Online psychological program for cancer survivors

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.