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

NCT ID: NCT06531135

Last Updated: 2024-07-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ENROLLING_BY_INVITATION

Clinical Phase

NA

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-11-23

Study Completion Date

2026-12-31

Brief Summary

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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

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Conditions

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Breast Cancer Female

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors

Study Groups

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stress management

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

Group Type EXPERIMENTAL

T-CBSM

Intervention Type BEHAVIORAL

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

Support group

5 weeks of supportive group intervention.

Group Type ACTIVE_COMPARATOR

Support group

Intervention Type BEHAVIORAL

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

Interventions

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T-CBSM

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

Intervention Type BEHAVIORAL

Support group

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

Intervention Type BEHAVIORAL

Other Intervention Names

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stress management Supportive-Expressive Group

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

70 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Soochow university taipei

UNKNOWN

Sponsor Role collaborator

Koo Foundation Sun Yat-Sen Cancer Center

OTHER

Sponsor Role lead

Responsible Party

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Chihtao Cheng

Director, Psychiatric department, KFSYSCC, Taiwan

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ashley Wei TIng Wang

Role: PRINCIPAL_INVESTIGATOR

Soochow University ITaipei)

Locations

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Koo Foundation Sun Yat-Sen Cancer Center

Taipei, , Taiwan

Site Status

Countries

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Taiwan

Other Identifiers

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20210628A

Identifier Type: -

Identifier Source: org_study_id