NCT01510236

Self-help Program Via Internet for Adolescents With Cancer

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

• Status: Withdrawn
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Uppsala University · Academic / Other
• Sex: All
• Age: 13 Years – 19 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Cancer
• Depression
• Anxiety

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2013-01-01
• Primary completion: 2015-07-01
• Completion: 2018-05-01
• First posted: 2012-01-16
• Last updated: 2015-05-28

Locations

6 sites across 1 country: Sweden