Internet-delivered Psycho-oncological Support

Study Overview
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Brief Summary
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Cancer patients develop a high psychological burden of the underlying disease. To support patients in outpatient phases psychotherapists are not sufficiently available for establish regularly face-to-face-contact. The availability of Internet-based psychotherapeutic support can bridge this gap. This study examines the effectiveness of MAC-CBT® via the Internet (called Incobeth®) in cancer patients.

Detailed Description
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In this study, a randomized trial is conducted in which the online users are allocated into two different care services (MAC-CBT® vs. psycho-educational support program). Participants are cancer patients who have been advised by their treating oncologists, family doctors or psychotherapists on the online support. All patients are randomized, based on the information the referring physician give about type of tumor, treatment status, prognosis and psychosocial factors. Initial will be done an extensive psychometric survey. The MAC-CBT® group receives an intervention program based on ten modules, in which the aspects of Mindfulness, Acceptance and Commitment in detail are included to start a process-oriented self-treatment with regular feedback by the individually assigned psychologists through the internet-portal and email and through live contacts (via video-telephony). The control group will have access to six modules with a psychoeducational support program, which is also constructed according to the MAC principle. Both groups can use crisis modules (in case of pain, psychological crisis, fear of dying) without access restriction. The control group, upon completion of 6 weeks (for each module one week) can switch to active treatment arm. Input and output results are determined using validated survey instruments. Randomisation is done by a physician not involved in the further course of the evaluation.

Official Title
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MAC-CBT Used as Internet-delivered Psycho-oncological Support

Conditions
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Cancer

Intervention / Treatment
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* Behavioral: cognitive behavior therapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Cancer patient psychological distress informed consent Exclusion Criteria: no informed consent no cancer

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: intervention arm / verum arm<br>Participants can work on ten modules specialized cognitive behavior treatments to learn and deal with mindfulness, acceptance and commitment. They should learn to handle their emotions, to accept the situation and to get in an active future. The participants can direct contact a psychotherapist via email, Chat or Skype/tokbox. The modules based on Cognitive Behavior Therapy. | Behavioral: cognitive behavior therapy<br>* treatment technique to help people to overcome psychological distress and mental diseases<br>|
| Active Comparator: non-intervention arm / control group<br>Participants can work on six modules with information und education goals for learning something about their possibilities to become a better mood, better psychovegetative or psychosocial situation as cancer patient. This modules are based on Cognitive Behavior Therapy. The non-intervention arm will only allow contact to the platform, no direct contact to a psychotherapist (in opposite to the intervention arm) is available. | Behavioral: cognitive behavior therapy<br>* treatment technique to help people to overcome psychological distress and mental diseases<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Scores of Prime-MD | Recording of change of score PRIME-MD, depression, anxiety and other mental health issues | Start at baseline (t1), Second measurement at t2 estimated 8 weeks later, Followup 6months (t3) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Scores of Quality of Life | Measurement of the changes of quality of life after the treatment | Start at baseline (t1), Second measurement at t2 estimated 8 weeks later, Followup 6months (t3) | 
| Resilience | Reflection of the changes of resilience to test if it is stable or fluid over the treatment period | Start at baseline (t1), Second measurement at t2 estimated 8 weeks later, Followup 6months (t3) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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psychooncology, mental health support, ICBT, supportive treatment for cancer patients, depression, online-therapy, Psycho-oncological support via internet, internet-delivered cognitive behavior medicine