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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 factorial pilot study, 48 cancer survivors with psychiatric symptoms are enrolled in variations on a 10-week therapist-guided online psychological treatment intended to address common negative psychological long-term effects of cancer. The aim of this study is to assess the feasibility of the study design and online treatment format. Key feasibility outcomes include interest in the study, patient-reported credibility of the intervention, adherence to the treatment protocol, satisfaction with the treatment, acceptability of the measurement strategy, missing data rates, adverse events, and preliminary efficacy on anxiety, depression, the fear of recurrence, and health-related quality of life.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Internet-delivered psychological treatment, arm #1 | Experimental | Support and information + Behavioral activation |
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| Internet-delivered psychological treatment, arm #2 | Experimental | Support and information + Systematic exposure with mindfulness training |
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| Internet-delivered psychological treatment, arm #3 | Experimental | Support and information + Promotion of health behaviors |
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| Internet-delivered psychological treatment, arm #4 | Experimental | Support and information + Behavioral activation + Systematic exposure with mindfulness training |
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| Internet-delivered psychological treatment, arm #5 | Experimental | Support and information + Behavioral activation + Promotion of health behaviors |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Support and information | Behavioral | Emotional and technical support. Information about the long-term effects of cancer. |
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| Measure | Description | Time Frame |
|---|---|---|
| Feasibility 1: Feasibility of the randomized factorial design | A key feasibility outcome of this pilot study is the overall experience of study administrators and therapists tasked with the assignment and delivery of treatment variants in accordance with the randomized factorial design. After the main phase, all study administrators and therapists will be asked to rate the feasibility of the planned study design from 0 ("not feasible at all") to 10 ("fully feasible"), which will reported as a mean (SD) and median. | Post-treatment assessment (immediately after treatment, completed within 45 days) |
| Feasibility 2: Credibility of the treatment as perceived by patients | Credibility/Expectancy scale (C/E scale). Theoretical range: 0-50, where a higher score indicates higher credibility/expectancy. | Week 2 of treatment |
| Feasibility 3: Adherence to the treatment protocol #1 | Number of modules initiated, as registered by the clinician. | Over the 10-week treatment period, with registration at the post-treatment assessment (immediately after treatment). |
| Feasibility 4: Adherence to the treatment protocol #2 | Number of completed exercises, as based on a short weekly questionnaire tailored to suit each treatment arm, with corresponding questions about the number of days devoted to exposure exercises, days devoted to activity planning, and days devoted to the promotion of health behaviors. | Each week from the beginning of treatment to the post-treatment assessment (immediately after treatment, completed within 45 days) |
| Feasibility 5: Acceptability of the online measurement strategy #1 | Number of measurements completed at each measurement point after the pre-treatment assessment. Preregistered target: at least 70% non-missing at the post-treatment and follow-up assessments. |
| Measure | Description | Time Frame |
|---|---|---|
| Symptom domains surveyed primarily to assess the feasibility of the measurement method: 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 45 days). Secondary analysis: from pre-treatment up to follow-up 3 months after treatment. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Erland Axelsson, PhD | Karolinska Institutet | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Karolinska Institutet | Stockholm | Sweden |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41136825 | Derived | Winter J, Gasslander N, Rane G, Sundstrom F, Bjorkhem-Bergman L, Hedman C, Axelsson E. Proof-of-concept for a randomized factorial design strategy to build a complex online support program for cancer survivors with psychiatric symptoms: the IN-FACT-0 feasibility trial. J Cancer Surviv. 2025 Oct 25. doi: 10.1007/s11764-025-01905-2. Online ahead of print. |
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Individual participant data from this pilot study fall under Swedish and European Union data protection and privacy legislation and can therefore not be share in their entirety. Reasonable requests may be directed to the corresponding author, and will be considered on a case-by-case basis.
