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

NCT06531135 | Enrolling By Invitation

• 1 other identifier: 20210628A
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Cancer Female

Outcome Measures

Primary Outcomes (2)

• posttraumatic growth by the PTGI

  the PTGI a 21-item questionnaire each scored on a range of 0-5.

  Baseline (T1), post-intervention (T2), 6 months post-intervention (T3)

• Distress by the HADS

  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.

  Baseline (T1), post-intervention (T2), 6 months post-intervention (T3)

Secondary Outcomes (3)

• Positive and Negative affect

  Baseline (T1), post-intervention (T2), 6 months post-intervention (T3)

• Perceived Stress Management Abilities

  Baseline (T1), post-intervention (T2), 6 months post-intervention (T3)

• Quality of Life by the SF-36

  Baseline (T1), post-intervention (T2), 6 months post-intervention (T3)

Study Arms (2)

stress management

EXPERIMENTAL

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

Behavioral: T-CBSM

Support group

ACTIVE COMPARATOR

5 weeks of supportive group intervention.

Behavioral: Support group

Interventions

T-CBSM BEHAVIORAL

A 10-week remotely-delivered group, lasting about 120 minutes each session.

Also known as: stress management

stress management

Support group BEHAVIORAL

Participants will receive weekly supportive-expressive group intervention for two hours per week for five weeks total.

Also known as: Supportive-Expressive Group

Support group

Eligibility Criteria

• Age: 20 Years - 70 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Major psychiatric disorders (such as schizophrenia), personality disorders, and substance addiction (excluding smoking)
• Currently participating in other breast cancer-related psychotherapy studies

Sponsors & Collaborators

• Koo Foundation Sun Yat-Sen Cancer Center: lead
• Soochow university taipei: collaborator

Study Sites (1)

Koo Foundation Sun Yat-Sen Cancer Center

Taipei, 11259, Taiwan

Location

MeSH Terms

Interventions

Self-Help Groups

Intervention Hierarchy (Ancestors)

Organizations; Health Care Economics and Organizations

Study Officials

• Ashley Wei TIng Wang

  Soochow University ITaipei)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Psychiatric department, KFSYSCC, Taiwan

Study Record Dates

• First Submitted: July 28, 2024
• First Posted: July 31, 2024
• Study Start: November 23, 2021
• Primary Completion: December 31, 2025
• Study Completion (Estimated): December 31, 2026
• Last Updated: July 31, 2024

Record last verified: 2024-07

Locations

TW (1)