scores indicating greater fatigue and greater propensity to rest (worse outcome).
Measured: Baseline before the intervention (T0), within 4 weeks after the start of the intervention (T1), after 10 weeks of intervention (T2), and at 6 months (T3) and 12 months (T4) post-intervention.
Daytime Sleepiness as Assessed by the Epworth Sleepiness Scale (ESS)
Daytime sleepiness is assessed using the Epworth Sleepiness Scale (ESS), an 8-item questionnaire. Each item is scored from 0 to 3, resulting in a total score ranging from 0 to 24, with higher scores indicating greater daytime sleepiness (worse outcome).
Measured: Baseline before the intervention (T0), within 4 weeks after the start of the intervention (T1), after 10 weeks of intervention (T2), and at 6 months (T3) and 12 months (T4) post-intervention.
Dysfunctional Beliefs and Attitudes About Sleep as Assessed by the Dysfunctional Beliefs and Attitudes About Sleep Scale - 16 Item (DBAS-16)
Dysfunctional beliefs and attitudes about sleep are assessed using the 16-Item Dysfunctional Beliefs and Attitudes About Sleep Scale (DBAS-16). Each of the 16 items is rated from 0 to 10, with higher scores indicating stronger endorsement of dysfunctional beliefs and attitudes about sleep (worse outcome).
Measured: Baseline before the intervention (T0), within 4 weeks after the start of the intervention (T1), after 10 weeks of intervention (T2), and at 6 months (T3) and 12 months (T4) post-intervention.
Subjective Sleep Quality as Assessed by a Sleep Visual Analogue Scale (VAS)
Subjective sleep quality is assessed using a Sleep Visual Analogue Scale (VAS). Participants rate their sleep quality over the past 2 weeks on a scale ranging from 0 to 10, with 0 indicating very poor sleep quality and 10 indicating excellent sleep quality. Higher scores indicate better subjective sleep quality.
Measured: Baseline before the intervention (T0), within 4 weeks after the start of the intervention (T1), after 10 weeks of intervention (T2), and at 6 months (T3) and 12 months (T4) post-intervention.
Sleep Chronotype as Assessed by the Munich Chronotype Questionnaire (MCTQ)
Sleep chronotype is assessed using the Munich Chronotype Questionnaire (MCTQ). Chronotype is estimated using the sleep-corrected midpoint of sleep on free days (MSFsc), expressed as clock time. MSFsc represents the midpoint of sleep on free days corrected for sleep debt accumulated during workdays. Earlier clock times indicate an earlier chronotype, while later clock times indicate a later chronotype.
Measured: Baseline before the intervention (T0), within 4 weeks after the start of the intervention (T1), after 10 weeks of intervention (T2), and at 6 months (T3) and 12 months (T4) post-intervention.
Pain Severity as Assessed by the Brief Pain Inventory (BPI)
Pain severity is assessed using the Brief Pain Inventory (BPI) through four items assessing worst pain, least pain, average pain, and pain right now. Each item is scored from 0 (no pain) to 10 (pain as bad as you can imagine). The mean pain severity score ranges from 0 to 10, with higher scores indicating greater pain severity (worse outcome).
Measured: Baseline before the intervention (T0), within 4 weeks after the start of the intervention (T1), after 10 weeks of intervention (post intervention)(T2), and at 6 months post-intervention (T3) and 12 months post-intervention (T4).
Health-Related Quality of Life as Assessed by the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30)
Health-related quality of life is assessed using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30). The global health status/quality of life scale is scored from 0 to 100, with higher scores indicating better health-related quality of life.
Measured: Baseline before the intervention (T0), after 10 weeks of intervention (post-intervention) (T2), and at 6 months post-intervention (T3) and 12 months post-intervention (T4).
Depressive Symptoms as Assessed by the Depression Subscale of the Depression Anxiety Stress Scale-21 (DASS-21)
Depressive symptoms are assessed using the Depression subscale of the Depression Anxiety Stress Scale-21 (DASS-21). The subscale consists of 7 items, each scored from 0 (did not apply to me at all) to 3 (applied to me very much, or most of the time). The scores are summed and multiplied by 2, resulting in a total score ranging from 0 to 42. Higher scores indicate more severe depressive symptoms (worse outcome).
