NCT01510236

Brief 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.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Jan 2013

Typical duration for phase_2 cancer

Geographic Reach
1 country

6 active sites

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 4, 2012

Completed
12 days until next milestone

First Posted

Study publicly available on registry

January 16, 2012

Completed
12 months until next milestone

Study Start

First participant enrolled

January 1, 2013

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2015

Completed
2.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2018

Completed
Last Updated

May 28, 2015

Status Verified

May 1, 2015

Enrollment Period

2.5 years

First QC Date

January 4, 2012

Last Update Submit

May 27, 2015

Conditions

CancerDepressionAnxiety

Keywords

AdolescenceCancerDepressionAnxietySelf-help via internet

Outcome Measures

Primary Outcomes (1)

  • Hospital Anxiety and Depression Scale (HADS)

    Observation 3 (38 weeks after DI)

Secondary Outcomes (9)

  • Posttraumatic Stress Disorder Checklist - Civilian Version (PCL-C)

    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.

  • UCLA Loneliness Scale

    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.

  • Rosenberg Self-Esteem Scale (RSE)

    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.

  • Satisfaction With Life Scale (SWLS)

    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.

  • Mental Health Continuum - Short form (MHC-SF)

    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 more secondary outcomes

Study Arms (2)

Early self-help program

EXPERIMENTAL

The early self-help program starts directly after randomization i.e. 4 weeks after diagnosis.

Behavioral: Self-help program

Later self-help program

EXPERIMENTAL

The later self-help program starts sixty-two weeks after diagnosis.

Behavioral: Self-help program

Interventions

Self-help programBEHAVIORAL

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.

Early self-help programLater self-help program

Eligibility Criteria

Age13 Years - 19 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Adolescents aged from 13 to 19
  • Recent cancer diagnosis

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

Drottning Silvias Barn- och Ungdomssjukhus

Gothenburg, Sweden

Location

Universitetssjukhuset

Linköping, Sweden

Location

Barn- och Ungdomssjukhuset

Lund, Sweden

Location

Astrid Lindgrens Barnsjukhus

Stockholm, Sweden

Location

Norrlands Universitetssjukhus

Umeå, Sweden

Location

Akademiska Barnsjukhuset

Uppsala, Sweden

Location

Related Links

MeSH Terms

Conditions

NeoplasmsDepressionAnxiety Disorders

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehaviorMental Disorders

Study Officials

  • Louise von Essen, PhD

    Uppsala University

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor, Programme Director for U-CARE

Study Record Dates

First Submitted

January 4, 2012

First Posted

January 16, 2012

Study Start

January 1, 2013

Primary Completion

July 1, 2015

Study Completion

May 1, 2018

Last Updated

May 28, 2015

Record last verified: 2015-05

Locations

SE(6)