Effect of ACTIVE-Care on Cancer-Related Fatigue, Hope, and Psychological Resilience in Adolescents With Acute Lymphoblastic Leukemia
Effect of the ACTIVE-Care Integrated Physical Activity-Based Supportive Care Program on Cancer-Related Fatigue, Hope, and Psychological Resilience in Adolescents With Acute Lymphoblastic Leukemia: A Randomized Controlled Trial
This study aimed to evaluate the effects of the ACTIVE-Care Integrated Physical Activity-Based Supportive Care Program on cancer-related fatigue, hope, and psychological resilience in adolescents with acute lymphoblastic leukemia (ALL). Seventy adolescents aged 13-16 years participated in a parallel-group randomized controlled trial. The intervention group received a six-week program integrating individualized physical activity with psychosocial support, while the control group received usual care. Outcomes were assessed at baseline and immediately after the six-week intervention.
Registry Overview
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
Recruitment status
completed
Actual enrollment (reported)
70 participants
Study completion date
August 14, 2026
Actual (reported)
Listed locations
1 countries · 1 sites
Trial Relationships
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Related Scientific Literature
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Study Timeline
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
Change in Cancer-Related Fatigue - Assessment Scale for Fatigue in Pediatric Oncology Patients Aged 13-18 Years
Cancer-related fatigue is assessed using the Assessment Scale for Fatigue in Pediatric Oncology Patients Aged 13-18 Years. Total scores range from 32 to 160, with higher scores indicating lower fatigue and a better outcome, and lower scores indicating greater fatigue and a worse outcome. Change in total score is evaluated from baseline to immediately after the six-week intervention.
Baseline (within 1 week before the intervention) and immediately after the 6-week intervention
Change in Hope - Children's Hope Scale (CHS)
Hope is assessed using the Children's Hope Scale, a six-item measure with each item rated from 1 to 6. Total scores range from 6 to 36, with higher scores indicating greater hope and a better outcome. Change in total score is evaluated from baseline to immediately after the six-week intervention.
Baseline (within 1 week before the intervention) and immediately after the 6-week intervention
Study Arms (2)
ACTIVE-Care Program
EXPERIMENTAL
Participants received the ACTIVE-Care Integrated Physical Activity-Based Supportive Care Program, comprising 12 supervised sessions delivered twice weekly over six weeks, in addition to usual care. The program integrated individualized physical activity with psychosocial support.
Behavioral: ACTIVE-Care Integrated Physical Activity-Based Supportive Care Program
Usual Care
NO INTERVENTION
Participants received usual care provided by the treating institution, without the ACTIVE-Care program or any additional study-specific intervention.
Interventions
ACTIVE-Care Integrated Physical Activity-Based Supportive Care ProgramBehavioral
ACTIVE-Care was developed as a supportive care program integrating individualized physical activity with fatigue and energy management, goal setting, self-monitoring, coping, problem-solving, and social support strategies.
ACTIVE-Care Program
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Eligibility Criteria
Age13 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
You may qualify if:
Aged 13-16 years;
Diagnosed with acute lymphoblastic leukemia (ALL) by a pediatric hematology-oncology specialist;
Colorectal NeoplasmsIntestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteDigestive System DiseasesGastrointestinal DiseasesColonic Diseases
Study Officials
Neslihan Lök, Prof. Dr.
Selcuk University
STUDY DIRECTOR
Bekir Mehtap, Asst. Prof.
Selcuk University
PRINCIPAL INVESTIGATOR
Sefa Lök, Prof. Dr.
Selcuk University
STUDY CHAIR
Alime Selçuk Tosun, Assoc. Prof.
Selcuk University
STUDY CHAIR
Enrollment
70 participants (actual enrollment reported by the registry).
Study Design
Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
The study was conducted as a randomized controlled trial with blinded outcome assessment and data analysis.
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: This study was a parallel-group randomized controlled trial with a pretest-posttest design
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof. Dr.
Study Record Dates
First Submitted
October 11, 2026
First Posted
October 20, 2026
Study Start
NCT07823881
Effect of a Nurse-Led Transition Program on Resilience and Career Decisions in Senior Students
Change in Psychological Resilience - Child and Youth Resilience Measure-12 (CYRM-12)
Psychological resilience is assessed using the Child and Youth Resilience Measure-12, a 12-item measure with each item rated from 1 to 5. Total scores range from 12 to 60, with higher scores indicating greater psychological resilience and a better outcome. Change in total score is evaluated from baseline to immediately after the six-week intervention.
Baseline (within 1 week before the intervention) and immediately after the 6-week intervention
Undergoing consolidation or maintenance chemotherapy;
Clinically stable and medically cleared by the responsible pediatric hematology-oncology specialist to participate in moderate-intensity physical activity;
Able to read and understand Turkish and have sufficient cognitive capacity to complete the data collection forms independently or, when necessary, with assistance from the researcher; and
Willing to participate in the study, with written assent obtained from the adolescent and written informed consent obtained from a parent/legal guardian.
You may not qualify if:
Receiving intensive treatment for active relapse, being clinically unstable, or not being medically cleared by the responsible pediatric hematology-oncology specialist to participate in physical activity;
Having a severe cardiovascular, respiratory, neurological, or musculoskeletal condition that contraindicated participation in exercise;
Having a severe functional limitation that prevented the safe performance of physical activity;
Being unable to participate in the intervention or data collection procedures because of a diagnosed severe psychiatric or cognitive disorder; or
Participating in another structured exercise or psychosocial intervention program during the study period that could affect the study outcomes.
Contact the study team to confirm eligibility.
Intestinal Diseases
Breast Diseases
Skin Diseases
Skin and Connective Tissue Diseases
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Hemic and Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Neoplasms, Plasma Cell
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Behavior
Leukemia, Lymphoid
Leukemia
Büşra Kayaaslan, P.hD.
Selcuk University
STUDY CHAIR
July 1, 2026
Actual (reported)
Primary Completion
July 7, 2026
Actual (reported)
Study Completion
August 14, 2026
Actual (reported)
Last Updated
October 20, 2026
Record last verified: 2026-10
Data Sharing
IPD Sharing
Will not share
Source record
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
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