Back to resultsPilot Study of Internet-Delivered Psychological Treatment for Cancer Survivors (IN-FACT-0)
Primary Purpose
Cancer Survivors, Anxiety, Depression
Status
Recruiting
Phase
Not Applicable
Locations
Sweden
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. 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) 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
Sites / Locations
- Karolinska InstitutetRecruiting
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
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.
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.
Feasibility 3: Adherence to the treatment protocol #1
Number of modules initiated, as registered by the clinician.
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.
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.
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").
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.
Feasibility 8: Patients' satisfaction with the treatment #2
Likert items pertaining to satisfaction with components.
Feasibility 9: Rate of adverse events and negative experiences #1
Questionnaire used in previous clinical trials (e.g., ClinicalTrials.gov: NCT04511286)
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.
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)
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)
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)
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)
Secondary Outcome Measures
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).
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.
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).
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).
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).
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.
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).
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.
Relationship with the therapist (therapeutic alliance)
Working Alliance Inventory (WAI, theoretical range: 6-42, where a higher score indicates a stronger therapeutic alliance)
Screening only: Alcohol use
Alcohol Use Disorders Identification Test (AUDIT, theoretical range: 0-40, where a higher score indicates more problematic alcohol use).
Screening only: Substance use
Drug Use Disorders Identification Test (DUDIT, theoretical range: 0-44, where a higher score indicates more problematic substance use).
Screening only: General distress
Hospital Anxiety and Depression Scale (HADS, theoretical range: 0-42, where a higher score indicates more general distress).
Full Information
NCT ID
NCT06046573
First Posted
September 6, 2023
Last Updated
October 4, 2023
Sponsor
Karolinska Institutet
1. Study Identification
Unique Protocol Identification Number
NCT06046573
Brief Title
Pilot Study of Internet-Delivered Psychological Treatment for Cancer Survivors
Acronym
IN-FACT-0
Official Title
Pilot Study 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
Recruiting
Study Start Date
October 5, 2023 (Anticipated)
Primary Completion Date
March 31, 2024 (Anticipated)
Study Completion Date
June 30, 2024 (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 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.
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
48 (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
Feasibility 1: Feasibility of the randomized factorial design
Description
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.
Time Frame
Post-treatment assessment (immediately after treatment, completed within 45 days)
Title
Feasibility 2: Credibility of the treatment as perceived by patients
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
Feasibility 3: Adherence to the treatment protocol #1
Description
Number of modules initiated, as registered by the clinician.
Time Frame
Over the 10-week treatment period, with registration at the post-treatment assessment (immediately after treatment).
Title
Feasibility 4: Adherence to the treatment protocol #2
Description
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.
Time Frame
Each week from the beginning of treatment to the post-treatment assessment (immediately after treatment, completed within 45 days)
Title
Feasibility 5: Acceptability of the online measurement strategy #1
Description
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.
Time Frame
Each week from the Each week from the beginning of treatment to the follow-up assessment (3 months after treatment)
Title
Feasibility 6: Acceptability of the online measurement strategy #2
Description
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").
Time Frame
Post-treatment assessment (within 45 days after treatment)
Title
Feasibility 7: Patients' satisfaction with the treatment #1
Description
The 8-item Client Satisfaction Questionnaire (CSQ-8). Theoretical range: 8-32, where a higher score indicates higher satisfaction.
Time Frame
Post-treatment assessment (within 45 days after treatment)
Title
Feasibility 8: Patients' satisfaction with the treatment #2
Description
Likert items pertaining to satisfaction with components.
Time Frame
Post-treatment assessment (within 45 days after treatment)
Title
Feasibility 9: Rate of adverse events and negative experiences #1
Description
Questionnaire used in previous clinical trials (e.g., ClinicalTrials.gov: NCT04511286)
Time Frame
Post-treatment assessment (within 45 days after treatment)
Title
Feasibility 10: Rate of adverse events and negative experiences #2
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 (within 45 days after treatment)
Title
Feasibility 11: Preliminary efficacy in terms of within-group average change in 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 assessment (within 2 weeks before treatment) to post-treatment assessment (immediately after treatment, completed within 45 days)
Title
Feasibility 12: Preliminary efficacy in terms of within-group average change in 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 assessment (within 2 weeks before treatment) to post-treatment assessment (immediately after treatment, completed within 45 days)
Title
Feasibility 13: Preliminary efficacy in terms of within-group improvement in the 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 assessment (within 2 weeks before treatment) to post-treatment assessment (immediately after treatment, completed within 45 days)
Title
Feasibility 14: Preliminary efficacy in terms of within-group improvement in 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 45 days)
Secondary Outcome Measure Information:
Title
Symptom domains surveyed primarily to assess the feasibility of the measurement method: 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 45 days). Secondary analysis: from pre-treatment up to follow-up 3 months after treatment.
Title
Symptom domains surveyed primarily to assess the feasibility of the measurement method: 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 45 days). Secondary analysis: from pre-treatment up to follow-up 3 months after treatment.
Title
Symptom domains surveyed primarily to assess the feasibility of the measurement method: 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 45 days).
Title
Symptom domains surveyed primarily to assess the feasibility of the measurement method: Disability.
Description
12-item WHO 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 45 days). Secondary analysis: from pre-treatment up to follow-up 3 months after treatment.
Title
Process and target variables surveyed primarily to assess the feasibility of the measurement method: Behavioral activation
Description
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).
Time Frame
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).
Title
Process and target variables surveyed primarily to assess the feasibility of the measurement method: 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 45 days), and at follow-up 3 months after treatment (completed within 45 days).
Title
Process and target variables surveyed primarily to assess the feasibility of the measurement method: 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 45 days), and at follow-up 3 months after treatment (completed within 45 days).
Title
Process and target variables surveyed primarily to assess the feasibility of the measurement method: 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 45 days), and at follow-up 3 months after treatment (completed within 45 days).
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
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. 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)
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
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
Facility Information:
Facility Name
Karolinska Institutet
City
Stockholm
Country
Sweden
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Erland Axelsson, PhD
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
Pilot Study of Internet-Delivered Psychological Treatment for Cancer Survivors
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