Depression Clinical Trial
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
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.
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.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care
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