Clinical trial · Interventional
Pilot Study of Internet-Delivered Psychological Treatment for Cancer Survivors
Pilot Study of Internet-Delivered Psychological Treatment for Cancer Survivors With Clinically Significant Psychiatric Symptoms
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Negative psychological effects of cancer are common, but cancer survivors are rarely offered structured psychological treatment. Internet-delivered treatments have shown some promise, but specific treatment components have not been empirically evaluated which means that it is not clear which therapies that should be prioritized. In this factorial pilot study, 48 cancer survivors with psychiatric symptoms are enrolled in variations on a 10-week therapist-guided online psychological treatment intended to address common negative psychological long-term effects of cancer. The aim of this study is to assess the feasibility of the study design and online treatment format. Key feasibility outcomes include interest in the study, patient-reported credibility of the intervention, adherence to the treatment protocol, satisfaction with the treatment, acceptability of the measurement strategy, missing data rates, adverse events, and preliminary efficacy on anxiety, depression, the fear of recurrence, and health-related quality of life.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Anxiety | — | UNRESOLVED | — |
| Cancer Survivors | — | UNRESOLVED | — |
| Depression | — | UNRESOLVED | — |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Behavioral activation | Behavioral | — | UNRESOLVED |
| Promotion of health behaviors | Behavioral | — | UNRESOLVED |
| Support and information | Behavioral | — | UNRESOLVED |
| Systematic exposure with mindfulness training | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (8)
- type
- EXPERIMENTAL
- label
- Internet-delivered psychological treatment, arm #1
- description
- Support and information + Behavioral activation
- interventionNames
- Behavioral: Support and information
- Behavioral: Behavioral activation
- type
- EXPERIMENTAL
- label
- Internet-delivered psychological treatment, arm #2
- description
- Support and information + Systematic exposure with mindfulness training
- interventionNames
- Behavioral: Support and information
- Behavioral: Systematic exposure with mindfulness training
- type
- EXPERIMENTAL
- label
- Internet-delivered psychological treatment, arm #3
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Cancer survivor at least 0.5 years after main therapy. Survivor of breast cancer (n=24), testicular cancer (n=12), or thyroid cancer (n=12). * Clinically significant anxiety or depression (Patient Health Questionnaire 9 \[PHQ-9\]≥10, or Generalized Anxiety Disorder 7 \[GAD-7\]≥8, or 9-item Fear of Cancer Recurrence Inventory \[FCRI-9\]≥16) * At least 18 years old * Resident of Sweden (listed and de facto) * Sufficient technical knowledge and knowledge of the Swedish language to take part in a text-based online treatment * Continuous access to an electronic device that can be used to access the study web platform Exclusion Criteria: * Recurrent thoughts of suicide, as based on clinical judgement aided by the structured interview and the self-report version of the Montgomery-Åsberg Depression Rating Scale (MADRS-S) item 9 * Severe medical condition (e.g., very poor prognosis, stage IV cancer), severe psychiatric disorder (e.g., psychotic disorder, bipolar disorder, or severely debilitating substance use disorder, severe depression), or medical treatment (e.g., chemotherapy, immunotherapy, radiotherapy) that makes the treatment unfeasible * Other ongoing psychological treatment * Continuous psychotropic medication not stable for the past 4 weeks, or not expected to remain stable during the treatment period * Planned absence for more than one week of the intended treatment period * No complete the pre-treatment assessment
References
Publications (1)
- DERIVEDWinter J, Gasslander N, Rane G, Sundstrom F, Bjorkhem-Bergman L, Hedman C, Axelsson E. Proof-of-concept for a randomized factorial design strategy to build a complex online support program for cancer survivors with psychiatric symptoms: the IN-FACT-0 feasibility trial. J Cancer Surviv. 2025 Oct 25. doi: 10.1007/s11764-025-01905-2. Online ahead of print. PMID 41136825