A RCT of Psychosocial Interventions Facilitating Positive Psychological Adaptation in Breast Cancer

Koo Foundation Sun Yat-Sen Cancer Center

Status: Invitation-only

Conditions: Breast Cancer Female

Treatments: Behavioral: T-CBSM; Behavioral: Support group

Study type: Interventional

Funder types: Other

Identifiers

NCT06531135

20210628A

Details and patient eligibility

About

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.

Enrollment: 200 estimated patients

Sex: Female

Ages: 20 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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200 participants in 2 patient groups

stress management

Experimental group

Description:

10 weeks of group intervention of Taiwanese version stress management intervention.

Treatment:

Behavioral: T-CBSM

Support group

Active Comparator group

Description:

5 weeks of supportive group intervention.

Treatment:

Behavioral: Support group