Self-help Program Via Internet for Adolescents With Cancer (U-CARE:TeenCan)

This study is not yet open for participant recruitment.
Verified January 2012 by Uppsala University
Sponsor:
Information provided by (Responsible Party):
Louise-von Essen, Uppsala University
ClinicalTrials.gov Identifier:
NCT01510236
First received: January 4, 2012
Last updated: August 27, 2012
Last verified: January 2012
  Purpose

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.


Condition Intervention Phase
Cancer
Depression
Anxiety
Behavioral: Self-help program
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
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

Resource links provided by NLM:


Further study details as provided by Uppsala University:

Primary Outcome Measures:
  • Hospital Anxiety and Depression Scale (HADS) [ Time Frame: Observation 3 (38 weeks after DI) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Posttraumatic Stress Disorder Checklist ‐ Civilian Version (PCL-C) [ Time Frame: 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. ] [ Designated as safety issue: No ]
  • UCLA Loneliness Scale [ Time Frame: 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. ] [ Designated as safety issue: No ]
  • Rosenberg Self-Esteem Scale (RSE) [ Time Frame: 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. ] [ Designated as safety issue: No ]
  • Satisfaction With Life Scale (SWLS) [ Time Frame: 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. ] [ Designated as safety issue: No ]
  • Mental Health Continuum - Short form (MHC-SF) [ Time Frame: 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. ] [ Designated as safety issue: No ]
  • EQ-5D [ Time Frame: 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. ] [ Designated as safety issue: No ]
    Quality of life for parents and adolescents

  • Posttraumatic Growth Inventory - Short form (PTGI-SF) [ Time Frame: Observation (OBS) 3: 38 weeks after diagnosis (DI); OBS 4: 62; OBS 6: 96 and OBS 7: 120 weeks after DI. ] [ Designated as safety issue: No ]
  • Health-related costs questionnaire [ Time Frame: 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. ] [ Designated as safety issue: No ]
    Measurement of health-related costs for parents and adolescents such as sick-leave, transports, health-care visits, consumption of medicines etc.

  • Time spent on self-help program [ Time Frame: 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. ] [ Designated as safety issue: No ]
    Measurement of hours spent on program (time cost)


Estimated Enrollment: 150
Study Start Date: January 2013
Estimated Study Completion Date: May 2018
Estimated Primary Completion Date: July 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Early self-help program
The early self-help program starts directly after randomization i.e. 4 weeks after diagnosis.
Behavioral: Self-help program
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.
Experimental: Later self-help program
The later self-help program starts sixty-two weeks after diagnosis.
Behavioral: Self-help program
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.

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.

  Eligibility

Ages Eligible for Study:   13 Years to 19 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria:

  • Adolescents aged from 13 to 19
  • Recent cancer diagnosis

Exclusion criteria:

  • No access to computer or internet
  • Difficulties reading or understanding Swedish
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01510236

Contacts
Contact: Annika Lindahl Norberg, PhD +46702260671 Annika.Lindahl.Norberg@ki.se
Contact: Louise von Essen, PhD +46704250714 louise-von.essen@pubcare.uu.se

Locations
Sweden
Drottning Silvias Barn- och Ungdomssjukhus
Göteborg, Sweden
Universitetssjukhuset
Linköping, Sweden
Barn- och Ungdomssjukhuset
Lund, Sweden
Astrid Lindgrens Barnsjukhus
Stockholm, Sweden
Norrlands Universitetssjukhus
Umeå, Sweden
Akademiska Barnsjukhuset
Uppsala, Sweden
Sponsors and Collaborators
Uppsala University
Investigators
Principal Investigator: Louise von Essen, PhD Uppsala University
  More Information

Additional Information:
U-CARE  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Louise-von Essen, Professor, Programme Director for U-CARE, Uppsala University
ClinicalTrials.gov Identifier: NCT01510236     History of Changes
Other Study ID Numbers: U-CARE: TeenCan
Study First Received: January 4, 2012
Last Updated: August 27, 2012
Health Authority: Sweden: Regional Ethical Review Board

Keywords provided by Uppsala University:
Adolescence
Cancer
Depression
Anxiety
Self-help via internet

Additional relevant MeSH terms:
Anxiety Disorders
Depression
Depressive Disorder
Mental Disorders
Behavioral Symptoms
Mood Disorders

ClinicalTrials.gov processed this record on April 23, 2014