Digital interventions for stress management in breast cancer patients
Coping After Breast Cancer - CABC - Stressmestring Etter Brystkreft - SEB
This study is testing two online programs to help breast cancer patients manage stress and see if they can improve their quality of life compared to a control group.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 390 (estimated) |
| Ages | 20 Years to 69 Years |
| Sex | Female |
| Sponsor | Norwegian Institute of Public Health Government |
| Locations | 1 site (Oslo) |
| Trial ID | NCT04480203 on ClinicalTrials.gov |
What this trial studies
This clinical trial invites breast cancer patients to participate in a randomized trial assessing two digital interventions aimed at managing stress: cognitive based stress management (CBSM) and mindfulness based intervention (MBI). Participants will first complete a health-related quality of life (HRQoL) assessment before being randomly assigned to one of the intervention groups or a control group. The study aims to evaluate the effectiveness of these digital interventions in reducing stress levels and improving HRQoL among breast cancer patients compared to the control group.
Who should consider this trial
Good fit: Ideal candidates are breast cancer patients diagnosed with non-metastatic cancer stages 0-III since January 1, 2020.
Not a fit: Patients with metastatic breast cancer or those diagnosed prior to January 1, 2020, may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide effective digital tools for stress management that enhance the quality of life for breast cancer patients.
How similar studies have performed: Other studies have shown promise in using digital interventions for stress management in cancer patients, indicating potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * first occurrence breast cancer diagnosed from Jan 1, 2020 * 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: * None
Where this trial is running
Oslo
- Cancer Registry of Norway — Oslo, Norway (Recruiting)
Study contacts
- Principal investigator: Giske Ursin, MD, PhD — Norwegian Institute of Public Health
- Study coordinator: Giske Ursin, MD, PhD
- Email: giske.ursin@kreftregisteret.no
- Phone: +4722451300
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.