Breast Neoplasms Clinical Trial
Official title:
An Online Enhanced Education Tool for Young Women Newly Diagnosed With Breast Cancer
This project proposes to develop and test an internet resource - a supported self-management website - that will guide younger women to relevant knowledge and resources, and provide tools that will help YWBC become more skilled and confident in coping with the many challenges of breast cancer. The study will be conducted in collaboration with the newly funded, pan-Canadian Young Breast Cancer Cohort (CYBCC) program being led from Women's College Hospital. The resource is expected to reduce knowledge gaps experienced by YWBC, and help them be partners in decision-making about their care, which has been shown to reduce anxiety and depression years later.
Women age 40 years and younger account for 5.4% of new breast cancer diagnoses in Canada,
but suffer more negative impacts than older women, due to having a worse prognosis, more
intensive treatment and greater physical, social, and emotional sequelae due to life-stage
factors. Consequently, younger women experience poorer quality of life, more problematic
psychosocial adjustment to breast cancer and report higher levels of emotional distress
throughout the cancer trajectory. Physicians tend to recognize and address physical symptoms
from cancer and its treatment, but emotional and psychological distress is addressed less
well. Furthermore, breast cancer care and treatment is typically lengthy, complex and
distributed across a wide range of service providers. Younger women with breast cancer
report difficulty navigating the healthcare system and feel ill informed, unprepared and
dissatisfied by the lack of continuity. While there are resources that can help women be
better informed and to manage symptoms, women are rarely informed of them early in the
breast cancer journey, when the need is greatest.There is an urgent need to identify
solutions that can be implemented at a population level and that can be accommodated within
limited healthcare budgets. Education and self-management approaches that help cancer
patients access appropriate knowledge and supports, and that impart skills could make a
significant contribution to improving their experience and quality of life. Internet-based
resources are convenient, accessible and acceptable circumventing childcare and
transportation issues making it an ideal modality for YWBC who are usually more familiar
with electronic communication compared to older women with breast cancer.
Active coping early in the breast cancer journey - in contrast to taking a passive stance -
predicts better adjustment and quality of life years later. Access to relevant, credible and
timely health information 'empowers' individuals to cope actively and better manage their
own health. Over 60% of cancer patients report using the Internet for prognostic
information, to identify alternative treatment options and for symptom management.
Nonetheless, too much or low quality information leads to confusion and stress, and YWBC
report being bombarded with information that is not relevant or timely, and lacks
age-appropriate content. YWBC also report that Internet searching is exhausting and scary.
Self management (SM) approaches in cancer care have the aim to empower patients by providing
knowledge, and additionally, providing skills that help persons manage the physical and
emotional impacts of their disease and treatment, as well as broader life challenges that
living with a disease bring. SM approaches address issues such as problem solving, finding
and using community resources effectively, working with the health care team, and learning
how to initiate new health promotion behaviours. SM interventions have been shown to
increase knowledge, reduce fatigue and distress, improve quality of life and improve
lifestyle changes such as physical activity. A well-designed website with links and
self-management tools could help YWBC by pointing them to the right information at the right
time, by ensuring that content addresses the specific knowledge and support needs of younger
women, and is based in current knowledge. We previously demonstrated that web-based
professionally led support helped YWBC survivors who reported high levels of satisfaction
and benefits including improved knowledge, mood, hope, and relief of burden. However, YWBC's
needs were highest at the time of diagnosis, and they reported dissatisfaction with the lack
of age-specific information.
We propose to develop a supported self-management website that will orient newly diagnosed
YWBC to the terrain ahead, and help them cope more skilfully and proactively. We will use a
time series research design to test the hypothesis that access to this website reduces
distress and enhances confidence in coping with breast cancer, in three samples of newly
diagnosed YWBC.
Objective 1: Develop a Supported Self-Management Website for YWBC We will develop a website
that directs YWBC to the "right information at the right time" and additionally offers
guidance, skills enactment and commentary that will help women be optimally active and
effective. As an example, to encourage active participation in treatment decision-making
which predicts later adjustment, the site will direct YWBC to the best sites for
diagnostic/medical information, and to newly-developed resources including a video with peer
modelling of a good doctor-patient interview, a tip sheet on effective communication with
physicians, and an engaging presentation of the evidence-supported strategy of recording the
consultation. We will develop engaging, age-appropriate tools include video interviews,
frequently asked questions with embedded links to information and resources, and
self-directed education presentations. Modules will include but not be limited to:
communicating with physicians, friends and family; problem solving; assessing and managing
symptoms of emotional distress and insomnia; education about the impact of hormonal changes
and fertility preservation.
