Web-based Stress Management for Newly Diagnosed Cancer Patients (STREAM-1) (STREAM)

May 5, 2017 updated by: University Hospital, Basel, Switzerland

Web-based Stress Management for Newly Diagnosed Cancer Patients (STREAM-1): A Randomized, Wait-list Controlled Intervention Study

Many cancer patients experience their illness as substantial psychological burden. About half of the cancer patients suffer from severe stress symptoms and around one third of the patients fulfill the criteria for a clinically relevant psychological disorder (mainly anxiety disorder and/or major depression). Studies show, that a high level of distress in cancer patients is associated with more side effects of and a reduced compliance for oncological treatment.

Today, the efficacy of psycho-oncological interventions is well studied and proven. Besides the reduction of levels of anxiety, distress and depression, psycho-oncological support facilitates dealing with physical complaints and increases quality of life. Yet, psycho-oncological support is rarely utilized by male patients and insufficiently accessible for many patients (i.a. lack of supply in the respective area, cost issues).

The internet overcomes some of these barriers, as it can be used independently of time and location. Internet-based therapies are therefore a growing field of interest in research and there is evidence for treatment efficacy for several psychological disorders. Moreover effect sizes of traditional face-to-face and interactive web-based interventions are comparable. However, web-based interventions for cancer patients are still scarce. The present research project therefore develops a comprehensive stress management program accessible for a vast number of cancer patients. The study targets primarily to evaluate the feasibility of the program (technical, organizational feasibility, accessibility). In addition, the preliminary efficacy of the program will be analyzed in order to adapt future programs for specific patient groups.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The present study is designed as a randomized controlled wait-list intervention study. Within 12 weeks of the start of anti-cancer treatment, patients will be randomly assigned to the web-based stress management intervention or a wait-list control condition.

Inclusion criteria:

Patients with any kind of newly diagnosed cancer undergoing first Treatment regardless of the Setting. Patients undergoing first treatment for newly diagnosed relapse of cancer, who have received prior curatively-intended Treatment.

Inclusion is allowed immediately prior to or within 12 weeks of the start of treatment. If surgery was performed initially and is followed by systemic treatment or radiotherapy, start of systemic treatment or radiotherapy is counted as first treatment. Prior treatment -including chemotherapy- for a different, prior malignant tumor is allowed. Concomitant participation in an experimental therapeutic drug trial is allowed. Age >18 years. Command of the German language. Internet access and basic computer skills. Life expectancy of >6 months.

Exclusion criteria:

Patients undergoing second- or further line treatment. Patients treated with surgery only. Patients participating in a concomitant psychological intervention trial

Study Type

Interventional

Enrollment (Actual)

129

Phase

  • 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 Locations

  • Switzerland
      • Basel, Switzerland, 4031
        • University Hospital Basel

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

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients with any kind of newly diagnosed cancer undergoing first treatment (including radiotherapy, hormonal treatment, targeted therapies, chemotherapy or combined-modality treatment) regardless of the setting (adjuvant treatment, curative treatment, palliative first-line treatment)
  • Patients with newly diagnosed relapse of cancer, who had received prior curatively-intended treatment
  • Inclusion is allowed immediately prior to or within 12 weeks of the start of treatment
  • Patients must have cytologically or histologically proven diagnosis of malignant disease (either at diagnosis or at relapse)
  • Prior treatment -including chemotherapy- for a different, prior malignant tumor is allowed
  • Concomitant participation in an experimental therapeutic drug trial is allowed
  • Age >18 years
  • Command of the German language
  • Internet access and basic computer skills
  • Life expectancy of >6 months

Exclusion Criteria:

  • Patients undergoing palliative second- or further line chemotherapy treatment
  • Patients treated with surgery only
  • Patients participating in a concomitant psychological intervention trial

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: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
NO_INTERVENTION: Wait-list control group
EXPERIMENTAL: Active treatment group
online stress Management program
Other: online stress Management program
Active treatment group

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Dropout rate during the internet-based recruitment procedure
Time Frame: Measures assessed at time point of recruitment
Measures assessed at time point of recruitment
Characteristics (Sociodemographic and medical history; i.e. age, gender, education, cancer diagnosis and cancer treatment) of the population willing to participate in an online stress management program shortly after diagnosis of cancer
Time Frame: Measures assessed at time point of recruitment
Measures assessed at time point of recruitment
Number of participants who completed at least 6 out of 8 modules, i.e. 75 % of each module
Time Frame: participants will be followed for the duration of the intervention, an expected average of 8 weeks
participants will be followed for the duration of the intervention, an expected average of 8 weeks
Working Alliance scores on the Working Alliance (WAI) Questionnaire
Time Frame: participants will be followed for the duration of the intervention, an expected average of 8 weeks
participants will be followed for the duration of the intervention, an expected average of 8 weeks
Usability scores on the System Usability Scale (SUS)
Time Frame: participants will be followed for the duration of the intervention, an expected average of 8 weeks
participants will be followed for the duration of the intervention, an expected average of 8 weeks
Client satisfaction on the Client Satisfaction Questionnaire-8 (CSQ-8)
Time Frame: Measures assessed after 8 weeks
German Version of the Client Satisfaction Questionnaire: Fragebogen zur Messung der Patientenzufriedenheit (ZUF-8) will be used
Measures assessed after 8 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Psychological distress on the Distress Thermometer (visual analogue scale)
Time Frame: Change measures (e.g., "baseline, 8 weeks")
Change measures (e.g., "baseline, 8 weeks")
Anxiety and Depression scores on the Hospital Anxiety and Depression Scale (HADS)
Time Frame: Change measures (e.g., "baseline, 8 weeks")
Change measures (e.g., "baseline, 8 weeks")
Quality of life and fatigue scores on the Functional Assessment in Cancer Therapy-Fatigue (FACT-F)
Time Frame: hange measures (e.g., "baseline, 8 weeks")
hange measures (e.g., "baseline, 8 weeks")
Avoidance and psychological inflexibility scores on the Acceptance and Action questionnaire (AAQ)
Time Frame: ange measures (e.g., "baseline, 8 weeks")
German Version of the Acceptance and Action questionnaire: Fragebogen zur Akzeptanz und Handeln (FAH II) will be used
ange measures (e.g., "baseline, 8 weeks")

Collaborators and Investigators

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

Sponsor

University Hospital, Basel, Switzerland

Collaborators

Swiss National Science Foundation
Krebsforschung Schweiz, Bern, Switzerland

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

January 1, 2014

Primary Completion (ACTUAL)

March 1, 2017

Study Completion (ACTUAL)

March 1, 2017

Study Registration Dates

First Submitted

October 9, 2014

First Submitted That Met QC Criteria

November 12, 2014

First Posted (ESTIMATE)

November 13, 2014

Study Record Updates

Last Update Posted (ACTUAL)

May 8, 2017

Last Update Submitted That Met QC Criteria

May 5, 2017

Last Verified

May 1, 2017

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • KFS-3260-08-2013

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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