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Psychological DistressSTREAMNCT02289014

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

A study testing online stress Management program in people with Psychological Distress and Cancer, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Psychological Distress, Cancer
What is being tested?
online stress Management program
Could I receive a placebo?
No, everyone receives an active treatment
How many people
129 participants
Where
1 siteSwitzerland
Study dates
Jan 2014to Mar 2017
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
Show all 10Show fewer
  • Age >18 years
  • Command of the German language
  • Internet access and basic computer skills
  • Life expectancy of >6 months

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Switzerland1 site

  • University Hospital Basel

    Basel, 4031

Other trials in Switzerland

About this study

Official title: 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.

Read the 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

Being tested
online stress Management program
Keywords
online intervention, stress management, cognitive behavioral therapy, acceptance and mindfulness based intervention
Medical subject headings
Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • online stress Management programOther

    Active treatment group

Study groups in NCT02289014
Study groupRoleWhat they receive
Wait-list control groupNo interventionWait-list control group
Active treatment groupExperimentalonline stress Management program
Receives: Other: online stress Management program

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Dropout rate during the internet-based recruitment procedure

    Measured: Measures assessed at time point of recruitment

  2. 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

    Measured: Measures assessed at time point of recruitment

  3. Number of participants who completed at least 6 out of 8 modules, i.e. 75 % of each module

    Measured: participants will be followed for the duration of the intervention, an expected average of 8 weeks

  4. Working Alliance scores on the Working Alliance (WAI) Questionnaire

    Measured: participants will be followed for the duration of the intervention, an expected average of 8 weeks

  5. Usability scores on the System Usability Scale (SUS)

    Measured: participants will be followed for the duration of the intervention, an expected average of 8 weeks

  6. Client satisfaction on the Client Satisfaction Questionnaire-8 (CSQ-8)

    German Version of the Client Satisfaction Questionnaire: Fragebogen zur Messung der Patientenzufriedenheit (ZUF-8) will be used

    Measured: Measures assessed after 8 weeks

Secondary outcomes (4)

  1. Psychological distress on the Distress Thermometer (visual analogue scale)

    Measured: Change measures (e.g., "baseline, 8 weeks")

  2. Anxiety and Depression scores on the Hospital Anxiety and Depression Scale (HADS)

    Measured: Change measures (e.g., "baseline, 8 weeks")

  3. Quality of life and fatigue scores on the Functional Assessment in Cancer Therapy-Fatigue (FACT-F)

    Measured: hange measures (e.g., "baseline, 8 weeks")

  4. Avoidance and psychological inflexibility scores on the Acceptance and Action questionnaire (AAQ)

    German Version of the Acceptance and Action questionnaire: Fragebogen zur Akzeptanz und Handeln (FAH II) will be used

    Measured: ange measures (e.g., "baseline, 8 weeks")

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Nov 2014 (estimated)
  2. Study startJan 2014
  3. Primary completionMar 2017
  4. Study completionMar 2017

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
129 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02289014
Sponsor's protocol ID
KFS-3260-08-2013
Acronym
STREAM
Status last verified
May 2017
First submitted
9 Oct 2014
Last updated
8 May 2017
Results posted
No
Data monitoring committee
No

Publications

  • Urech C, Grossert A, Alder J, Scherer S, Handschin B, Kasenda B, Borislavova B, Degen S, Erb J, Faessler A, Gattlen L, Schibli S, Werndli C, Gaab J, Berger T, Zumbrunn T, Hess V. Web-Based Stress Management for Newly Diagnosed Patients With Cancer (STREAM): A Randomized, Wait-List Controlled Intervention Study. J Clin Oncol. 2018 Mar 10;36(8):780-788. doi: 10.1200/JCO.2017.74.8491. Epub 2018 Jan 25.

    PubMed 29369731

  • Grossert A, Urech C, Alder J, Gaab J, Berger T, Hess V. Web-based stress management for newly diagnosed cancer patients (STREAM-1): a randomized, wait-list controlled intervention study. BMC Cancer. 2016 Nov 3;16(1):838. doi: 10.1186/s12885-016-2866-0.

    PubMed 27809796

Questions about this trial

What is this clinical trial studying?

A study testing online stress Management program in people with Psychological Distress and Cancer, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 8 May 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Dropout rate during the internet-based recruitment procedure (time frame: Measures assessed at time point of recruitment). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02289014, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 May 2017.

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