An interventional study of Blended pain-sleep intervention in Life After Cancer, sponsored by Vrije Universiteit Brussel. Not yet recruiting at 1 site in Belgium. Open to participants aged 16 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-11-13.
Sponsored by Vrije Universiteit Brussel · Not applicable, Interventional, and Supportive care
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Among 12 studies in Pain by Vrije Universiteit Brussel — 4 open to participants now, 5 under way, none of them phase 3. Pain · Vrije Universiteit Brussel.
Among the 12 studies in Pain by Vrije Universiteit Brussel, this one is one of 2 that started in 2026, is one of 9 with no phase, and was the 12th registered.
10,066 studies on the registry are indexed under Pain; 1,651 are open to participants now.
Browse Pain studies →4 of the 12 studies in Pain by Vrije Universiteit Brussel are open now, in 1 country. Recruiting first, the newest first:
Vrije Universiteit Brussel · Sites in Belgium
Ages 18–70 · Healthy volunteers
Vrije Universiteit Brussel · Sites in Belgium
Ages 18–60 · Healthy volunteers
Vrije Universiteit Brussel · Sites in Belgium
Ages 6–12 · Healthy volunteers
By country, each count listing its studies:
Of the 928 Pain studies recruiting now, 383 (41%) set no upper age limit and 434 (47%) stop at 75 or younger; 146 take children under 18; 222 take healthy volunteers.
This study: 16 Years and older · all sexes · healthy volunteers too.
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12 studies; the count open now beside each. This study's row is marked.
First in 2017; this study’s year is marked. 2 started in 2026.
This study's planned enrollment of 46 is below the median of 66 across 8,502 interventional studies indexed under Pain.
Median enrollment 46 across the 9 interventional studies, 80 across the 3 observational. Of the 6 that completed or were terminated, 0 (0%) have results posted.
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Vrije Universiteit Brussel is the lead sponsor of 160 studies on the registry; 44 are open to participants now.
2 of the studies in Pain by Vrije Universiteit Brussel that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07120646Vrije Universiteit BrusselPain and Sleep Disturbances in Children Living Beyond Cancer: A Case-Control Study | 2026-12 |
| NCT05387473Vrije Universiteit BrusselAdded Value of Cognitive Behavioural Therapy for Insomnia in Persons With Knee Osteoarthritis | 2026-12 |
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Among the 12 studies in Pain by Vrije Universiteit Brussel, from their registry updates:
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The COMPAZzz project aims to co-develop and evaluate the feasibility of a blended pain and sleep management intervention for adolescents and young adults (AYA) living beyond cancer. Pain and sleep disturbances are common among AYA living beyond cancer and frequently coexist, whereby pain may disrupt sleep and poor sleep may increase pain. In turn, these symptoms may negatively affect quality of life, psychological well-being, and participation in education, work, and social activities.
Despite the considerable impact of these symptoms, pain and sleep disturbances are often addressed separately in survivorship care. COMPAZzz seeks to address this gap by developing an integrated, non-pharmacological (= without administering medication) intervention combining principles of Pain Science Education (PSE) and Cognitive Behavioural Therapy for insomnia (= sleeplessness) (CBT-i). PSE aims to improve understanding of pain by addressing misconceptions and explaining the biological, psychological, and social factors that influence pain experiences. CBT-i targets thoughts, behaviours, and emotions that contribute to sleep disturbances.
Using a Participatory Action Research (PAR) approach, AYA living beyond cancer will actively contribute to the development of the intervention in collaboration with relevant stakeholders, including significant others and oncology clinicians. This collaborative approach aims to ensure that the intervention reflects the needs, preferences, and lived experiences of the target population, thereby supporting its acceptability, engagement, and potential implementation in clinical practice and everyday life.
COMPAZzz aims to establish a foundation for more integrated and person-centered survivorship care addressing co-occurring pain and sleep disturbances in AYA living beyond cancer.
Adolescents and young adults (AYA) living beyond cancer may experience persistent pain and sleep disturbances following cancer treatment. These symptoms frequently coexist and interact bidirectionally. Together, pain and sleep disturbances may negatively affect fatigue, psychological well-being, daily functioning, and quality of life. Despite their close relationship, these symptoms are often managed separately in clinical practice.
Pain Science Education (PSE) aims to improve understanding of pain by addressing misconceptions and explaining the biological, psychological, and social factors that influence pain experiences. Cognitive Behavioural Therapy for insomnia (CBT-i) targets thoughts, behaviours, and emotions that contribute to sleep disturbances. Integrating PSE and CBT-i principles into a blended pain-sleep intervention may offer a more comprehensive approach to managing both symptoms. However, such an intervention has not yet been developed specifically for AYA living beyond cancer. The COMPAZzz project therefore aims to co-develop an integrated pain-sleep intervention with and for AYA living beyond cancer (WP1) and to evaluate its feasibility in practice in a second workpackage.
In this first workpackage the intervention development will take place using a Participatory Action Research (PAR) approach. The development will be guided by the Intervention Mapping Protocol (IMP), an iterative framework that supports the development of interventions based on identified needs, behavioural and environmental targets, theory-based methods, and practical implementation requirements.
