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CancerNCT02299219

Teens Taking Charge: Managing Cancer Online

A study testing Taking Charge: Managing Cancer Online and Standard Medical Care and Cancer Resource Center in people with Cancer, run by The Hospital for Sick Children at 3 sites in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Cancer is the most common potentially fatal disease of adolescence and the Internet represents an ideal means to deliver education, self-monitoring capabilities, and social support to enhance disease self-management by adolescents with cancer. Read more about this study

Who is it for?
Ages 12 to 18 years
Conditions the study is for
Cancer
What is being tested?
Taking Charge: Managing Cancer Online and Standard Medical Care and Cancer Resource Center
Could I receive a placebo?
No, everyone receives an active treatment
How many people
73 participants
Where
3 sitesCanada
Study dates
Jan 2016to 1 Apr 2019
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 12 to 18 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

Who may be able to join

  • Parents and adolescents will be eligible to participate if the adolescents are:
  • between 12-18 years of age
  • diagnosed with cancer (at least 3 months from diagnosis)
  • on active treatment
  • able to speak and read English and/or French at a Grade 6 level

Who cannot join

  • Adolescents will be excluded if they:
  • have major cognitive impairments
  • have reduced executive function that may impact their ability to understand and use the online program
  • are terminal/palliative as determined by their oncologist Parents/caregivers are not eligible to participate in the study alone (without an adolescent)

Trial locations and contacts

3 sites in 1 country.

Canada3 sites

  • McMaster Children's Hospital

    Hamilton, Ontario, L8S 4K1

  • CHU Sainte-Justine

    Montreal, Quebec, H3T 1C5

  • Children's Hospital Eastern Ontario

    Ottawa, Ontario, K1H 8L1

Other trials in Canada

About this study

Official title: Teens Taking Charge: A Pilot Randomized Controlled Trial of an Online Self-Management and Transitional Care Program for Youth With Cancer

Cancer is the most common potentially fatal disease of adolescence and the Internet represents an ideal means to deliver education, self-monitoring capabilities, and social support to enhance disease self-management by adolescents with cancer. While two interactive coping websites exist for young people with cancer, they are: (1) not interactive, (2) do not focus on helping youth gain skills for transition and independence, and (3) do not provide opportunities for meaningful social support. In summary, there is a crucial need to develop a comprehensive interactive Internet-based self-management program targeting AWC that is comprised of cancer education, self-management skills, and opportunities for social support, and that is cost-effective.

Read the detailed description

Overall aim of this program of research is to develop and evaluate the "Teens Taking Charge: Managing Cancer Online" Internet intervention that will help AWC to better cope with their disease, improve their HRQL, and enhance readiness to transition to adult health care using a sequential phased approach. The first phase of this project has determined the self-management and transitional care needs of adolescents with cancer. The second phase consisted of website development and usability testing to ensure the website is easy to use and understand, and is efficient and satisfying to complete. Subsequently, we will assess the feasibility of the program and the outcomes from the use of the site in a randomized controlled trial (RCT) pilot study (Phase 3). This will inform the design and methods of the main trial, and will permit us to obtain estimates of treatment effects on AWC health outcomes to inform the calculation of an appropriate sample size for the future definitive RCT (Phase 4). The focus of this study is Phase 3. Phase 4 will be a multicentre randomized controlled trial to assess outcomes for teens that complete the intervention as compared to those of an attention control group.

Conditions
Cancer
Being tested
Taking Charge: Managing Cancer Online, Standard Medical Care and Cancer Resource Center
Keywords
Adolescent, Internet Self-Management, Managing Cancer
Medical subject headings
Neoplasms

What participants receive

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

  • Taking Charge: Managing Cancer OnlineBehavioural

    n addition to standard medical care, adolescents in the experimental group will receive the "Taking Charge: Managing Cancer Online" Internet self-management program. The intervention is a 12-module interactive multi-component treatment protocol that consists of Cancer-specific education, self-management strategies, and social support that is available in English and French.

  • Standard Medical Care and Cancer Resource CenterBehavioural

    The control group is designed to control for the potential effects on outcomes of time, attention and computer use during the intervention. In addition to standard medical care, adolescents in the attention control group will be provided with access to a self-guided patient education study website, which will have two components: basic patient educational materials about Cancer ("Cancer Resource Centre") and online assessments.

