Cancer (Colon Cancer, Breast Cancer, Lymphoma, Chronic Lymphoma Leukemia, Multiple Myeloma)NCT07882069
Effect of ACTIVE-Care on Cancer-Related Fatigue, Hope, and Psychological Resilience in Adolescents With Acute Lymphoblastic Leukemia
A study testing ACTIVE-Care Integrated Physical Activity-Based Supportive Care Program in people with Cancer (Colon Cancer, Breast Cancer, Lymphoma, Chronic Lymphoma Leukemia, Multiple Myeloma) and Adolescent, run by Selcuk University at 1 site in Turkey (Türkiye).
Trial summary
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). Read more about this study
- Who is it for?
- Ages 13 to 18 years
- Conditions the study is for
- Cancer (Colon Cancer, Breast Cancer, Lymphoma, Chronic Lymphoma Leukemia, Multiple Myeloma), Adolescent, Resilience, Psychological
- What is being tested?
- ACTIVE-Care Integrated Physical Activity-Based Supportive Care Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jul 2026to 14 Aug 2026
- Phase
- Interventional
- 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 13 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Aged 13-16 years;
- Diagnosed with acute lymphoblastic leukemia (ALL) by a pediatric hematology-oncology specialist;
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the detailed description
This parallel-group randomized controlled trial used a pretest-posttest design 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 were randomly assigned to the intervention group or the control group, with 35 participants in each group.
The intervention group received 12 supervised sessions delivered twice weekly over six weeks. The program integrated individualized physical activity with supportive care components addressing fatigue and energy management, goal setting, self-monitoring, positive feedback, coping, problem-solving, and social support.
The control group received usual care provided by the treating institution, without the ACTIVE-Care program or any additional study-specific intervention.
Cancer-related fatigue was assessed using the Assessment Scale for Fatigue in Pediatric Oncology Patients Aged 13-18 Years. Hope was assessed using the Children's Hope Scale (CHS), and psychological resilience was assessed using the Child and Youth Resilience Measure-12 (CYRM-12). Assessments were conducted at baseline, within one week before the intervention, and immediately after the six-week intervention.
- Conditions
- Cancer (Colon Cancer, Breast Cancer, Lymphoma, Chronic Lymphoma Leukemia, Multiple Myeloma), Adolescent, Resilience, Psychological, Physical Activities
- Being tested
- ACTIVE-Care Integrated Physical Activity-Based Supportive Care Program
- Keywords
- acute lymphoblastic leukemia, adolescent, physical activity, cancer-related fatigue, hope, psychological resilience
- Medical subject headings
- Neoplasms, Colonic Neoplasms, Breast Neoplasms, Lymphoma, Multiple Myeloma, Motor Activity, Precursor Cell Lymphoblastic Leukemia-Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ACTIVE-Care Integrated Physical Activity-Based Supportive Care ProgramBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Baseline (within 1 week before the intervention) and immediately after the 6-week intervention
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.
Measured: Baseline (within 1 week before the intervention) and immediately after the 6-week intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2026
- Study start1 Jul 2026
- Primary completion7 Jul 2026
- Study completion14 Aug 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cancer (Colon Cancer, Breast Cancer, Lymphoma, Chronic Lymphoma Leukemia, Multiple Myeloma)Studies of the same condition, open and under way.
