INPACT: Implementation of Nutritional Support and Physical Activity During Cancer Treatment
NCT07929597, Not applicable, Not yet recruiting, General Hospital Groeninge
Trial 10
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
| Field | Value | Source |
|---|---|---|
| Title | INPACT: Implementation of Nutritional Support and Physical Activity During Cancer Treatment | ClinicalTrials.gov |
| NCT number | NCT07929597 | ClinicalTrials.gov |
| Status | Not yet recruiting | ClinicalTrials.gov |
| Phases | Not applicable | ClinicalTrials.gov |
| Enrollment | 103 participants, estimated | ClinicalTrials.gov |
| Lead sponsor | General Hospital Groeninge | ClinicalTrials.gov |
| Conditions | Primary Liver Cancer, Liver Metastasis | ClinicalTrials.gov |
| Interventions | Multimodal Prehabilitation and Rehabilitation Program, Usual Care | ClinicalTrials.gov |
| First posted | 2026-11-10 | ClinicalTrials.gov |
| Last updated | 2026-11-10 | ClinicalTrials.gov |
Registered outcomes 28
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description | Source |
|---|---|---|---|---|
| Primary | Functional capacity measured by the 6-Minute Walk Test (6MWT) | 4 weeks after baseline, prior to surgery | Functional capacity will be assessed using the 6-Minute Walk Test (6MWT). The distance walked during 6 minutes will be recorded in meters. The 6MWT distance at the preoperative assessment will be compared between the multimodal prehabilitation group and the usual care group. | ClinicalTrials.gov |
| Secondary | Change in functional capacity measured by the 6-Minute Walk Test (6MWT) | From baseline to 4 weeks after baseline and 6 weeks after surgery | Change in distance walked during the 6-Minute Walk Test (6MWT), expressed in meters, will be assessed and compared between the intervention and usual care groups. | ClinicalTrials.gov |
| Secondary | Cardiorespiratory fitness measured by VO2max | Baseline, 4 weeks after baseline, and 6 weeks after surgery | Cardiorespiratory fitness will be assessed using cardiopulmonary exercise testing (CPET). Maximum oxygen uptake (VO2max) will be compared between the intervention and usual care groups. | ClinicalTrials.gov |
| Secondary | Handgrip strength | Baseline, 4 weeks after baseline, 2 weeks after surgery, and 6 weeks after surgery | Upper-body muscle strength will be assessed using a handgrip strength test and expressed in kilograms. Results will be compared between groups over time. | ClinicalTrials.gov |
| Secondary | Lower-extremity muscle strength measured by Biodex | Baseline, 4 weeks after baseline, 2 weeks after surgery, and 6 weeks after surgery | Lower-extremity muscle strength will be assessed using Biodex dynamometry and compared between the intervention and usual care groups over time. | ClinicalTrials.gov |
| Secondary | Single-leg calf raise performance | Baseline, 4 weeks after baseline, 2 weeks after surgery, and 6 weeks after surgery | Lower-extremity muscle performance will be assessed using the single-leg calf raise test and compared between groups over time. | ClinicalTrials.gov |
| Secondary | Sit-to-stand performance | Baseline, 4 weeks after baseline, 2 weeks after surgery, and 6 weeks after surgery | Functional lower-extremity performance will be assessed using the Sit-to-Stand Test. Participants are instructed to stand up and sit down 10 times as quickly as possible from a chair without using their hands. The outcome measure is the time required to complete 10 repetitions, expressed in seconds. Scores range from 0 seconds to no predefined maximum value. Lower completion times indicate better lower-extremity functional performance, whereas higher completion times indicate worse functional performance. | ClinicalTrials.gov |
| Secondary | Health-related quality of life measured by EORTC QLQ-C30 | Baseline, 4 weeks after baseline, 2 weeks after surgery, and 6 weeks after surgery | 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). Scores are linearly transformed to a 0-100 scale according to the EORTC scoring manual. For the Global Health Status/Quality of Life scale and functional scales, higher scores indicate better quality of life and functioning. For symptom scales and single-item symptom measures, higher scores indicate greater symptom burden and worse quality of life. | ClinicalTrials.gov |
| Secondary | Health-related quality of life measured by EQ-5D | Baseline, 4 weeks after baseline, 2 weeks after surgery, and 6 weeks after surgery | Health-related quality of life and general health status will be assessed using the EuroQol 5-Dimension Questionnaire (EQ-5D). The EQ-5D descriptive system generates an index score ranging from less than 0 (health states considered worse than death) to 1.0 (perfect health), with higher scores indicating better health-related quality of life. The EQ-5D also includes a Visual Analogue Scale (EQ VAS), ranging from 0 to 100, where higher scores indicate better perceived health status. | ClinicalTrials.gov |
| Secondary | Postoperative complications measured by the Comprehensive Complication Index (CCI) | within 90 days after surgery | Postoperative morbidity will be assessed using the Comprehensive Complication Index (CCI), which summarizes all postoperative complications weighted according to their severity. The CCI score ranges from 0 to 100, where 0 indicates no postoperative complications and 100 indicates death. Higher scores indicate a greater overall burden of postoperative complications and therefore a worse postoperative outcome. | ClinicalTrials.gov |