Measured: Baseline before the intervention (T0), after 10 weeks of intervention (post-intervention) (T2), and at 6 months post-intervention (T3) and 12 months post-intervention (T4).
Anxiety Symptoms as Assessed by the Anxiety Subscale of the Depression Anxiety Stress Scale-21 (DASS-21)
Anxiety symptoms are assessed using the Anxiety subscale of the Depression Anxiety Stress Scale-21 (DASS-21). The subscale consists of 7 items, each scored from 0 (did not apply to me at all) to 3 (applied to me very much, or most of the time). The scores are summed and multiplied by 2, resulting in a total score ranging from 0 to 42. Higher scores indicate more severe anxiety symptoms (worse outcome).
Measured: Baseline before the intervention (T0), after 10 weeks of intervention (post-intervention) (T2), and at 6 months post-intervention (T3) and 12 months post-intervention (T4).
Stress Symptoms as Assessed by the Stress Subscale of the Depression Anxiety Stress Scale-21 (DASS-21)
Stress symptoms are assessed using the Stress subscale of the Depression Anxiety Stress Scale-21 (DASS-21). The subscale consists of 7 items, each scored from 0 (did not apply to me at all) to 3 (applied to me very much, or most of the time). The scores are summed and multiplied by 2, resulting in a total score ranging from 0 to 42. Higher scores indicate more severe stress symptoms (worse outcome).
Measured: Baseline before the intervention (T0), after 10 weeks of intervention (post-intervention) (T2), and at 6 months post-intervention (T3) and 12 months post-intervention (T4).
Bodily Threat Monitoring as Assessed by the Bodily Threat Monitoring Scale (BTMS)
Bodily threat monitoring is assessed using the validated Bodily Threat Monitoring Scale (BTMS). The scale assesses the tendency to monitor bodily sensations and concerns about bodily sensations. The total score ranges from 0 to 24, with higher scores indicating a greater tendency to monitor bodily sensations.
Measured: Baseline before the intervention (T0), after 10 weeks of intervention (post-intervention) (T2), and at 6 months post-intervention (T3) and 12 months post-intervention (T4).
Fear of cancer recurrence as assesed using the Fear of Cancer Recurrence Inventory (FCRI).
Fear of cancer recurrence is assessed using the 42-item Fear of Cancer Recurrence Inventory (FCRI). The FCRI consists of 42 items rated on a 5-point scale from 0 to 4. The total score ranges from 0 to 168, with higher scores indicating greater fear of cancer recurrence (worse outcome).
Measured: Baseline before the intervention (T0), after 10 weeks of intervention (post-intervention) (T2), and at 6 months post-intervention (T3) and 12 months post-intervention (T4).
Perceptions of Insomnia as Assessed by self-designed study-specific questions
Perceptions of insomnia are assesed using three self-designed study-specific questions which are based on the Ilness Cognition Questionnaire (ICQ). Self-designed study specific questions were used to reduce patient burden. Participants rate their response on a scale from 0 to 100, with 0 indicating that insomnia perceptions are not negatively impacting their life and 100 indicating that insomnia has a significant impact on their lives. Higher scores indicate greater perceived negative outcomes related to insomnia.
Measured: Baseline before the intervention (T0), after 10 weeks of intervention (post-intervention) (T2), and at 6 months post-intervention (T3) and 12 months post-intervention (T4).
Perceptions about cancer as assesed by self-designed study-specific questions
Perceptions of cancer are assesed using three self-designed study-specific questions which are based on the Ilness Cognition Questionnaire (ICQ). Self-designed study specific questions were used to reduce patient burden. Participants rate their response on a scale from 0 to 100, with 0 indicating that cancer perceptions are not negatively impacting their life and 100 indicating that cancer has a significant impact on their lives. Higher scores indicate greater perceived negative outcomes related to cancer.
Measured: Baseline before the intervention (T0), after 10 weeks of intervention (post-intervention) (T2), and at 6 months post-intervention (T3) and 12 months post-intervention (T4).
