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

July 28, 2024 updated by: Chihtao Cheng, Koo Foundation Sun Yat-Sen Cancer Center

A Randomized Controlled Trial of Psychosocial Interventions Facilitating Positive Psychological Adaptation in Patients With Breast Cancer

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.

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

200

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Taiwan
      • Taipei City, Taiwan, 11259
        • Koo Foundation Sun Yat-Sen Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: stress management
10 weeks of group intervention of Taiwanese version stress management intervention.
Behavioral: T-CBSM
A 10-week remotely-delivered group, lasting about 120 minutes each session.
Other Names:
  • stress management
Active Comparator: Support group
5 weeks of supportive group intervention.
Behavioral: Support group
Participants will receive weekly supportive-expressive group intervention for two hours per week for five weeks total.
Other Names:
  • Supportive-Expressive Group

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
posttraumatic growth by the PTGI
Time Frame: Baseline (T1), post-intervention (T2), 6 months post-intervention (T3)
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
Time Frame: 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.
Baseline (T1), post-intervention (T2), 6 months post-intervention (T3)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Positive and Negative affect
Time Frame: 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.
Baseline (T1), post-intervention (T2), 6 months post-intervention (T3)
Perceived Stress Management Abilities
Time Frame: 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.
Baseline (T1), post-intervention (T2), 6 months post-intervention (T3)
Quality of Life by the SF-36
Time Frame: Baseline (T1), post-intervention (T2), 6 months post-intervention (T3)
SF-36
Baseline (T1), post-intervention (T2), 6 months post-intervention (T3)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Koo Foundation Sun Yat-Sen Cancer Center

Collaborators

Soochow university taipei

Investigators

  • Principal Investigator: Ashley Wei TIng Wang, Soochow University ITaipei)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 23, 2021

Primary Completion (Estimated)

December 31, 2025

Study Completion (Estimated)

December 31, 2026

Study Registration Dates

First Submitted

July 28, 2024

First Submitted That Met QC Criteria

July 28, 2024

First Posted (Actual)

July 31, 2024

Study Record Updates

Last Update Posted (Actual)

July 31, 2024

Last Update Submitted That Met QC Criteria

July 28, 2024

Last Verified

July 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20210628A

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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