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Trial · NCT07912684

The Value of a Tailored-based, Exercise Program for Improving Quality of Life of Patients With Hematologic Malignancies: a Pilot Randomized Trial

NCT07912684, Not applicable, Recruiting, Gruppo Italiano Malattie EMatologiche dell'Adulto

3 sourcestrials-2026-11-12-0.4.0

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ConductScience Library. The Value of a Tailored-based, Exercise Program for Improving Quality of Life of Patients With Hematologic Malignancies: a Pilot Randomized Trial. Trials, record NCT07912684. Release trials-2026-11-12-0.4.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT07912684

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title
The Value of a Tailored-based, Exercise Program for Improving Quality of Life of Patients With Hematologic Malignancies: a Pilot Randomized Trial
NCT number
NCT07912684
Status
Recruiting
Phases
Not applicable
Enrollment
75 participants, estimated
Lead sponsor
Gruppo Italiano Malattie EMatologiche dell'Adulto
Conditions
Acute Myeloid Leukemia, Multiple Myeloma, Lymphoma
Interventions
Structured Exercise Program (SEP)
First posted
2026-11-03
Last updated
2026-11-03

Source ClinicalTrials.gov

Registered outcomes9

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

ListOutcomeTime frameDescription
PrimaryAdherence to the Structured Exercise ProgramAt 16 weeks (end of intervention)
Adherence will be assessed as the percentage of participants in the intervention group who attend at least 65% of the planned supervised exercise sessions. The intervention will be considered feasible if at least 70% of participants meet this adherence t
PrimaryPatient Satisfaction With the Structured Exercise ProgramAt 16 weeks (end of intervention)
Patient satisfaction will be assessed in the intervention group using the item "Overall, I am satisfied with the exercise program" from a study-specific satisfaction questionnaire. Responses are rated on a 4-point scale: "disagree", "somewhat disagree", "somewhat agree", and "agree". Satisfaction will be measured as the percentage of participants responding "somewhat agree" or "agree". The intervention will be considered feasible if at least 75% of participants meet this satisfaction criterion.
SecondaryChange in Health-Related Quality of Life (EORTC QLQ-C30)Baseline (T0), 8 weeks (T1), 16 weeks (T2), and 24 weeks (T3) after randomization.
Health-related quality of life will be assessed using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30). Changes in mean scores across all questionnaire scales will be compared between and within study groups. Scores are transformed to a 0-100 scale, with higher scores indicating better functioning or global health status on functional and global health scales, and greater symptom burden on symptom scales.
SecondaryChange in Fatigue (FACIT-Fatigue)Baseline (T0), 8 weeks (T1), 16 weeks (T2), and 24 weeks (T3) after randomization.
Fatigue will be assessed using the Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) questionnaire. Changes in mean fatigue scores will be compared between and within study groups at baseline, 8 weeks, and 16 weeks. Fatigue will also be assessed at 24 weeks for descriptive follow-up analyses.
SecondaryStudy Engagement RateDuring the 18-month recruitment period.
The engagement rate will be calculated as the percentage of patients who agree to participate in the study among all patients invited to participate. Reasons for refusal will be documented to identify potential barriers to study participation.
SecondaryIncidence of Intervention-Related Adverse EventsThroughout the 16-week intervention period.
The number and severity of adverse events potentially related to the structured exercise program will be assessed in the intervention group. Adverse events will be monitored and recorded by exercise professionals and study personnel throughout the intervention period. Severity will be graded according to the Common Terminology Criteria for Adverse Events (CTCAE), version 5.0.
SecondaryPatient-Reported Burden of the Intervention (FACT-G Item GP5)At 8 weeks (T1) and 16 weeks (T2) after randomization.Patient-Reported Burden of the Intervention (FACT-G Item GP5)
SecondaryChange in Physical Activity Levels (Godin-Shephard Questionnaire)Baseline (T0), 8 weeks (T1), 16 weeks (T2), and 24 weeks (T3) after randomization.
Changes in physical activity levels will be assessed using the Godin-Shephard Leisure-Time Physical Activity Questionnaire, which evaluates the frequency of mild, moderate, and vigorous physical activity performed during leisure time. Changes will be compared between and within study groups.
SecondaryNon-Hematological Adverse EventsThroughout the 16-week intervention period.
The prevalence of non-hematological adverse events of grade 3 or higher will be described and compared between the intervention and control groups. Adverse event severity will be classified according to CTCAE version 5.0.

Outcomes0

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

None in this release.

Results by group0

Each measurement the trial posted, group by group, in the words and numbers it posted.

None in this release.

Participant flow0

How many started, completed or left each group, period by period.

None in this release.

Adverse events0

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

None in this release.

Adverse event totals0

The totals the trial posted for each group.

None in this release.

Papers0

The papers the trial lists on ClinicalTrials.gov.

None in this release.

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons0

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

None in this release.

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Source

Release
trials-2026-11-12-0.4.0
Release manifest SHA-256
0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4
Registry capture
2026-11-12
Results copy, AACT
2026-03-23
NIH clinical studies file
2026-11-13

Source ClinicalTrials.gov

Sources 3

  • ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
  • ClinicalTrials.govNone stated
  • NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
  • ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
  • ClinicalTrials.govnone stated
  • NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT07912684

GET https://conductscience.org/api/trials/v1/NCT07912684/registered