Cultivating Resilience in Oncology Practice

NCT04902313 | Completed Phase 1

• 1 other identifier: 2020-01044
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of the CROP study is to investigate the potential to cultivate psychological resources and resilience in childhood cancer patients and their family members using a mobile phone-based intervention. The feasibility study aims to evaluate the implementation and participant experience of the digital intervention and register psychological outcome measures preliminary evidence for its acceptability, feasibility, and potential beneficial effects.

Conditions

Childhood Cancer; Depressive Symptoms; Anxiety Disorders and Symptoms; Mental Health Issue

Outcome Measures

Primary Outcomes (3)

• Mental Health Continuum-Short Form (MHC-SF)

  14 items. Score (min-max): 0-70. A high score indicates mental well-being.

  At the beginning of the trial.

• Mental Health Continuum-Short Form (MHC-SF)

  14 items. Score (min-max): 0-70. A high score indicates mental well-being.

  After 12 weeks of participation in the trial.

• Mental Health Continuum-Short Form (MHC-SF)

  14 items. Score (min-max): 0-70. A high score indicates mental well-being.

  At 12-month after completion of the trial.

Secondary Outcomes (7)

• Strengths and Difficulties Questionnaire (SDQ)

  At the beginning of the trial.

• Strenghs and Difficulties Questionnaire (SDQ)

  After 12 weeks of participation in the trial.

• Strengths and Difficulties Questionnaire (SDQ)

  At 12-month after completion of the trial.

• Revised Child Anxiety and Depression Scale Short form (RCADS-SF)

  At the beginning of the trial.

• Revised Child Anxiety and Depression Scale (RCADS)

  After 12 weeks of participation in the trial.

Study Arms (2)

Cancer patients

EXPERIMENTAL

Youths (10-18 y) with newly diagnosed cancer, as well as their family members.

Behavioral: Awareness and insight Modules (AiM)

Pediatric patients

ACTIVE COMPARATOR

Youths (10-18 y) with a chronic somatic disease receiving care at a pediatric outpatient facility.

Behavioral: Awareness and insight Modules (AiM)

Interventions

Awareness and insight Modules (AiM) BEHAVIORAL

12 week of daily reflection and meditation exercises, delivered by mobile phone text messages, after 3-4 live introduction sessions.

Cancer patients; Pediatric patients

Eligibility Criteria

• Age: 10 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Newly diagnosed cancer
• Chronic pediatric disease

You may not qualify if:

• Severe crisis reaction
• Late-stage palliative care
• Severe intellectual disability
• Psychiatric disease hindrance
• Participation in other study with psychological intervention

Sponsors & Collaborators

• Linkoeping University: lead

Study Sites (1)

H.K.H. Crown Princess Victoria Children's Hospital, Linköping University Hospital, Sweden

Linköping, 58183, Sweden

Location

MeSH Terms

Conditions

Neoplasms; Depression; Anxiety Disorders

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Mental Disorders

Study Officials

• Catrin Furuhjelm, MD, PhD

  Region Östergötland

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Collection of data and analysis will be made by researcher with limited knowledge of participant status.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer

Model Details: Interventional group of cancer patients, and observational group of pediatric patients with other chronic conditions.

Study Record Dates

• First Submitted: April 23, 2021
• First Posted: May 26, 2021
• Study Start: May 31, 2021
• Primary Completion: December 1, 2023
• Study Completion: December 2, 2023
• Last Updated: February 3, 2026

Record last verified: 2021-05

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)