NCT05845294

Brief Summary

The study explored the effects of short-term structured psychological care on the level of postoperative psychological resilience, stigma, anxiety and depression in patients with colorectal cancer colostomy.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
70

participants targeted

Target at P25-P50 for not_applicable colorectal-cancer

Timeline
Completed

Started Aug 2019

Geographic Reach
1 country

1 active site

Status
completed

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

August 1, 2019

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2020

Completed
2.4 years until next milestone

First Submitted

Initial submission to the registry

April 13, 2023

Completed
23 days until next milestone

First Posted

Study publicly available on registry

May 6, 2023

Completed
Last Updated

May 6, 2023

Status Verified

April 1, 2023

Enrollment Period

1.3 years

First QC Date

April 13, 2023

Last Update Submit

April 25, 2023

Conditions

Colorectal Cancer

Outcome Measures

Primary Outcomes (3)

  • Anxiety of patients was assessed by Chinese version of the Mental Toughness Scale

    Anxiety of patients was assessed by Chinese version of the Mental Toughness Scale

    1 month

  • Anxiety of patients was assessed by the Social Impact Scale

    Anxiety of patients was assessed by the Social Impact Scale

    1 month

  • Anxiety of patients was assessed by Hospital Anxiety and Depression Scale

    Anxiety of patients was assessed by Hospital Anxiety and Depression Scale

    1 month

Study Arms (2)

Control group

ACTIVE COMPARATOR
Procedure: Routine Care

Experimental group

EXPERIMENTAL
Procedure: Short-term structured psychological Care

Interventions

Routine CarePROCEDURE

Routine care for patients undergoing colorectal cancer stoma

Control group
Short-term structured psychological CarePROCEDURE

Short-term structured psychological care for colorectal cancer stoma patients based on conventional care

Experimental group

Eligibility Criteria

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

You may qualify if:

  • voluntary participation in the study and ability to cooperate with treatment and care;
  • patients who were to undergo enterostomy;
  • age ≥18 years;
  • consciousness (being able to complete the questionnaire alone or able to answer the questions correctly);
  • social impact scale (SIS) score ≥24.

You may not qualify if:

  • Critically ill and unable to cooperate with the study;
  • Impaired cognitive function that affects communication;
  • Patients with other organic diseases in combination.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Zunyi Medical College

Zunyi, Guizhou, 563000, China

Location

MeSH Terms

Conditions

Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Intestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Study Director

Study Record Dates

First Submitted

April 13, 2023

First Posted

May 6, 2023

Study Start

August 1, 2019

Primary Completion

December 1, 2020

Study Completion

December 1, 2020

Last Updated

May 6, 2023

Record last verified: 2023-04

Locations

CN(1)