Cancer-related psychological distress Mental and Behavioural Disorders
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: Eligible participants will: 1. be aged 15-25 years at study start 2. have been diagnosed with cancer when aged 13-18 years 3. have been treated at a paediatric oncology unit in Sweden 4. have completed successful cancer treatment 5. be able to read and write text in Swedish 6. have access to e-mail, the internet, and a mobile telephone 7. report a need for psychological support
Exclusion criteria
Exclusion criteria: Potential participants will be excluded if they: 1. currently receive psychotherapy 2. display symptoms of severe depression, active suicidality, psychosis, bipolar disorder and/or alcohol and/or substance abuse in immediate need of treatment
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Feasibility of recruitment and eligibility criteria will be evaluated by examining: 1.1. Number of people identified via the Swedish Childhood Cancer Registry, invited via telephone, invited via letter, assessed for eligibility 1.2. Percentages of people interested in participation, assessed for eligibility, meeting the inclusion criteria, and included, of the total number identified 1.3. Ambiguities regarding eligibility criteria 1.4. Reasons for ineligibility and for non-participation 2. Feasibility of data collection will be evaluated by examining: 2.1. Percentage of participants completing the baseline assessment and the assessments three months and six months post baseline 2.2. Numbers of missing items in outcomes 2.3. Types and number of potential uncertainties in diagnostic interviews 3. Attrition, evaluated by calculating dropout rates. 4. Resources needed to complete the study and the programme will be evaluated by examining: 4.1. Length of time for participants to work through the programme and complete questionnaires and interviews 4.2. Length of time for therapists and study personnel to deliver the programme and administer the study 5. Participants’ adherence to programme, evaluated by examining number of activities in the programme 6. Therapists’ adherence to programme, examined by analysing the content of online written therapist-participant communication. 7. Participants’ acceptability of programme and data collection and exploration of mechanisms of impact, via semi-structured interviews Self-report data will be collected either by telephone or online at one or more of the following time points: the eligibility interview, baseline assessment, assessment three months post baseline (post-assessment) and assessment six months post baseline (follow-up assessment). | — |
Secondary
| Measure | Time frame |
|---|---|
| The feasibility of using the following psychological and health economics measurements will be examined to assess whether or not to include them in a controlled study: 1. The PHQ-9 to measure symptoms of depression 2. The GAD-7 to measure anxiety symptoms 3. Body Image Scale Body to measure body image 4. PCL-C to measure posttraumatic stress symptoms 5. SIAS to measure Reactions to social interaction situations 6. The EuroQol EQ-5D to calculate quality-adjusted life years 7. TiC-P to measure aspects regarding use of healthcare services, employment, absence and sick leave Data will be collected at baseline, and three and six months post baseline | — |
Countries
Sweden