Effect of Triple Pre-rehabilitation on Radiotherapy for Head and Neck Cancer Patients

Sponsor
Peking University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05594069
Collaborator
China International Medical Foundation (Other)
80
2
13

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Other: triple pre-rehabilitation
  • Other: triple rehabilitation
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
80 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Supportive Care
Official Title:
Effect of Triple Pre-rehabilitation on Radiotherapy for Head and Neck Cancer Patients: a Randomized Controlled Trial
Anticipated Study Start Date :
Nov 1, 2022
Anticipated Primary Completion Date :
Aug 1, 2023
Anticipated Study Completion Date :
Dec 1, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: Pre Group

intervention before and during radiotherapy

Other: triple pre-rehabilitation
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.

Other: triple rehabilitation
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.

Other: Re Group

intervention during radiotherapy only

Other: triple rehabilitation
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.

Outcome Measures

Primary Outcome Measures

  1. Critical weight loss [About 6 weeks]

    Weight loss over 5% during radiotherapy

Secondary Outcome Measures

  1. Rate of adverse reactions of radiotherapy assessed by CTCAE v5.0 [About 6 weeks]

    Adverse reactions of radiotherapy

  2. Physical performance [About 6 weeks]

    Physical performance measured by the 4-Meter Walk Test

  3. Physical performance [About 6 weeks]

    Physical performance measured by 30-Second Chair Stand Test (30-SCST)

  4. Physical performance [About 6 weeks]

    Physical performance measured by hand grip strength

  5. Body composition measured by Bioelectrical Impedance Analysis (BIA) [About 6 weeks]

    Body composition measured by Bioelectrical Impedance Analysis (BIA)

  6. Quality of life of patients assessed by QLQ-C30 [About 6 weeks]

    Quality of life of patients assessed by QLQ-C30

  7. Intake assessed by a simple diet self-assessment tool (SDSAT) [About 6 weeks]

    Intake assessed by a simple diet self-assessment tool (SDSAT)

  8. Psychological status assessed by hospital anxiety and depression scale (HADS) [About 6 weeks]

    Psychological status assessed by hospital anxiety and depression scale (HADS)

  9. Number of participants with intervention-related adverse events [About 6 weeks]

    Number of participants with intervention-related adverse events

  10. 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 compliance of the study

  11. Patients in the intervention group were interviewed about the experience of the study [About 6 weeks]

    Patients in the intervention group were interviewed about the experience of the study

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 75 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • 18≤ age < 75 years old

  • The pathological diagnosis of HNC included nasopharyngeal cancer, oral cancer, oropharyngeal cancer, hypopharyngeal cancer, laryngeal cancer, salivary gland cancer;

  • Plan to receive radiotherapy

  • Basic communication skills

  • Volunteer to participate in this study.

Exclusion Criteria:
  • Combined with other malignant tumors

  • Distant metastasis

  • Inability to measure body composition, such as metal in the body or inability to stand alone

  • With contraindications to exercise (such as cardiovascular and cerebrovascular diseases, respiratory diseases, etc)

  • Complicated with severe liver and kidney function damage

  • Previous diagnosis of other cancers

  • pregnant or lactation women.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Peking University
  • China International Medical Foundation

Investigators

  • Study Chair: Qian Lu, Professor, School of Nursing Peking University

Study Documents (Full-Text)

More Information

Publications

None provided.
Responsible Party:
luqian@bjmu.edu.cn, professor, Peking University
ClinicalTrials.gov Identifier:
NCT05594069
Other Study ID Numbers:
  • Pre-rehabilitation
First Posted:
Oct 26, 2022
Last Update Posted:
Oct 26, 2022
Last Verified:
Oct 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Oct 26, 2022