Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Study of the Utility of the BOMET-QOL Questionnaire Patients With Breast Cancer and Bone Metastasis (MAbomet)

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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03847220
Recruitment Status : Completed
First Posted : February 20, 2019
Last Update Posted : February 25, 2019
Sponsor:
Collaborator:
Novartis Pharmaceuticals
Information provided by (Responsible Party):
Spanish Breast Cancer Research Group

Brief Summary:
Epidemiological, prospective and multicenter study to evaluate the utility of the BOMET-QoL questionnaire in patients with breast cancer (BC) and bone metastases (BM).

Condition or disease Intervention/treatment
Breast Carcinoma Metastatic to the Bone Diagnostic Test: BOMET-QoL questionnaire

Detailed Description:

Population: Patients over 18 with breast cancer and bone metastasis.

Inclusion criteria:

  • Patient over 18 years of age.
  • Patient diagnosed with breast cancer (BC) and bone metastases (BM).
  • Patient who has granted informed consent in writing to participate in the study.
  • Patient capable of understanding and completing the questionnaires.

Exclusion criteria:

  • Patient with another type of disease that, in the investigator's opinion, could mask the study results.
  • Patients with a life expectancy of less than 8 months.
  • Patient who is participating in a clinical trial with an unregistered drug at the start of the study.

Layout table for study information
Study Type : Observational [Patient Registry]
Actual Enrollment : 241 participants
Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration: 12 Months
Official Title: Prospective Study of the Utility of the BOMET-QOL Questionnaire Patients With Breast Cancer and Bone Metastasis
Actual Study Start Date : October 23, 2007
Actual Primary Completion Date : May 20, 2010
Actual Study Completion Date : July 7, 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer


Intervention Details:
  • Diagnostic Test: BOMET-QoL questionnaire
    study to evaluate the utility of the BOMET-QoL questionnaire in patients with BC and BM


Primary Outcome Measures :
  1. Impact on the HRQoL [ Time Frame: Up to 24 months ]
    Impact on the HRQoL of patients with BC and BM will be measured by the BOMET-QoL questionnaire in the context of normal clinical practice. The questionnaire will be administered to patients in each study visit from baseline visit to the final visit at 24 months. The score of the questionnaire will be measured as: Score: 0 - Always, 1 - Nearly always, 2 - Sometimes, 3 - Rarely, 4 - Never, were never is the best option and always means patient has a bad health condition.


Secondary Outcome Measures :
  1. Measurement properties of the BOMET-QoL questionnaire: validity [ Time Frame: Up to 24 months ]
    Its cross-sectional validity will be evaluated by analysing the relationship between the BOMET-QoL scores and different clinical variables (presence of Skeleton-Related Event (SREs), symptoms and Eastern Cooperative Oncology Group (ECOG) index). The relationship between the pain VAS score and the question about state of health perceived by patient with HRQoL according to BOMET-QoL will be analysed.

  2. Measurement properties of the BOMET-QoL questionnaire: feasibility [ Time Frame: Up to 24 months ]
    BOMET-QoL will be considered rapidly completed if patients complete questionnaire in less than 10 minutes.

  3. Measurement properties of the BOMET-QoL questionnaire: sensitivity to change [ Time Frame: Up to 24 months ]
    Sensitivity to change can be evaluated by calculating the effect size or the Minimum Clinically Important Difference, as statistics based on effect size provide direct information about the magnitude of the change, expressed as a variation, also used to calculate the Minimum Clinically Important Difference.

  4. Impact of skeletal-related events (SREs) on HRQoL (BOMET-QoL scores) [ Time Frame: Up to 24 months ]
    The impact of skeletal-related events (SREs) on HRQoL (BOMET-QoL scores) will be measured by comparing patients who presented SREs with patients with without SREs.

  5. Relation between Eastern Cooperative Oncology Group (ECOG) and HRQoL (BOMET-QoL scores). [ Time Frame: Up to 24 months ]
    ECOG: This scale consists of 5 levels (0 = No restrictions to carry out the activities normal, 1 = Restrictions to perform vigorous physical activities. It has the capacity to perform ambulation and light work, 2 = Ability to ambulate and perform personal care but not able to work. Capacity for standing and walking for> 50% of waking hours, 3 = Able to perform care limited personal; Incarcerated or restrained to be in a chair for> 50% of the hours of vigil, 4 = complete disability; he can not perform any personal care; it remains in bed or in a chair all the time, 5 = Death). In it the observer assesses the state of symptoms and the level of functioning in relation to ambulatory status and need for care. Patients with an Eastern Cooperative Oncology Group (ECOG) functional scale between 0-1 will obtain a higher score (better HRQoL) in the BOMET-QoL questionnaire.

  6. Correlation between visual analogue scale (VAS) score of pain and HRQoL (BOMET-QoL scores). [ Time Frame: Up to 24 months ]
    At the baseline visit, patients who obtain higher scores on the Analogue Visual Pain Scale will obtain a lower score (worse HRQOL) in the BOMET-QoL questionnaire. Correlation between the BOMET-QoL scores and the pain VAS scores regarding whether it improves, stays the same or gets worse between the different study visits. VAS: 0 no pain - 10 unbearable pain



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   female patient over 18 years of age
Sampling Method:   Non-Probability Sample
Study Population
The patients susceptible for inclusion in the study were women with breast cancer and bone metastasis in any location who met the screening criteria described in the study protoco
Criteria

Inclusion Criteria:

  • Patient over 18 years of age.
  • Patient diagnosed with BC and BM.
  • Patient who has granted informed consent in writing to participate in the study.
  • Patient capable of understanding and completing the questionnaires

Exclusion Criteria:

  • Patient with another type of disease that, in the investigator's opinion, could mask the study results.
  • Patients with a life expectancy of less than 8 months.
  • Patient who is participating in a clinical trial with an unregistered drug at the start of the study.

Information from the National Library of Medicine

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): NCT03847220


Locations
Layout table for location information
Spain
Hospital Universitario Virgen Del Rocío
Sevilla, Andalucia, Spain, 41013
Hospital General de Guadalajara
Guadalajara, Castilla-La Mancha, Spain, 19002
ICO Badalona Hospital Universitari Germans Trias I Pujol
Badalona, Cataluña, Spain, 08916
Hospital Universitari Clinic I Provincial
Barcelona, Cataluña, Spain, 08036
Hospital Santa Creu I Sant Pau
Barcelona, Cataluña, Spain, 08041
Hospital Mutua de Terrassa
Barcelona, Cataluña, Spain, 08221
ICO Girona Hospital Dr. Josep Trueta
Gerona, Cataluña, Spain, 17007
Hospital Universitari Arnau de Vilanova
Lleida, Cataluña, Spain, 25198
Fundació Althaia, Xarxa Assistencial de Manresa
Manresa, Cataluña, Spain, 08243
Hospital General Universitario de Alicante
Alicante, Cominidad Valenciana, Spain, 03010
Hospital Clínico Universitario de Valencia
Valencia, Comunidad Valenciana, Spain, 46010
Complejo Hospitalario Universitario A Coruña
A Coruña, Galicia, Spain, 15006
Centro Oncologico de Galicia
A Coruña, Galicia, Spain, 15009
Complejo Hospitalario de Pontevedra
Pontevedra, Galicia, Spain, 36164
Hospital de Barbastro
Barbastro, Huesca, Spain, 22300
Sponsors and Collaborators
Spanish Breast Cancer Research Group
Novartis Pharmaceuticals
Investigators
Layout table for investigator information
Study Director: Study Director Hospital Santa Creu I Sant Pau

Additional Information:
Layout table for additonal information
Responsible Party: Spanish Breast Cancer Research Group
ClinicalTrials.gov Identifier: NCT03847220     History of Changes
Other Study ID Numbers: Mabomet
First Posted: February 20, 2019    Key Record Dates
Last Update Posted: February 25, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Spanish Breast Cancer Research Group:
metastatic breast cancer
bone metastasis
quality of life
psychometric
treatment
assessments
Additional relevant MeSH terms:
Layout table for MeSH terms
Breast Neoplasms
Neoplasm Metastasis
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Neoplastic Processes
Pathologic Processes