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

Not Applicable

• Conditions: Breast Cancer Female
• Interventions: Behavioral: T-CBSM; Behavioral: Support group

• Registration Number: NCT06531135
• Lead Sponsor: Koo Foundation Sun Yat-Sen Cancer Center

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-11-23
• Status Verified: 2024-07
• Study First Submitted: 2024-07-28
• Study First Submitted QC: 2024-07-28
• Last Update Submitted: 2024-07-28
• Study First Posted: 2024-07-31
• Last Update Posted: 2024-07-31
• Primary Completion: 2025-12-31
• Study Completion: 2026-12-31

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: Female
• Target Recruitment: 200

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
stress management	T-CBSM	10 weeks of group intervention of Taiwanese version stress management intervention.
Support group	Support group	5 weeks of supportive group intervention.

Primary Outcome Measures

Name	Time	Method
posttraumatic growth by the PTGI	Baseline (T1), post-intervention (T2), 6 months post-intervention (T3)	the PTGI a 21-item questionnaire each scored on a range of 0-5.
Distress by the HADS	Baseline (T1), post-intervention (T2), 6 months post-intervention (T3)	The HADS is a 14-item scale, with seven items relating to anxiety and seven relating to depression. Each item on the questionnaire is scored from 0-3 and this means that a person can score between 0 and 21 for either anxiety or depression.

Secondary Outcome Measures

Name	Time	Method
Perceived Stress Management Abilities	Baseline (T1), post-intervention (T2), 6 months post-intervention (T3)	The Measure of Current Status questionnaire and self-designed items were used to measure abilities learned from the group interventions.
Quality of Life by the SF-36	Baseline (T1), post-intervention (T2), 6 months post-intervention (T3)	SF-36
Positive and Negative affect	Baseline (T1), post-intervention (T2), 6 months post-intervention (T3)	The Affect Balance Scale includes 20 adjectives assessing negative and positive mood. Possible scores range from 1-5.

Trial Locations

Locations (1)

Koo Foundation Sun Yat-Sen Cancer Center; 🇨🇳 Taipei City, Taiwan