A Randomized Controlled Trial of Psychosocial Interventions Facilitating Positive Psychological Adaptation in Patients With Breast Cancer
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Breast Cancer Female
- Sponsor
- Koo Foundation Sun Yat-Sen Cancer Center
- Enrollment
- 200
- Locations
- 1
- Primary Endpoint
- posttraumatic growth by the PTGI
- Status
- Enrolling By Invitation
- Last Updated
- last year
Overview
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.
Investigators
Chihtao Cheng
Director, Psychiatric department, KFSYSCC, Taiwan
Koo Foundation Sun Yat-Sen Cancer Center
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
Outcomes
Primary Outcomes
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.
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
- Perceived Stress Management Abilities(Baseline (T1), post-intervention (T2), 6 months post-intervention (T3))
- Quality of Life by the SF-36(Baseline (T1), post-intervention (T2), 6 months post-intervention (T3))
- Positive and Negative affect(Baseline (T1), post-intervention (T2), 6 months post-intervention (T3))