NCT05602051

Brief Summary

Through virtual reality technology and mindfulness therapy, we can intervene the patients with Hematologic Neoplasms during chemotherapy, hoping to improve their symptoms and self-efficacy.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
110

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Nov 2021

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2021

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

October 26, 2022

Completed
6 days until next milestone

First Posted

Study publicly available on registry

November 1, 2022

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2022

Completed
Last Updated

November 1, 2022

Status Verified

October 1, 2022

Enrollment Period

1.1 years

First QC Date

October 26, 2022

Last Update Submit

October 28, 2022

Conditions

Hematologic Neoplasms

Outcome Measures

Primary Outcomes (2)

  • MDASI-C

    Symptom burden was assessed using the Chinese version of the M. D. Anderson Symptom Inventory (MDASI-C),39 which is a self-report scale consisting of two domains. The first domain is named "core symptom severity items" and has 13 symptoms. Each symptom is rated on an 11-point scale (0-10) to indicate the presence and severity of the symptom, with 0 indicating "not present" and 10 indicating "as bad as you can imagine." Each symptom is rated based on the severity of the symptom, at its worst, in the last 24 h. The second domain is named "six symptoms interference items" and includes ratings of how much symptoms interfered with different aspects of the survivor's life in the last 24 h. The interference items are also rated on a scale of 0-10, with 0 indicating "did not interfere" and 10 indicating "interfered completely." A score of 0-3 indicated a mild level, 4-6 indicated a moderate level, and 7-10 indicated a severe level of symptom severity or interference.

    up to 7 weeks

  • Hospital Anxiety and Depression Scale (HADS)

    The hospital anxiety and depression scale The HADS was compiled by Zigmond AS Which was used to detect states of depression and anxiety in the setting of an hospital medical outpatient clinic . It is a 14-question instrument, with each question being scored between 0 (no impairment) and 3 (severe impairment), with a maximum score of 21 for anxiety or depression.

    up to 7 weeks

Secondary Outcomes (1)

  • the self-management efficacy scale (C-SUPPH)

    up to 7 weeks

Study Arms (2)

Virtual reality+Mindfulness

EXPERIMENTAL

Intervention method combining virtual reality technology and mindfulness therapy, twice a week, lasting for 7 weeks

Device: virtual reality device

Mindfulness

NO INTERVENTION

Intervention method of mindfulness therapy, twice a week, lasting for 7 weeks

Interventions

virtual reality deviceDEVICE

mindfulness combined with virtual reality

Also known as: Mindfulness
Virtual reality+Mindfulness

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Clinical diagnosis of Hematologic Neoplasms(leukemia, lymphoma or multiple myeloma) and receiving chemotherapy
  • Hospitalized for more than 4 weeks
  • Have normal communication ability, clear consciousness, and willing to participate in this study

You may not qualify if:

  • People are cognitive dysfunction and audio-visual dysfunction
  • Have mental problems or have reported mental disorders

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

the First Affiliated Hospital of Nanjing Medical University

Nanjing, Jiangsu, China

RECRUITING

MeSH Terms

Conditions

Hematologic Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsHematologic DiseasesHemic and Lymphatic Diseases

Study Officials

  • yuxi Zhang

    The First Affiliated Hospital with Nanjing Medical University

    STUDY DIRECTOR

Central Study Contacts

Yuan Wu

CONTACT

188956115171528046998@qq.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
master

Study Record Dates

First Submitted

October 26, 2022

First Posted

November 1, 2022

Study Start

November 1, 2021

Primary Completion

December 1, 2022

Study Completion

December 1, 2022

Last Updated

November 1, 2022

Record last verified: 2022-10

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)