Internet-Delivered Psychological Treatment for Cancer Survivors

Study Overview
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Brief Summary
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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.

Official Title
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Randomized Factorial Trial of Internet-Delivered Psychological Treatment for Cancer Survivors With Clinically Significant Psychiatric Symptoms

Conditions
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Anxiety, Cancer Survivors, Depression

Intervention / Treatment
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* Behavioral: Support and information
* Behavioral: Behavioral activation
* Behavioral: Systematic exposure with mindfulness training
* Behavioral: Promotion of health behaviors


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Cancer survivor 0.5-20 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 Stockholms län, Västra Götalands län, or Skåne län, 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Internet-delivered psychological treatment, arm #1<br>Support and information + Behavioral activation | Behavioral: Support and information<br>* Emotional and technical support. Information about the long-term effects of cancer.<br>Behavioral: Behavioral activation<br>* Behavioral activation with existential themes and emphasis on values and relationships.<br>|
| Experimental: Internet-delivered psychological treatment, arm #2<br>Support and information + Systematic exposure with mindfulness training | Behavioral: Support and information<br>* Emotional and technical support. Information about the long-term effects of cancer.<br>Behavioral: Systematic exposure with mindfulness training<br>* Systematic exposure with mindfulness training with a focus on anxiety about health and/or death, body image, and cancer-related trauma.<br>|
| Experimental: Internet-delivered psychological treatment, arm #3<br>Support and information + Promotion of health behaviors | Behavioral: Support and information<br>* Emotional and technical support. Information about the long-term effects of cancer.<br>Behavioral: Promotion of health behaviors<br>* An overview of self-management techniques in terms of physical exercise, dietary advice, and strategies for improved sleep.<br>|
| Experimental: Internet-delivered psychological treatment, arm #4<br>Support and information + Behavioral activation + Systematic exposure with mindfulness training | Behavioral: Support and information<br>* Emotional and technical support. Information about the long-term effects of cancer.<br>Behavioral: Behavioral activation<br>* Behavioral activation with existential themes and emphasis on values and relationships.<br>Behavioral: Systematic exposure with mindfulness training<br>* Systematic exposure with mindfulness training with a focus on anxiety about health and/or death, body image, and cancer-related trauma.<br>|
| Experimental: Internet-delivered psychological treatment, arm #5<br>Support and information + Behavioral activation + Promotion of health behaviors | Behavioral: Support and information<br>* Emotional and technical support. Information about the long-term effects of cancer.<br>Behavioral: Behavioral activation<br>* Behavioral activation with existential themes and emphasis on values and relationships.<br>Behavioral: Promotion of health behaviors<br>* An overview of self-management techniques in terms of physical exercise, dietary advice, and strategies for improved sleep.<br>|
| Experimental: Internet-delivered psychological treatment, arm #6<br>Support and information + Systematic exposure with mindfulness training + Promotion of health behaviors | Behavioral: Support and information<br>* Emotional and technical support. Information about the long-term effects of cancer.<br>Behavioral: Systematic exposure with mindfulness training<br>* Systematic exposure with mindfulness training with a focus on anxiety about health and/or death, body image, and cancer-related trauma.<br>Behavioral: Promotion of health behaviors<br>* An overview of self-management techniques in terms of physical exercise, dietary advice, and strategies for improved sleep.<br>|
| Experimental: Internet-delivered psychological treatment, arm #7<br>Support and information + Behavioral activation + Systematic exposure with mindfulness training + Promotion of health behaviors | Behavioral: Support and information<br>* Emotional and technical support. Information about the long-term effects of cancer.<br>Behavioral: Behavioral activation<br>* Behavioral activation with existential themes and emphasis on values and relationships.<br>Behavioral: Systematic exposure with mindfulness training<br>* Systematic exposure with mindfulness training with a focus on anxiety about health and/or death, body image, and cancer-related trauma.<br>Behavioral: Promotion of health behaviors<br>* An overview of self-management techniques in terms of physical exercise, dietary advice, and strategies for improved sleep.<br>|
| Experimental: Internet-delivered psychological treatment, arm #8<br>Support and information | Behavioral: Support and information<br>* Emotional and technical support. Information about the long-term effects of cancer.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| General anxiety | General Anxiety Disorder 7 (GAD-7, theoretical range: 0-21, where a higher score indicates more 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). | 
| Depressive symptoms | Patient Health Questionnaire 9 (PHQ-9, theoretical range: 0-27, where a higher score indicates more symptoms of depression) | 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | 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). | 
| Health anxiety | 14-item Health Anxiety Inventory (HAI-14, theoretical range: 0-42, where a higher score indicates more 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). | 
| 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. | 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). | 
| Body image distress | Body Image Scale (BIS, theoretical range: 0-30, where a higher score indicates a higher level of body image distress) | Pre-treatment assessment (within 2 weeks before treatment) to post-treatment assessment (immediately after treatment, completed within 90 days) | 
| Disability | 12-item World Health Organization Disability Assessment Schedule 2.0 (WD2-12, theoretical range: 0-100, where a higher score indicates more 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). | 
| Health-related quality of life | 36-item Short Form Health Survey (SF-36, scored as a Mental Health Component Score and a Physical Health Component Score according to standard norms, both with a theoretical range of 0-100, where a higher score indicates a higher health-related quality of life) | Pre-treatment assessment (within 2 weeks before treatment) to post-treatment assessment (immediately after treatment, completed within 90 days) | 
| Treatment credibility and patient expectancy of improvement | Credibility/Expectancy scale (C/E scale, theoretical range: 0-50, where a higher score indicates higher credibility/expectancy) | Week 2 of treatment | 
| Relationship with the therapist (therapeutic alliance) | Working Alliance Inventory (WAI, theoretical range: 6-42, where a higher score indicates a stronger therapeutic alliance) | Week 2 of treatment | 
| Patient satisfaction with treatment | 8-item Client satisfaction questionnaire (CSQ-8, theoretical range: 8-32, where a higher score indicates higher satisfaction with treatment) | Post-treatment assessment (immediately after treatment, completed within 90 days) | 
| Adverse events | 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. | Post-treatment assessment (immediately after treatment, completed within 90 days) | 
| Perceived negative effects of treatment | 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. | Post-treatment assessment (immediately after treatment, completed within 90 days) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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psycho-oncology, randomized factorial trial, Internet-delivered cognitive behavior therapy