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Trial Title:
Dyadic Intervention for Psychological Distress of Patients With Colorectal Cancer and Their Spouses
NCT ID:
NCT06326437
Condition:
Colorectal Cancer
Conditions: Official terms:
Colorectal Neoplasms
Study type:
Interventional
Study phase:
N/A
Overall status:
Not yet recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Supportive Care
Masking:
Double (Investigator, Outcomes Assessor)
Intervention:
Intervention type:
Other
Intervention name:
6-week dyadic intervention
Description:
Comprising 1 session with 60-90min, followed by 5 weekly internet-based sessions.
Arm group label:
6-week dyadic intervention
Summary:
The overall aim of the study is to evaluate the preliminary effect and feasibility of a
dyadic intervention on mutuality, psychological strengths (i.e., illness cognition and
dyadic coping), psychological distress, and QoL outcomes of patients with colorectal
cancer and spouses. The colorectal cancer couples will be randomly allocated to the
intervention group to receive a 6-week dyadic intervention, or to the control group to
receive the usual care provided by the clinical team in the hospital.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
patients and spouses aged 18 years or older patients diagnosed with colorectal cancer
Patients scored ≥ 22 points on the Kessler Psychological Distress Scale assessment
patients and spouses able to read simplified Chinese
Exclusion Criteria:
psychiatric problems requiring active treatment other terminal illnesses, such as
advanced cancer currently undergoing psychotherapy or participating in similar trials
Gender:
All
Minimum age:
20 Years
Maximum age:
59 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
The Sixth Affiliated Hospital of Sun Yat-sen University
Address:
City:
Guangzhou
Zip:
510000
Country:
China
Contact:
Last name:
Qian Sun
Phone:
+86 15616167998
Email:
sunq68@mail2.sysu.edu.cn
Start date:
April 1, 2024
Completion date:
July 1, 2024
Lead sponsor:
Agency:
Sun Yat-sen University
Agency class:
Other
Source:
Sun Yat-sen University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06326437
