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CompletedNCT07882069Updated Oct 20, 2026

Effect of ACTIVE-Care on Cancer-Related Fatigue, Hope, and Psychological Resilience in Adolescents With Acute Lymphoblastic Leukemia

An interventional study of ACTIVE-Care Integrated Physical Activity-Based Supportive Care Program in Cancer (Colon Cancer, Breast Cancer, Lymphoma, Chronic Lymphoma Leukemia, Multiple Myeloma), Adolescent and Resilience, Psychological, sponsored by Selcuk University. Completed at 1 site in Turkey (Türkiye). Open to participants aged 13 Years to 18 Years. Per ClinicalTrials.gov, last updated 2026-10-20.

Sponsored by Selcuk University · Not applicable, Interventional, and Supportive care

From the registry’s dates

  • Registered 3 months after the study started (first participant enrolled Jul 2026, registered Oct 2026).
Updated Oct 20, 2026Newly registeredGo to Updates ↓
Phase
Not applicable
Study type
Interventional
Enrollment
70
Allocation
Randomized
Ages
13 Years to 18 Years
Sex
All
01

Study 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). 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.

02

Conditions studied

  • 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
03

In context

Neoplasms

9,610 studies on the registry are indexed under Neoplasms; 2,508 are open to participants now.

This study's enrollment of 70 is above the median of 50 across 7,429 interventional studies indexed under Neoplasms.

Browse Neoplasms studies →

Lead sponsor

Selcuk University is the lead sponsor of 255 studies on the registry; 66 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
13 Years to 18 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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.

Exclusion criteria

Exclusion Criteria:

  • 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.
05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
70 participants (actual)

Study arms

  • Experimental
    ACTIVE-Care Program

    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

  • No intervention
    Usual Care

    Participants received usual care provided by the treating institution, without the ACTIVE-Care program or any additional study-specific intervention.

Interventions

  • BehavioralACTIVE-Care Integrated Physical Activity-Based Supportive Care Program

    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.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: Baseline (within 1 week before the intervention) and immediately after the 6-week intervention

  2. 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.

    Time frame: Baseline (within 1 week before the intervention) and immediately after the 6-week intervention

  3. 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.

    Time frame: Baseline (within 1 week before the intervention) and immediately after the 6-week intervention

07

Study locations

1 site
  • Selçuk University
    Konya, Selçuklu 42250, Turkey (Türkiye)
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Jul 2026 to primary completion in Jul 2026, 0 months.

Of 1,358 non-industry interventional studies with no phase under Neoplasms, half reached primary completion within 37 months of starting (the median), counting those still running; a quarter within 17 and three quarters within 71. This study's 0 months is below that.

Counting every sponsor, half of 1,404 studies reached it within 38 months; a quarter within 17 and three quarters within 71.

Neoplasms covers many different conditions, not one, so the studies compared here vary widely. Read these figures as a rough guide.

How these figures are worked out, and which studies are left out of them.

Registered
Oct 11, 2026
First posted
Oct 20, 2026
StartActual
Jul 1, 2026
Primary completionActual
Jul 7, 2026
CompletionActual
Aug 14, 2026
Last update
Oct 20, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Registered
First appeared on the registry. No changes since
Oct 20, 2026
Show all 1 update
  1. Oct 20, 2026
    First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07882069
Lead sponsor
Selcuk University
Responsible party
Neslihan Lok (Prof. Dr., Selcuk University) — Principal investigator
First posted
Oct 20, 2026
Start date
Jul 1, 2026
Primary completion
Jul 7, 2026
Completion
Aug 14, 2026
Last update
Oct 20, 2026

Study contacts

Neslihan Lök, Prof. Dr.
study director · Selcuk University
Bekir Mehtap, Asst. Prof.
principal investigator · Selcuk University
Sefa Lök, Prof. Dr.
study chair · Selcuk University
Alime Selçuk Tosun, Assoc. Prof.
study chair · Selcuk University
Büşra Kayaaslan, P.hD.
study chair · Selcuk University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.

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