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The study aims to assess the feasibility and acceptability of the implementation of a routine digital psychosocial screening combined with a psycho-oncological Navigation Call for cancer survivors after completion of primary treatment with the goal to improve identification of psychosocial needs and facilitate access to supportive care.
Cancer survivors frequently experience persistent psychosocial distress, including anxiety, fatigue, fear of recurrence, and reduced quality of life after completion of active treatment. Although routine distress screening is widely recommended, screening results alone often fail to translate into the utilization of psychosocial support services due to motivational, informational, and organizational barriers.
This single-centre prospective feasibility study evaluates a combined intervention consisting of routine digital patient-reported outcome screening and a structured psycho-oncological Navigation Call conducted shortly after follow-up consultation. The Navigation Call aims to discuss screening results, identify unmet psychosocial needs, address barriers to care, and facilitate referral to appropriate support services. The study primarily assesses the feasibility and acceptability of this intervention while also exploring psychosocial burden, support utilization, and reasons for accepting or declining psychosocial care.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Navigation Call | Experimental | Routine digital psychosocial screening plus a semi-structured psycho-oncological Navigation Call conducted 7-14 days after follow-up. The call focuses on discussion of screening results, identification of psychosocial needs and barriers, and facilitation of access to supportive care services. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Navigation Call | Behavioral | Semi-structured psycho-oncological Navigation Call to discuss screening results, identify psychosocial needs and barriers, and facilitate access to supportive care services. |
| Measure | Description | Time Frame |
|---|---|---|
| Feasibility of the Navigation Call | Assessment: Proportion of included participants who complete the Navigation Call Scale: Dichotomous outcome (completed yes/no) Interpretation: Higher proportion indicates greater feasibility | During the study intervention period, approximately 3 months after 1. follow-up consultation |
| Measure | Description | Time Frame |
|---|---|---|
| Acceptance of the Navigation Call: | Instrument: Adapted German version of the Theoretical Framework of Acceptability (TFA) questionnaire Items: 8 items Response scale: 5-point Likert scale Score range: 1-5 per item (or corresponding mean score across items) Interpretation: Higher scores indicate greater acceptability of the Navigation Call | 1 day to 1 week after the Navigation Call |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Noa Roemmel | Contact | +41 61 55 65325 | noanaa-wansa.roemmel@usb.ch |
| Name | Affiliation | Role |
|---|---|---|
| Diana Zwahlen,, Dr. phil. | University Hospital of Basel | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital Basel | Basel | 4031 | Switzerland |
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Random invitation single-arm trial (RISAT) in which eligible patients are randomly invited to receive a psycho-oncological Navigation Call in addition to routine care, while non-invited patients receive routine follow-up care only. Randomization applies to the invitation to the intervention rather than treatment allocation, and any comparison with non-invited patients is exploratory.
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| Acceptance of the digital screening in routine care | Instrument: Adapted German version of the Theoretical Framework of Acceptability (TFA) questionnaire Items: 8 items Response scale: 5-point Likert scale Score range: 1-5 per item (or corresponding mean score across items) Interpretation: Higher scores indicate greater acceptability of the digital screening | 1 day to 1 week after routine digital screening |
| Prevalence of psychosocial burden - Distress | Instrument: Distress Thermometer Score range: 0-10 Interpretation: Higher scores indicate greater distress Threshold for clinically relevant distress: ≥5 | At study inclusion (first follow-up consultation) |
| Prevalence of psychosocial burden - Physical functioning | Instrument: EORTC QLQ-F17 Physical Functioning scale Score range: 0-100 Interpretation: Higher scores indicate better functioning Threshold indicating impairment: <83 | At study inclusion (first follow-up consultation) |
| Prevalence of psychosocial burden - Role functioning | Instrument: EORTC QLQ-F17 Role Functioning scale Score range: 0-100 Interpretation: Higher scores indicate better functioning Threshold indicating impairment: <58 | At study inclusion (first follow-up consultation) |
| Prevalence of psychosocial burden - Emotional functioning | Instrument: EORTC QLQ-F17 Emotional Functioning scale Score range: 0-100 Interpretation: Higher scores indicate better functioning Threshold indicating impairment: <70 | At study inclusion (first follow-up consultation) |
| Prevalence of psychosocial burden - Cognitive functioning | Instrument: EORTC QLQ-F17 Cognitive Functioning scale Score range: 0-100 Interpretation: Higher scores indicate better functioning Threshold indicating impairment: <75 | At study inclusion (first follow-up consultation) |
| Prevalence of psychosocial burden - Social functioning | Instrument: EORTC QLQ-F17 Social Functioning scale Score range: 0-100 Interpretation: Higher scores indicate better functioning Threshold indicating impairment: <58 | At study inclusion (first follow-up consultation) |
| Prevalence of psychosocial burden - Global health status / quality of life | Instrument: EORTC QLQ-F17 Global Health Status / QoL scale Score range: 0-100 Interpretation: Higher scores indicate better global quality of life Threshold indicating impairment: <66.1 | At study inclusion (first follow-up consultation) |
| Prevalence of psychosocial burden - Fatigue | symptom-specific screening single items are collected using the standard EORTC 4-point response format: Response options: 1 = Not at all, 2 = A little, 3 = Quite a bit, 4 = Very much Score range: 1-4 Interpretation: Higher scores indicate greater symptom burden Threshold indicating clinically relevant symptoms: responses of 3 ("Quite a bit") or 4 ("Very much") | At study inclusion (first follow-up consultation) |
| Prevalence of psychosocial burden - Sleep problems | symptom-specific screening single items are collected using the standard EORTC 4-point response format: Response options: 1 = Not at all, 2 = A little, 3 = Quite a bit, 4 = Very much Score range: 1-4 Interpretation: Higher scores indicate greater symptom burden Threshold indicating clinically relevant symptoms: responses of 3 ("Quite a bit") or 4 ("Very much") | At study inclusion (first follow-up consultation) |
| Utilization of psycho-oncological support | Outcome measure: New engagement with in-house psycho-oncology services following screening Scale: Dichotomous outcome (yes/no) Interpretation: Higher proportions indicate greater uptake of psycho-oncological support | Within 4 months after screening |
| Engagement in community-based support programs and barriers to support uptake | Outcome measure: Use of community-based support services and reported barriers/facilitators Assessment method: Qualitative data collected during the Navigation Call and documented in structured field notes or call transcripts | During the Navigation Call |