Psychological StressPhase 2NCT01519895
Effectiveness of Telephone Intervention for Colorectal Cancer Caregivers
A Phase 2 study testing Telephone intervention in people with Psychological Stress, run by Hospital Authority, Hong Kong at 1 site in China.
Trial summary
The purpose of this study is to assess the effectiveness of the telephone intervention program for caregivers of colorectal cancer. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Psychological Stress
- What is being tested?
- Telephone intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- 1 siteChina
- Study dates
- Jun 2011to Dec 2012
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Family members with newly diagnosed colorectal cancer within the past 4 week and treated in Queen Mary Hospital
- Self identified as formal or informal family caregivers
- Over 18 years old
- Chinese
- Cantonese speaking
Who cannot join
- Cognitive disability
- Domestic helpers or maids
- Non Chinese
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effectiveness of Telephone-based Intervention on Distress, Burden and Quality of Life of Chinese Caregivers of Colorectal Cancer Patients
The purpose of this study is to assess the effectiveness of the telephone intervention program for caregivers of colorectal cancer.
Read the detailed description
telephone Intervention refer to provide counseling and education to caregivers of colorectal cancer by mode of telephone
- Conditions
- Psychological Stress
- Being tested
- Telephone intervention
- Keywords
- quality of life, anxiety, stress, carers, colorectal or colon cancer
- Medical subject headings
- Stress, Psychological, Anxiety Disorders, Colonic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Telephone interventionBehavioural
counseling and education support
| Study group | Role | What they receive |
|---|---|---|
| Existing care | No intervention | routine existing care |
| Telephone intervention | Experimental | in addition to provide telephone intervention support Receives: Behavioral: Telephone intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Distress level
Effect of telephone intervention on distress level measured at pre-discharged(baseline) and 2 weeks and 4 weeks and 8 weeks post intervention .
Measured: Change of distress level at pre-discharged(base-line) and 2 weeks and 4 weeks and 8 weeks post intervention
Secondary outcomes (2)
Burden of care
Effect of telephone intervention on burden of care measured at pre-discharged(baseline) and 2 weeks and 4 weeks and 8 weeks post intervention
Measured: Measured at pre-discharged(base-line) and 2 weeks and 4 weeks and 8 weeks post intervention
Quality of life
Effect of telephone intervention at pre-discharged(base-line) and 2 weeks and 4 weeks and 8 weeks post intervention
Measured: Measured at pre-discharged(base-line) and 2 weeks and 4 weeks and 8 weeks post intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2012 (estimated)
- Study startJun 2011
- Primary completionAug 2012
- Study completionDec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Psychological StressStudies 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 2
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 140 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital Authority, Hong Kong
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Shum Nga Fan, Hospital Authority, Hong Kong
- Investigators
- N F Shum, Principal investigator, Queen Mary Hospital, Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01519895
- Sponsor's protocol ID
- HKCTR-1336
- Status last verified
- Apr 2015
- First submitted
- 11 Jan 2012
- Last updated
- 15 Apr 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Telephone-based Intervention on Distress, Burden and Quality of Life of Chinese Caregivers of Colorectal Cancer Patients
- ClinicalTrials.gov ID
- NCT01519895
- Acronym / sponsor ID
- HKCTR-1336
- Conditions
- Psychological Stress
- Keywords
- quality of life, anxiety, stress, carers, colorectal or colon cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 140 participants (actual)
- Lead sponsor
- Hospital Authority, Hong KongOther government
- Study start
- Jun 2011
- Primary completion
- Aug 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 27 Jan 2012 (estimated)
- 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.
The purpose of this study is to assess the effectiveness of the telephone intervention program for caregivers of colorectal cancer.
Detailed description
telephone Intervention refer to provide counseling and education to caregivers of colorectal cancer by mode of telephone
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Existing care | No intervention | –routine existing care |
| Telephone intervention | Experimental | Behavioral: Telephone interventionin addition to provide telephone intervention support |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Family members with newly diagnosed colorectal cancer within the past 4 week and treated in Queen Mary Hospital
- Self identified as formal or informal family caregivers
- Over 18 years old
- Chinese
- Cantonese speaking
Key exclusion criteria (3 listed)
- Cognitive disability
- Domestic helpers or maids
- Non Chinese
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 |
|---|---|---|
| Telephone interventioncounseling and education support | Behavioural | Telephone intervention |
Primary outcome
Distress level
Time frame: Change of distress level at pre-discharged(base-line) and 2 weeks and 4 weeks and 8 weeks post intervention
Effect of telephone intervention on distress level measured at pre-discharged(baseline) and 2 weeks and 4 weeks and 8 weeks post intervention .
2 secondary outcomes
Burden of care
Time frame: Measured at pre-discharged(base-line) and 2 weeks and 4 weeks and 8 weeks post intervention
Quality of life
Time frame: Measured at pre-discharged(base-line) and 2 weeks and 4 weeks and 8 weeks post intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Apr 2015.
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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.
N F Shum principal investigator
Queen Mary Hospital, Hong Kong
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Telephone intervention in people with Psychological Stress, run by Hospital Authority, Hong Kong 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 5 inclusion and 3 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 15 Apr 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Distress level (time frame: Change of distress level at pre-discharged(base-line) and 2 weeks and 4 weeks and 8 weeks post intervention). 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 15 Apr 2015.