Feasibility of a Life Coping Program: A Study Protocol

NCT06709248 | Completed

• 2 other identifiers: 578213Recruitment PhD
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

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

Outcome Measures

Primary Outcomes (2)

• Proportion of completed components

  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.

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

• Checklist for health personnel

  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; 1. Primary digital consultation, 2. primary individual consultation during the Life Coping Course, 3. Activities during the Life Coping Course, and 4. The digital follow-up consultation 3-4 weeks after.

  Immediately after the procedures

Secondary Outcomes (4)

• Evaluation of the Life Coping Course

  Immediately after the procedure

• Health related Quality of Life

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

• Activity Levels

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

• Self-reported activity levels and satisfaction with relevant activities

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

Study Arms (1)

Intervention

EXPERIMENTAL

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

Behavioral: Life Coping Program

Interventions

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.

Intervention

Eligibility Criteria

• Age: 8 Years - 16 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Haukeland University Hospital: lead
• University of Bergen: collaborator
• Western Norway University of Applied Sciences: collaborator

Study Sites (1)

Haukeland university hospital - Department of Pediatrics

Bergen, Vestland, 5009, Norway

Location

Related Publications (1)

• Bovim LPV, Rotevatn EO, Kvidaland HK, Bogen B, Halvorsen T, Engan M. 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. Pilot Feasibility Stud. 2025 Jul 17;11(1):101. doi: 10.1186/s40814-025-01682-w.

  PMID: 40676648 DERIVED

Related Links

• (NORWEGIAN) Brief description of the intervention Life Coping Program, as presented to the public
• (NORWEGIAN) Open part of the digital portal

MeSH Terms

Conditions

Motor Activity; Precursor Cell Lymphoblastic Leukemia-Lymphoma

Condition Hierarchy (Ancestors)

Behavior; Leukemia, Lymphoid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Study Officials

• Mette Engan, MD PhD

  Haukeland University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 25, 2024
• First Posted: November 29, 2024
• Study Start: May 1, 2023
• Primary Completion: May 31, 2025
• Study Completion: May 31, 2025
• Last Updated: June 11, 2025

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

NO (1)