Pilot Study of Internet-Delivered Psychological Treatment for Cancer Survivors

Depression Clinical Trial

— IN-FACT-0  

Official title:

Pilot Study of Internet-Delivered Psychological Treatment for Cancer Survivors With Clinically Significant Psychiatric Symptoms

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06046573
• Other study ID #: 2023-04056-01 #1
• Status: Recruiting
• Phase: N/A
• Start date: March 7, 2024
• Est. completion date: December 31, 2025

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 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 48
• Est. completion date: December 31, 2025
• Est. primary completion date: July 10, 2024
• 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. Survivor of breast cancer (n=24), testicular cancer (n=12), or thyroid cancer (n=12).
• 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 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
Sweden	Karolinska Institutet	Stockholm

Sponsors (1)

Lead Sponsor	Collaborator
Karolinska Institutet

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Post-treatment assessment (immediately after treatment, completed within 45 days)
Primary	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.	Week 2 of treatment
Primary	Feasibility 3: Adherence to the treatment protocol #1	Number of modules initiated, as registered by the clinician.	Over the 10-week treatment period, with registration at the post-treatment assessment (immediately after treatment).
Primary	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.	Each week from the beginning of treatment to the post-treatment assessment (immediately after treatment, completed within 45 days)
Primary	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.	Each week from the Each week from the beginning of treatment to the follow-up assessment (3 months after treatment)
Primary	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").	Post-treatment assessment (within 45 days after treatment)
Primary	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.	Post-treatment assessment (within 45 days after treatment)
Primary	Feasibility 8: Patients' satisfaction with the treatment #2	Likert items pertaining to satisfaction with components.	Post-treatment assessment (within 45 days after treatment)
Primary	Feasibility 9: Rate of adverse events and negative experiences #1	Questionnaire used in previous clinical trials (e.g., ClinicalTrials.gov: NCT04511286)	Post-treatment assessment (within 45 days after treatment)
Primary	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.	Post-treatment assessment (within 45 days after treatment)
Primary	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)	Pre-treatment assessment (within 2 weeks before treatment) to post-treatment assessment (immediately after treatment, completed within 45 days)
Primary	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)	Pre-treatment assessment (within 2 weeks before treatment) to post-treatment assessment (immediately after treatment, completed within 45 days)
Primary	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)	Pre-treatment assessment (within 2 weeks before treatment) to post-treatment assessment (immediately after treatment, completed within 45 days)
Primary	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)	Pre-treatment assessment (within 2 weeks before treatment) to post-treatment assessment (immediately after treatment, completed within 45 days)
Secondary	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).	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.
Secondary	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.	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.
Secondary	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).	Screening (within 6 months before treatment) to post-treatment assessment (immediately after treatment, completed within 45 days).
Secondary	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).	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.
Secondary	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).	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).
Secondary	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.	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).
Secondary	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).	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).
Secondary	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.	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).
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	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
Secondary	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
Secondary	Screening only: General distress	Hospital Anxiety and Depression Scale (HADS, theoretical range: 0-42, where a higher score indicates more general distress).	At screening