An interventional study of Support and information and Behavioral activation in Cancer Survivors, Anxiety and Depression, sponsored by Karolinska Institutet. Completed at 1 site in Sweden. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-12-16.
Sponsored by Karolinska Institutet · Not applicable, Interventional, and Treatment
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.
8,057 studies on the registry are indexed under Depression; 1,641 are open to participants now.
This study's enrollment of 40 is below the median of 84 across 6,720 interventional studies indexed under Depression.
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Exclusion Criteria:
Support and information + Behavioral activation
Behavioral: Support and information · Behavioral: Behavioral activation
Support and information + Systematic exposure with mindfulness training
Behavioral: Support and information · Behavioral: Systematic exposure with mindfulness training
Support and information + Promotion of health behaviors
Behavioral: Support and information · Behavioral: Promotion of health behaviors
Support and information + Behavioral activation + Systematic exposure with mindfulness training
Behavioral: Support and information · Behavioral: Behavioral activation · Behavioral: Systematic exposure with mindfulness training
Support and information + Behavioral activation + Promotion of health behaviors
Behavioral: Support and information · Behavioral: Behavioral activation · Behavioral: Promotion of health behaviors
Support and information + Systematic exposure with mindfulness training + Promotion of health behaviors
Behavioral: Support and information · Behavioral: Systematic exposure with mindfulness training · Behavioral: Promotion of health behaviors
Support and information + Behavioral activation + Systematic exposure with mindfulness training + Promotion of health behaviors
Behavioral: Support and information · Behavioral: Behavioral activation · Behavioral: Systematic exposure with mindfulness training · Behavioral: Promotion of health behaviors
Support and information
Behavioral: Support and information
Emotional and technical support. Information about the long-term effects of cancer.
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.
An overview of self-management techniques in terms of physical exercise, dietary advice, and strategies for improved sleep.
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.
Time frame: 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.
Time frame: Week 2 of treatment
Feasibility 3: Adherence to the treatment protocol #1
Number of modules initiated, as registered by the clinician.
Time frame: 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.
Time frame: 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.
Time frame: 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").
Time frame: 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.
Time frame: Post-treatment assessment (within 45 days after treatment)
Feasibility 8: Patients' satisfaction with the treatment #2
Likert items pertaining to satisfaction with components.
Time frame: 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)
Time frame: 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.
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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: Health anxiety.
14-item Health Anxiety Inventory (HAI-14, theoretical range: 0-42, where a higher score indicates more health anxiety).
Time frame: 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: 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.
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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.
Time frame: 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).
Time frame: 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.
Time frame: 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)
Time frame: 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).
Time frame: 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).
Time frame: At screening
Screening only: General distress
Hospital Anxiety and Depression Scale (HADS, theoretical range: 0-42, where a higher score indicates more general distress).
Time frame: At screening
Documents are hosted by the registry — open the source record to download them.
Plan to share: No — 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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