Internet-based Support for Adjustment to Prostate Cancer (ISAC)

Internet-based Support for Adjustment to Prostate Cancer (ISAC) - A Randomized Controlled Trial of ICBT for Distress Related to Prostate Cancer

The study aims to study the efficacy of internet-based cognitive behavior therapy (ICBT) in reducing subjective distress and comorbid psychiatric symptoms in men diagnosed with prostate cancer. Participants who have been diagnosed with prostate cancer and are currently not undergoing or scheduled to undergo medical treatment will be recruited. Once recruited, they will be randomized to receive either a tailored, eight-week long ICBT intervention or an attention control group. Both group receive weekly support by a trained therapist.

Study Overview

• Status: Recruiting
• Conditions: Insomnia; Anxiety; Prostate Cancer; Psychological Distress; Depression - Major Depressive Disorder
• Intervention / Treatment: Behavioral: Internet-based cognitive behavioral therapy; Behavioral: Non-directive support

Detailed Description

Men diagnosed with prostate cancer frequently suffer from a wide range of psychological problems that can be traced to their disorder. Examples include depressed mood and worry regarding the prognosis and/or cancer recurrence. Psychological treatments can be used for helping cancer patients deal with this kind of distress, but frequently only targets one kind of symptoms.

This study investigates a tailored approach to providing help for men diagnosed with prostate cancer. Participants randomized to the treatment condition will receive an eight week ICBT intervention which is tailored to the problem profile of the participant in question. The treatment will last eight weeks and participants will receive weekly support and feedback from a therapist. Participants randomized to the control condition will receive weekly therapist support, but not access to the treatment modules. The primary outcome of interest is psychological distress, and other health-related outcomes will be measured as well. Participants will be recruited in Sweden with a nationwide recruitment.

• Study Type: Interventional
• Enrollment (Estimated): 180
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Gerhard Andersson, Ph.D.; Phone Number: +46-13285840; Email: gerhard.andersson@liu.se
• Study Contact Backup: Name: Anton Käll, Ph.D.; Email: anton.kall@liu.se

Study Locations

• Sweden
  • Linköping, Sweden, 58183
    • Recruiting
    • Department of Behavioral Sciences and Learning
    • Contact: Gerhard Andersson, Ph.D.; Phone Number: +46-13285840; Email: gerhard.andersson@liu.se
    • Principal Investigator: Gerhard Andersson, Ph.D.
    • Sub-Investigator: Anton Käll, Ph.D.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Subjectively reported psychological symptoms and problems that have come about after a prostate cancer diagnosis.
• A sum score above 19 on the primary outcome measure (Kessler-10).
• An age of 18 or older.
• Ability to speak, read, and write Swedish.
• Access to a computer/laptop/tablet/smartphone and internet access.
• Sufficient computer profiency to be able to use the treatment platform.

Exclusion Criteria:

• Planned medical treatment or planned change in medication related to the prostate cancer during the treatment period.
• Recently finished (within the past six months) medical treatment for prostate cancer.
• Severe psychiatric or somatic conditions that impedes participation in the study.
• Ongoing substance use problems.
• Acute suicidality.
• Other ongoing psychological treatment.
• Psychopharmaceutic treatment that has been changed within the past month or with planned changes during the treatment phase.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Tailored ICBT; An eight week long ICBT treatment that is tailored to the problem profile of the participant. The treatment is modular, with one module being administered per week of the treatment.	Behavioral: Internet-based cognitive behavioral therapy; An eight week ICBT treatment. The treatment is modular and tailored to the problem profile of the participant. One module will be administered every week during the treatment phase.
Active Comparator: Non-directive support; The control group will receive weekly support via contact with a therapist, without receiving access to the treatment modules.	Behavioral: Non-directive support; Participants randomized to this condition will receive weekly support and contact with a therapist via the treatment platform. They will not have access to the treatment modules during the treatment phase.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Kessler-10 (K10)	Measure of psychological distress. Consists of 10 items. Higher scores indicate greater psychological distress. Scores can range between 10 and 50.	At pretreatment, weekly during the treatment, after nine weeks, six months after completion of treatment, and twelve months after completion of treatment.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Fear of Cancer Recurrence Inventory, short form (FCRI)	Measure of fear of the cancer recurring and/or spreading. Consists of 9 items. Higher scores indicate greater fear/anxiety levels. Scores can range between 0 and 36.	At pretreatment, after nine weeks, six months after completion of treatment, and twelve months after completion of treatment.
Generalized Anxiety Disorder-7 item scale (GAD-7)	Measure of symptoms of generalized anxiety disorder. Consists of seven items. Higher scores indicate greater anxiety. Scores can range between 0 and 21.	At pretreatment, after nine weeks, six months after completion of treatment, and twelve months after completion of treatment.
Insomnia Severity Index (ISI)	Measure of insomnia and sleep related-difficulties. Consists of seven items. Higher scores indicate greater sleep related-difficulties. Scores can range from 0 to 28.	At pretreatment, after nine weeks, six months after completion of treatment, and twelve months after completion of treatment.
Brunnsviken Brief Quality of Life Scale (BBQ)	Measure of quality of life. Consists of 12 items. Higher scores indicate a greater quality of life. Scores can range between 0 and 96.	At pretreatment, after nine weeks, six months after completion of treatment, and twelve months after completion of treatment.
The EORTC Core Quality of Life questionnaire (EORTC QLQ-C30)	Measure of health-related quality of life. Consists of 30 items and three main subscales which each will serve as an outcome: Global health status, Functional status, and Symptom status. Higher scores indicate a greater health status within the domain. Scores can range between 0 and 100.	At pretreatment, after nine weeks, six months after completion of treatment, and twelve months after completion of treatment.
The Illness Cognition Questionnaire (ICQ)	Measure of cognitions about the illness (in this case prostate cancer). Consists of 18 items. Analyzed separately as three subscales: Acceptance, Perceived benefits, and Helplessness. Greater scores indicate greater acceptance, more perceived benefits, and greater helplessness, respectively. Will also be used as mediators in a mediation analysis with the rate of change in subscale sum scores used as mediators. Sum scores for each subscale can range between 6 and 24.	At pretreatment, weekly during the treatment, after nine weeks, six months after completion of treatment, and twelve months after completion of treatment.

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Client Satisfaction Questionnaire-8 item version (CSQ-8)	Measure of treatment satisfaction. Consists of eight items. Higher scores indicate greater treatment satisfaction. Scores can range between 8 and 32.	Measured after nine weeks of treatment.

Collaborators and Investigators

• Sponsor: Linkoeping University
• Collaborators: University Hospital, Linkoeping
• Investigators: Principal Investigator: Gerhard Andersson, PhD, Linkoeping University

Publications and helpful links

Helpful Links

• Website used for the treatment.

Study record dates

Study Major Dates

• Study Start (Actual): January 5, 2025
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): December 1, 2026

Study Registration Dates

• First Submitted: January 2, 2025
• First Submitted That Met QC Criteria: January 8, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 21, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Keywords: Cancer; Prostate cancer; Cognitive behavior therapy; Psychological distress; ICBT
• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Mental Disorders; Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Prostatic Diseases; Male Urogenital Diseases; Mood Disorders; Prostatic Neoplasms; Depressive Disorder; Depressive Disorder, Major
• Other Study ID Numbers: ISAC

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No