Stress Management Intervention in Early Stage Cancer: Randomized Controlled Trial

• Register: ClinicalTrials.gov
• Last refreshed on: 15 April 2024
• Main ID: NCT02939612
• Date of registration: 17/10/2016
• Prospective Registration: No
• Primary sponsor: Oslo University Hospital
• Public title: Stress Management Intervention in Early Stage Cancer: Randomized Controlled Trial
• Scientific title: Testing a Computerized Interactive Stress Management Intervention in Early Stage Cancer: A Randomized Controlled Trial
• Date of first enrolment: October 2016
• Target sample size: 200
• Recruitment status: Active, not recruiting
• URL: https://clinicaltrials.gov/ct2/show/NCT02939612
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Supportive Care. Masking: None (Open Label).
• Phase: N/A

Countries of recruitment

Norway

Contacts

• Name: Lise Solberg Nes, PhD
• Affiliation: Oslo University Hospital

Key inclusion & exclusion criteria

Inclusion Criteria:

- Patients diagnosed with cancer (all diagnosis).

- Maximum time since completed treatment at hospital: 12 months

- Patients are > 18 years of age, able to write/read/speak Norwegian and have their own
smart phone or tablet

Exclusion Criteria:

• None



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Stress, Psychological

Cancer

Intervention(s)

Behavioral: App for stress management

Primary Outcome(s)

The Perceived Stress Scale (PSS-14) [Time Frame: Baseline, post intervention follow up at 3, 6, and 12 months]

Secondary Outcome(s)

The Distress Thermometer [Time Frame: Baseline, post intervention follow up at 3, 6, and 12 months]

The Self-Regulatory Fatigue-18 (SRF-18) [Time Frame: Baseline, post intervention follow up at 3 and 12 months]

The Brief Coping Orientation to Problems (Brief COPE) [Time Frame: Baseline]

The Hospital Anxiety and Depression Scale (HADS) [Time Frame: Baseline, post intervention follow up at 3, 6, and 12 months]

Health, well-being and sleep [Time Frame: Baseline, post intervention follow up at 3, 6, and 12 months]

SF-36 Item Short Form Health Survey (RAND-36 version) [Time Frame: Baseline, post intervention follow up at 3, 6, and 12 months]

Intervention commentary [Time Frame: Post intervention (immediately post intervention)]

Secondary ID(s)

2016/1436

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Norwegian Cancer Society