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| Name | Class |
|---|---|
| China International Medical Foundation | OTHER |
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To evaluate the intervention effect of triple pre-rehabilitation on head and neck cancer patients with radiotherapy, and process evaluation to further optimize the intervention program.
The pre-rehabilitation intervention was develped previously based on the process of evidence-based-nursing, including interventions of nurtrtion, exercise, and psychology.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pre Group | Experimental | intervention before and during radiotherapy |
|
| Re Group | Other | intervention during radiotherapy only |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| triple pre-rehabilitation | Other | The triple intervention consisted of exercise, nutrition and psychology. Based on the intervention framework, face-to-face intervention adjustment and intensive intervention measures were carried out from the time of enrollment (T0). Combined with weekly telephone follow-up during the intervention, the intervention content formulated face-to-face last time was reviewed, reinforcement behaviors were performed, and questions were answered during the intervention. |
| Measure | Description | Time Frame |
|---|---|---|
| Critical weight loss | Weight loss over 5% during radiotherapy | About 6 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of adverse reactions of radiotherapy assessed by CTCAE v5.0 | Adverse reactions of radiotherapy | About 6 weeks |
| Physical performance | Physical performance measured by the 4-Meter Walk Test |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Qian Lu, Professor | School of Nursing Peking University | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tianjin medical university cancer institute and hospital | Tianjin | China |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| ICF | No | No | Yes | Informed Consent Form | Oct 20, 2022 | Oct 20, 2022 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D006258 | Head and Neck Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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|
| triple rehabilitation | Other | The triple intervention consisted of exercise, nutrition and psychology. Based on the intervention framework, face-to-face intervention adjustment and intensive intervention measures were carried out at the time of the beginning of radiotherapy (T1), and the middle stage of radiotherapy (T2). Combined with weekly telephone follow-up during the intervention, the intervention content formulated face-to-face last time was reviewed, reinforcement behaviors were performed, and questions were answered during the intervention. |
|
| About 6 weeks |
| Physical performance | Physical performance measured by 30-Second Chair Stand Test (30-SCST) | About 6 weeks |
| Physical performance | Physical performance measured by hand grip strength | About 6 weeks |
| Body composition measured by Bioelectrical Impedance Analysis (BIA) | Body composition measured by Bioelectrical Impedance Analysis (BIA) | About 6 weeks |
| Quality of life of patients assessed by QLQ-C30 | Quality of life of patients assessed by QLQ-C30 | About 6 weeks |
| Intake assessed by a simple diet self-assessment tool (SDSAT) | Intake assessed by a simple diet self-assessment tool (SDSAT) | About 6 weeks |
| Psychological status assessed by hospital anxiety and depression scale (HADS) | Psychological status assessed by hospital anxiety and depression scale (HADS) | About 6 weeks |
| Number of participants with intervention-related adverse events | Number of participants with intervention-related adverse events | About 6 weeks |
| Patients in the intervention group were interviewed about the compliance of the study | Patients in the intervention group were interviewed about the compliance of the study | About 6 weeks |
| Patients in the intervention group were interviewed about the experience of the study | Patients in the intervention group were interviewed about the experience of the study | About 6 weeks |