Ignite Creation Date:
2024-05-06 @ 2:58 PM
Last Modification Date:
2024-10-26 @ 1:40 PM
Study NCT ID:
NCT04480203
Status:
RECRUITING
Last Update Posted:
2022-03-02
First Post:
2020-07-09
Brief Title:
Coping After Breast Cancer - a Randomized Clinical Trial With Two Digital Interventions
Sponsor:
Cancer Registry of Norway
Organization:
Cancer Registry of Norway
Study Overview
Official Title:
Coping After Breast Cancer - CABC - Stressmestring Etter Brystkreft - SEB
Status:
RECRUITING
Status Verified Date:
2022-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CABC
Brief Summary:
1 Breast cancer patients and age-matched controls are first invited to answer questions on HRQoL
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
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
Detailed Description:
After completing the baseline HRQoL assessment eligible breast cancer patients will be invited to participate in a randomized clinical trial
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None