Clinical trial NCT06046586: Internet-Delivered Psychological Treatment for Cancer Survivors
Official title: Randomized Factorial Trial of Internet-Delivered Psychological Treatment for Cancer Survivors With Clinically Significant Psychiatric Symptoms
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Cancer Survivors
Anxiety
Depression
Keywords: psycho-oncology
randomized factorial trial
Internet-delivered cognitive behavior therapy
Lead sponsor: Karolinska Institutet
Sponsor class: OTHER
Collaborators: name: Region Stockholm
First posted: 2023-09-21
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

Brief summary: 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 randomized factorial trial at Karolinska Institutet, Stockholm, Sweden, 400 cancer survivors with psychiatric symptoms are enrolled in variations on a 10-week therapist-guided online psychological treatment intended to address the negative psychological long-term effects of cancer. The aim is to determine the contribution of treatment components to the overall effect.


Eligibility 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

Primary outcomes:
measure: General anxiety
timeFrame: Pre-treatment (within 2 weeks before treatment), via weekly assessments, to post-treatment (after treatment, completed within 90 days). Secondary analysis: from pre-treatment up to follow-up 12-months after treatment (completed within 90 days).
measure: Depressive symptoms
timeFrame: Pre-treatment (within 2 weeks before treatment), via weekly assessments, to post-treatment (after treatment, completed within 90 days). Secondary analysis: from pre-treatment up to follow-up 12-months after treatment (completed within 90 days).
measure: Fear of cancer recurrence
timeFrame: Pre-treatment (within 2 weeks before treatment), via weekly assessments, to post-treatment (after treatment, completed within 90 days). Secondary analysis: from pre-treatment up to follow-up 12-months after treatment (completed within 90 days).
Secondary outcomes:
measure: Health anxiety
timeFrame: Pre-treatment assessment (within 2 weeks before treatment) to post-treatment assessment (immediately after treatment, completed within 90 days). Secondary analysis: from pre-treatment up to follow-up 12-months after treatment (completed within 90 days).
measure: Somatic symptom burden
timeFrame: Pre-treatment assessment (within 2 weeks before treatment) to post-treatment assessment (immediately after treatment, completed within 90 days). Secondary analysis: from pre-treatment up to follow-up 12-months after treatment (completed within 90 days).
measure: Body image distress
timeFrame: Screening (within 6 months before treatment) to post-treatment assessment (immediately after treatment, completed within 90 days)
measure: Disability
timeFrame: Pre-treatment assessment (within 2 weeks before treatment) to post-treatment assessment (immediately after treatment, completed within 90 days). Secondary analysis: from pre-treatment up to follow-up 12-months after treatment (completed within 90 days).
measure: Treatment credibility and patient expectancy of improvement
timeFrame: Week 2 of treatment
measure: Relationship with the therapist (therapeutic alliance)
timeFrame: Week 2 of treatment
measure: Patient satisfaction with treatment
timeFrame: Post-treatment assessment (immediately after treatment, completed within 90 days)
measure: Adverse events
timeFrame: Post-treatment assessment (immediately after treatment, completed within 90 days)
measure: Perceived negative effects of treatment
timeFrame: Post-treatment assessment (immediately after treatment, completed within 90 days)
measure: Lifestyle behaviors
timeFrame: Pre-treatment assessment (within 2 weeks before treatment) to post-treatment assessment (immediately after treatment, completed within 90 days).
Other outcomes:
measure: Process and target variables: Behavioral activation
timeFrame: Pre-treatment (within 2 weeks before treatment), once each week during treatment (9 assessments in total), post-treatment (after treatment, completed within 90 days), and at follow-up 6 and 12 months after treatment (each completed within 90 days).
measure: Process and target variables: Symptom preoccupation
timeFrame: Pre-treatment (within 2 weeks before treatment), once each week during treatment (9 assessments in total), post-treatment (after treatment, completed within 90 days), and at follow-up 6 and 12 months after treatment (each completed within 90 days).
measure: Process and target variables: Physical activity
timeFrame: Pre-treatment (within 2 weeks before treatment), once each week during treatment (9 assessments in total), post-treatment (after treatment, completed within 90 days), and at follow-up 6 and 12 months after treatment (each completed within 90 days).
measure: Process and target variables: Health-related self-efficacy
timeFrame: Pre-treatment (within 2 weeks before treatment), once each week during treatment (9 assessments in total), post-treatment (after treatment, completed within 90 days), and at follow-up 6 and 12 months after treatment (each completed within 90 days).
measure: Basis for cost-effectiveness analysis: Utility (health-related quality of life)
timeFrame: Pre-treatment assessment (within 2 weeks before treatment), post-treatment assessment (immediately after treatment, completed within 90 days), 6 months after treatment (completed within 90 days), 12 months after treatment (completed within 90 days).
measure: Basis for cost-effectiveness analysis: Resource use (medical costs and productivity losses)
timeFrame: Pre-treatment assessment (within 2 weeks before treatment), post-treatment assessment (immediately after treatment, completed within 90 days), 6 months after treatment (completed within 90 days), 12 months after treatment (completed within 90 days).
measure: Process and target variables: Health anxiety behaviors
timeFrame: Pre-treatment (within 2 weeks before treatment), once each week during treatment (9 assessments in total), post-treatment (after treatment, completed within 90 days)
measure: Screening only: Alcohol use
timeFrame: Screening (within 6 months before treatment)
measure: Screening only: Substance use
timeFrame: Screening (within 6 months before treatment)
Locations:
Study officials:
affiliation: Karolinska Institutet
name: Erland Axelsson, PhD
role: PRINCIPAL_INVESTIGATOR
References: