Breast Cancer Clinical Trial
— CONTACTOfficial title:
CONTACT: A Prospective Interventional Multicentre Before-after Study for the Implementation of a Care Pathway to Increase Self-management of Patients With Cancer Who Are Treated With Oral Anticancer Medications
This study aims to develop, implement and evaluate a care pathway for patients with cancer
who are treated with oral anticancer drugs (OACD).
The care pathway will be developed in six hospitals in Flanders, and will be adapted to the
local setting and situation.
The investigators hypothesize that the implementation of a care pathway will increase the
quality of the drug therapy, the communication between health care professionals (HCPs) and
patients, and will lead to an improved level of self-management and adherence. Moreover, the
invesitgators hypothesize that the care pathway will facilitate the communication between
HCPs in the hospital setting and in ambulatory care, and will improve counseling skills,
self-efficacy and self-confidence of HCPs.
At the end of the study, a roadmap for the nation-wide implementation of a similar care
pathway will be constructed based on the experiences of the participating hospitals. This
roadmap will certainly include an e-learning platform for healthcare professionals.
Status | Recruiting |
Enrollment | 228 |
Est. completion date | November 2022 |
Est. primary completion date | November 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - a hematological cancer of solid tumor - starting an oral anticancer drug for the first time - able to understand and speak Dutch Exclusion Criteria: - patients following an adjuvant oral anticancer therapy (e.g. tamoxifen) - patients following a therapy with a study drug |
Country | Name | City | State |
---|---|---|---|
Belgium | Imelda Bonheiden | Bonheiden | Vlaams-Brabant |
Belgium | Maria Middelares Gent | Ghent | Oost-Vlaanderen |
Belgium | AZ Groeninge Kortrijk | Kortrijk | West-Vlaanderen |
Belgium | AZ Turnhout | Turnhout | Antwerpen |
Lead Sponsor | Collaborator |
---|---|
KU Leuven |
Belgium,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Change in Self-efficacy in HCPs using the Self-efficacy and Performance in Self-management Instrument (SEPSS) | SEPSS investigates the ability of a HCP to evaluate their own performance in daily practice and caregiving. | at baseline (before the implementation of the care pathway) and after 24 months (during implementation) | |
Other | Change in perceptions on self-management in HCPs using the Clinician Support for Patient activation measure | at baseline (before the implementation of the care pathway) and after 24 months (during implementation) | ||
Primary | Change in self-management skills | There is no gold standard to define self-management. A definition from Barlow et al., 2002 (2) defines self-management as follows: the ability of an individual to manage the symptoms, treatment, physical and psychosocial consequences and life style changes due to his/her condition. Adequate self-management refers to the ability to monitor one's condition and to effect cognitive, behavioural and emotional responses necessary to maintain a satisfactory quality of life. The studied self-management skills in this project comprise "social integration and support", "health service navigation", "constructive attitudes and approaches", "skill and technique acquisition" and "emotional distress". |
at the start of the therapy, after one and three months | |
Secondary | Change in medication Adherence | after one and three months of therapy | ||
Secondary | Change in patient satisfaction with treatment using the Cancer Therapy Satisfaction Questionnaire (CTSQ) | after one and three months | ||
Secondary | Change in patient satisfaction with care using Out-patsat 35 | The outpatsat is a questionnaire for ambulatory cancer patients in which they are asked to rate in different subscales their perceptions on care delivered by doctors, nurses and rate te overall organisation (accessibility of the hospital, ease of reaching the hospital by telephone, ...) during their stay at day hospital of consultations | at the start of the therapy, after one and three months | |
Secondary | Health Related Quality of Life | at the start of the therapy, after one and three months | ||
Secondary | Change in Distress using the Distress Barometer | at the start of the therapy, after one and three months | ||
Secondary | Efficacy of treatment Using ECOG performance scale and RECIST criteria | at the start of the therapy, after one and three months | ||
Secondary | Toxicity of treatment | Summarizing adverse drug events | at the start of the therapy, after one and three months | |
Secondary | Cost of care | Prospective report on health care expenditures (use of healthcare and other services, use of medicines, …) | at the start of the therapy, after one and three months |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT04681911 -
Inetetamab Combined With Pyrotinib and Chemotherapy in the Treatment of HER2 Positive Metastatic Breast Cancer
|
Phase 2 | |
Terminated |
NCT04066790 -
Pyrotinib or Trastuzumab Plus Nab-paclitaxel as Neoadjuvant Therapy in HER2-positive Breast Cancer
|
Phase 2 | |
Completed |
NCT04890327 -
Web-based Family History Tool
|
N/A | |
Completed |
NCT03591848 -
Pilot Study of a Web-based Decision Aid for Young Women With Breast Cancer, During the Proposal for Preservation of Fertility
|
N/A | |
Recruiting |
NCT03954197 -
Evaluation of Priming Before in Vitro Maturation for Fertility Preservation in Breast Cancer Patients
|
N/A | |
Terminated |
NCT02202746 -
A Study to Assess the Safety and Efficacy of the VEGFR-FGFR-PDGFR Inhibitor, Lucitanib, Given to Patients With Metastatic Breast Cancer
|
Phase 2 | |
Active, not recruiting |
NCT01472094 -
The Hurria Older PatiEnts (HOPE) With Breast Cancer Study
|
||
Withdrawn |
NCT06057636 -
Hypnosis for Pain in Black Women With Advanced Breast Cancer: A Feasibility Study
|
N/A | |
Completed |
NCT06049446 -
Combining CEM and Magnetic Seed Localization of Non-Palpable Breast Tumors
|
||
Recruiting |
NCT05560334 -
A Single-Arm, Open, Exploratory Clinical Study of Pemigatinib in the Treatment of HER2-negative Advanced Breast Cancer Patients With FGFR Alterations
|
Phase 2 | |
Active, not recruiting |
NCT05501769 -
ARV-471 in Combination With Everolimus for the Treatment of Advanced or Metastatic ER+, HER2- Breast Cancer
|
Phase 1 | |
Recruiting |
NCT04631835 -
Phase I Study of the HS-10352 in Patients With Advanced Breast Cancer
|
Phase 1 | |
Completed |
NCT04307407 -
Exercise in Breast Cancer Survivors
|
N/A | |
Recruiting |
NCT03544762 -
Correlation of 16α-[18F]Fluoro-17β-estradiol PET Imaging With ESR1 Mutation
|
Phase 3 | |
Terminated |
NCT02482389 -
Study of Preoperative Boost Radiotherapy
|
N/A | |
Enrolling by invitation |
NCT00068003 -
Harvesting Cells for Experimental Cancer Treatments
|
||
Completed |
NCT00226967 -
Stress, Diurnal Cortisol, and Breast Cancer Survival
|
||
Recruiting |
NCT06006390 -
CEA Targeting Chimeric Antigen Receptor T Lymphocytes (CAR-T) in the Treatment of CEA Positive Advanced Solid Tumors
|
Phase 1/Phase 2 | |
Recruiting |
NCT06037954 -
A Study of Mental Health Care in People With Cancer
|
N/A | |
Recruiting |
NCT06019325 -
Rhomboid Intercostal Plane Block on Chronic Pain Incidence and Acute Pain Scores After Mastectomy
|
N/A |