The intervention development process will involve AYA living beyond cancer, significant others, oncology clinicians, and the research consortium. The AYA co-creation group will comprise 10-12 participants, aiming to include 5-6 individuals diagnosed with cancer between 16 and 25 years of age and 5-6 diagnosed between 26 and 35 years of age. This distribution is intended to represent different life stages and experiences within the AYA population. Significant others and a multidisciplinary group of oncology clinicians will contribute additional perspectives on the challenges experienced by AYA, their support needs, and the practical requirements of integrating an intervention into survivorship care. At least one psychologist will be recruited to provide expertise in the development of the sleep intervention based on CBT-i principles.
Intervention development will proceed through five iterative phases, with six co-creation sessions with AYA, each lasting approximately 1.5 hours, and an additional seventh session focused on the planned feasibility evaluation. In the first session, participants will be introduced to the project and invited to identify their needs, experiences, barriers, and facilitators related to pain and sleep management. Sessions two and three will focus on defining and prioritising behavioural and environmental targets and selecting appropriate theory-based intervention methods. Sessions four and five will translate these priorities into a practical intervention by determining its content, format, delivery method, timing, materials, and organisation. Session six will involve trying out a preliminary version of the co-developed intervention, for example through a webinar, website, or face-to-face format, and collecting feedback. Additional sessions may be organised if needed to reach consensus. The seventh session will gather AYA input on the proposed feasibility study.
In parallel with the initial AYA co-creation activities, focusgroup discussions will be organised separately for significant others and oncology clinicians to explore their perspectives on AYA's challenges and gaps in current pain and sleep management. Approximately three focusgroups per stakeholder category are anticipated, with 6-8 participants per group; the final number will depend on whether data saturation is achieved. Significant others and oncology clinicians will also participate in joint expert consulting sessions during the subsequent development phases. Each expert consulting session will include approximately 6-8 participants, with an equal distribution of significant others and oncology clinicians. Participants in the focus groups may also take part in the expert consulting sessions if they wish.
Throughout the development process, the research consortium will review findings between sessions and use stakeholder feedback to refine subsequent activities. The iterative nature of the IMP will allow earlier decisions to be revisited when necessary. Co-creation sessions, focus groups, and expert consulting sessions will be organised in person, online, or in a hybrid format according to participant preferences. The final co-developed intervention will be offered to participating AYA free of charge.
The resulting intervention will be a blended, non-pharmacological pain-sleep management programme tailored to AYA living beyond cancer. Its content and delivery format will be determined through the participatory development process. The intervention will integrate PSE to improve understanding of pain and its biopsychosocial determinants, CBT-i principles to address factors contributing to sleep disturbances, and strategies that address the interaction between pain and sleep. Broader self-management approaches, potentially including physical activity and stress reduction, may also be incorporated. The specific intervention components, duration, number of sessions, delivery methods, and supporting materials will be finalised during co-development.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
A. Pain: Pain that started during cancer treatment or after completion of cancer treatment, with no minimum cut-off for pain intensity or duration, but with a self-reported significant impact on daily functioning and/or quality of life (QoL).
B. Insomnia disorder: Meeting the research diagnostic criteria for insomnia disorder, defined as self-reported sleep difficulties on ≥3 nights per week during the past month, accompanied by ≥1 daytime sleep-related problem).
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
This arm encompasses the AYA, who will participate in 7 co-creation sessions. To co-create the intervention and plan a feasible implementation.
Other: Blended pain-sleep intervention
This arm encompasses significant others, who will provide information and extra insights in the issue next to the information gathered from the AYA.
Other: Blended pain-sleep intervention
This arm encompasses oncology clinicians, who will provide information and extra insights in the issue next to the information gathered from the AYA.
Other: Blended pain-sleep intervention
Intervention development will involve AYA (10-12 participants), significant others, and oncology clinicians. AYA will attend six co-creation sessions (1.5 hours each) and a seventh on feasibility evaluation. Sessions cover pain and sleep needs (session 1), behavioural and environmental targets and theory-based methods (sessions 2-3), intervention development (sessions 4-5), and testing a preliminary intervention (session 6). Separate focus groups with significant others and oncology clinicians will explore AYA's challenges and care gaps. Approximately three groups per stakeholder category are planned, with 6-8 participants each, depending on data saturation. Joint expert consultations (6-8 participants, equally representing both groups) will refine intervention targets and components, ensure guideline alignment, and assess scientific and practical feasibility. Consultations follow sessions 2 and 5, with feedback informing further development. Focus group participants may also join.
Development and documentation of a blended pain-sleep intervention using Participatory Action Research and the Intervention Mapping Protocol
A blended pain-sleep intervention for AYA living beyond cancer will be developed using a Participatory Action Research (PAR) approach guided by the Intervention Mapping Protocol (IMP), a framework for developing, implementing, and evaluating health-promoting interventions. Development will involve seven co-creation sessions with AYA living beyond cancer, as well as focus group discussions with significant others and oncology clinicians to identify the needs and preferences of AYA. Two subsequent expert consultation sessions will gather further feedback on the co-created intervention. Qualitative input and recommendations will be documented and used to refine the intervention objectives, components, and content.
