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Trial Title:
A RCT of Psychosocial Interventions Facilitating Positive Psychological Adaptation in Breast Cancer
NCT ID:
NCT06531135
Condition:
Breast Cancer Female
Conditions: Official terms:
Breast Neoplasms
Study type:
Interventional
Study phase:
N/A
Overall status:
Enrolling by invitation
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
Triple (Participant, Care Provider, Outcomes Assessor)
Intervention:
Intervention type:
Behavioral
Intervention name:
T-CBSM
Description:
A 10-week remotely-delivered group, lasting about 120 minutes each session.
Arm group label:
stress management
Other name:
stress management
Intervention type:
Behavioral
Intervention name:
Support group
Description:
Participants will receive weekly supportive-expressive group intervention for two hours
per week for five weeks total.
Arm group label:
Support group
Other name:
Supportive-Expressive Group
Summary:
To test the effects of a 10-wk stress management interventions vs. a 5-wk control
condition on positive psychosocial adaptation in women being treated for breast cancer.
Participants assigned to either of the stress management groups will show better positive
psychosocial adaptation compared to those in the control group.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- Aged between 20 and 70 years
- Newly diagnosed breast cancer patients in stages I, II, or III (with no prior
history of cancer)
- Literate, without significant cognitive impairments
- Capable of writing and expressing themselves in Chinese
Exclusion Criteria:
- Major psychiatric disorders (such as schizophrenia), personality disorders, and
substance addiction (excluding smoking)
- Currently participating in other breast cancer-related psychotherapy studies
Gender:
Female
Minimum age:
20 Years
Maximum age:
70 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Koo Foundation Sun Yat-Sen Cancer Center
Address:
City:
Taipei City
Zip:
11259
Country:
Taiwan
Start date:
November 23, 2021
Completion date:
December 31, 2026
Lead sponsor:
Agency:
Koo Foundation Sun Yat-Sen Cancer Center
Agency class:
Other
Collaborator:
Agency:
Soochow university taipei
Agency class:
Other
Source:
Koo Foundation Sun Yat-Sen Cancer Center
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06531135
