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NCT Number: NCT06709248

Feasibility of a Life Coping Program: A Study Protocol

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.

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Key information

Conditions

Health Literacy Behavior Health Related Quality of Life Hematologic Diseases Hemic and Lymphatic Diseases Immune System Diseases Immunoproliferative Disorders Leukemia Leukemia, Lymphoid Lymphatic Diseases Lymphoproliferative Disorders Motor Activity Neoplasms Neoplasms by Histologic Type Pediatric ALL Physical Activity Precursor Cell Lymphoblastic Leukemia-Lymphoma

Age range

8 year–16 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Haukeland university hospital - Department of Pediatrics

Bergen, Vestland, 5009, Norway

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Life Coping Program

Behavioral

The Life Coping Program is built around a coordinated 5-day Life Coping Course. Participants included are grouped by their primary condition, meaning the diagnosis or illness reasoning the referral. Each family is assigned a dedicated Primary Contact throughout the program, and the program consists of three phases: Phase 1: Preparation - Written/visual materials and questionnaires are provided to motivate and inform. A digital consultation occurs 3-5 weeks before the Life Coping Course, covering goals, commitment, and follow-up. Materials are offered in paper or digital formats. Phase 2: Life Coping Course - The 5-day course includes individual consultations, group activities, education, and medical follow-ups, focusing on coping strategies and well-being. Phase 3: Implementation - A summary meeting is conducted, including key persons for further implementation in own local area. Digital follow-ups at 3-4 weeks and 6 months post course assess progress and guide goal achievement.

Primary outcomes

  1. Proportion of completed components

    Time frame: From enrollment to 6 months after the 5-day Life Coping Course

    The proportion of completed components of the Life Coping Program per participant, as reported on checklists completed by health personnel, fully completed questionnaires by participants, and successful use of activity monitors.

  2. Checklist for health personnel

    Time frame: Immediately after the procedures

    Based on the work of Bellg et al. (2004) and Husted et al. (2014), purpose-built checklists are designed for four pre-defined key procedures of the intervention;

    • Primary digital consultation,
    • primary individual consultation during the Life Coping Course,
    • Activities during the Life Coping Course, and
    • The digital follow-up consultation 3-4 weeks after.

Secondary outcomes

  1. Evaluation of the Life Coping Course

    Time frame: Immediately after the procedure

    A purpose-design evaluation form aiming to assess adolescent and caregivers' experiences and acceptance of phase 2: the five-day Life Coping Course. The questionnaire covers practical aspects, perceived relevance of the activities, interactions with healthcare staff, and overall alignment with their life situation

  2. Health related Quality of Life

    Time frame: From enrollment to 3-4 weeks and 6 months after the 5-days Life Coping Course

    The standardised and valid questionnaire KidScreen27 will be used. Both the version for children and adolescents and the version for parents will be implemented in the study.

  3. Activity Levels

    Time frame: From enrollment to 6 months after the 5-days Life Coping Course

    Objective activity levels will be measured using ActiGraph GT3X+-monitors following a standardized protocol of seven consecutive days of measuring.

  4. Self-reported activity levels and satisfaction with relevant activities

    Time frame: From enrollment to 3-4 weeks and 6 months after the five-day Life Coping Course.

    A purpose-made questionnaire aiming on investigating the child or adolescents relations to physical activity. The questionnaire is partly based on the WHO-survey "Health Behavior in School-Aged Children".

Sponsors and collaborators

Lead sponsor

Haukeland University Hospital

Other

Collaborators

  • University of Bergen
  • Western Norway University of Applied Sciences

Registry information

Official study title

Feasibility of a Group-Based Intervention to Enhance Health-Related Quality of Life and Physical Activity in Children and Adolescents With Chronic Illness: A Study Protocol

Acronym: LifeCOPE

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Nov 29, 2024
Registry last updated
Jun 11, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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