search
Back to results

Cultivating Resilience in Oncology Practice (CROP)

Primary Purpose

Childhood Cancer, Depressive Symptoms, Anxiety Disorders and Symptoms

Status
Unknown status
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
Awareness and insight Modules (AiM)
Sponsored by
Linkoeping University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Childhood Cancer

Eligibility Criteria

10 Years - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Cancer patients

Pediatric patients

Arm Description

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

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

Outcomes

Primary Outcome Measures

Mental Health Continuum-Short Form (MHC-SF)
14 items. Score (min-max): 0-70. A high score indicates mental well-being.
Mental Health Continuum-Short Form (MHC-SF)
14 items. Score (min-max): 0-70. A high score indicates mental well-being.
Mental Health Continuum-Short Form (MHC-SF)
14 items. Score (min-max): 0-70. A high score indicates mental well-being.

Secondary Outcome Measures

Strengths and Difficulties Questionnaire (SDQ)
25 items. Score (min-max): 0-25. A high score indicates psychiatric difficulties.
Strenghs and Difficulties Questionnaire (SDQ)
25 items. Score (min-max): 0-25. A high score indicates psychiatric difficulties.
Strengths and Difficulties Questionnaire (SDQ)
25 items. Score (min-max): 0-25. A high score indicate psychiatric difficulties.
Revised Child Anxiety and Depression Scale Short form (RCADS-SF)
25 items. Score (min-max): 0-75. A high score indicates symptoms of anxiety and depression.
Revised Child Anxiety and Depression Scale (RCADS)
25 items. Score (min-max): 0-75. A high score indicates symptoms of anxiety and depression.
Revised Child Anxiety and Depression Scale (RCADS)
25 items. Score (min-max): 0-75. A high score indicates symptoms of anxiety and depression.
System Usability Scale (SUS)
10 items. Score (min-max): 10-50. A high score indicates a high level of usability.

Full Information

First Posted
April 23, 2021
Last Updated
May 20, 2021
Sponsor
Linkoeping University
search

1. Study Identification

Unique Protocol Identification Number
NCT04902313
Brief Title
Cultivating Resilience in Oncology Practice
Acronym
CROP
Official Title
Cultivating Resilience in Oncology Practice: A Feasibility Study of Pediatric Patients
Study Type
Interventional

2. Study Status

Record Verification Date
May 2021
Overall Recruitment Status
Unknown status
Study Start Date
May 31, 2021 (Anticipated)
Primary Completion Date
December 31, 2022 (Anticipated)
Study Completion Date
May 2, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Linkoeping University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Childhood Cancer, Depressive Symptoms, Anxiety Disorders and Symptoms, Mental Health Issue

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Interventional group of cancer patients, and observational group of pediatric patients with other chronic conditions.
Masking
Outcomes Assessor
Masking Description
Collection of data and analysis will be made by researcher with limited knowledge of participant status.
Allocation
Non-Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Cancer patients
Arm Type
Experimental
Arm Description
Youths (10-18 y) with newly diagnosed cancer, as well as their family members.
Arm Title
Pediatric patients
Arm Type
Active Comparator
Arm Description
Youths (10-18 y) with a chronic somatic disease receiving care at a pediatric outpatient facility.
Intervention Type
Behavioral
Intervention Name(s)
Awareness and insight Modules (AiM)
Intervention Description
12 week of daily reflection and meditation exercises, delivered by mobile phone text messages, after 3-4 live introduction sessions.
Primary Outcome Measure Information:
Title
Mental Health Continuum-Short Form (MHC-SF)
Description
14 items. Score (min-max): 0-70. A high score indicates mental well-being.
Time Frame
At the beginning of the trial.
Title
Mental Health Continuum-Short Form (MHC-SF)
Description
14 items. Score (min-max): 0-70. A high score indicates mental well-being.
Time Frame
After 12 weeks of participation in the trial.
Title
Mental Health Continuum-Short Form (MHC-SF)
Description
14 items. Score (min-max): 0-70. A high score indicates mental well-being.
Time Frame
At 12-month after completion of the trial.
Secondary Outcome Measure Information:
Title
Strengths and Difficulties Questionnaire (SDQ)
Description
25 items. Score (min-max): 0-25. A high score indicates psychiatric difficulties.
Time Frame
At the beginning of the trial.
Title
Strenghs and Difficulties Questionnaire (SDQ)
Description
25 items. Score (min-max): 0-25. A high score indicates psychiatric difficulties.
Time Frame
After 12 weeks of participation in the trial.
Title
Strengths and Difficulties Questionnaire (SDQ)
Description
25 items. Score (min-max): 0-25. A high score indicate psychiatric difficulties.
Time Frame
At 12-month after completion of the trial.
Title
Revised Child Anxiety and Depression Scale Short form (RCADS-SF)
Description
25 items. Score (min-max): 0-75. A high score indicates symptoms of anxiety and depression.
Time Frame
At the beginning of the trial.
Title
Revised Child Anxiety and Depression Scale (RCADS)
Description
25 items. Score (min-max): 0-75. A high score indicates symptoms of anxiety and depression.
Time Frame
After 12 weeks of participation in the trial.
Title
Revised Child Anxiety and Depression Scale (RCADS)
Description
25 items. Score (min-max): 0-75. A high score indicates symptoms of anxiety and depression.
Time Frame
At 12-month after completion of the trial.
Title
System Usability Scale (SUS)
Description
10 items. Score (min-max): 10-50. A high score indicates a high level of usability.
Time Frame
After completion of the 12 week trial.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
10 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Oskar Lundgren, MD, Phd, MSc
Phone
70-2285546
Ext
46
Email
oskar.lundgren@liu.se
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Catrin Furuhjelm, MD, PhD
Organizational Affiliation
Region Östergötland
Official's Role
Study Chair
Facility Information:
Facility Name
H.K.H. Crown Princess Victoria Children's Hospital, Linköping University Hospital, Sweden
City
Linköping
ZIP/Postal Code
58183
Country
Sweden
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Oskar Lundgren, MD, PhD, MSc
Phone
010-1030326
Ext
46
Email
oskar.lundgren@regionostergotland.se

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
Study data will be made available upon reasonable request from other researchers.

Learn more about this trial

Cultivating Resilience in Oncology Practice

We'll reach out to this number within 24 hrs