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Completed

NCT Number: NCT04902313

Cultivating Resilience in Oncology Practice

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.

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Key information

Age range

10 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

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

Linköping, 58183, Sweden

About this study

The feasibility study (CROP) will recruit 20 youths with newly diagnosed cancer (10-18 y) and family members for participation in a 12-week digital intervention to cultivate psychological resources.

Investigators will recruit an equal number of pediatric patients with other chronic conditions to an observational comparison group to indicate the influences on participation and outcome from the oncology care context.

Investigators will obtain informed consent from all participants. Upon inclusion in the study, participants will start getting a text message every day for 12 consecutive weeks. The texts will contain links to a digital platform on which participants will complete an exercise in either self-reflection or guided mindfulness meditation.

The psychological training program is based on 12 modules with evidence-based treatments in other medical contexts and age groups. The practices are based on acceptance, commitment, re-appraisal, meaning and purpose, expressive writing, narrative processes, mindfulness, compassion, equanimity, and gratitude. The combination of practices and the implementation in pediatric oncology has not been studied earlier.

The cancer patients will be recruited during the first month after diagnosis, meet with an instructor during 2-4 start-up meetings, and thereafter practice on their own or with participating family members.

The pediatric patients with chronic diseases will be recruited during a follow-up visit to an out-patient clinic and meet with an instructor during 2-4 start-up meetings, and thereafter practice on their own or together with participating family members.

Investigators will address the primary research question of the feasibility of the intervention by investigating participant activity data, written evaluations of the experience of participation, and through phone interviews of participants.

Secondary research questions, such as preliminary data on changes in mental health and psychological distress, will be investigated with self-report questionnaires.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Newly diagnosed cancer
  • Chronic pediatric disease

Exclusion criteria

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

Treatment and study plan

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.

Primary outcomes

  1. Mental Health Continuum-Short Form (MHC-SF)

    Time frame: At the beginning of the trial.

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

  2. Mental Health Continuum-Short Form (MHC-SF)

    Time frame: After 12 weeks of participation in the trial.

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

  3. Mental Health Continuum-Short Form (MHC-SF)

    Time frame: At 12-month after completion of the trial.

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

Secondary outcomes

  1. Strengths and Difficulties Questionnaire (SDQ)

    Time frame: At the beginning of the trial.

    25 items. Score (min-max): 0-25. A high score indicates psychiatric difficulties.

  2. Strenghs and Difficulties Questionnaire (SDQ)

    Time frame: After 12 weeks of participation in the trial.

    25 items. Score (min-max): 0-25. A high score indicates psychiatric difficulties.

  3. Strengths and Difficulties Questionnaire (SDQ)

    Time frame: At 12-month after completion of the trial.

    25 items. Score (min-max): 0-25. A high score indicate psychiatric difficulties.

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

    Time frame: At the beginning of the trial.

    25 items. Score (min-max): 0-75. A high score indicates symptoms of anxiety and depression.

  5. Revised Child Anxiety and Depression Scale (RCADS)

    Time frame: After 12 weeks of participation in the trial.

    25 items. Score (min-max): 0-75. A high score indicates symptoms of anxiety and depression.

  6. Revised Child Anxiety and Depression Scale (RCADS)

    Time frame: At 12-month after completion of the trial.

    25 items. Score (min-max): 0-75. A high score indicates symptoms of anxiety and depression.

  7. System Usability Scale (SUS)

    Time frame: After completion of the 12 week trial.

    10 items. Score (min-max): 10-50. A high score indicates a high level of usability.

Sponsors and collaborators

Lead sponsor

Linkoeping University

Other Gov

Registry information

Official study title

Cultivating Resilience in Oncology Practice: A Feasibility Study of Pediatric Patients

Acronym: CROP

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
May 26, 2021
Registry last updated
Feb 3, 2026

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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