Back to resultsInternet-Delivered Psychological Treatment for Cancer Survivors (IN-FACT-1)
Primary Purpose
Cancer Survivors, Anxiety, Depression
Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Support and information
Behavioral activation
Systematic exposure with mindfulness training
Promotion of health behaviors
Sponsored by
About this trial
This is an interventional treatment trial for Cancer Survivors focused on measuring psycho-oncology, randomized factorial trial, Internet-delivered cognitive behavior therapy
Eligibility Criteria
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) 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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm 6
Arm 7
Arm 8
Arm Type
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Arm Label
Internet-delivered psychological treatment, arm #1
Internet-delivered psychological treatment, arm #2
Internet-delivered psychological treatment, arm #3
Internet-delivered psychological treatment, arm #4
Internet-delivered psychological treatment, arm #5
Internet-delivered psychological treatment, arm #6
Internet-delivered psychological treatment, arm #7
Internet-delivered psychological treatment, arm #8
Arm Description
Support and information + Behavioral activation
Support and information + Systematic exposure with mindfulness training
Support and information + Promotion of health behaviors
Support and information + Behavioral activation + Systematic exposure with mindfulness training
Support and information + Behavioral activation + Promotion of health behaviors
Support and information + Systematic exposure with mindfulness training + Promotion of health behaviors
Support and information + Behavioral activation + Systematic exposure with mindfulness training + Promotion of health behaviors
Support and information
Outcomes
Primary Outcome Measures
General anxiety
General Anxiety Disorder 7 (GAD-7, theoretical range: 0-21, where a higher score indicates more general anxiety)
Depressive symptoms
Patient Health Questionnaire 9 (PHQ-9, theoretical range: 0-27, where a higher score indicates more symptoms of depression)
Secondary Outcome Measures
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)
Health anxiety
14-item Health Anxiety Inventory (HAI-14, theoretical range: 0-42, where a higher score indicates more health anxiety)
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.
Body image distress
Body Image Scale (BIS, theoretical range: 0-30, where a higher score indicates a higher level of body image distress)
Disability
12-item World Health Organization Disability Assessment Schedule 2.0 (WD2-12, theoretical range: 0-100, where a higher score indicates more disability)
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)
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)
Relationship with the therapist (therapeutic alliance)
Working Alliance Inventory (WAI, theoretical range: 6-42, where a higher score indicates a stronger therapeutic alliance)
Patient satisfaction with treatment
8-item Client satisfaction questionnaire (CSQ-8, theoretical range: 8-32, where a higher score indicates higher satisfaction with treatment)
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.
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.
Full Information
NCT ID
NCT06046586
First Posted
September 6, 2023
Last Updated
October 4, 2023
Sponsor
Karolinska Institutet
1. Study Identification
Unique Protocol Identification Number
NCT06046586
Brief Title
Internet-Delivered Psychological Treatment for Cancer Survivors
Acronym
IN-FACT-1
Official Title
Randomized Factorial Trial of Internet-Delivered Psychological Treatment for Cancer Survivors With Clinically Significant Psychiatric Symptoms
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
August 1, 2024 (Anticipated)
Primary Completion Date
December 31, 2026 (Anticipated)
Study Completion Date
December 31, 2027 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Karolinska Institutet
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cancer Survivors, Anxiety, Depression
Keywords
psycho-oncology, randomized factorial trial, Internet-delivered cognitive behavior therapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
400 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Internet-delivered psychological treatment, arm #1
Arm Type
Experimental
Arm Description
Support and information + Behavioral activation
Arm Title
Internet-delivered psychological treatment, arm #2
Arm Type
Experimental
Arm Description
Support and information + Systematic exposure with mindfulness training
Arm Title
Internet-delivered psychological treatment, arm #3
Arm Type
Experimental
Arm Description
Support and information + Promotion of health behaviors
Arm Title
Internet-delivered psychological treatment, arm #4
Arm Type
Experimental
Arm Description
Support and information + Behavioral activation + Systematic exposure with mindfulness training
Arm Title
Internet-delivered psychological treatment, arm #5
Arm Type
Experimental
Arm Description
Support and information + Behavioral activation + Promotion of health behaviors
Arm Title
Internet-delivered psychological treatment, arm #6
Arm Type
Experimental
Arm Description
Support and information + Systematic exposure with mindfulness training + Promotion of health behaviors
Arm Title
Internet-delivered psychological treatment, arm #7
Arm Type
Experimental
Arm Description
Support and information + Behavioral activation + Systematic exposure with mindfulness training + Promotion of health behaviors
Arm Title
Internet-delivered psychological treatment, arm #8
Arm Type
Experimental
Arm Description
Support and information
Intervention Type
Behavioral
Intervention Name(s)
Support and information
Intervention Description
Emotional and technical support. Information about the long-term effects of cancer.
