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

NCT02289014 | Completed

• 1 other identifier: KFS-3260-08-2013
• Study Type: interventional
• Target: 129
• Locations: 1 country
• Sites: 1

Brief 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). 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.

Conditions

Psychological Distress; Cancer

Keywords

online intervention; stress management; cognitive behavioral therapy; acceptance and mindfulness based intervention

Outcome Measures

Primary Outcomes (6)

• Dropout rate during the internet-based recruitment procedure

  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

  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

  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

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

• Usability scores on the System Usability Scale (SUS)

  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)

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

  Measures assessed after 8 weeks

Secondary Outcomes (4)

• Psychological distress on the Distress Thermometer (visual analogue scale)

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

• Anxiety and Depression scores on the Hospital Anxiety and Depression Scale (HADS)

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

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

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

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

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

Study Arms (2)

Wait-list control group

NO INTERVENTION

Wait-list control group

Active treatment group

EXPERIMENTAL

online stress Management program

Other: online stress Management program

Interventions

online stress Management program OTHER

Active treatment group

Active treatment group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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

You may not qualify if:

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

Sponsors & Collaborators

• University Hospital, Basel, Switzerland: lead
• Krebsforschung Schweiz, Bern, Switzerland: collaborator
• Swiss National Science Foundation: collaborator

Study Sites (1)

University Hospital Basel

Basel, 4031, Switzerland

Location

Related Publications (2)

• 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.

  PMID: 29369731 DERIVED

• 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.

  PMID: 27809796 DERIVED

MeSH Terms

Conditions

Neoplasms

Study Officials

• Corinne Urech, Dr. phil.

  University Hospital, Basel, Switzerland

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 9, 2014
• First Posted: November 13, 2014
• Study Start: January 1, 2014
• Primary Completion: March 1, 2017
• Study Completion: March 1, 2017
• Last Updated: May 8, 2017

Record last verified: 2017-05

Locations

CH (1)