Objective 2: Conduct an experiment to test the clinical promise of the website The study
will be conducted at 3 sites (Women's College Hospital, Princess Margaret Hospital, and
Calgary Breast Health Centre), selected among the 28 sites that are participating in the
CYBCC cohort study. Prior to launching the website, a baseline comparison group of 100 newly
diagnosed YWBC will be recruited. They will be assessed on a number of variables, including
emotional distress and self-efficacy for coping with cancer. Four months later, emotional
distress and self-efficacy will be assessed again. Following completion of the website,
another cohort of 100 patients will undergo the same procedure, however these participants
will have the Internet website introduced to them. The two groups will then be compared to
determine if access to the website reduces the traumatic stress associated with a breast
cancer diagnosis and treatment, and improves coping confidence.
;
Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care
Status | Clinical Trial | Phase | |
---|---|---|---|
Enrolling by invitation |
NCT05558917 -
Comparison Between PECS BLOCK 2 vs ESP BLOCK in Ocnologic Breast Surgery
|
N/A | |
Active, not recruiting |
NCT03664778 -
Abbreviated Breast MRI After Cancer Treatment
|
||
Recruiting |
NCT03144622 -
18F-FSPG PET/CT Imaging in Patients With Cancers
|
||
Completed |
NCT05452499 -
Pain Neuroscience Education and Therapeutic Exercise as a Treatment for Breast Cancer Survivors Living With Sequelae
|
N/A | |
Active, not recruiting |
NCT04568902 -
Study of H3B-6545 in Japanese Women With Estrogen Receptor (ER)-Positive, Human Epidermal Growth Factor Receptor 2 (HER2)-Negative Breast Cancer
|
Phase 1 | |
Completed |
NCT02860585 -
Evaluation of Survival in Patients With Metastatic Breast Cancer Receiving High-dose Chemotherapy With Autologous Haematopoietic Stem Cell Transplantation
|
N/A | |
Completed |
NCT04059809 -
Photobiomodulation for Breast Cancer Radiodermatitis
|
Phase 2/Phase 3 | |
Recruiting |
NCT04557449 -
Study to Test the Safety and Tolerability of PF-07220060 in Participants With Advance Solid Tumors
|
Phase 1/Phase 2 | |
Completed |
NCT03698942 -
Delphinus SoftVueâ„¢ ROC Reader Study
|
||
Completed |
NCT00092950 -
Exercise in Women at Risk for Breast Cancer
|
Phase 2 | |
Terminated |
NCT04123704 -
Sitravatinib in Metastatic Breast Cancer
|
Phase 2 | |
Not yet recruiting |
NCT02151071 -
The Breast Surgery EnLight and LightPath Imaging System Study
|
Phase 1/Phase 2 | |
Recruiting |
NCT02934360 -
TR(ACE) Assay Clinical Specimen Study
|
N/A | |
Active, not recruiting |
NCT02950064 -
A Study to Determine the Safety of BTP-114 for Treatment in Patients With Advanced Solid Tumors With BRCA Mutations
|
Phase 1 | |
Not yet recruiting |
NCT02876848 -
A Novel E-Health Approach in Optimizing Treatment for Seniors (OPTIMUM Study)
|
N/A | |
Completed |
NCT02931552 -
Nuevo Amanecer II: Translating a Stress Management Program for Latinas
|
N/A | |
Recruiting |
NCT02547545 -
Breast Cancer Chemotherapy Risk Prediction Mathematical Model
|
N/A | |
Completed |
NCT02652975 -
Anticancer Treatment of Breast Cancer Related to Cardiotoxicity and Dysfunctional Endothelium
|
N/A | |
Completed |
NCT02303366 -
Pilot Study of Stereotactic Ablation for Oligometastatic Breast Neoplasia in Combination With the Anti-PD-1 Antibody MK-3475
|
Phase 1 | |
Completed |
NCT02518477 -
Preventive Intervention Against Lymphedema After Breast Cancer Surgery
|
N/A |