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CancerPhase 2U-CARE:TeenCanNCT01510236

Self-help Program Via Internet for Adolescents With Cancer

A Phase 2 study testing Self-help program in people with Cancer and Depression, run by Uppsala University at 6 sites in Sweden.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial summary

The overall aim is to evaluate the clinical efficacy and cost-effectiveness of a self-help program via internet aiming at preventing development and maintenance of cancer-related emotional distress among adolescents with cancer. Read more about this study

Who is it for?
Ages 13 to 19 years
Conditions the study is for
Cancer, Depression, Anxiety
What is being tested?
Self-help program
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
6 sitesSweden
Study dates
Jan 2013to May 2018
Phase
Phase 2
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 13 to 19 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

Who may be able to join

  • Adolescents aged from 13 to 19
  • Recent cancer diagnosis

Who cannot join

  • No access to computer or internet
  • Difficulties reading or understanding Swedish

Trial locations and contacts

6 sites in 1 country.

6 sites in 1 country

Sweden6 sites

  • Drottning Silvias Barn- och Ungdomssjukhus

    Gothenburg

  • Universitetssjukhuset

    Linköping

  • Barn- och Ungdomssjukhuset

    Lund

  • Astrid Lindgrens Barnsjukhus

    Stockholm

  • Norrlands Universitetssjukhus

    Umeå

  • Akademiska Barnsjukhuset

    Uppsala

Other trials in Sweden

About this study

Official title: A Randomized Controlled Study of the Clinical Efficacy and Cost-effectiveness of a Self-help Program Via Internet on Psychosocial Function Among Adolescents With Cancer

The overall aim is to evaluate the clinical efficacy and cost-effectiveness of a self-help program via internet aiming at preventing development and maintenance of cancer-related emotional distress among adolescents with cancer.

Read the detailed description

A significant number of adolescents reports less anxiety and depression and a better quality of life than a healthy reference group from eighteen months up to four years after diagnosis. However, a significant minority of adolescents struck by cancer reports a clinically relevant level of emotional distress from shortly after diagnosis up to four years after diagnosis. The provided self-help program is designed to promote psychological health.

150 adolescents recently diagnosed with cancer will be randomized to either of two conditions: (1) Early program and (2) Later program. In both conditions an internet-based self-help program is provided. Adolescents randomized to Early program start the program directly after randomization i.e. 4 weeks after diagnosis whereas adolescents randomized to Later program start the program sixty-two weeks after diagnosis. The larger part of data are collected at seven assessments, Observations 1-7. Observation 1 takes place 4 weeks after diagnosis (DI); Observation 2: 28 weeks after DI; Observation 3: 38 weeks after DI; Observation 4: 62 weeks after DI; Observation 5: 86 weeks after DI; Observation 6: 96 weeks after DI and Observation 7: 120 weeks after DI. The main research question is to investigate whether the program is superior to standard care in preventing development and maintenance of anxiety and depression at 38 weeks after diagnosis among adolescents with cancer.

Being tested
Self-help program
Keywords
Adolescence, Cancer, Depression, Anxiety, Self-help via internet
Medical subject headings
Neoplasms, Depression, Anxiety Disorders

What participants receive

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

  • Self-help programBehavioural

    The program is available via an internet platform (www.carebase.se) and consists of two steps: interactive support (Step 1) and cognitive behavioral therapy (CBT) delivered via internet (2). Step 1 provides information about the cancer experience and psychoeducation about frequent reactions and distress and how to manage this. The information and education is provided via texts, audio files, and video-interviews with persons who have survived cancer during adolescence. Step 1 also capitalizes on interaction between participants via chat and forum. There is also a possibility to ask questions to an expert via the website. Twenty-eight weeks after start of Step 1 participants are offered access to Step 2 which lasts ten weeks and consists of a self-help CBT material consisting of modules and weekly contact with a psychologist. Each module is focused on one problem area, e.g. worry or depressive symptoms. Step 1 is available during Step 2. The whole program lasts for 34 weeks.

