Breast NeoplasmsPCONCT02866994
Project Connect Online: An Internet-based Intervention for Women With Breast Cancer
A study testing Project Connect Online and PCO PLUS in people with Breast Neoplasms, run by Jonsson Comprehensive Cancer Center at 1 site in United States.
Trial summary
This randomized comparative effectiveness trial examines the potential psychosocial and physical health-related benefits of sharing personal websites with other women with breast cancer, as well as with family and friends (PCO PLUS condition) versus sharing with family and friends only (PCO condition) in a sample of… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Neoplasms
- What is being tested?
- Project Connect Online and PCO PLUS
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Jun 2015to 17 Jun 2019
- Phase
- Interventional
- 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- women at least 18 years of age;
- first diagnosis of Stage IV breast cancer or a recurrent diagnosis of metastatic breast cancer, any interval since diagnosis;
- ability to complete the intervention and assessments in English; and
- willingness to attend in-person PCO workshop;
Who cannot join
- male (because men constitute less than 1% of breast cancer patients, numbers would not be sufficient for reliable analyses);
- local (i.e., same breast, surgical scar, chest wall) or regional (i.e., lymph nodes) recurrent disease; and
- use of a personal website to post cancer-relevant material in the past six months
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California, Los Angeles
Los Angeles, California, 90095
About this study
Official title: Project Connect: Enhancing Connections During Metastatic Breast Cancer (PCO)
This randomized comparative effectiveness trial examines the potential psychosocial and physical health-related benefits of sharing personal websites with other women with breast cancer, as well as with family and friends (PCO PLUS condition) versus sharing with family and friends only (PCO condition) in a sample of women with metastatic breast cancer.
- Conditions
- Breast Neoplasms
- Being tested
- Project Connect Online, PCO PLUS
- Keywords
- Women
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Project Connect OnlineBehavioural
Three-hour workshop to complete personal website regarding breast cancer experience to share with friends and family
PCO PLUSBehavioural
Three-hour workshop to complete personal website regarding breast cancer experience to share with friends and family, as well as other women diagnosed with breast cancer
| Study group | Role | What they receive |
|---|---|---|
| Project Connect Online (PCO) | Experimental | Creation of personal website to share breast cancer experience with friends and family Receives: Behavioral: Project Connect Online |
| PCO PLUS | Experimental | Creation of personal website to share breast cancer experience with friends and family, as well as other women diagnosed with breast cancer Receives: Behavioral: PCO PLUS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of general and cancer-related psychological status
web site self reported
Measured: Baseline, 2 months, 4 months
Secondary outcomes (1)
Change in overall physical health status
web site self reported
Measured: Baseline, 2 months, 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2016 (estimated)
- Study start4 Jun 2015
- Primary completion17 Jun 2019
- Study completion17 Jun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast NeoplasmsStudies of the same condition, open and under way.
- More trials run by Jonsson Comprehensive Cancer CenterThe sponsor's other registered studies.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jonsson Comprehensive Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- Susan G. Komen Breast Cancer Foundation, Breast Cancer Research Foundation
- Responsible party
- Sponsor
- Investigators
- Patricia Ganz, MD, Principal investigator, Proffessor and Director, Health Policy & Management
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02866994
- Sponsor's protocol ID
- 14-001744
- Other IDs
- 20155036, SAC110009
- Acronym
- PCO
- Status last verified
- Apr 2020
- First submitted
- 1 Aug 2016
- Last updated
- 1 Oct 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Project Connect: Enhancing Connections During Metastatic Breast Cancer (PCO)
- ClinicalTrials.gov ID
- NCT02866994
- Acronym / sponsor ID
- PCO / 14-001744
- Conditions
- Breast Neoplasms
- Keywords
- Women
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- Jonsson Comprehensive Cancer CenterUniversity, hospital or other
- Collaborators
- Susan G. Komen Breast Cancer Foundation, Breast Cancer Research Foundation
- Study start
- 4 Jun 2015 (actual)
- Primary completion
- 17 Jun 2019 (actual)
- Study completion
- 17 Jun 2019 (actual)
- First posted
- 15 Aug 2016 (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.
This randomized comparative effectiveness trial examines the potential psychosocial and physical health-related benefits of sharing personal websites with other women with breast cancer, as well as with family and friends (PCO PLUS condition) versus sharing with family and friends only (PCO condition) in a sample of women with metastatic breast cancer.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Project Connect Online (PCO) | Experimental | Behavioral: Project Connect OnlineCreation of personal website to share breast cancer experience with friends and family |
| PCO PLUS | Experimental | Behavioral: PCO PLUSCreation of personal website to share breast cancer experience with friends and family, as well as other women diagnosed with breast cancer |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- women at least 18 years of age;
- first diagnosis of Stage IV breast cancer or a recurrent diagnosis of metastatic breast cancer, any interval since diagnosis;
- ability to complete the intervention and assessments in English; and
- willingness to attend in-person PCO workshop;
Key exclusion criteria (3 listed)
- male (because men constitute less than 1% of breast cancer patients, numbers would not be sufficient for reliable analyses);
- local (i.e., same breast, surgical scar, chest wall) or regional (i.e., lymph nodes) recurrent disease; and
- use of a personal website to post cancer-relevant material in the past six months
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 |
|---|---|---|
| Project Connect OnlineThree-hour workshop to complete personal website regarding breast cancer experience to share with friends and family | Behavioural | Project Connect Online (PCO) |
| PCO PLUSThree-hour workshop to complete personal website regarding breast cancer experience to share with friends and family, as well as other women diagnosed with breast cancer | Behavioural | PCO PLUS |
Primary outcome
Change of general and cancer-related psychological status
Time frame: Baseline, 2 months, 4 months
web site self reported
1 secondary outcome
Change in overall physical health status
Time frame: Baseline, 2 months, 4 months
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 1 Oct 2020.
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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.
Patricia Ganz, MD principal investigator
Proffessor and Director, Health Policy & Management
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Project Connect Online and PCO PLUS in people with Breast Neoplasms, run by Jonsson Comprehensive Cancer Center at 1 site in United States.
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 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 1 Oct 2020. 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 United States. 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?
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?
Change of general and cancer-related psychological status (time frame: Baseline, 2 months, 4 months). 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 1 Oct 2020.