Anxiety, Cancer Survivors, Depression
Conditions
Keywords
psycho-oncology, randomized factorial trial, Internet-delivered cognitive behavior therapy
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.
Interventions
BEHAVIORALSupport and information
Emotional and technical support. Information about the long-term effects of cancer.
BEHAVIORALBehavioral activation
Behavioral activation with existential themes and emphasis on values and relationships.
Systematic exposure with mindfulness training with a focus on anxiety about health and/or death, body image, and cancer-related trauma.
BEHAVIORALPromotion of health behaviors
An overview of self-management techniques in terms of physical exercise, dietary advice, and strategies for improved sleep.
Sponsors
Karolinska Institutet
Region Stockholm
Study design
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| General anxiety | 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). | 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. |
| Depressive symptoms | 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). | 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. |
| Fear of cancer recurrence | 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). | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Health anxiety | 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). | 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. |
| Somatic symptom burden | 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). | 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. |
| Body image distress | Screening (within 6 months before treatment) to post-treatment assessment (immediately after treatment, completed within 90 days) | Body Image Scale (BIS, theoretical range: 0-30, where a higher score indicates a higher level of body image distress) |
| Disability | 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). | 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. |
| Treatment credibility and patient expectancy of improvement | Week 2 of treatment | Credibility/Expectancy scale (C/E scale, theoretical range: 0-50, where a higher score indicates higher credibility/expectancy) |
| Relationship with the therapist (therapeutic alliance) | Week 2 of treatment | Working Alliance Inventory (WAI, theoretical range: 6-42, where a higher score indicates a stronger therapeutic alliance) |
| Patient satisfaction with treatment | Post-treatment assessment (immediately after treatment, completed within 90 days) | 8-item Client satisfaction questionnaire (CSQ-8, theoretical range: 8-32, where a higher score indicates higher satisfaction with treatment) |
| Adverse events | Post-treatment assessment (immediately after treatment, completed within 90 days) | Brief questionnaire with three free-text items, each of which can be used to report an adverse event. For each adverse event, a rating is given of initial negative impact, and negative impact at post-treatment, on a scale from 0: "not at all", to 3: "very negatively". Reported primarily in terms of the number of participants reporting at least one adverse event. |
| Perceived negative effects of treatment | Post-treatment assessment (immediately after treatment, completed within 90 days) | 20-item Negative Effects Questionnaire (NEQ-20). This will be reported as the proportion of endorsed items in the following subdomains: increase in symptoms, perceived insufficient quality of treatment, dependency, stigma, and hopelessness. |
| Lifestyle behaviors | Pre-treatment assessment (within 2 weeks before treatment) to post-treatment assessment (immediately after treatment, completed within 90 days). | Lifestyle Behaviors Questionnaire (LBQ). The LBQ comprises 11 items that cover tobacco use, alcohol use, physical activity and diet. Dichotomous risky lifestyle behavior variables will be derived from the LBQ in terms of: "At least one unhealthy lifestyle behavior", "Daily smoking", "Binge drinking more than once a month OR more than 9/14 (w/m) glasses/week", "Insufficient physical activity, less than 150 minutes/week", and "Notably unhealthy dietary habits (diet index 0-4)". Risky lifestyle behavior will be defined as daily smoking, binge drinking of 4/5 (women/men) drinks at one occasion more than once a month and/or more than 9/14 (women/men) standard glasses of alcohol weekly, insufficient physical activity (\<150 minutes/week) or significantly unhealthy diet habits (a score of 0-4 on a diet index in the questionnaire, ranging from 0-12). |
Countries
Sweden
Contacts
CONTACTErland Axelsson, PhD
PRINCIPAL_INVESTIGATORErland Axelsson, PhD
Karolinska Institutet
Outcome results
None listed