Intervention for COMorbid PAin and SLEEP in AYA Living Beyond Cancer (WP1) (COMPAZzz)

This arm encompasses the AYA, who will participate in 7 co-creation sessions. To co-create the intervention and plan a feasible implementation.

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.

This arm encompasses significant others, who will provide information and extra insights in the issue next to the information gathered from the AYA.

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.

This arm encompasses oncology clinicians, who will provide information and extra insights in the issue next to the information gathered from the AYA.

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.

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.

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.

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.

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.

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.

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.

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.

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).