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Enrolling by invitation NCT06531135

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

No phase Interventional Breast Cancer Female

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: T-CBSM, Support group.
Who it may be relevant to
Registry conditions: Breast Cancer Female. Basic parameters: 20 years — 70 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Taiwan
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Interventions

  • Behavioral T-CBSM
    A 10-week remotely-delivered group, lasting about 120 minutes each session.
  • Behavioral Support group
    Participants will receive weekly supportive-expressive group intervention for two hours per week for five weeks total.

Primary outcome measures

  • posttraumatic growth by the PTGI [Time frame: 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)]
Secondary outcome measures (3)
  • Positive and Negative affect [Time frame: 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)]
  • Quality of Life by the SF-36 [Time frame: Baseline (T1), post-intervention (T2), 6 months post-intervention (T3)]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Triple blind
Primary purpose
Treatment

Study locations

Taiwan · 1 center
  • Koo Foundation Sun Yat-Sen Cancer Center — Taipei

Identifiers

NCT: NCT06531135 · 20210628A

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