CancerBEACONNCT06353178
Building Empowerment and Coping Outcomes for CaNcer Patients, Survivors and Their Caregivers
A study testing Cancer Connect Program in people with Cancer and Caregiving Stress, run by Color Health, Inc. at 1 site in United States.
Trial summary
Cancer has a psychological, emotional and social impact beyond a patient's physical health. This study examines three new online peer mental-wellness support program for cancer patients, survivors or their caregivers. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cancer, Caregiving Stress, Caregiver Burnout
- What is being tested?
- Cancer Connect Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 133 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Apr 2024to 25 Jan 2025
- 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
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Lived experience as either a current cancer patient, cancer survivor or caregiver of someone with cancer
- Adult - 18+
- Has health insurance provided by employer or union (can be dependent of person on insurance)
- Read/speak English
- Have access to internet and personal email account
Who cannot join
- Severe mental illness that is disruptive to other group members
Trial locations and contacts
1 site in 1 country.
About this study
Official title: BEACON Study: Virtual Coping Skills Groups for Cancer Patients, Survivors and Their Caregivers
Cancer has a psychological, emotional and social impact beyond a patient's physical health. This study examines three new online peer mental-wellness support program for cancer patients, survivors or their caregivers. Each program teaches evidence-based skills, in the context of that groups lived experience, to manage the emotional impact of cancer. This study examines the impact of that program.
Read the detailed description
Cancer has a psychological, emotional and social impact beyond a patient's physical health. These problems often ripple beyond the individual with the diagnosis, to their broader community, and also beyond a cancer treatment course into survivorship. As a result, there are a wide range of socioemotional needs in those who have been impacted by cancer. Further, these emotional impacts have a direct impact on morbidity and mortality of cancer. A new peer mental-wellness support program, called Color Cancer Connect (CCC) supports cancer patients, survivors and their caregivers by teaching them evidence-based skills to manage the emotional impact of cancer. This study will examine all three programs (i.e., patient, survivor, caregiver) to gather data to measure the impact of the program on emotional well-being, quality of life and health behaviors.
- Conditions
- Cancer, Caregiving Stress, Caregiver Burnout, Survivorship
- Being tested
- Cancer Connect Program
- Keywords
- cancer, caregiving, emotional support, psychology
- Medical subject headings
- Neoplasms, Caregiver Burden
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cancer Connect ProgramBehavioural
Online group peer program where participants learn evidence based skills for managing stressors and emotions related to their cancer experience.
| Study group | Role | What they receive |
|---|---|---|
| Cancer Connect Program | Experimental | Participants assigned to this arm will be able to attend the online peer program upon entering the study. Receives: Behavioral: Cancer Connect Program |
| Waitlist | Placebo comparator | Participants assigned to this arm will be on a waitlist and will be invited to join the online peer program in 3 months. Receives: Behavioral: Cancer Connect Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Depression
Patient Health Questionnaire-9 (PHQ-9)
Measured: Multiple time points across 8 months (waitlist; baseline, 2 months post waitlist, 3 months post waitlist, 2 months post program start, 3 months post program start) or 5 months (intervention; baseline, 2 months post program start, 3 months post program)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2024
- Study start8 Apr 2024
- Primary completion25 Jan 2025
- Study completion25 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be randomized to waitlist or intervention group. Those in intervention group will receive the peer program; those on the waitlist will receive it after being on the waitlist for 3 months.
- Masking
- None (open label)
- Enrolment
- 133 participants (actual)
Sponsor and investigators
- Lead sponsor
- Color Health, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06353178
- Sponsor's protocol ID
- 20240314
- Acronym
- BEACON
- Status last verified
- Jan 2025
- First submitted
- 2 Apr 2024
- Last updated
- 28 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- BEACON Study: Virtual Coping Skills Groups for Cancer Patients, Survivors and Their Caregivers
- ClinicalTrials.gov ID
- NCT06353178
- Acronym / sponsor ID
- BEACON / 20240314
- Conditions
- Cancer, Caregiving Stress, Caregiver Burnout, Survivorship
- Keywords
- cancer, caregiving, emotional support, psychology
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 133 participants (actual)
- Lead sponsor
- Color Health, Inc.Industry (pharma, biotech, devices)
- Study start
- 8 Apr 2024 (actual)
- Primary completion
- 25 Jan 2025 (actual)
- Study completion
- 25 Jan 2025 (actual)
- First posted
- 8 Apr 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.
Cancer has a psychological, emotional and social impact beyond a patient's physical health. This study examines three new online peer mental-wellness support program for cancer patients, survivors or their caregivers. Each program teaches evidence-based skills, in the context of that groups lived experience, to manage the emotional impact of cancer. This study examines the impact of that program.
Detailed description
Cancer has a psychological, emotional and social impact beyond a patient's physical health. These problems often ripple beyond the individual with the diagnosis, to their broader community, and also beyond a cancer treatment course into survivorship. As a result, there are a wide range of socioemotional needs in those who have been impacted by cancer. Further, these emotional impacts have a direct impact on morbidity and mortality of cancer. A new peer mental-wellness support program, called Color Cancer Connect (CCC) supports cancer patients, survivors and their caregivers by teaching them evidence-based skills to manage the emotional impact of cancer. This study will examine all three programs (i.e., patient, survivor, caregiver) to gather data to measure the impact of the program on emotional well-being, quality of life and health behaviors.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants will be randomized to waitlist or intervention group. Those in intervention group will receive the peer program; those on the waitlist will receive it after being on the waitlist for 3 months.
| Arm | Type | Receives |
|---|---|---|
| Cancer Connect Program | Experimental | Behavioral: Cancer Connect ProgramParticipants assigned to this arm will be able to attend the online peer program upon entering the study. |
| Waitlist | Placebo comparator | Behavioral: Cancer Connect ProgramParticipants assigned to this arm will be on a waitlist and will be invited to join the online peer program in 3 months. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Lived experience as either a current cancer patient, cancer survivor or caregiver of someone with cancer
- Adult - 18+
- Has health insurance provided by employer or union (can be dependent of person on insurance)
- Read/speak English
- Have access to internet and personal email account
Key exclusion criteria (1 listed)
- Severe mental illness that is disruptive to other group members
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 |
|---|---|---|
| Cancer Connect ProgramOnline group peer program where participants learn evidence based skills for managing stressors and emotions related to their cancer experience. | Behavioural | Cancer Connect Program, Waitlist |
Primary outcome
Depression
Time frame: Multiple time points across 8 months (waitlist; baseline, 2 months post waitlist, 3 months post waitlist, 2 months post program start, 3 months post program start) or 5 months (intervention; baseline, 2 months post program start, 3 months post program)
Patient Health Questionnaire-9 (PHQ-9)
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 28 Jan 2025.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cancer Connect Program in people with Cancer and Caregiving Stress, run by Color Health, Inc. 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 5 inclusion and 1 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 28 Jan 2025. 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. 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?
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?
Depression (time frame: Multiple time points across 8 months (waitlist; baseline, 2 months post waitlist, 3 months post waitlist, 2 months post program start, 3 months post program start) or 5 months (intervention; baseline, 2 months post program start, 3 months post program)). 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 28 Jan 2025.