Study groups in NCT02299219
Study groupRoleWhat they receive
Taking Charge Experimental GroupExperimentalNot described
Receives: Behavioral: Taking Charge: Managing Cancer Online
Control GroupActive comparatorNot described
Receives: Behavioral: Standard Medical Care and Cancer Resource Center

What is being measured

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

  1. Participant Accrual and Dropout Rates

    These rates will be centrally tracked by the Clinical Research Project Coordinator

    Measured: 12 weeks

  2. Fidelity (Any issues or difficulties encountered during implementation of the intervention, control strategy, or outcome measures)

    Any issues or difficulties encountered during implementation of the intervention, control strategy, or outcome measures will be tracked throughout the study by the Clinical Research Project Coordinator

    Measured: 12 weeks

  3. Acceptability and Satisfaction with Intervention (rate their acceptability of and satisfaction with the intervention)

    Post-treatment, adolescents with cancer and their parents in the intervention group will rate their acceptability of and satisfaction with the intervention

    Measured: 12 weeks

  4. Engagement with Intervention (Google Analytics will be used to track patterns of website program usage)

    Google Analytics will be used to track patterns of website program usage by adolescents with cancer and their parents

    Measured: 12 weeks

Secondary outcomes (10)

  1. Knowledge (Adolescent Cancer Knowledge Questionnaire)

    Measured using the Adolescent Cancer Knowledge Questionnaire, a 15-item tool that assesses cancer-specific knowledge.

    Measured: 12 weeks

  2. Self-Efficacy (Generalized Self-Efficacy-Sherer Scale)

    Measured by the Generalized Self-Efficacy-Sherer Scale, a 12-item scale that requires adolescents to indicate their level of agreement with a series of statements about self-efficacy.

    Measured: 12 weeks

  3. Treatment adherence (Medication Adherence Scale)

    Measured with the Medication Adherence Scale, a 4-item scale for assessing self-reported adherence.

    Measured: 12 weeks

  4. Physical Symptoms - Pain (short form Brief Pain Inventory (BPI)

    Measured using the short form Brief Pain Inventory (BPI), a 15-item measure that includes scales for measuring pain intensity, impact of pain on functioning and well being, and pain interference.

    Measured: 12 weeks

  5. Physical Symptoms - Fatigue (PedsQL Multidimensional Fatigue Module)

    Measured using the PedsQL Multidimensional Fatigue Module, an 18-item scale with validated versions for child report (ages 8-12 years), teen report (ages 13-18 years), and parental report for children and teens.

    Measured: 12 weeks

  6. Emotional symptoms (Hospital Anxiety and Depression Scale (HADS)

    Measured using the Hospital Anxiety and Depression Scale (HADS), a 14-item measure for individuals aged >12 years, which can be completed within 2-5 minutes.

    Measured: 12 weeks

  7. Social functioning (Perceived Social Support from Friends (PSS-Fr) Scale)

    Measured with the Perceived Social Support from Friends (PSS-Fr) Scale, a 20-item scale that assesses the extent to which an individual perceives that their friends fulfill their needs for support.

    Measured: 12 weeks

  8. Transition readiness (Cancer Transition Scales)

    Measured with the Cancer Transition Scales, which include sub-scales for 'cancer worry' (6 items), 'self-management skills' (15 items), and 'expectations' (12 items).

    Measured: 12 weeks

  9. Health Related Quality of Life (PedsQL Cancer Module)

    measured with the PedsQL Cancer Module, a 27-item scale, which has validated versions for child, teen, and parental report, and the Health Utility Index [HUI].

    Measured: 12 weeks

  10. Cost effectiveness (ascertaining direct health care costs and family out of pocket costs)

    Measured by ascertaining direct health care costs and family out of pocket costs related to cancer care incurred over the 12-week study period using the Health Care Utilization form modified from the Ambulatory and Home Care Record84-90 as well as direct costs related to the online intervention technology, intervention training and personnel. Quality adjusted life years will be calculated using the HUI to determine the incremental cost-effectiveness

    Measured: 12 weeks

Timeline

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

  1. First posted24 Nov 2014 (estimated)
  2. Study startJan 2016
  3. Primary completion1 Apr 2019
  4. Study completion1 Apr 2019

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
Health services research
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
73 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02299219
Sponsor's protocol ID
1000045896
Status last verified
Oct 2019
First submitted
17 Nov 2014
Last updated
9 Oct 2019
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A study testing Taking Charge: Managing Cancer Online and Standard Medical Care and Cancer Resource Center in people with Cancer, run by The Hospital for Sick Children at 3 sites in Canada.

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 5 inclusion and 4 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: finished, as of the sponsor's last update on 9 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Participant Accrual and Dropout Rates (time frame: 12 weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02299219.

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 9 Oct 2019.

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