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Enrolling by Invitation

NCT Number: NCT06531135

A RCT of Psychosocial Interventions Facilitating Positive Psychological Adaptation in 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.

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Key information

Conditions

Breast Cancer Female

Age range

20 year–70 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Koo Foundation Sun Yat-Sen Cancer Center

Taipei, 11259, Taiwan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

T-CBSM

Behavioral

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

Other names: stress management

Support group

Behavioral

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

Other names: Supportive-Expressive Group

Primary outcomes

  1. 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.

  2. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. Quality of Life by the SF-36

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

    SF-36

Sponsors and collaborators

Lead sponsor

Koo Foundation Sun Yat-Sen Cancer Center

Other

Collaborators

  • Soochow university taipei

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2025
Study completion
2026
First posted
Jul 31, 2024
Registry last updated
Jul 31, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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