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

Cancer Clinical Trial

— STREAM  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02289014
• Other study ID #: KFS-3260-08-2013
• Status: Completed
• Phase: N/A
• First received: October 9, 2014
• Last updated: May 5, 2017
• Start date: January 2014
• Est. completion date: March 2017

Study information

• Verified date: May 2017
• Source: University Hospital, Basel, Switzerland
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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). 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 129
• Est. completion date: March 2017
• Est. primary completion date: March 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cancer
• Psychological Distress

Intervention

Other:
• online stress Management program
Active treatment group

Locations

Country	Name	City	State
Switzerland	University Hospital Basel	Basel

Sponsors (3)

Lead Sponsor	Collaborator
University Hospital, Basel, Switzerland	Swiss Cancer Research, Swiss National Science Foundation

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Dropout rate during the internet-based recruitment procedure		Measures assessed at time point of recruitment
Primary	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
Primary	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
Primary	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
Primary	Usability scores on the System Usability Scale (SUS)		participants will be followed for the duration of the intervention, an expected average of 8 weeks
Primary	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	Psychological distress on the Distress Thermometer (visual analogue scale)		Change measures (e.g., "baseline, 8 weeks")
Secondary	Anxiety and Depression scores on the Hospital Anxiety and Depression Scale (HADS)		Change measures (e.g., "baseline, 8 weeks")
Secondary	Quality of life and fatigue scores on the Functional Assessment in Cancer Therapy-Fatigue (FACT-F)		hange measures (e.g., "baseline, 8 weeks")
Secondary	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	ange measures (e.g., "baseline, 8 weeks")