Karolinska Institutet
Stockholm, Sweden
Location status: Recruiting
NCT Number: NCT06046586
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.
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Not applicable
Stockholm, Sweden
Location status: Recruiting
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
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).
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).
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).
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 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.
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).
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: 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)
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).
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: Week 2 of treatment
Credibility/Expectancy scale (C/E scale, theoretical range: 0-50, where a higher score indicates higher credibility/expectancy)
Time frame: Week 2 of treatment
Working Alliance Inventory (WAI, theoretical range: 6-42, where a higher score indicates a stronger therapeutic alliance)
Time frame: 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)
Time frame: 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.
Time frame: 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.
Time frame: 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).
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-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).
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).
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).
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 assessment (within 2 weeks before treatment), post-treatment assessment (immediately after treatment, completed within 90 days), 6 months after treatment (completed within 90 days), 12 months after treatment (completed within 90 days).
EuroQol 5D (EQ-5D). Theoretical range: 0-1, i.e., scored as utility for the purpose of calculating quality-adjusted life years for health economic analysis. A higher utility score indicates a higher health-related quality of life.
Time frame: Pre-treatment assessment (within 2 weeks before treatment), post-treatment assessment (immediately after treatment, completed within 90 days), 6 months after treatment (completed within 90 days), 12 months after treatment (completed within 90 days).
Trimbos Institute and Institute of Medical Technology Questionnaire for Costs Associated with Psychiatric Illness (TIC-P). This instrument is scored in terms of resource use for the purpose of calculating societal costs for health economic analysis.
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)
Health Anxiety Behavior Inventory (HABI, scored as four subscales of "bodily preoccupation and checking", "information- and reassurance-seeking", "prevention and planning" and "overt avoidance"; each with a theoretical range of 0-9 where a higher score indicates a higher level of health anxiety behaviors within each respective subdomain)
Time frame: Screening (within 6 months before treatment)
Alcohol Use Disorders Identification Test (AUDIT, theoretical range: 0-40, where a higher score indicates more problematic alcohol use). This scale is administered to inform the eligibility assessment and describe the sample only.
Time frame: Screening (within 6 months before treatment)
Drug Use Disorders Identification Test (DUDIT, theoretical range: 0-44, where a higher score indicates more problematic substance use). This scale is administered to inform the eligibility assessment and describe the sample only.
Contact information is provided by the study sponsor or research team.
Karolinska Institutet
Other
Randomized Factorial Trial of Internet-Delivered Psychological Treatment for Cancer Survivors With Clinically Significant Psychiatric Symptoms
Acronym: IN-FACT-1
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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