- More trials run by Selcuk 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 N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This study was a parallel-group randomized controlled trial with a pretest-posttest design
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Selcuk University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Neslihan Lok, Selcuk University
- Investigators
- Neslihan Lök, Prof. Dr., Study director, Selcuk UniversityBekir Mehtap, Asst. Prof., Principal investigator, Selcuk UniversitySefa Lök, Prof. Dr., Study chair, Selcuk UniversityAlime Selçuk Tosun, Assoc. Prof., Study chair, Selcuk UniversityBüşra Kayaaslan, P.hD., Study chair, Selcuk University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07882069
- Sponsor's protocol ID
- 24202627
- Status last verified
- Oct 2026
- First submitted
- 11 Oct 2026
- Last updated
- 20 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07882069
- Acronym / sponsor ID
- 24202627
- Conditions
- Cancer (Colon Cancer, Breast Cancer, Lymphoma, Chronic Lymphoma Leukemia, Multiple Myeloma), Adolescent, Resilience, Psychological, Physical Activities
- Keywords
- acute lymphoblastic leukemia, adolescent, physical activity, cancer-related fatigue, hope, psychological resilience
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Selcuk UniversityUniversity, hospital or other
- Study start
- 1 Jul 2026 (actual)
- Primary completion
- 7 Jul 2026 (actual)
- Study completion
- 14 Aug 2026 (actual)
- First posted
- 20 Oct 2026 (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.
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.
Detailed description
This parallel-group randomized controlled trial used a pretest-posttest design 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 were randomly assigned to the intervention group or the control group, with 35 participants in each group.
The intervention group received 12 supervised sessions delivered twice weekly over six weeks. The program integrated individualized physical activity with supportive care components addressing fatigue and energy management, goal setting, self-monitoring, positive feedback, coping, problem-solving, and social support.
The control group received usual care provided by the treating institution, without the ACTIVE-Care program or any additional study-specific intervention.
Cancer-related fatigue was assessed using the Assessment Scale for Fatigue in Pediatric Oncology Patients Aged 13-18 Years. Hope was assessed using the Children's Hope Scale (CHS), and psychological resilience was assessed using the Child and Youth Resilience Measure-12 (CYRM-12). Assessments were conducted at baseline, within one week before the intervention, and immediately after the six-week intervention.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- This study was a parallel-group randomized controlled trial with a pretest-posttest design
| Arm | Type | Receives |
|---|---|---|
| ACTIVE-Care Program | Experimental | Behavioral: ACTIVE-Care Integrated Physical Activity-Based Supportive Care ProgramParticipants 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. |
| Usual Care | No intervention | –Participants received usual care provided by the treating institution, without the ACTIVE-Care program or any additional study-specific intervention. |
Who may qualify
- Ages
- 13 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (6 listed)
- Aged 13-16 years;
- Diagnosed with acute lymphoblastic leukemia (ALL) by a pediatric hematology-oncology specialist;
- 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
Key exclusion criteria (5 listed)
- 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.
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 |
|---|---|---|
| ACTIVE-Care Integrated Physical Activity-Based Supportive Care ProgramACTIVE-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. | Behavioural | ACTIVE-Care Program |
Primary outcome
Change in Cancer-Related Fatigue - Assessment Scale for Fatigue in Pediatric Oncology Patients Aged 13-18 Years
Time frame: Baseline (within 1 week before the intervention) and immediately after the 6-week intervention
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.
Change in Hope - Children's Hope Scale (CHS)
Time frame: Baseline (within 1 week before the intervention) and immediately after the 6-week intervention
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.
Change in Psychological Resilience - Child and Youth Resilience Measure-12 (CYRM-12)
Time frame: Baseline (within 1 week before the intervention) and immediately after the 6-week intervention
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.
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 20 Oct 2026.
- Individual participant dataSharing planned: No
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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.
Neslihan Lök, Prof. Dr. study director
Selcuk University
Bekir Mehtap, Asst. Prof. principal investigator
Selcuk University
Sefa Lök, Prof. Dr. study chair
Selcuk University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ACTIVE-Care Integrated Physical Activity-Based Supportive Care Program in people with Cancer (Colon Cancer, Breast Cancer, Lymphoma, Chronic Lymphoma Leukemia, Multiple Myeloma) and Adolescent, run by Selcuk University at 1 site in Turkey (Türkiye).
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 6 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 20 Oct 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 Turkey (Türkiye). 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.
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?
Change in Cancer-Related Fatigue - Assessment Scale for Fatigue in Pediatric Oncology Patients Aged 13-18 Years (time frame: Baseline (within 1 week before the intervention) and immediately after the 6-week intervention). 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 20 Oct 2026.