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

Primary Purpose

Cancer, Depression, Anxiety

Status
Withdrawn
Phase
Phase 2
Locations
Sweden
Study Type
Interventional
Intervention
Self-help program
Sponsored by
Uppsala University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Cancer focused on measuring Adolescence, Cancer, Depression, Anxiety, Self-help via internet

Eligibility Criteria

13 Years - 19 Years (Child, Adult)All SexesDoes not accept healthy volunteers

Inclusion criteria:

  • Adolescents aged from 13 to 19
  • Recent cancer diagnosis

Exclusion criteria:

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

Sites / Locations

  • Drottning Silvias Barn- och Ungdomssjukhus
  • Universitetssjukhuset
  • Barn- och Ungdomssjukhuset
  • Astrid Lindgrens Barnsjukhus
  • Norrlands Universitetssjukhus
  • Akademiska Barnsjukhuset

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Early self-help program

Later self-help program

Arm Description

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

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

Outcomes

Primary Outcome Measures

Hospital Anxiety and Depression Scale (HADS)

Secondary Outcome Measures

Posttraumatic Stress Disorder Checklist - Civilian Version (PCL-C)
UCLA Loneliness Scale
Rosenberg Self-Esteem Scale (RSE)
Satisfaction With Life Scale (SWLS)
Mental Health Continuum - Short form (MHC-SF)
EQ-5D
Quality of life for parents and adolescents
Posttraumatic Growth Inventory - Short form (PTGI-SF)
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.
Time spent on self-help program
Measurement of hours spent on program (time cost)

Full Information

First Posted
January 4, 2012
Last Updated
May 27, 2015
Sponsor
Uppsala University
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1. Study Identification

Unique Protocol Identification Number
NCT01510236
Brief Title
Self-help Program Via Internet for Adolescents With Cancer
Acronym
U-CARE:TeenCan
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
Study Type
Interventional

2. Study Status

Record Verification Date
May 2015
Overall Recruitment Status
Withdrawn
Why Stopped
a feasibility study showed low recruitment and adherence
Study Start Date
January 2013 (undefined)
Primary Completion Date
July 2015 (Anticipated)
Study Completion Date
May 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Uppsala University

4. Oversight

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cancer, Depression, Anxiety
Keywords
Adolescence, Cancer, Depression, Anxiety, Self-help via internet

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Early self-help program
Arm Type
Experimental
Arm Description
The early self-help program starts directly after randomization i.e. 4 weeks after diagnosis.
Arm Title
Later self-help program
Arm Type
Experimental
Arm Description
The later self-help program starts sixty-two weeks after diagnosis.
Intervention Type
Behavioral
Intervention Name(s)
Self-help program
Intervention Description
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.
Primary Outcome Measure Information:
Title
Hospital Anxiety and Depression Scale (HADS)
Time Frame
Observation 3 (38 weeks after DI)
Secondary Outcome Measure Information:
Title
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.
Title
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.
Title
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.
Title
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.
Title
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.
Title
EQ-5D
Description
Quality of life for parents and adolescents
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.
Title
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.
Title
Health-related costs questionnaire
Description
Measurement of health-related costs for parents and adolescents such as sick-leave, transports, health-care visits, consumption of medicines etc.
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.
Title
Time spent on self-help program
Description
Measurement of hours spent on program (time cost)
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.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
13 Years
Maximum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Louise von Essen, PhD
Organizational Affiliation
Uppsala University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Drottning Silvias Barn- och Ungdomssjukhus
City
Göteborg
Country
Sweden
Facility Name
Universitetssjukhuset
City
Linköping
Country
Sweden
Facility Name
Barn- och Ungdomssjukhuset
City
Lund
Country
Sweden
Facility Name
Astrid Lindgrens Barnsjukhus
City
Stockholm
Country
Sweden
Facility Name
Norrlands Universitetssjukhus
City
Umeå
Country
Sweden
Facility Name
Akademiska Barnsjukhuset
City
Uppsala
Country
Sweden

12. IPD Sharing Statement

Links:
URL
http://www.u-care.uu.se/?languageId=1
Description
U-CARE

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Self-help Program Via Internet for Adolescents With Cancer

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