Intervention Type
Behavioral
Intervention Name(s)
Behavioral activation
Intervention Description
Behavioral activation with existential themes and emphasis on values and relationships.
Intervention Type
Behavioral
Intervention Name(s)
Systematic exposure with mindfulness training
Intervention Description
Systematic exposure with mindfulness training with a focus on anxiety about health and/or death, body image, and cancer-related trauma.
Intervention Type
Behavioral
Intervention Name(s)
Promotion of health behaviors
Intervention Description
An overview of self-management techniques in terms of physical exercise, dietary advice, and strategies for improved sleep.
Primary Outcome Measure Information:
Title
General anxiety
Description
General Anxiety Disorder 7 (GAD-7, theoretical range: 0-21, where a higher score indicates more general anxiety)
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).
Title
Depressive symptoms
Description
Patient Health Questionnaire 9 (PHQ-9, theoretical range: 0-27, where a higher score indicates more symptoms of depression)
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).
Secondary Outcome Measure Information:
Title
Fear of cancer recurrence
Description
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 (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).
Title
Health anxiety
Description
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 90 days). Secondary analysis: from pre-treatment up to follow-up 12-months after treatment (completed within 90 days).
Title
Somatic symptom burden
Description
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 90 days). Secondary analysis: from pre-treatment up to follow-up 12-months after treatment (completed within 90 days).
Title
Body image distress
Description
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)
Title
Disability
Description
12-item World Health Organization 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 90 days). Secondary analysis: from pre-treatment up to follow-up 12-months after treatment (completed within 90 days).
Title
Health-related quality of life
Description
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 90 days)
Title
Treatment credibility and patient expectancy of improvement
Description
Credibility/Expectancy scale (C/E scale, theoretical range: 0-50, where a higher score indicates higher credibility/expectancy)
Time Frame
Week 2 of treatment
Title
Relationship with the therapist (therapeutic alliance)
Description
Working Alliance Inventory (WAI, theoretical range: 6-42, where a higher score indicates a stronger therapeutic alliance)
Time Frame
Week 2 of treatment
Title
Patient satisfaction with treatment
Description
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)
Title
Adverse events
Description
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)
Title
Perceived negative effects of treatment
Description
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 (immediately after treatment, completed within 90 days)
Other Pre-specified Outcome Measures:
Title
Process and target variables: Behavioral activation
Description
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)
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).
Title
Process and target variables: Symptom preoccupation
Description
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).
Title
Process and target variables: Physical activity
Description
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).
Title
Process and target variables: Health-related self-efficacy
Description
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 90 days), and at follow-up 6 and 12 months after treatment (each completed within 90 days).
Title
Basis for cost-effectiveness analysis: Utility (health-related quality of life)
Description
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).
Title
Basis for cost-effectiveness analysis: Resource use (medical costs and productivity losses)
Description
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 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).
Title
Screening only: Alcohol use
Description
Alcohol Use Disorders Identification Test (AUDIT, theoretical range: 0-40, where a higher score indicates more problematic alcohol use)
Time Frame
At screening
Title
Screening only: Substance use
Description
Drug Use Disorders Identification Test (DUDIT, theoretical range: 0-44, where a higher score indicates more problematic substance use)
Time Frame
At screening
Title
Screening only: General distress
Description
Hospital Anxiety and Depression Scale (HADS, theoretical range: 0-42, where a higher score indicates more general distress)
Time Frame
At screening
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Erland Axelsson, PhD
Phone
0706171039
Ext
+46
Email
erland.axelsson@ki.se
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Erland Axelsson, PhD
Organizational Affiliation
Karolinska Institutet
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
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.
Learn more about this trial
Internet-Delivered Psychological Treatment for Cancer Survivors
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