Internet-Delivered Psychological Treatment for Cancer Survivors
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorKarolinska Institutet
About this trial
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
This trial does not accept healthy volunteersQualifiers
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)
Disqualifiers
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
Trial design
Design model
Factorial
Treatments tested in this trial
Support and information
BehavioralEmotional and technical support. Information about the long-term effects of cancer.
Behavioral activation
BehavioralBehavioral activation with existential themes and emphasis on values and relationships.
Systematic exposure with mindfulness training
BehavioralSystematic exposure with mindfulness training with a focus on anxiety about health and/or death, body image, and cancer-related trauma.
Promotion of health behaviors
BehavioralAn overview of self-management techniques in terms of physical exercise, dietary advice, and strategies for improved sleep.
Treatment groups
400 Participants
are divided into 8 treatment groups8
Treatment groupsSee each treatment group below.
Group A: Internet-delivered psychological treatment, arm #1Experimental treatment 2 interventions
Group B: Internet-delivered psychological treatment, arm #2Experimental treatment 2 interventions
Group C: Internet-delivered psychological treatment, arm #3Experimental treatment 2 interventions
Group D: Internet-delivered psychological treatment, arm #4Experimental treatment 3 interventions
Group E: Internet-delivered psychological treatment, arm #5Experimental treatment 3 interventions
Group F: Internet-delivered psychological treatment, arm #6Experimental treatment 3 interventions
Group G: Internet-delivered psychological treatment, arm #7Experimental treatment 4 interventions
Group H: Internet-delivered psychological treatment, arm #8Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
General anxiety
General Anxiety Disorder 7 (GAD-7, theoretical range: 0-21, where a higher score indicates more general anxiety). The phrasing is revised to concern the past week. The conventional version is also administered at screening (within 6 months before treatment), used to inform the eligibility assessment and to describe the sample.
Time frame
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).2
Depressive symptoms
Patient Health Questionnaire 9 (PHQ-9, theoretical range: 0-27, where a higher score indicates more symptoms of depression). The phrasing is revised to concern the past week. The conventional version is also administered at screening (within 6 months before treatment), used to inform the eligibility assessment and to describe the sample.
Time frame
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).3
Fear of cancer recurrence
9-item Fear of Cancer Recurrence Inventory (FCRI-9, theoretical range: 0-36, where a higher score indicates a more pronounced fear of cancer recurrence). This scale is also administered at screening (within 6 months before treatment), used to inform the eligibility assessment and to describe the sample.
Time frame
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
1
Health anxiety
14-item Health Anxiety Inventory (HAI-14, theoretical range: 0-42, where a higher score indicates more health anxiety). This scale is also administered at screening (within 6 months before treatment), used to inform the eligibility assessment and to describe the sample.
Time frame
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).2
Somatic symptom burden
Somatic Symptom Scale 8 (SSS-8, theoretical range: 0-32, where a higher score indicates a higher somatic symptom burden). Exploratory secondary analyses will be based on individual items, each scored 0-4. This scale is also administered at screening (within 6 months before treatment), used to inform the eligibility assessment and to describe the sample.
Time frame
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).3
Body image distress
Body Image Scale (BIS, theoretical range: 0-30, where a higher score indicates a higher level of body image distress)
Time frame
Screening (within 6 months before treatment) to post-treatment assessment (immediately after treatment, completed within 90 days)4
Disability
12-item World Health Organization Disability Assessment Schedule 2.0 (WD2-12, theoretical range: 0-100, where a higher score indicates more disability). This scale is also administered at screening (within 6 months before treatment), used to inform the eligibility assessment and to describe the sample.
Time frame
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).Other outcomes
1
Process and target variables: Behavioral activation
3-item Behavioral Activation for Depression Scale - ACtivation subscale (BADS-AC-3, theoretical range: 0-18, where a higher score indicates a higher level of behavioral activation). This scale is also administered at screening (within 6 months before treatment), used to inform the eligibility assessment and to describe the sample.
Time frame
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).2
Process and target variables: Symptom preoccupation
Symptom Preoccupation Scale (preliminary scale). A higher score indicates higher degree of preoccupation with symptoms. This is to be regarded as an an item pool, and the scale is is under development, which means that the total range cannot be preregistered.
Time frame
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).3
Process and target variables: Physical activity
Godin-Shephard Leisure-Time Physical Activity Questionnaire (GSLTPAQ, theoretical range 0-99, where a higher score indicates a higher level of physical activity). If necessary for statistical modeling, the GSLTPAQ will be dichotomized to indicate active (≥24) vs. insufficiently active (\<24).
Time frame
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).4
Process and target variables: Health-related self-efficacy
Based loosely on the Arthritis Self-efficacy Scale. Theoretical range of 0-60, where a higher score indicates a higher level of general health-related self-efficacy.
Time frame
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).Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Karolinska Institutet
Lead sponsor
Region Stockholm
Collaborator
Source ClinicalTrials.gov