Monitoring of Chronic Conditions in Breast Cancer (REBECCA-1)
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT05587777 |
Recruitment Status :
Recruiting
First Posted : October 20, 2022
Last Update Posted : October 20, 2022
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Condition or disease |
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Breast Cancer Chronic Fatigue Syndrome |
Study Type : | Observational |
Estimated Enrollment : | 150 participants |
Observational Model: | Case-Control |
Time Perspective: | Prospective |
Official Title: | REsearch on BrEast Cancer Induced Chronic Conditions Supported by Causal Analysis of Multi-source Data |
Actual Study Start Date : | June 15, 2022 |
Estimated Primary Completion Date : | June 15, 2024 |
Estimated Study Completion Date : | June 15, 2028 |
Group/Cohort |
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Mild Cancer Related Fatigue
After treatment(6 months from inclusion) is ended a fVAS < 50
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Cancer related Fatigue
After treatment (6 months from inclusion) with fVAS ≥ 50 mm or a rise of fVAS of ≥ 25 mm.
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Healthy control
Healthy women matches with age
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- Level of fatigue at diagnosis - baseline [ Time Frame: This will be done at diagnosis, before treatment. ]Visual Analogue Scale (fVAS), which is a score from 0 to 100 mm marked on a 100 mm line on a paper.
- Change from baseline fVAS after treatment 6 months [ Time Frame: 6 months after diagnosis and treatment ]fVAS (score from 0 to 100 mm marked on a 100 mm line on paper)
- fVAS follow up 12 months [ Time Frame: 12 months after diagnosis and treatment ]fVAS (score from 0 to 100 mm marked on a 100 mm line on paper)
- fVAS follow up 18 months [ Time Frame: 18 months after diagnosis and treatment ]fVAS (score from 0 to 100 mm marked on a 100 mm line on paper)
- Activity and sleep disorder measured with a smart watch. [ Time Frame: This will be measured at month 6 ]We may measure number of steps each day, papttern of movement and sleep quality
- Activity and sleep disorder measured with a smart watch. [ Time Frame: This will be measured at month 12 ]We may measure number of steps each day, papttern of movement and sleep quality
- Activity and sleep disorder measured with a smart watch. [ Time Frame: This will be measured at month 18 ]We may measure number of steps each day, papttern of movement and sleep quality
Biospecimen Retention: Samples With DNA
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Ages Eligible for Study: | 19 Years to 80 Years (Adult, Older Adult) |
Sexes Eligible for Study: | Female |
Gender Based Eligibility: | Yes |
Gender Eligibility Description: | Breast Cancer affects women in 99% of all cases |
Accepts Healthy Volunteers: | Yes |
Sampling Method: | Non-Probability Sample |
Inclusion Criteria:
- Breast cancer patients with histologically detectable M0 breast cancer (stage 0-III) who require neoadjuvant or adjuvant endocrine, chemo and / or radiation therapy at least and no more than 3 months before initiation of study.
- Female breast cancer patients between 19 and 80 years of age.
- Patients who have increased their life expectancy beyond the first 3 months after starting treatment.
- Patients who have the ability to understand the protocol and can participate in the follow-up plan.
- Patients who have an absence of psychological, familial, sociological or geographical condition that potentially impedes compliance with the study protocol and follow-up plan.
Exclusion criteria:
- Male breast cancer patients.
- Patients who do not agree to the study protocol.
- Patients with a previous cancer diagnosis (excluding skin cancer treated only by surgery).
- Patients who have previously been treated with some form of chemotherapy / radiation therapy.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05587777
Contact: Tone Hoel Lende, PhD | 47861295 | leth@SUS.no | |
Contact: Håvard Søiland, PhD | 45636028 | hsoiland@gmail.com |
Norway | |
Helse Stavanger HF | Recruiting |
Stavanger, Norway, 4068 | |
Contact: Tone Hoel Lende, PhD 47861295 leth@sus.no | |
Contact: Håvard Søiland, PhD 45636028 hsoiland@gmail.com |
Study Director: | Svein Skeie, PhD | Helse Stavanger HF |
Responsible Party: | Helse Stavanger HF |
ClinicalTrials.gov Identifier: | NCT05587777 |
Other Study ID Numbers: |
1234 |
First Posted: | October 20, 2022 Key Record Dates |
Last Update Posted: | October 20, 2022 |
Last Verified: | June 2022 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
fatigue breast cancer |
Breast Neoplasms Fatigue Syndrome, Chronic Fatigue Chronic Disease Neoplasms by Site Neoplasms Breast Diseases Skin Diseases |
Muscular Diseases Musculoskeletal Diseases Encephalomyelitis Neuroinflammatory Diseases Nervous System Diseases Neuromuscular Diseases Disease Attributes Pathologic Processes |