Study groups in NCT01510236
Study groupRoleWhat they receive
Early self-help programExperimentalThe early self-help program starts directly after randomization i.e. 4 weeks after diagnosis.
Receives: Behavioral: Self-help program
Later self-help programExperimentalThe later self-help program starts sixty-two weeks after diagnosis.
Receives: Behavioral: Self-help program

What is being measured

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

  1. Hospital Anxiety and Depression Scale (HADS)

    Measured: Observation 3 (38 weeks after DI)

Secondary outcomes (9)

  1. Posttraumatic Stress Disorder Checklist - Civilian Version (PCL-C)

    Measured: Observation (OBS) 1: 4 weeks after diagnosis (DI); OBS 2: 28; OBS 3: 38; OBS 4: 62; OBS 5: 86; OBS 6: 96 and OBS 7: 120 weeks after DI.

  2. UCLA Loneliness Scale

    Measured: Observation (OBS) 1: 4 weeks after diagnosis (DI); OBS 2: 28; OBS 3: 38; OBS 4: 62; OBS 5: 86; OBS 6: 96 and OBS 7: 120 weeks after DI.

  3. Rosenberg Self-Esteem Scale (RSE)

    Measured: Observation (OBS) 1: 4 weeks after diagnosis (DI); OBS 2: 28; OBS 3: 38; OBS 4: 62; OBS 5: 86; OBS 6: 96 and OBS 7: 120 weeks after DI.

  4. Satisfaction With Life Scale (SWLS)

    Measured: Observation (OBS) 1: 4 weeks after diagnosis (DI); OBS 2: 28; OBS 3: 38; OBS 4: 62; OBS 5: 86; OBS 6: 96 and OBS 7: 120 weeks after DI.

  5. Mental Health Continuum - Short form (MHC-SF)

    Measured: Observation (OBS) 1: 4 weeks after diagnosis (DI); OBS 2: 28; OBS 3: 38; OBS 4: 62; OBS 5: 86; OBS 6: 96 and OBS 7: 120 weeks after DI.

  6. EQ-5D

    Quality of life for parents and adolescents

    Measured: Observation (OBS) 1: 4 weeks after diagnosis (DI); OBS 2: 28; OBS 3: 38; OBS 4: 62; OBS 5: 86; OBS 6: 96 and OBS 7: 120 weeks after DI and 6, 8, 12, 16, 20, 24, 29, 33, 37, 38, 64, 66, 70, 74, 78, 82, 87, 91, and 95 weeks after DI.

  7. Posttraumatic Growth Inventory - Short form (PTGI-SF)

    Measured: Observation (OBS) 3: 38 weeks after diagnosis (DI); OBS 4: 62; OBS 6: 96 and OBS 7: 120 weeks after DI.

  8. Health-related costs questionnaire

    Measurement of health-related costs for parents and adolescents such as sick-leave, transports, health-care visits, consumption of medicines etc.

    Measured: Observation (OBS) 2: 28 weeks after diagnosis (DI); OBS 3: 38; OBS 4: 62; OBS 5: 86; OBS 6: 96 and OBS 7: 120 weeks after DI and 8, 16, 66, and 74 weeks after DI.

  9. Time spent on self-help program

    Measurement of hours spent on program (time cost)

    Measured: Observation (OBS) 1: 4 weeks after diagnosis (DI); OBS 2: 28; OBS 3: 38; OBS 4: 62; OBS 5: 86; OBS 6: 96 and OBS 7: 120 weeks after DI.

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 2012 (estimated)
  2. Study startJan 2013
  3. Primary completionJul 2015 (estimated)
  4. Study completionMay 2018 (estimated)

Why it stopped: a feasibility study showed low recruitment and adherence

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 2
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01510236
Sponsor's protocol ID
U-CARE: TeenCan
Acronym
U-CARE:TeenCan
Status last verified
May 2015
First submitted
4 Jan 2012
Last updated
28 May 2015
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Self-help program in people with Cancer and Depression, run by Uppsala University at 6 sites in Sweden.

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 2 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: withdrawn, as of the sponsor's last update on 28 May 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites in Sweden. 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.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

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?

Hospital Anxiety and Depression Scale (HADS) (time frame: Observation 3 (38 weeks after DI)). 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 NCT01510236.

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 28 May 2015.

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