Feasibility of a Life Coping Program: A Study Protocol (LifeCOPE)

Haukeland University Hospital

Status: Completed

Conditions: Physical Activity; Pediatric ALL; Health Related Quality of Life; Health Literacy

Treatments: Behavioral: Life Coping Program

Study type: Interventional

Funder types: Other

Identifiers

NCT06709248

578213

Recruitment PhD (Other Grant/Funding Number)

Details and patient eligibility

About

The goal of this observational study is to evaluate the feasibility of the intervention Life Coping Program in children and adolescents 8-16 years of age. The main question it aims to answer is:

Is the Life Coping Program in its current form feasible among children and adolescents with a variety of primary conditions?

The health care providers of participants already undergoing the Life Coping Program will answer survey questions after key procedures of the intervention, and the research team will be given access to measures provided by the participants.

Full description

Feasibility and acceptability of the intervention Life Coping Program will be evaluated in an uncontrolled open-label trial using quantitative measures. Sixty children or adolescents with chronic illness or severe medical condition will be recruited along with one associated caregiver. Feasibility will be assessed by tracking attendance and participation in different parts of the intervention. Acceptability of the intervention will be assessed using patient reported experience measures (PREM). Health related quality of life (HrQoL) and level of physical activity will be measured using the Kidscreen 27 and Actigraph GT3X+ monitor, respectively, at baseline and post-intervention.

The study is based on the British Medical Research Council's (MRC) framework for developing and evaluating complex interventions, and will explore innovative treatment strategies that could potentially improve current clinical outcomes and reduce the need for ongoing healthcare follow-up. The findings from this feasibility study will lay the groundwork for a future definitive randomized controlled trial in accordance with the MRC framework for developing and evaluating complex interventions.

Enrollment: 54 patients

Sex: All

Ages: 8 to 16 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Have received treatment at Haukeland University Hospital
• One or more of the following primary conditions: congenital heart defects, congenital oral clefts, premature birth before 32 weeks of gestation, completion of cancer treatment, chronic pain conditions, or significant burn injuries
• Must be able to answer questionnaires in Norwegian

Exclusion criteria

• Medical condition that may hinder og alter participation
• Treatment plan that may hinder or alter participation

Trial design

Primary purpose: Health Services Research

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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54 participants in 1 patient group

Intervention

Experimental group

Description:

In this feasability study following established clinical practice, all participants are included in the intervention Life Coping Program.

Treatment:

Behavioral: Life Coping Program