A Study of the Effect of Short-term Structured Psychological Care in Patients

A Study of the Effect of Short-term Structured Psychological Care on the Level of Postoperative Stigma in Patients With Colorectal Cancer

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.

Study Overview

• Status: Completed
• Conditions: Colorectal Cancer
• Intervention / Treatment: Procedure: Routine Care; Procedure: Short-term structured psychological Care

• Study Type: Interventional
• Enrollment (Actual): 70
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Guizhou
    • Zunyi, Guizhou, China, 563000
      • Zunyi Medical College

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Control group	Procedure: Routine Care; Routine care for patients undergoing colorectal cancer stoma
Experimental: Experimental group	Procedure: Short-term structured psychological Care; Short-term structured psychological care for colorectal cancer stoma patients based on conventional care

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Zunyi Medical College

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2019
• Primary Completion (Actual): December 1, 2020
• Study Completion (Actual): December 1, 2020

Study Registration Dates

• First Submitted: April 13, 2023
• First Submitted That Met QC Criteria: April 25, 2023
• First Posted (Estimate): May 5, 2023

Study Record Updates

• Last Update Posted (Estimate): May 5, 2023
• Last Update Submitted That Met QC Criteria: April 25, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colorectal Neoplasms
• Other Study ID Numbers: Zunyi002

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No