Breast Cancer Clinical Trial
— CoSMaS-qlOfficial title:
Collaborative Self-Management Support in Chronic Conditions: a Qualitative Study of Patients', Caregivers' and Health Care Professionals' Views and Experiences of Integrated Care in Asthma, Breast Cancer and Stroke
| NCT number | NCT03262428 |
| Other study ID # | 69HCL17_0480 |
| Secondary ID | |
| Status | Completed |
| Phase | |
| First received | |
| Last updated | |
| Start date | April 14, 2018 |
| Est. completion date | June 27, 2019 |
| Verified date | August 2019 |
| Source | Hospices Civils de Lyon |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational |
The management of chronic conditions is a challenge for health systems worldwide,
particularly in the context of an aging population, and requires urgent improvement of health
services. Integrated care and patient empowerment represent promising solutions: offering
tailored self-management support in a collaborative framework led to good results in several
clinical contexts. Yet, large scale implementation remains a challenge. An important
limitation of existing solutions is a lack of utilization of behavioural and communication
theory for identifying the dynamics of pluridisciplinary collaboration and the interactive
effects of the activities performed by several actors involved in self-management support in
a given chronic condition. A second limitation is not involving all relevant actors in the
development of health service improvement solutions, which leads to limited programme
adoption and sustainability in routine care.
This study is part of a project that proposes to address these limitations and develop and
interdisciplinary model of collaborative care in the self-management of chronic conditions
(CoSMaS) that adopts a community-based participative approach. CoSMaS-ql is a qualitative
study that will consist of semi-structured interviews with several types of stakeholders:
patients, caregivers, and health care professionals of different specialties (e.g. general
practitioners, nurses, specialist consultants, pharmacists). The main objective of the study
is to explore the experiences and of patients, caregivers, and HCPs on how self-management
support is currently delivered in asthma, cancer and stroke (content, communication,
organisation of care), their needs related to self-management support provision, and
envisaged solutions for improving current practice. Three different chronic conditions will
be targeted: asthma, breast cancer and stroke. The qualitative data will be analysed via
grounded-theory and template analysis. It will inform the development of a theoretical model
of collaborative self-management support in chronic conditions. It will also result in three
profiles describing 'real' versus 'ideal' care processes, which will represent needs
assessment stages for future health services improvement interventions in the three
conditions.
| Status | Completed |
| Enrollment | 109 |
| Est. completion date | June 27, 2019 |
| Est. primary completion date | June 27, 2019 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility |
PATIENTS Inclusion Criteria: - having (had) one of the health conditions targeted. - age >18 years (in order to have had the opportunity to achieve full transition from parent/caregiver-managed to self-managed care), - at least 1 year since diagnosis (in order to have had sufficient time to experience adjustments to their condition on the long term), and - at least 1 consultation with an HCP of any specialty in the past year (in order to ensure minimum 1 recent experience of care they could reflect on). Exclusion Criteria: - unable to communicate in French - level of severity of health condition or comorbidities making participation in the study too burdensome CAREGIVERS: Inclusion Criteria: - nominated by a participating patients as principal caregiver Exclusion Criteria: - none HEALTH CARE PROFESSIONALS : Inclusion Criteria: - at least 1 year of experience working in one of the 3 chronic conditions targeted (irrespective of the number of patients consulted) Exclusion Criteria: - none |
| Country | Name | City | State |
|---|---|---|---|
| France | EA 7425 HESPER - Health Services and Performance Research, Université Claude Bernard Lyon 1 | Lyon |
| Lead Sponsor | Collaborator |
|---|---|
| Hospices Civils de Lyon |
France,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Experiences and views of patients, caregivers, and health care professionals involved in the long-term management of asthma, cancer and stroke about real and ideal practices in collaborative self-management support. | Interviews will be semi-structured and follow a topic guide designed to explore participants' goals, behaviours and determinants, perceptions of others' goals and behaviours, communication processes, tools used in self-management, support, and communication, and their vision on optimal processes and ways to implement them. Caregivers will be interviewed separately on their experiences of caregiving and self-management support by HCPs. HCPs will be interviewed regarding their experiences of providing care in one or more of the 3 chronic conditions (depending on their experience and time constraints) and their thoughts on collaborating with other professionals and solutions for integrated care and ensuring continuity of care. | About 60 minutes |
| 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 |