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

Uppsala University

Status and phase: Withdrawn; Phase 2

Conditions: Depression; Cancer; Anxiety

Treatments: Behavioral: Self-help program

Study type: Interventional

Funder types: Other

Identifiers

NCT01510236

U-CARE: TeenCan

Details and patient eligibility

About

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.

Full 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.

Sex: All

Ages: 13 to 19 years old

Volunteers: No 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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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0 participants in 2 patient groups

Early self-help program

Experimental group

Description:

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

Treatment:

Behavioral: Self-help program

Later self-help program

Experimental group

Description:

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

Treatment:

Behavioral: Self-help program