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EducationNCT02340494

An Online Enhanced Education Tool for Young Women Newly Diagnosed With Breast Cancer

A study testing Online Enhanced Education Tool in people with Education and Breast Neoplasms, run by Women's College Hospital.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 to 40 years, women only
Conditions the study is for
Education, Breast Neoplasms, Internet
What is being tested?
Online Enhanced Education Tool
Could I receive a placebo?
No, everyone receives an active treatment
How many people
200 participants
Where
No sites listed yet
Study dates
Apr 2015to Mar 2016
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 40 years
  • Women only
  • No healthy volunteers
  • Adult

Who may be able to join

  • are diagnosed with invasive or ductal carcinoma in-situ disease
  • are able to read and understand English

Who cannot join

  • under 18 or over 40

Trial locations and contacts

No sites are listed yet.

About this study

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.

Read the detailed description

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.

Being tested
Online Enhanced Education Tool
Medical subject headings
Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Online Enhanced Education ToolBehavioural

    The website resource will be credible, comprehensive, relevant and engaging information that young women with breast cancer will use intensively for self-management and education.

Study groups in NCT02340494
Study groupRoleWhat they receive
Control groupNo interventionWomen without access to the website.
Intervention groupExperimentalWomen with access to the website.
Receives: Behavioral: Online Enhanced Education Tool

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Traumatic stress

    Tramatic stress will be assessed with the Impact of Event Scale (IES), measuring intrusion and avoidance symptoms related to the diagnosis of breast cancer.

    Measured: 4 months

Secondary outcomes (1)
  1. Cancer Behavior Inventory

    The Cancer Behavior Inventory will assess a) beliefs about maintaining independence and a positive attitude, b) belief in ability to participate in medical care, c) skills important for coping and stress management, and d) capacity to manage emotions in difficult situations.

    Measured: 4 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Jan 2015 (estimated)
  2. Study startApr 2015
  3. Primary completionMar 2016 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
200 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02340494
Sponsor's protocol ID
WomensCHCanada
Status last verified
Jan 2015
First submitted
13 Jan 2015
Last updated
16 Jan 2015
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A study testing Online Enhanced Education Tool in people with Education and Breast Neoplasms, run by Women's College Hospital.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 16 Jan 2015. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Dina Nikitina, MPH (4163513800 ext. 2872, dina.nikitina@wchospital.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Traumatic stress (time frame: 4 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jan 2015.

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