Clinical trial NCT01510236: Self-help Program Via Internet for Adolescents With Cancer
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
Overall status: WITHDRAWN
Phase: PHASE2
Conditions: Cancer
Depression
Anxiety
Keywords: Adolescence
Cancer
Depression
Anxiety
Self-help via internet
Lead sponsor: Uppsala University
Sponsor class: OTHER
First posted: 2012-01-16
Enrollment: 0
Sex: ALL
Minimum age (years): 13
Maximum age (years): 19
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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

Primary outcomes:
measure: Hospital Anxiety and Depression Scale (HADS)
timeFrame: Observation 3 (38 weeks after DI)
Secondary outcomes:
measure: Posttraumatic Stress Disorder Checklist - Civilian Version (PCL-C)
timeFrame: 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.
measure: UCLA Loneliness Scale
timeFrame: 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.
measure: Rosenberg Self-Esteem Scale (RSE)
timeFrame: 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.
measure: Satisfaction With Life Scale (SWLS)
timeFrame: 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.
measure: Mental Health Continuum - Short form (MHC-SF)
timeFrame: 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.
measure: EQ-5D
timeFrame: 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.
measure: Posttraumatic Growth Inventory - Short form (PTGI-SF)
timeFrame: Observation (OBS) 3: 38 weeks after diagnosis (DI); OBS 4: 62; OBS 6: 96 and OBS 7: 120 weeks after DI.
measure: Health-related costs questionnaire
timeFrame: 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.
measure: Time spent on self-help program
timeFrame: 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.
Other outcomes:
Locations:
city: Göteborg
country: Sweden
facility: Drottning Silvias Barn- och Ungdomssjukhus
city: Linköping
country: Sweden
facility: Universitetssjukhuset
city: Lund
country: Sweden
facility: Barn- och Ungdomssjukhuset
city: Stockholm
country: Sweden
facility: Astrid Lindgrens Barnsjukhus
city: Umeå
country: Sweden
facility: Norrlands Universitetssjukhus
city: Uppsala
country: Sweden
facility: Akademiska Barnsjukhuset
Study officials:
affiliation: Uppsala University
name: Louise von Essen, PhD
role: PRINCIPAL_INVESTIGATOR
References: