Internet-Delivered Psychological Treatment for Cancer Survivors (IN-FACT-1)

• ClinicalTrials.gov Identifier: NCT06046586
• Recruitment Status: Not yet recruiting
• First Posted: September 21, 2023
• Last Update Posted: March 8, 2024
• Sponsor: Karolinska Institutet
• Information provided by (Responsible Party): Erland Axelsson, Karolinska Institutet

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.

Condition or disease	Intervention/treatment	Phase
Cancer Survivors; Anxiety; Depression	Behavioral: Support and information; Behavioral: Behavioral activation; Behavioral: Systematic exposure with mindfulness training; Behavioral: Promotion of health behaviors	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 400 participants
• Allocation: Randomized
• Intervention Model: Factorial Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Randomized Factorial Trial of Internet-Delivered Psychological Treatment for Cancer Survivors With Clinically Significant Psychiatric Symptoms
• Estimated Study Start Date: January 1, 2025
• Estimated Primary Completion Date: December 31, 2027
• Estimated Study Completion Date: December 31, 2029

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures :

1. 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). ]
   General Anxiety Disorder 7 (GAD-7, theoretical range: 0-21, where a higher score indicates more general anxiety)
2. Depressive symptoms [ 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)

Secondary Outcome Measures :

1. 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). ]
   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)
2. 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). ]
   14-item Health Anxiety Inventory (HAI-14, theoretical range: 0-42, where a higher score indicates more health anxiety)
3. Somatic symptom burden [ 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.
4. Body image distress [ 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)
5. 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). ]
   12-item World Health Organization Disability Assessment Schedule 2.0 (WD2-12, theoretical range: 0-100, where a higher score indicates more disability)
6. 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) ]
   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)
7. Treatment credibility and patient expectancy of improvement [ Time Frame: Week 2 of treatment ]
   Credibility/Expectancy scale (C/E scale, theoretical range: 0-50, where a higher score indicates higher credibility/expectancy)
8. Relationship with the therapist (therapeutic alliance) [ Time Frame: Week 2 of treatment ]
   Working Alliance Inventory (WAI, theoretical range: 6-42, where a higher score indicates a stronger therapeutic alliance)
9. Patient satisfaction with treatment [ 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)
10. Adverse events [ 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.
11. Perceived negative effects of treatment [ 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.

Other Outcome Measures:

1. Process and target variables: 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). ]
   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)
2. Process and target variables: Symptom preoccupation [ 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.
3. Process and target variables: Physical activity [ 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).
4. Process and target variables: 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). ]
   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.
5. Basis for cost-effectiveness analysis: Utility (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). ]
   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.
6. Basis for cost-effectiveness analysis: Resource use (medical costs and productivity losses) [ 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.
7. Screening only: Alcohol use [ Time Frame: At screening ]
   Alcohol Use Disorders Identification Test (AUDIT, theoretical range: 0-40, where a higher score indicates more problematic alcohol use)
8. Screening only: Substance use [ Time Frame: At screening ]
   Drug Use Disorders Identification Test (DUDIT, theoretical range: 0-44, where a higher score indicates more problematic substance use)
9. Screening only: General distress [ Time Frame: At screening ]
   Hospital Anxiety and Depression Scale (HADS, theoretical range: 0-42, where a higher score indicates more general distress)

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria:

• Cancer survivor at least 0.5 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

Contacts and Locations

Contacts

Contact: Erland Axelsson, PhD; 0706171039 ext +46; erland.axelsson@ki.se

Sponsors and Collaborators

Karolinska Institutet

Investigators

• Principal Investigator: Erland Axelsson, PhD; Karolinska Institutet

More Information

• Responsible Party: Erland Axelsson, Principal Investigator, Karolinska Institutet
• ClinicalTrials.gov Identifier: NCT06046586
• Other Study ID Numbers: 2023-04056-01 #2
• First Posted: September 21, 2023
• Last Update Posted: March 8, 2024
• Last Verified: March 2024

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No
• 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.

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Erland Axelsson, Karolinska Institutet:

psycho-oncology; randomized factorial trial; Internet-delivered cognitive behavior therapy

Additional relevant MeSH terms:

Depression; Behavioral Symptoms