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

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

Status
Enrolling by invitation
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06531135
Enrollment
200
Registered
2024-07-31
Start date
2021-11-23
Completion date
2026-12-31
Last updated
2024-07-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Cancer Female

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.

Interventions

BEHAVIORALT-CBSM

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

BEHAVIORALSupport group

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

Sponsors

Soochow university taipei
CollaboratorUNKNOWN
Koo Foundation Sun Yat-Sen Cancer Center
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)

Eligibility

Sex/Gender
FEMALE
Age
20 Years to 70 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Distress by the HADSBaseline (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.
posttraumatic growth by the PTGIBaseline (T1), post-intervention (T2), 6 months post-intervention (T3)the PTGI a 21-item questionnaire each scored on a range of 0-5.

Secondary

MeasureTime frameDescription
Positive and Negative affectBaseline (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.
Perceived Stress Management AbilitiesBaseline (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.
Quality of Life by the SF-36Baseline (T1), post-intervention (T2), 6 months post-intervention (T3)SF-36

Countries

Taiwan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026