Pilot Study of Internet-Delivered Psychological Treatment for Cancer Survivors (IN-FACT-0)

December 13, 2024 updated by: Erland Axelsson, Karolinska Institutet

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
40

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Sweden
      • Stockholm, Sweden
        • Karolinska Institutet

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Factorial Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Feasibility 1: Feasibility of the randomized factorial design
Time Frame: Post-treatment assessment (immediately after treatment, completed within 45 days)
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)
Feasibility 2: Credibility of the treatment as perceived by patients
Time Frame: Week 2 of treatment
Credibility/Expectancy scale (C/E scale). Theoretical range: 0-50, where a higher score indicates higher credibility/expectancy.
Week 2 of treatment
Feasibility 3: Adherence to the treatment protocol #1
Time Frame: Over the 10-week treatment period, with registration at the post-treatment assessment (immediately after treatment).
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).
Feasibility 4: Adherence to the treatment protocol #2
Time Frame: Each week from the beginning of treatment to the post-treatment assessment (immediately after treatment, completed within 45 days)
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)
Feasibility 5: Acceptability of the online measurement strategy #1
Time Frame: Each week from the Each week from the beginning of treatment to the follow-up assessment (3 months after treatment)
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)
Feasibility 6: Acceptability of the online measurement strategy #2
Time Frame: Post-treatment assessment (within 45 days after treatment)
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)
Feasibility 7: Patients' satisfaction with the treatment #1
Time Frame: Post-treatment assessment (within 45 days after treatment)
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)
Feasibility 8: Patients' satisfaction with the treatment #2
Time Frame: Post-treatment assessment (within 45 days after treatment)
Likert items pertaining to satisfaction with components.
Post-treatment assessment (within 45 days after treatment)
Feasibility 9: Rate of adverse events and negative experiences #1
Time Frame: Post-treatment assessment (within 45 days after treatment)
Questionnaire used in previous clinical trials (e.g., ClinicalTrials.gov: NCT04511286)
Post-treatment assessment (within 45 days after treatment)
Feasibility 10: Rate of adverse events and negative experiences #2
Time Frame: Post-treatment assessment (within 45 days after 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 (within 45 days after treatment)
Feasibility 11: Preliminary efficacy in terms of within-group average change in general anxiety
Time Frame: Pre-treatment assessment (within 2 weeks before treatment) to post-treatment assessment (immediately after treatment, completed within 45 days)
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)
Feasibility 12: Preliminary efficacy in terms of within-group average change in depressive symptoms
Time Frame: Pre-treatment assessment (within 2 weeks before treatment) to post-treatment assessment (immediately after treatment, completed within 45 days)
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)
Feasibility 13: Preliminary efficacy in terms of within-group improvement in the 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)
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)
Feasibility 14: Preliminary efficacy in terms of within-group improvement in 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)
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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)
Week 2 of treatment
Symptom domains surveyed primarily to assess the feasibility of the measurement method: 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.
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.
Symptom domains surveyed primarily to assess the feasibility of the measurement method: Somatic symptom burden.
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.
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.
Symptom domains surveyed primarily to assess the feasibility of the measurement method: 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.
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.
Process and target variables surveyed primarily to assess the feasibility of the measurement method: 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).
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).
Process and target variables surveyed primarily to assess the feasibility of the measurement method: 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 45 days), and at follow-up 3 months after treatment (completed within 45 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.
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).
Process and target variables surveyed primarily to assess the feasibility of the measurement method: 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 45 days), and at follow-up 3 months after treatment (completed within 45 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).
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).
Process and target variables surveyed primarily to assess the feasibility of the measurement method: 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).
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).
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).
At screening
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).
At screening
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).
At screening
Symptom domains surveyed primarily to assess the feasibility of the measurement method: Body image distress.
Time Frame: Screening (within 6 months before treatment) to post-treatment assessment (immediately after treatment, completed within 45 days).
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).

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Karolinska Institutet

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Erland Axelsson, PhD, Karolinska Institutet

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 10, 2024

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 22, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 22, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 6, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 13, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 21, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 25, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 13, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2023-04056-01 #1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD 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.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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