Breast Cancer FemaleNCT06531135
A RCT of Psychosocial Interventions Facilitating Positive Psychological Adaptation in Breast Cancer
A study testing T-CBSM and Support group in people with Breast Cancer Female, run by Koo Foundation Sun Yat-Sen Cancer Center at 1 site in Taiwan.
Trial 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… Read more about this study
- Who is it for?
- Ages 20 to 70 years, women only
- Conditions the study is for
- Breast Cancer Female
- What is being tested?
- T-CBSM and Support group
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteTaiwan
- Study dates
- 23 Nov 2021to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Major psychiatric disorders (such as schizophrenia), personality disorders, and substance addiction (excluding smoking)
- Currently participating in other breast cancer-related psychotherapy studies
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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.
- Conditions
- Breast Cancer Female
- Being tested
- T-CBSM, Support group
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
T-CBSMBehavioural
Also called stress management
A 10-week remotely-delivered group, lasting about 120 minutes each session.
Support groupBehavioural
Also called Supportive-Expressive Group
Participants will receive weekly supportive-expressive group intervention for two hours per week for five weeks total.
| Study group | Role | What they receive |
|---|---|---|
| stress management | Experimental | 10 weeks of group intervention of Taiwanese version stress management intervention. Receives: Behavioral: T-CBSM |
| Support group | Active comparator | 5 weeks of supportive group intervention. Receives: Behavioral: Support group |
What is being measured
The primary outcome is the main question the study is designed to answer.
posttraumatic growth by the PTGI
the PTGI a 21-item questionnaire each scored on a range of 0-5.
Measured: Baseline (T1), post-intervention (T2), 6 months post-intervention (T3)
Distress by the HADS
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.
Measured: Baseline (T1), post-intervention (T2), 6 months post-intervention (T3)
Secondary outcomes (3)
Positive and Negative affect
The Affect Balance Scale includes 20 adjectives assessing negative and positive mood. Possible scores range from 1-5.
Measured: Baseline (T1), post-intervention (T2), 6 months post-intervention (T3)
Perceived Stress Management Abilities
The Measure of Current Status questionnaire and self-designed items were used to measure abilities learned from the group interventions.
Measured: Baseline (T1), post-intervention (T2), 6 months post-intervention (T3)
Quality of Life by the SF-36
SF-36
Measured: Baseline (T1), post-intervention (T2), 6 months post-intervention (T3)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2024
- Study start23 Nov 2021
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast Cancer FemaleStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Koo Foundation Sun Yat-Sen Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- Soochow university taipei
- Responsible party
- Principal investigator, Chihtao Cheng, Koo Foundation Sun Yat-Sen Cancer Center
- Investigators
- Ashley Wei TIng Wang, Principal investigator, Soochow University ITaipei)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06531135
- Sponsor's protocol ID
- 20210628A
- Status last verified
- Jul 2024
- First submitted
- 28 Jul 2024
- Last updated
- 31 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial of Psychosocial Interventions Facilitating Positive Psychological Adaptation in Patients With Breast Cancer
- ClinicalTrials.gov ID
- NCT06531135
- Acronym / sponsor ID
- 20210628A
- Conditions
- Breast Cancer Female
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Koo Foundation Sun Yat-Sen Cancer CenterUniversity, hospital or other
- Collaborators
- Soochow university taipei
- Study start
- 23 Nov 2021 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 31 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| stress management | Experimental | Behavioral: T-CBSM10 weeks of group intervention of Taiwanese version stress management intervention. |
| Support group | Active comparator | Behavioral: Support group5 weeks of supportive group intervention. |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (2 listed)
- Major psychiatric disorders (such as schizophrenia), personality disorders, and substance addiction (excluding smoking)
- Currently participating in other breast cancer-related psychotherapy studies
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| T-CBSMAlso: stress managementA 10-week remotely-delivered group, lasting about 120 minutes each session. | Behavioural | stress management |
| Support groupAlso: Supportive-Expressive GroupParticipants will receive weekly supportive-expressive group intervention for two hours per week for five weeks total. | Behavioural | Support group |
Primary outcome
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.
3 secondary outcomes
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)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jul 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Ashley Wei TIng Wang principal investigator
Soochow University ITaipei)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing T-CBSM and Support group in people with Breast Cancer Female, run by Koo Foundation Sun Yat-Sen Cancer Center at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 31 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
posttraumatic growth by the PTGI (time frame: Baseline (T1), post-intervention (T2), 6 months post-intervention (T3)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jul 2024.