Cancer SurvivorshipBRIDGENCT07672314
Bridging the Gap in Psychosocial Care for Cancer Survivors
A study testing Navigation Call in people with Cancer Survivorship and Psychological Distress, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer Survivorship, Psychological Distress, Psycho-Oncology
- What is being tested?
- Navigation Call
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteSwitzerland
- Study dates
- 26 Jun 2026to May 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Adults aged ≥18 years
- Under oncological care at the USB for ≥9 months
- Completion of primary cancer treatment (see definition below)
- Attendance at routine oncological follow-up at USB
- Ability to provide written informed consent
Who cannot join
- Primary brain tumors
- Severe cognitive impairment
- Acute psychiatric symptoms that may impair the participant's ability to provide informed consent or comply with study procedures
- Insufficient German language skills
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Switzerland1 site, 1 recruiting
- Recruiting
University Hospital Basel
Basel, 4031
Noa Roemmel, +41 61 55 65325, noanaa-wansa.roemmel@usb.ch
Diana Zwahlen, Dr. Phil., +41 61 55 65740, diana.zwahlen@usb.ch
About this study
Official title: Bridging the Gap in Psychosocial Care for Cancer Survivors: Integrating Digital Screening With Navigation Call
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.
Read the detailed description
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.
- Being tested
- Navigation Call
- Keywords
- Cancer survivors, Survivorship care, Digital screening, Psycho-oncology, Psychosocial distress, Patient-reported outcomes (PROs), Navigation Call, Feasibility study, Acceptability
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Navigation CallBehavioural
Semi-structured psycho-oncological Navigation Call to discuss screening results, identify psychosocial needs and barriers, and facilitate access to supportive care services.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Navigation Call |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: During the study intervention period, approximately 3 months after 1. follow-up consultation
Secondary outcomes (13)
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
Measured: 1 day to 1 week after the Navigation Call
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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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")
Measured: 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")
Measured: 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
Measured: 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
Measured: During the Navigation Call
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2026
- Study start26 Jun 2026
- Primary completionMay 2028 (estimated)
- Study completionMay 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cancer SurvivorshipStudies of the same condition, open and under way.
- More trials run by University Hospital, Basel, SwitzerlandThe sponsor's other registered studies.
- 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
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Basel, Switzerland
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Diana Zwahlen,, Dr. phil., Study chair, University Hospital of Basel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07672314
- Sponsor's protocol ID
- 2026-00954;th26Zwahlen
- Acronym
- BRIDGE
- Status last verified
- Aug 2026
- First submitted
- 17 Jun 2026
- Last updated
- 10 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 10 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bridging the Gap in Psychosocial Care for Cancer Survivors: Integrating Digital Screening With Navigation Call
- ClinicalTrials.gov ID
- NCT07672314
- Acronym / sponsor ID
- BRIDGE / 2026-00954;th26Zwahlen
- Keywords
- Cancer survivors, Survivorship care, Digital screening, Psycho-oncology, Psychosocial distress, Patient-reported outcomes (PROs), Navigation Call, Feasibility study
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- University Hospital, Basel, SwitzerlandUniversity, hospital or other
- Study start
- 26 Jun 2026 (actual)
- Primary completion
- May 2028 (estimated)
- Study completion
- May 2028 (estimated)
- First posted
- 26 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Navigation Call | Experimental | Behavioral: Navigation CallRoutine 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Adults aged ≥18 years
- Under oncological care at the USB for ≥9 months
- Completion of primary cancer treatment (see definition below)
- Attendance at routine oncological follow-up at USB
- Ability to provide written informed consent
Key exclusion criteria (4 listed)
- Primary brain tumors
- Severe cognitive impairment
- Acute psychiatric symptoms that may impair the participant's ability to provide informed consent or comply with study procedures
- Insufficient German language skills
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Navigation CallSemi-structured psycho-oncological Navigation Call to discuss screening results, identify psychosocial needs and barriers, and facilitate access to supportive care services. | Behavioural | Navigation Call |
Primary outcome
Feasibility of the Navigation Call
Time frame: During the study intervention period, approximately 3 months after 1. follow-up consultation
Assessment: Proportion of included participants who complete the Navigation Call Scale: Dichotomous outcome (completed yes/no) Interpretation: Higher proportion indicates greater feasibility
13 secondary outcomes
Acceptance of the Navigation Call:
Time frame: 1 day to 1 week after the Navigation Call
Acceptance of the digital screening in routine care
Time frame: 1 day to 1 week after routine digital screening
Prevalence of psychosocial burden - Distress
Time frame: At study inclusion (first follow-up consultation)
Prevalence of psychosocial burden - Physical functioning
Time frame: At study inclusion (first follow-up consultation)
Prevalence of psychosocial burden - Role functioning
Time frame: At study inclusion (first follow-up consultation)
Prevalence of psychosocial burden - Emotional functioning
Time frame: At study inclusion (first follow-up consultation)
Prevalence of psychosocial burden - Cognitive functioning
Time frame: At study inclusion (first follow-up consultation)
Prevalence of psychosocial burden - Social functioning
Time frame: At study inclusion (first follow-up consultation)
Prevalence of psychosocial burden - Global health status / quality of life
Time frame: At study inclusion (first follow-up consultation)
Prevalence of psychosocial burden - Fatigue
Time frame: At study inclusion (first follow-up consultation)
Prevalence of psychosocial burden - Sleep problems
Time frame: At study inclusion (first follow-up consultation)
Utilization of psycho-oncological support
Time frame: Within 4 months after screening
Engagement in community-based support programs and barriers to support uptake
Time frame: During the Navigation Call
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Aug 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Diana Zwahlen,, Dr. phil. study chair
University Hospital of Basel
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Navigation Call in people with Cancer Survivorship and Psychological Distress, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 10 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Noa Roemmel (+41 61 55 65325, noanaa-wansa.roemmel@usb.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of the Navigation Call (time frame: During the study intervention period, approximately 3 months after 1. follow-up consultation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Aug 2026.