| Secondary | Length of hospital stay | From the date of surgery until hospital discharge, assessed up to 90 days after surgery | Length of postoperative hospital stay will be recorded as the number of days from the date of surgery until discharge from the hospital and compared between the intervention and usual care groups. | ClinicalTrials.gov |
| Secondary | Nutritional status measured by PG-SGA SF | Baseline, 4 weeks after baseline, 2 weeks after surgery, and 6 weeks after surgery | Nutritional status will be assessed using the Patient-Generated Subjective Global Assessment Short Form (PG-SGA SF). The total PG-SGA SF score ranges from 0 to 36, with higher scores indicating a greater risk of malnutrition and a worse nutritional status. Lower scores indicate a better nutritional status. | ClinicalTrials.gov |
| Secondary | Compliance with nutritional supplementation | From baseline until 6 weeks after surgery | Compliance with the prescribed nutritional supplementation will be assessed using the patient diary in participants allocated to the intervention group. | ClinicalTrials.gov |
| Secondary | Safety assessed by adverse events and serious adverse events | From baseline until 6 weeks after surgery | Safety will be assessed by recording the total number of adverse events (AEs) and serious adverse events (SAEs), as well as the proportion of participants experiencing an AE or SAE. | ClinicalTrials.gov |
| Secondary | Compliance with the exercise program | Throughout the prehabilitation and rehabilitation program, up to 6 weeks after surgery | Adherence to the exercise program will be assessed using the patient exercise diary and expressed as the percentage of prescribed exercise sessions completed. Perceived exertion during training will be assessed using the Borg Rating of Perceived Exertion Scale. The Borg Rating of Perceived Exertion Scale ranges from 6 to 20, with higher scores indicating greater perceived exercise intensity and exertion. | ClinicalTrials.gov |
| Secondary | Three-year disease-free survival | 3 years after surgery | Disease-free survival is defined as the time from surgery to the first occurrence of disease recurrence. Participants without recurrence will be censored at the time of last follow-up. | ClinicalTrials.gov |
| Secondary | Three-year overall survival | 3 years after surgery | Overall survival is defined as the time from surgery to death. Participants who are alive will be censored at the time of last follow-up. | ClinicalTrials.gov |
| Other | Health-economic impact of the multimodal program (sing EQ-5D utility scores and Quality-Adjusted Life Years (QALYs) | Through study completion, up to 6 weeks after surgery | An exploratory health-economic analysis will be performed using EQ-5D utility scores to estimate Quality-Adjusted Life Years (QALYs). The health-economic impact of the multimodal prehabilitation and rehabilitation program will be evaluated by comparing QALYs and healthcare resource utilization between the intervention and usual care groups. | ClinicalTrials.gov |
| Other | Patient perceptions of breathing exercises | At or after 6 weeks after surgery | Participants' perceptions and experiences regarding the breathing exercises using the Moonbird device will be explored through semi-structured interviews. Responses will undergo qualitative thematic analysis. This is a qualitative outcome measure and no numerical score will be calculated. | ClinicalTrials.gov |
| Other | C-Reactive Protein (CRP) | Baseline, 4 weeks after baseline, 2 weeks after surgery, and 6 weeks after surgery | Serum C-reactive protein (CRP) concentration (mg/L) will be measured and compared between groups. Higher values indicate a greater systemic inflammatory response. | ClinicalTrials.gov |
Outcomes 0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as | Source |
|---|
Results by group 0
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units | Source |
|---|
Participant flow 0
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted | Source |
|---|
Adverse events 0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events | Source |
|---|
Adverse event totals 0
The totals the trial posted for each group.
| Total | Group | Affected | At risk | Source |
|---|
Papers 0
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as | Source |
|---|
Grants 0
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.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years | Source |
|---|
Trial comparisons 0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|
Tests 0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as | Source |
|---|
Source 5
| Field | Value | Source |
|---|---|---|
| Release | trials-2026-11-12-0.4.0 | ClinicalTrials.gov |
| Release manifest SHA-256 | 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4 | ClinicalTrials.gov |
| Registry capture | 2026-11-12 | ClinicalTrials.gov |
| Results copy, AACT | 2026-03-23 | ClinicalTrials.gov |
| NIH clinical studies file | 2026-11-13 | ClinicalTrials.gov |
Release trials-2026-11-12-0.4.0
ClinicalTrials.gov's posted results, through CTTI's AACT: ClinicalTrials.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.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
ClinicalTrials.gov: none stated ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
NIH RePORTER's clinical studies and project files: Public domain (NIH RePORTER)