Physical Fatigue as assessed by the Multidimensional Fatigue Inventory (MFI)
Physical fatigue is assessed using the Physical Fatigue subscale of the Multidimensional Fatigue Inventory (MFI). The subscale consists of 4 items, with a total score ranging from 4 to 20. Higher scores indicate greater physical fatigue (worse outcome).
Measured: Baseline before the intervention (T0), after 10 weeks of intervention (post-intervention) (T2), and at 6 months post-intervention (T3) and 12 months post-intervention (T4).
Mental Fatigue as assessed by the Multidimensional Fatigue Inventory
Mental fatigue is assessed using the Mental Fatigue subscale of the Multidimensional Fatigue Inventory (MFI). The subscale consists of 4 items, with a total score ranging from 4 to 20. Higher scores indicate greater mental fatigue (worse outcome).
Measured: Baseline before the intervention (T0), after 10 weeks of intervention (post-intervention) (T2), and at 6 months post-intervention (T3) and 12 months post-intervention (T4).
Reduced Motivation as assessed by the Multidimensional Fatigue Inventory
Reduced motivation is assessed using the Reduced Motivation subscale of the Multidimensional Fatigue Inventory (MFI). The subscale consists of 4 items, with a total score ranging from 4 to 20. Higher scores indicate greater reduction in motivation.
Measured: Baseline before the intervention (T0), after 10 weeks of intervention (post-intervention) (T2), and at 6 months post-intervention (T3) and 12 months post-intervention (T4).
Reduced Activity as assessed by the Multidimensional Fatigue Inventory
Reduced activity is assessed using the Reduced Activity subscale of the Multidimensional Fatigue Inventory (MFI). The subscale consists of 4 items, with a total score ranging from 4 to 20. Higher scores indicate greater reduction in activity.
Measured: Baseline before the intervention (T0), after 10 weeks of intervention (post-intervention) (T2), and at 6 months post-intervention (T3) and 12 months post-intervention (T4).
Pain Interference as Assessed by the Brief Pain Inventory (BPI)
Pain interference is assessed using the Brief Pain Inventory (BPI) through seven items assessing interference with general activity, mood, walking ability, normal work, relations with other people, sleep, and enjoyment of life. Each item is scored from 0 (does not interfere) to 10 (completely interferes). The mean pain interference score ranges from 0 to 10, with higher scores indicating greater pain interference (worse outcome).
Measured: Baseline before the intervention (T0), within 4 weeks after the start of the intervention (T1), after 10 weeks of intervention (post intervention)(T2), and at 6 months post-intervention (T3) and 12 months post-intervention (T4).
Perceived injustve as assesed by use of the injustice Experience Questionnaire (IEQ)
Perceived Injustice is assed by use of the Injustice Experience Questionnaire (IEQ). The Injustice experience Questionnaire has 12 items (ranging 0-4) with a total score ranging from 0-48. A total score on of 17 or more indicates the presence of cliniclly relevant perceived injustice by the participant.
Measured: Baseline before the intervention (T0), after 10 weeks of intervention (post-intervention) (T2), and at 6 months post-intervention (T3) and 12 months post-intervention (T4).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2026
- Study start15 Oct 2026 (estimated)
- Primary completion1 Jan 2030 (estimated)
- Study completion1 Apr 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NeoplasmsStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This project will use a three-armed, multicenter randomized controlled trial involving 140 cancer survivors that will compare eSTEPCBT-I with eSTANDCBT-I and CAU. Measurements will take place at four points in time (T0-(T1)-T2-T3-T4). Participants in the eSTEPCBT-I treatment arm who do not achieve insomnia remission at T1 (ISI score below 11) following sleep coaching (Step 1) will be referred to the full eSTANDCBT-I program (STEP 2), delivered over a shorter period (6 weeks).
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 140 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Vrije Universiteit Brussel
- Sponsor type
- University, hospital or other
- Collaborators
- Kom Op Tegen Kanker
- Responsible party
- Sponsor
- Investigators
- Astrid Lahousse, PhD, Principal investigator, Vrije Universiteit Brussel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07876661
- Sponsor's protocol ID
- 25454_eNightfall
- Acronym
- eNightfall
- Status last verified
- Sep 2026
- First submitted
- 18 Sep 2026
- Last updated
- 15 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes