Breast CancerNCT01256008

Intervention Study of Depression in Breast Cancer Patients

A study testing CBT and Clinical Management in people with Breast Cancer and Depression, run by Wenzhou Medical University at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The purpose of this study is to evaluate the efficacy of cognitive-behavioral therapy on depression and anxiety in breast cancer patients. Read more about this study

Who is it for?: Ages 20 to 65 years, women only
Conditions the study is for: Breast Cancer, Depression, Anxiety
What is being tested?: CBT and Clinical Management
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 392 participants
Where: 1 siteChina
Study dates: Dec 2010to Feb 2013
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 65 years
Women only
No healthy volunteers
Adult, Older adult

Who may be able to join

Age: 20-65 years;
Pathologically diagnosed breast cancer patients, with the diagnosis from at least 2 comprehensive clinical attending physicians, in line with clinical diagnosis of breast cancer;
A week after breast cancer surgery;
With complaints and symptoms of depression or anxiety
HAMD-17 ≥ 8 points or / and HAMA ≥ 8 points;
Have some reading comprehension skills (could complete the self-rating scale independently or with others' help);
Informed consent

Who cannot join

Previous diagnosis of mental disorder or Bipolar Disorder; alcohol and drug abusing history;
Use antidepressants, antipsychotics or accept any form of psychological treatment, or participation in other clinical trials in the last month
Patients with cardiovascular disease, liver and kidney dysfunction and other serious diseases;
Hearing, visual or understanding impairment;
Severe depression, suicidal tendencies;
Can not or will not comply with clinical treatment programs based on the physicians' judgment

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Exit criteria:
Persons with poor compliance during the trial period;
Persons whose depression increased during the trial period, has serious suicidal tendencies and requires urgent intervention;
Persons who are believed have other circumstances and should be suspended by Physicians

Trial locations and contacts

1 site in 1 country.

China1 site

Wenzhou Medical University
Wenzhou, Zhejiang, 325000

Other trials in China

About this study

Official title: Early Identification and Early Warning of Psychological Problems in Breast Cancer Patients, and Intervention Study Using Cognitive Behavioral Therapy on Depression in Breast Cancer Patients

The purpose of this study is to evaluate the efficacy of cognitive-behavioral therapy on depression and anxiety in breast cancer patients.

Read the detailed description

Comprehensive intervention on depression and anxiety in breast cancer patients is a 24-week, multicenter, randomized, blinded controlled clinical study, which uses cognitive-behavioral therapy. This study tries to evaluate the efficacy of sequential therapy on breast cancer patients' depression and its improvement on breast cancer patients' life quality, pain and sleeping.

Conditions: Breast Cancer, Depression, Anxiety
Being tested: CBT, Clinical Management
Keywords: Breast Cancer, Depression, Anxiety, Cognitive-Behavioral Therapy
Medical subject headings: Breast Neoplasms, Depression, Anxiety Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

CBTBehavioural
Also called cognitive-behavioral intervention, psychological intervention
The subjects will receive standardized CBT treatment regularly for 9 sessions(once per week in the first month and once half a month in the second and third months), and each session will last for about 60 minutes.The treatment includes three steps:Concept stage (the first and second sessions): establishment of therapeutic relationships with the subjects; Skills acquisition and repeat stage (the third session to the 8th session): clarification of sources of stress, patients' cognitive and behavioral response to stress. Application and complete price segment (the 9th session): return visit to test efficacy of psychological intervention.
Clinical ManagementBehavioural
Also called Placebo of Cognitive-Behavioral therapy
Clinical management is a clear contrast method of psychological therapy, which is a half-structured interview and lasting for 20-25 minutes each session. Clinical management will be assigned to both experimental group and controlled group in the first stage of intervention.
Following are major elements:
Talk to the subjects to find their main problems; introduce knowledge and medication knowledge about cancer and depression; subjects reporting use of drugs for cancer and depression and a variety of signs and symptoms of the reaction. Encourage patients to adhere to drug treatment and to comply with this research program; The operation of CBT and clinical management should be conducted by the same person as far as possible.

Study groups in NCT01256008
Study group	Role	What they receive
stage 1 Clinical Management	Placebo comparator	The group will receive clinical management treatment only each session. Receives: Behavioral: Clinical Management
stage1 CBT	Experimental	The experimental group will receive CBT Receives: Behavioral: CBT
stage1 Control group	No intervention	Participants with breast cancer in the control group received standard medical care, but don't receive any other interventions.

What is being measured

The primary outcome is the main question the study is designed to answer.

Hamilton Depression Rating Scale (HAMD-17)
1. The scale(HAMD-17) is used to assessed the depression symptoms of patients.
2. The scale range is 0-53.Higher value represents a worse outcome.
3. The scale was assessed at baseline,2 week,4 week,8 week,12 week,16 week,24 week
Measured: baseline,2 w,4 w,8 w,12 w,16 w,24 w
Hamilton Anxiety Scale (HAMA-14)
1. The scale(HAMA-14) is used to assessed the anxiety symptoms of patients.
2. The scale range is 0-56.Higher value represents a worse outcome.
3. The scale was assessed at baseline,2 week,4 week,8 week,12 week,16 week,24 week.
Measured: baseline,2 w,4 w,8 w,12 w,16 w,24 w

Secondary outcomes (3)

Visual Analogue Scale (VAS)
1. The scale is used to assess the pain intensity of patients.
2. The scale range of VAS is 0-10. Higher score indicates a higher intensity of pain.
3. The scale was assessed at baseline,4 week,8 week,12 week,24 week
Measured: baseline,4 w,8 w,12 w,24 w
Athens Insomnia Scale(AIS)
1. The scale is used to assess the sleep quality of patients.
2. The scale range of AIS is 0-21. Higher score indicates worse sleep quality.
3. The scale was assessed at baseline,4 week,8 week,12 week,24 week
Measured: baseline, 4w,8w,12w,24w
Functional Assessment of Cancer Treatment (FACT-B)
1. The scale is used to assess the life quality of patients.
2. The scale includes 5 subscales. The scores of each scale are summed to compute a total score.
3. The scale range is 0-144. Higher score indicates better life quality.
4. The scale was assessed at baseline,4 week,12 week,24 week.
Measured: baseline, 4w,12w,24w

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Dec 2010Feb 2013

First posted8 Dec 2010 (estimated)
Study startDec 2010
Primary completionDec 2012
Study completionFeb 2013

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Breast CancerStudies 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: Single blind
Who is masked: Participant
Enrolment: 392 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01256008
Sponsor's protocol ID: 2009BAI77B06-3
Status last verified: Apr 2015
First submitted: 6 Dec 2010
Last updated: 1 May 2015
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 1 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Early Identification and Early Warning of Psychological Problems in Breast Cancer Patients, and Intervention Study Using Cognitive Behavioral Therapy on Depression in Breast Cancer Patients
ClinicalTrials.gov ID: NCT01256008
Acronym / sponsor ID: 2009BAI77B06-3
Conditions: Breast Cancer, Depression, Anxiety
Keywords: Breast Cancer, Depression, Anxiety, Cognitive-Behavioral Therapy
Study type: Interventional
Recruitment status: Completed
Enrolment: 392 participants (actual)
Lead sponsor: Wenzhou Medical UniversityUniversity, hospital or other
Collaborators: Anhui Medical University, Central South University, Harbin Medical University, Second Affiliated Hospital, Zhejiang University, School of Medicine, Wuhan University
Study start: Dec 2010
Primary completion: Dec 2012 (actual)
Study completion: Feb 2013 (actual)
First posted: 8 Dec 2010 (estimated)
Results: Posted 10 Apr 2015

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

The purpose of this study is to evaluate the efficacy of cognitive-behavioral therapy on depression and anxiety in breast cancer patients.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (participant)
Number of arms: 3

Arm	Type	Receives
stage 1 Clinical Management	Placebo comparator	Behavioral: Clinical ManagementThe group will receive clinical management treatment only each session.
stage1 CBT	Experimental	Behavioral: CBTThe experimental group will receive CBT
stage1 Control group	No intervention	–Participants with breast cancer in the control group received standard medical care, but don't receive any other interventions.

Who may qualify

Ages: 20 to 65 years
Sex: Female only
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (7 listed)

Age: 20-65 years;
Pathologically diagnosed breast cancer patients, with the diagnosis from at least 2 comprehensive clinical attending physicians, in line with clinical diagnosis of breast cancer;
A week after breast cancer surgery;
With complaints and symptoms of depression or anxiety
HAMD-17 ≥ 8 points or / and HAMA ≥ 8 points;

Key exclusion criteria (10 listed)

Previous diagnosis of mental disorder or Bipolar Disorder; alcohol and drug abusing history;
Use antidepressants, antipsychotics or accept any form of psychological treatment, or participation in other clinical trials in the last month
Patients with cardiovascular disease, liver and kidney dysfunction and other serious diseases;
Hearing, visual or understanding impairment;
Severe depression, suicidal tendencies;

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
CBTAlso: cognitive-behavioral intervention, psychological interventionThe subjects will receive standardized CBT treatment regularly for 9 sessions(once per week in the first month and once half a month in the second and third months), and each session will last for about 60 minutes.The treatment includes three steps:Concept stage (the first and second sessions): establishment of therapeutic relationships with the subjects; Skills acquisition and repeat stage (the third session to the 8th session): clarification of sources of stress, patients' cognitive and behavioral response to stress. Application and complete price segment (the 9th session): return visit to test efficacy of psychological intervention.	Behavioural	stage1 CBT
Clinical ManagementAlso: Placebo of Cognitive-Behavioral therapyClinical management is a clear contrast method of psychological therapy, which is a half-structured interview and lasting for 20-25 minutes each session. Clinical management will be assigned to both experimental group and controlled group in the first stage of intervention. Following are major elements: Talk to the subjects to find their main problems; introduce knowledge and medication knowledge about cancer and depression; subjects reporting use of drugs for cancer and depression and a variety of signs and symptoms of the reaction. Encourage patients to adhere to drug treatment and to comply with this research program; The operation of CBT and clinical management should be conducted by the same person as far as possible.	Behavioural	stage 1 Clinical Management

Primary outcome

Hamilton Depression Rating Scale (HAMD-17)
Time frame: baseline,2 w,4 w,8 w,12 w,16 w,24 w
1. The scale(HAMD-17) is used to assessed the depression symptoms of patients. 2. The scale range is 0-53.Higher value represents a worse outcome. 3. The scale was assessed at baseline,2 week,4 week,8 week,12 week,16 week,24 week
Hamilton Anxiety Scale (HAMA-14)
Time frame: baseline,2 w,4 w,8 w,12 w,16 w,24 w
1. The scale(HAMA-14) is used to assessed the anxiety symptoms of patients. 2. The scale range is 0-56.Higher value represents a worse outcome. 3. The scale was assessed at baseline,2 week,4 week,8 week,12 week,16 week,24 week.

3 secondary outcomes

Visual Analogue Scale (VAS)
Time frame: baseline,4 w,8 w,12 w,24 w
Athens Insomnia Scale(AIS)
Time frame: baseline, 4w,8w,12w,24w
Functional Assessment of Cancer Treatment (FACT-B)
Time frame: baseline, 4w,12w,24w

Results and safety

Results posted to the registry on 10 Apr 2015, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Stage 1 Clinical Management	98	90
Stage 1 CBT	98	91
Stage 1 Control Group	196	175

Primary outcome: Hamilton Depression Rating Scale (HAMD-17)

Time frame: baseline,2 w,4 w,8 w,12 w,16 w,24 w. Mean (Standard Deviation). Unit: units on a scale

Measure	Stage 1 Clinical Management n = 98	Stage 1 CBT n = 98	Stage 1 Control Group n = 196
baseline	11.52 (3.789)	13.31 (5.090)	11.01 (3.844)
2W	10.23 (3.207)	11.72 (4.976)	10.28 (3.462)
4W	9.80 (3.056)	9.72 (4.835)	10.24 (3.688)
8W	8.71 (3.601)	7.80 (4.440)	9.42 (4.175)
12W	8.01 (3.200)	5.71 (3.979)	8.81 (4.198)
16W	7.42 (3.019)	5.13 (4.108)	8.26 (4.338)
24W	7.01 (3.317)	4.45 (3.875)	7.86 (4.410)

Primary outcome: Hamilton Anxiety Scale (HAMA-14)

Time frame: baseline,2 w,4 w,8 w,12 w,16 w,24 w. Mean (Standard Deviation). Unit: units on a scale

Measure	Stage 1 Clinical Management n = 98	Stage 1 CBT n = 98	Stage 1 Control Group n = 196
baseline	12.11 (3.188)	13.38 (4.883)	11.37 (2.736)
2W	10.89 (3.401)	11.34 (4.433)	10.63 (3.105)
4W	10.34 (3.505)	9.82 (3.952)	10.40 (3.663)
8W	9.15 (3.709)	8.26 (4.120)	9.36 (3.802)
12W	8.57 (3.364)	6.30 (3.518)	8.81 (4.231)
16W	7.90 (3.263)	5.42 (3.638)	8.31 (4.348)
24W	7.60 (3.305)	4.99 (3.263)	7.91 (4.277)

3 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Stage 1 Clinical Management	0 of 98 (0%)	0 of 98 (0%)	Not reported
stage1 CBT	0 of 98 (0%)	0 of 98 (0%)	Not reported
stage1 Control Group	0 of 196 (0%)	0 of 196 (0%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2015.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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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. This study is not recruiting at the moment.

Jin C He, MD study chair

Wenzhou Medical University

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing CBT and Clinical Management in people with Breast Cancer and Depression, run by Wenzhou Medical University at 1 site in China.

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 7 inclusion and 10 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: finished, as of the sponsor's last update on 1 May 2015. 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 China. 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. Some participants in this study may receive a placebo. 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?

Yes. Results are posted in the registry (first posted 10 Apr 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Hamilton Depression Rating Scale (HAMD-17) (time frame: baseline,2 w,4 w,8 w,12 w,16 w,24 w). 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?

On the ClinicalTrials.gov record for NCT01256008.

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 1 May 2015.