Time frame: 13 months. The time between the enrollment-period and the end of co-creation-period.
Baseline assessment of demographic, socioeconomic, clinical, and professional characteristics using a self-developed questionnaire in AYAs, significant others, and oncology clinicians
At baseline, all study participants will complete a self-developed questionnaire to collect demographic and socioeconomic characteristics, including age, sex, gender, socioeconomic status, and ethnicity. For AYAs living beyond cancer, additional information will be collected on cancer history, including cancer type(s), date(s) of diagnosis, cancer treatment(s), treating hospital(s), other medical history, and current or previous psychosocial, physical, and pharmacological treatments. Significant others will report their relationship with the AYA and provide relevant information about the AYA's cancer history. Oncology clinicians will report their oncology experience and experience in pain and sleep management for AYAs living beyond cancer.
Time frame: At the start of the study, before the intervention development activities begin.
Pain severity and pain interference assessed using the Brief Pain Inventory (BPI) in AYAs living beyond cancer
The Brief Pain Inventory (BPI) is a 14-item questionnaire used to assess pain severity and pain interference with daily functioning in people with cancer. It evaluates worst pain and other aspects of pain severity and interference over the past week, with items rated on a scale from 0 to 10. The pain interference score is calculated as the mean of seven items assessing the extent to which pain interferes with daily activities, including walking, mood, and sleep. Higher scores indicate greater pain severity or interference.
Time frame: At the start of the study, before the intervention development activities begin.
Neuropathic pain symptoms assessed using the 7-item Douleur Neuropathique 4 (DN-4) in AYAs
Neuropathic pain symptoms will be assessed using the 7-item DN-4 questionnaire. The 7-item DN-4 questionnaire is on the first 7 items of the 10-item DN-4 questionnaire. The items are related to the quality of pain (burning, painful cold, electric shocks) and its association to abnormal sensations (tingling, pins and needles, numbness, itching). Each item is scored as 0 (no) or 1 (yes). A total score of ≥4/7 is indicative for the diagnosis of neuropathic pain.
Time frame: At the start of the study, before the intervention development activities begin.
Central sensitization-related symptoms assessed using the Central Sensitization Inventory (CSI) in AYAs
Central sensitization-related symptoms will be assessed using the Central Sensitization Inventory (CSI), a questionnaire measuring the frequency and severity of symptoms associated with central sensitivity syndromes. The CSI consists of 25 items, each scored on a 5-point scale from 0 (never) to 4 (always), yielding a total score ranging from 0 to 100. Higher scores reflect a greater burden of symptoms. A score of 40 or higher indicates the presence of central sensitization pain.
Time frame: At the start of the study, before the intervention development activities begin.
Insomnia severity assessed using the Insomnia Severity Index (ISI) in AYAs
The Insomnia Severity Index (ISI) is a self-report questionnaire used to identify potential cases of insomnia and assess insomnia severity, covering both nighttime symptoms and daytime impairment. It consists of seven items, each rated on a 5-point Likert scale ranging from 0 to 4, yielding a total score between 0 and 28. Higher scores indicate greater insomnia severity. A cut-off score of 10 is considered optimal for detecting insomnia cases, while a reduction of 8.4 points has been associated with moderate improvement in insomnia severity.
Time frame: At the start of the study, before the intervention development activities begin.
Multidimensional fatigue assessed using the Multidimensional Fatigue Inventory (MFI) in AYAs
The Multidimensional Fatigue Inventory (MFI) is a 20-item self-report questionnaire designed to assess fatigue across five domains: general fatigue, physical fatigue, reduced activity, reduced motivation, and mental fatigue. Each item is scored on a 5-point scale ranging from 1 (totally agree) to 5 (disagree). The total score ranges from 20 to 100, with higher scores indicating greater levels of fatigue.
Time frame: At the start of the study, before the intervention development activities begin.
Participant-reported process evaluation of the Intervention Mapping Protocol process using a self-developed questionnaire and the PEET-12
The Intervention Mapping Protocol (IMP) process will be evaluated at the end of each session (co-creation/focus group discussions/expert consultations) using a self-developed questionnaire and the PEET-12. All study participants involved in these sessions will be asked to complete both questionnaires. The PEET-12 assesses participants' engagement in the process. The self-developed questionnaire assesses participants' satisfaction and appreciation, perceived knowledge and self-efficacy, and their overall feedback on the session. Items in the self-developed questionnaire will be rated on a 5-point Likert scale ranging from 1 (strongly disagree) to 5 (strongly agree).
Time frame: 12 months. From the start to the completion of the intervention development process.
Plan to share: No — IPD will not be shared due to ethical and legal restrictions and different privacy aspects.
No publications or documents are linked to this record.
Start is estimated for Oct 2026; primary completion for Dec 2027, 14 months later.
Of 3,738 non-industry interventional studies with no phase under Pain, half reached primary completion within 10 months of starting (the median), counting those still running; a quarter within 4 and three quarters within 23. This study's planned 14 months is above that.
Counting every sponsor, half of 3,837 studies reached it within 10 months; a quarter within 4 and three quarters within 23.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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