Childhood CancerPhase 1CROPNCT04902313
Cultivating Resilience in Oncology Practice
A Phase 1 study testing Awareness and insight Modules (AiM) in people with Childhood Cancer and Depressive Symptoms, run by Linkoeping University at 1 site in Sweden.
Trial 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. Read more about this study
- Who is it for?
- Ages 10 to 18 years
- Conditions the study is for
- Childhood Cancer, Depressive Symptoms, Anxiety Disorders and Symptoms
- What is being tested?
- Awareness and insight Modules (AiM)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteSweden
- Study dates
- 31 May 2021to 2 Dec 2023
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Newly diagnosed cancer
- Chronic pediatric disease
Who cannot join
- Severe crisis reaction
- Late-stage palliative care
- Severe intellectual disability
- Psychiatric disease hindrance
- Participation in other study with psychological intervention
Trial locations and contacts
1 site in 1 country.
Sweden1 site
H.K.H. Crown Princess Victoria Children's Hospital, Linköping University Hospital, Sweden
Linköping, 58183
About this study
Official title: Cultivating Resilience in Oncology Practice: A Feasibility Study of Pediatric Patients
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.
Read the 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.
- Conditions
- Childhood Cancer, Depressive Symptoms, Anxiety Disorders and Symptoms, Mental Health Issue
- Being tested
- Awareness and insight Modules (AiM)
- Medical subject headings
- Neoplasms, Depression, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Awareness and insight Modules (AiM)Behavioural
12 week of daily reflection and meditation exercises, delivered by mobile phone text messages, after 3-4 live introduction sessions.
| Study group | Role | What they receive |
|---|---|---|
| Cancer patients | Experimental | Youths (10-18 y) with newly diagnosed cancer, as well as their family members. Receives: 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. Receives: Behavioral: Awareness and insight Modules (AiM) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mental Health Continuum-Short Form (MHC-SF)
14 items. Score (min-max): 0-70. A high score indicates mental well-being.
Measured: 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.
Measured: 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.
Measured: At 12-month after completion of the trial.
Secondary outcomes (7)
Strengths and Difficulties Questionnaire (SDQ)
25 items. Score (min-max): 0-25. A high score indicates psychiatric difficulties.
Measured: At the beginning of the trial.
Strenghs and Difficulties Questionnaire (SDQ)
25 items. Score (min-max): 0-25. A high score indicates psychiatric difficulties.
Measured: After 12 weeks of participation in the trial.
Strengths and Difficulties Questionnaire (SDQ)
25 items. Score (min-max): 0-25. A high score indicate psychiatric difficulties.
Measured: At 12-month after completion of the trial.
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.
Measured: At the beginning of the trial.
Revised Child Anxiety and Depression Scale (RCADS)
25 items. Score (min-max): 0-75. A high score indicates symptoms of anxiety and depression.
Measured: After 12 weeks of participation in the trial.
Revised Child Anxiety and Depression Scale (RCADS)
25 items. Score (min-max): 0-75. A high score indicates symptoms of anxiety and depression.
Measured: At 12-month after completion of the trial.
System Usability Scale (SUS)
10 items. Score (min-max): 10-50. A high score indicates a high level of usability.
Measured: After completion of the 12 week trial.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 May 2021
- Study start31 May 2021
- Primary completion1 Dec 2023
- Study completion2 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Childhood CancerStudies of the same condition, open and under way.
- More trials run by Linkoeping UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Interventional group of cancer patients, and observational group of pediatric patients with other chronic conditions.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Linkoeping University
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Oskar Lundgren, MD, PhD, MSc, Linkoeping University
- Investigators
- Catrin Furuhjelm, MD, PhD, Study chair, Region Östergötland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04902313
- Sponsor's protocol ID
- 2020-01044
- Acronym
- CROP
- Status last verified
- May 2021
- First submitted
- 23 Apr 2021
- Last updated
- 3 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Study data will be made available upon reasonable request from other researchers.
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cultivating Resilience in Oncology Practice: A Feasibility Study of Pediatric Patients
- ClinicalTrials.gov ID
- NCT04902313
- Acronym / sponsor ID
- CROP / 2020-01044
- Conditions
- Childhood Cancer, Depressive Symptoms, Anxiety Disorders and Symptoms, Mental Health Issue
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Linkoeping UniversityOther government
- Study start
- 31 May 2021 (actual)
- Primary completion
- 1 Dec 2023 (actual)
- Study completion
- 2 Dec 2023 (actual)
- First posted
- 26 May 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Interventional group of cancer patients, and observational group of pediatric patients with other chronic conditions.
| Arm | Type | Receives |
|---|---|---|
| Cancer patients | Experimental | Behavioral: Awareness and insight Modules (AiM)Youths (10-18 y) with newly diagnosed cancer, as well as their family members. |
| Pediatric patients | Active comparator | Behavioral: Awareness and insight Modules (AiM)Youths (10-18 y) with a chronic somatic disease receiving care at a pediatric outpatient facility. |
Who may qualify
- Ages
- 10 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- Newly diagnosed cancer
- Chronic pediatric disease
Key exclusion criteria (5 listed)
- Severe crisis reaction
- Late-stage palliative care
- Severe intellectual disability
- Psychiatric disease hindrance
- Participation in other study with psychological intervention
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Awareness and insight Modules (AiM)12 week of daily reflection and meditation exercises, delivered by mobile phone text messages, after 3-4 live introduction sessions. | Behavioural | Cancer patients, Pediatric patients |
Primary outcome
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.
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.
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.
7 secondary outcomes
Strengths and Difficulties Questionnaire (SDQ)
Time frame: At the beginning of the trial.
Strenghs and Difficulties Questionnaire (SDQ)
Time frame: After 12 weeks of participation in the trial.
Strengths and Difficulties Questionnaire (SDQ)
Time frame: At 12-month after completion of the trial.
Revised Child Anxiety and Depression Scale Short form (RCADS-SF)
Time frame: At the beginning of the trial.
Revised Child Anxiety and Depression Scale (RCADS)
Time frame: After 12 weeks of participation in the trial.
Revised Child Anxiety and Depression Scale (RCADS)
Time frame: At 12-month after completion of the trial.
System Usability Scale (SUS)
Time frame: After completion of the 12 week trial.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Feb 2026.
- Individual participant dataSharing planned: No. Study data will be made available upon reasonable request from other researchers.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Catrin Furuhjelm, MD, PhD study chair
Region Östergötland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Awareness and insight Modules (AiM) in people with Childhood Cancer and Depressive Symptoms, run by Linkoeping University at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mental Health Continuum-Short Form (MHC-SF) (time frame: At the beginning of the trial.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Feb 2026.