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OpenTrials
Recruiting

NCT Number: NCT06230445

Effects of Digital Therapeutic in Whole Process Management of Lung Cancer

This trial will randomize patients into two groups, the treatment group will use the digital therapeutic application named 'UHealth' for the whole process management and the control group will use regular follow-up. The trial aims to look into the difference between quality of life, anxiety/depression index, emergency treatment times, hospital admission rate, treatment compliance, OS, DFS and follow-up cost.

Recruiting

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Key information

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, 510060, China

Location status: Recruiting

Location contact

Hao Long, MD

CONTACT

[email protected]

+86-13802770989

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients with histologically or cytologically confirmed lung cancer;
  • Patients have received surgery, neoadjuvant therapy, adjuvant therapy, radiotherapy or other chemotherapy, such as cytotoxic chemotherapy, targeted therapy and immunotherapy;
  • ECOG (Performance status) 0-1;
  • Patients aged > 18 years and < 70 years;
  • The patients themselves or their family members are familiar with mobile and internet;

Exclusion criteria

  • Patients have disease progression in the screening period;
  • Patients with symptomatic brain metastasis;
  • Patients with dementia, schizophrenia or other psychological diseases that may affect the cognitive behavior;
  • Other medical, mental or psychological condition which in the opinion of the investigator would not permit the patient to complete the study or understand the patient information;
  • Women who are pregnant or in the period of breastfeeding.

Treatment and study plan

UHealth digital therapeutic

Other

UHealth digital therapeutic is an application that patients can report their symptoms. If the contents that patients fill in reach the threshold, UHealth application will automatic report to doctor and the doctor will give medical advisement through UHealth digital therapeutic application.

Primary outcomes

  1. The quality of life after 6 months follow-up

    Time frame: From enrollment to 6 months after follow-up

    The evaluation of quality of life is based on FACT questionnaire (Version 4.0)

Secondary outcomes

  1. The score of anxiety/depression after 6 months follow-up

    Time frame: From enrollment to 6 months after follow-up

    The evaluation of anxiety/depression is based on HADS questionnaire

  2. The physical fitness score at the time of tumor progression

    Time frame: From enrollment to the time of tumor progression (up to 72 months)

    The physical fitness score at the time of tumor progression

  3. The frequency of emergency treatment

    Time frame: 24 months after enrollment

    The frequency of emergency treatment

  4. The frequency of rehospitalization

    Time frame: 24 months after enrollment

    The frequency of rehospitalization

  5. The compliance of follow-up

    Time frame: 24 months after enrollment

    The evaluation of follow-up compliance is based on the frequency of drop out

  6. Disease-free survival

    Time frame: 24 months after enrollment

  7. Overall survival

    Time frame: 24 months after enrollment

Study contacts

Contact information is provided by the study sponsor or research team.

Hao Long, MD

CONTACT

[email protected]

+86-13802770989

Sponsors and collaborators

Lead sponsor

Sun Yat-sen University

Other

Registry information

Official study title

A Phase 3, Randomized, Open-label Trial of Digital Therapeutic vs Regular Follow-up in Whole Process Management of Lung Cancer

Important dates

Study start
2023
Primary completion
2026
Study completion
2028
First posted
Jan 30, 2024
Registry last updated
Feb 26, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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