Skip to main content
OpenTrials
Completed

NCT Number: NCT02289014

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Psychological Distress Cancer Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Hospital Basel

Basel, 4031, Switzerland

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

online stress Management program

Other

Active treatment group

Primary outcomes

  1. Dropout rate during the internet-based recruitment procedure

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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)

    Time frame: 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)

    Time frame: Measures assessed after 8 weeks

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

Secondary outcomes

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

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

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

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

  3. 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")

  4. 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

Sponsors and collaborators

Lead sponsor

University Hospital, Basel, Switzerland

Other

Collaborators

  • Krebsforschung Schweiz, Bern, Switzerland
  • Swiss National Science Foundation

Registry information

Official study title

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

Acronym: STREAM

Important dates

Study start
2014
Primary completion
2017
Study completion
2017
First posted
Nov 13, 2014
Registry last updated
May 8, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.