Coping After Breast Cancer - a Randomized Clinical Trial With Two Digital Interventions
NCT ID: NCT04480203
Last Updated: 2022-03-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
390 participants
INTERVENTIONAL
2021-01-15
2035-12-31
Brief Summary
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2. Among responding breast cancer patients, a subset are invited in a randomized clinical trial with two digital interventions for cancer stress management, cognitive based stress management (CBSM) and mindfulness based intervention (MBI), as well as a control group.
3. The goal is to determine whether digital CBSM or MBI can effectively reduce stress levels as compared to a control group. Second, whether these interventions can improve HRQoL (or avoid onset of HRQoL problems) for patients with breast cancer, compared to a control group.
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Detailed Description
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Those who are willing will be randomly allocated to one of the following arms: a) Digital cognitive based stress management, b) Digital mindfulness based intervention or c) Control group.
The intervention is based on a revised version of the Stressproffen app, which was developed by the Oslo University Hospital (Lise Solberg Nes, Elin Børøsund and others).
Outcome measures include measures of perceived stress and HRQoL.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
DOUBLE
Study Groups
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Cognitive based stress management (CBSM)
Cognitive based digital intervention.
Stressproffen cognitive based stress management
The participants will download an app (Stressproffen 2A) with cognitive based stress management.
Mindfulness based intervention (MBI)
Mindfulness based digital intervention.
Stressproffen mindfulness based intervention
The participants will download an app (Stressproffen 2B) with mindfulness based intervention.
Control
Control arm. No intervention.
Control
The participants will receive no app. (They will be able to download it after the end of the 3 year study).
Interventions
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Stressproffen cognitive based stress management
The participants will download an app (Stressproffen 2A) with cognitive based stress management.
Stressproffen mindfulness based intervention
The participants will download an app (Stressproffen 2B) with mindfulness based intervention.
Control
The participants will receive no app. (They will be able to download it after the end of the 3 year study).
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* non-metastatic cancer stage 0-III
Invasive tumors must be:
* HER2 positive (regardless of ER, PR) or
* ER negative
* (may later include other ER+ if not conflict with recruitment for EMIT/OPTIMA)
Exclusion Criteria
20 Years
69 Years
FEMALE
No
Sponsors
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Norwegian Institute of Public Health
OTHER_GOV
Responsible Party
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Principal Investigators
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Giske Ursin, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Norwegian Institute of Public Health
Locations
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Cancer Registry of Norway
Oslo, , Norway
Countries
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Central Contacts
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Facility Contacts
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References
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Svendsen K, Nes LS, Meland A, Larsson IM, Gjelsvik YM, Borosund E, Rygg CM, Myklebust TA, Reinertsen KV, Kiserud CE, Skjerven H, Antoni MH, Chalder T, Mjaaland I, Carlson LE, Eriksen HR, Ursin G. Coping After Breast Cancer: Protocol for a Randomized Controlled Trial of Stress Management eHealth Interventions. JMIR Res Protoc. 2023 May 24;12:e47195. doi: 10.2196/47195.
Other Identifiers
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CABC - Kreftfor project - SEB
Identifier Type: -
Identifier Source: org_study_id
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