Internet-Delivered Psychological Treatment for Cancer Survivors

Depression Clinical Trial

— IN-FACT-1  

Official title:

Randomized Factorial Trial of Internet-Delivered Psychological Treatment for Cancer Survivors With Clinically Significant Psychiatric Symptoms

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06046586
• Other study ID #: 2023-04056-01 #2
• Status: Not yet recruiting
• Phase: N/A
• Start date: January 1, 2025
• Est. completion date: December 31, 2029

Study information

• Verified date: March 2024
• Source: Karolinska Institutet
• Contact: Erland Axelsson, PhD
• Phone: 0706171039
• Email: erland.axelsson[@]ki.se
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 400
• Est. completion date: December 31, 2029
• Est. primary completion date: December 31, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Anxiety
• Cancer Survivors
• Depression

Intervention

Behavioral:
• Support and information
Emotional and technical support. Information about the long-term effects of cancer.
• Behavioral activation
Behavioral activation with existential themes and emphasis on values and relationships.
• 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.
• Promotion of health behaviors
An overview of self-management techniques in terms of physical exercise, dietary advice, and strategies for improved sleep.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Karolinska Institutet

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Process and target variables: Behavioral activation	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)	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).
Other	Process and target variables: 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 90 days), and at follow-up 6 and 12 months after treatment (each completed within 90 days).
Other	Process and target variables: 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 90 days), and at follow-up 6 and 12 months after treatment (each completed within 90 days).
Other	Process and target variables: 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 90 days), and at follow-up 6 and 12 months after treatment (each completed within 90 days).
Other	Basis for cost-effectiveness analysis: Utility (health-related quality of life)	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.	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).
Other	Basis for cost-effectiveness analysis: Resource use (medical costs and productivity losses)	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.	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).
Other	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
Other	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
Other	Screening only: General distress	Hospital Anxiety and Depression Scale (HADS, theoretical range: 0-42, where a higher score indicates more general distress)	At screening
Primary	General anxiety	General Anxiety Disorder 7 (GAD-7, theoretical range: 0-21, where a higher score indicates more general anxiety)	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).
Primary	Depressive symptoms	Patient Health Questionnaire 9 (PHQ-9, theoretical range: 0-27, where a higher score indicates more symptoms of depression)	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	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 (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	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 90 days). Secondary analysis: from pre-treatment up to follow-up 12-months after treatment (completed within 90 days).
Secondary	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 90 days). Secondary analysis: from pre-treatment up to follow-up 12-months after treatment (completed within 90 days).
Secondary	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 90 days)
Secondary	Disability	12-item World Health Organization 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 90 days). Secondary analysis: from pre-treatment up to follow-up 12-months after treatment (completed within 90 days).
Secondary	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 90 days)
Secondary	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)	Week 2 of treatment
Secondary	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
Secondary	Patient satisfaction with treatment	8-item Client satisfaction questionnaire (CSQ-8, theoretical range: 8-32, where a higher score indicates higher satisfaction with treatment)	Post-treatment assessment (immediately after treatment, completed within 90 days)
Secondary	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.	Post-treatment assessment (immediately after treatment, completed within 90 days)
Secondary	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.	Post-treatment assessment (immediately after treatment, completed within 90 days)