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Aug 16, 2023 | May 18, 2024 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D001008 | Anxiety Disorders |
| D003863 | Depression |
| ID | Term |
|---|---|
| D001523 | Mental Disorders |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
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| ID | Term |
|---|---|
| D010166 | Palliative Care |
| ID | Term |
|---|---|
| D005791 | Patient Care |
| D013812 | Therapeutics |
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |
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| Internet-delivered psychological treatment, arm #6 | Experimental | Support and information + Systematic exposure with mindfulness training + Promotion of health behaviors |
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| Internet-delivered psychological treatment, arm #7 | Experimental | Support and information + Behavioral activation + Systematic exposure with mindfulness training + Promotion of health behaviors |
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| Internet-delivered psychological treatment, arm #8 | Experimental | Support and information |
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| Behavioral activation | Behavioral | Behavioral activation with existential themes and emphasis on values and relationships. |
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| Systematic exposure with mindfulness training | Behavioral | Systematic exposure with mindfulness training with a focus on anxiety about health and/or death, body image, and cancer-related trauma. |
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| Promotion of health behaviors | Behavioral | An overview of self-management techniques in terms of physical exercise, dietary advice, and strategies for improved sleep. |
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| Each week from the Each week from the beginning of treatment to the follow-up assessment (3 months after treatment) |
| Feasibility 6: Acceptability of the online measurement strategy #2 | Perceived strain caused by the measurement strategy. Preregistered target: at least 75% with a rating below 7 from 0 ("not at all stressful/distressing") to 10 ("extremely stressful/distressing"). | Post-treatment assessment (within 45 days after treatment) |
| Feasibility 7: Patients' satisfaction with the treatment #1 | The 8-item Client Satisfaction Questionnaire (CSQ-8). Theoretical range: 8-32, where a higher score indicates higher satisfaction. | Post-treatment assessment (within 45 days after treatment) |
| Feasibility 8: Patients' satisfaction with the treatment #2 | Likert items pertaining to satisfaction with components. | Post-treatment assessment (within 45 days after treatment) |
| Feasibility 9: Rate of adverse events and negative experiences #1 | Questionnaire used in previous clinical trials (e.g., ClinicalTrials.gov: NCT04511286) | Post-treatment assessment (within 45 days after treatment) |
| Feasibility 10: Rate of adverse events and negative experiences #2 | 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 (within 45 days after treatment) |
| Feasibility 11: Preliminary efficacy in terms of within-group average change in general anxiety | General Anxiety Disorder 7 (GAD-7, theoretical range: 0-21, where a higher score indicates more general anxiety) | Pre-treatment assessment (within 2 weeks before treatment) to post-treatment assessment (immediately after treatment, completed within 45 days) |
| Feasibility 12: Preliminary efficacy in terms of within-group average change in depressive symptoms | Patient Health Questionnaire 9 (PHQ-9, theoretical range: 0-27, where a higher score indicates more symptoms of depression) | Pre-treatment assessment (within 2 weeks before treatment) to post-treatment assessment (immediately after treatment, completed within 45 days) |
| Feasibility 13: Preliminary efficacy in terms of within-group improvement in the 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 assessment (within 2 weeks before treatment) to post-treatment assessment (immediately after treatment, completed within 45 days) |
| Feasibility 14: Preliminary efficacy in terms of within-group improvement in 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 45 days) |
| Symptom domains surveyed primarily to assess the feasibility of the measurement method: 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 45 days). Secondary analysis: from pre-treatment up to follow-up 3 months after treatment. |
| Symptom domains surveyed primarily to assess the feasibility of the measurement method: Body image distress. | Body Image Scale (BIS, theoretical range: 0-30, where a higher score indicates a higher level of body image distress). | Screening (within 6 months before treatment) to post-treatment assessment (immediately after treatment, completed within 45 days). |
| Symptom domains surveyed primarily to assess the feasibility of the measurement method: Disability. | 12-item WHO 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 45 days). Secondary analysis: from pre-treatment up to follow-up 3 months after treatment. |
| Process and target variables surveyed primarily to assess the feasibility of the measurement method: Behavioral activation | 3-item Behavioral Activation for Depression Scale - Activation (BADS-AC-3, theoretical range: 0-18, where a higher score indicates a higher level of behavioral activation). | Pre-treatment (within 2 weeks before treatment), once each week during treatment (9 assessments in total), post-treatment (after treatment, completed within 45 days), and at follow-up 3 months after treatment (completed within 45 days). |
| Process and target variables surveyed primarily to assess the feasibility of the measurement method: 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. | Pre-treatment (within 2 weeks before treatment), once each week during treatment (9 assessments in total), post-treatment (after treatment, completed within 45 days), and at follow-up 3 months after treatment (completed within 45 days). |
| Process and target variables surveyed primarily to assess the feasibility of the measurement method: 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). | Pre-treatment (within 2 weeks before treatment), once each week during treatment (9 assessments in total), post-treatment (after treatment, completed within 45 days), and at follow-up 3 months after treatment (completed within 45 days). |
| Process and target variables surveyed primarily to assess the feasibility of the measurement method: 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. | Pre-treatment (within 2 weeks before treatment), once each week during treatment (9 assessments in total), post-treatment (after treatment, completed within 45 days), and at follow-up 3 months after treatment (completed within 45 days). |
| 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 |
| Screening only: Alcohol use | Alcohol Use Disorders Identification Test (AUDIT, theoretical range: 0-40, where a higher score indicates more problematic alcohol use). | At screening |
| Screening only: Substance use | Drug Use Disorders Identification Test (DUDIT, theoretical range: 0-44, where a higher score indicates more problematic substance use). | At screening |
| Screening only: General distress | Hospital Anxiety and Depression Scale (HADS, theoretical range: 0-42, where a higher score indicates more general distress). | At screening |