Online psychological program for cancer survivors
Randomized Factorial Trial of Internet-Delivered Psychological Treatment for Cancer Survivors With Clinically Significant Psychiatric Symptoms
This trial tests whether different parts of a 10-week therapist-guided online psychological program help adult cancer survivors with anxiety, depression, or fear of recurrence.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 400 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Karolinska Institutet Academic / other |
| Drugs / interventions | chemotherapy, immunotherapy |
| Locations | 1 site (Stockholm) |
| Trial ID | NCT06046586 on ClinicalTrials.gov |
What this trial studies
In this randomized factorial trial at Karolinska Institutet, 400 cancer survivors with clinically significant anxiety, depression, or fear of recurrence are randomized to receive variations of a 10-week therapist-guided online psychological program. The intervention manipulates four components—support and information, behavioral activation, systematic exposure with mindfulness training, and promotion of health behaviors—to determine which elements contribute most to improvement. The factorial design permits estimation of each component’s independent and combined effects on symptom change using standardized self-report scales and structured interviews over the treatment and follow-up periods. Eligible participants are adults at least six months after primary cancer therapy, fluent in Swedish, residents of specified Swedish regions, and able to access the web platform via a personal electronic device.
Who should consider this trial
Good fit: Adult cancer survivors (≥18 years), at least 6 months after primary therapy, living in Region Stockholm, Västra Götaland, or Region Skåne, who have clinically significant anxiety, depression, or fear of recurrence and can read Swedish and use an internet device are ideal candidates.
Not a fit: Patients with severe psychiatric disorders (e.g., psychosis or bipolar disorder), high suicide risk, very poor prognosis or advanced (stage IV) cancer, those who cannot use Swedish or lack reliable internet access are unlikely to benefit or be eligible.
Why it matters
Potential benefit: If successful, the trial could identify the most effective parts of online therapy so survivors can receive shorter, more focused, and more widely accessible psychological care.
How similar studies have performed: Previous internet-delivered cognitive behavioral therapy programs have shown promise in cancer survivors, but the component-level effects targeted by this factorial design are relatively untested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Cancer survivor at least 0.5 years after main therapy * 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 Region Stockholms, Västra Götalandsregionen, or Region Skåne, 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
Where this trial is running
Stockholm
- Karolinska Institutet — Stockholm, Sweden (Recruiting)
Study contacts
- Principal investigator: Erland Axelsson, PhD — Karolinska Institutet
- Study coordinator: Erland Axelsson, PhD
- Email: erland.axelsson@ki.se
- Phone: 0706171039
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.