Self-help Program Via Internet for Adolescents With Cancer

Phase 2

Withdrawn

• Conditions: Depression; Anxiety; Cancer
• Interventions: Behavioral: Self-help program

• Registration Number: NCT01510236
• Lead Sponsor: Uppsala University

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.

Study Timeline

• Study First Submitted: 2012-01-04
• Study First Submitted QC: 2012-01-10
• Study First Posted: 2012-01-16
• Study Start: 2013-01
• Status Verified: 2015-05
• Last Update Submitted: 2015-05-27
• Last Update Posted: 2015-05-28
• Primary Completion: 2015-07
• Study Completion: 2018-05

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Early self-help program	Self-help program	The early self-help program starts directly after randomization i.e. 4 weeks after diagnosis.
Later self-help program	Self-help program	The later self-help program starts sixty-two weeks after diagnosis.

Primary Outcome Measures

Name	Time	Method
Hospital Anxiety and Depression Scale (HADS)	Observation 3 (38 weeks after DI)

Secondary Outcome Measures

Name	Time	Method
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.
EQ-5D	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.	Quality of life for parents and adolescents
Posttraumatic Growth Inventory - Short form (PTGI-SF)	Observation (OBS) 3: 38 weeks after diagnosis (DI); OBS 4: 62; 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.
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.
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.
Health-related costs questionnaire	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.	Measurement of health-related costs for parents and adolescents such as sick-leave, transports, health-care visits, consumption of medicines etc.
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.
Time spent on self-help program	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.	Measurement of hours spent on program (time cost)

Trial Locations

Locations (6)

Drottning Silvias Barn- och Ungdomssjukhus; 🇸🇪 Göteborg, Sweden

Universitetssjukhuset; 🇸🇪 Linköping, Sweden

Astrid Lindgrens Barnsjukhus; 🇸🇪 Stockholm, Sweden

Norrlands Universitetssjukhus; 🇸🇪 Umeå, Sweden

Akademiska Barnsjukhuset; 🇸🇪 Uppsala, Sweden

Barn- och Ungdomssjukhuset; 🇸🇪 Lund, Sweden