StressC-PRIMENCT05379933
Caregiver Protocol for Remotely Improving, Monitoring, and Extending Quality of Life
A study testing Remote health coaching to improve self-care behaviors in people with Stress and Quality of Life, run by H. Lee Moffitt Cancer Center and Research Institute at 1 site in United States.
Trial summary
The purpose of this study is to test an intervention to improve health promoting behaviors in family caregivers of patients receiving cancer therapy Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Stress, Quality of Life, Sleep Disturbance
- What is being tested?
- Remote health coaching to improve self-care behaviors
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- 1 siteUnited States
- Study dates
- 11 May 2022to 15 Nov 2022
- 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
- Eligible family caregivers will be:
- An unpaid family member or friend who provides assistance and support with healthcare of a non-institutionalized patient receiving some form of treatment for stage III or IV colorectal cancer at Moffitt Cancer Center
- Age 18+ years
- English or Spanish speaking
- Able to complete questionnaires and engage in short discussions with coaches
- Able to identify a primary care medical provider
- Willing/able to use a mobile device provided by the study team or their own their device.
Who cannot join
- Participants who do not meet the study inclusion criteria
Trial locations and contacts
1 site in 1 country.
About this study
Official title: C-PRIME: Caregiver Protocol for Remotely Improving, Monitoring, and Extending Quality of Life
The purpose of this study is to test an intervention to improve health promoting behaviors in family caregivers of patients receiving cancer therapy
- Conditions
- Stress, Quality of Life, Sleep Disturbance
- Being tested
- Remote health coaching to improve self-care behaviors
- Keywords
- Family Caregiver, Well-being
- Medical subject headings
- Parasomnias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Remote health coaching to improve self-care behaviorsOther
Participants will be asked to wear an activity tracker, complete brief surveys, and participate in weekly health coaching sessions remotely for 8 weeks
| Study group | Role | What they receive |
|---|---|---|
| C-PRIME | Experimental | Participants will wear an activity tracker for 8 weeks. During the 8 weeks of the study, participants will complete weekly survey questions about health and well-being and engage in weekly, 15-20 minute telephone/videoconference coaching sessions with a health coach. Receives: Other: Remote health coaching to improve self-care behaviors |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants Who Agree to Participate (Acceptability)
The study will be deemed acceptable if at least 50% of eligible family caregivers agree to participate
Measured: 12 Months
Percentage of Participants Who Provide Data (Feasibility)
The study will be deemed feasible if at least 75% of family caregivers who participate provide data for at least 50% of study days
Measured: 12 Months
Secondary outcomes (2)
Self Care Behaviors - Primary Efficacy
Participant's self care behaviors will be measured using the Health-Promoting Lifestyle Profile-II. This is a 52-item questionnaire that assesses use of behaviors likely to promote a healthy lifestyle and indicate greater selfcare. Responses are categorized into an overall health-promoting lifestyle score as well as subscales assessing health responsibility, physical activity, nutrition, spiritual growth, interpersonal relations, and stress management.
Measured: 8 Weeks
Quality of Life -Secondary Efficacy
Participants' quality of life will be assessed using the EORT QLQ-C30, a 30-item measure that assesses quality of life in various domains of functioning and symptoms.
Measured: 8 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2022
- Study start11 May 2022
- Primary completion15 Nov 2022
- Study completion15 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for StressStudies of the same condition, open and under way.
- More trials run by H. Lee Moffitt Cancer Center and Research InstituteThe 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Brian Gonzalez, PhD, Principal investigator, Moffitt Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05379933
- Sponsor's protocol ID
- MCC-21751
- Acronym
- C-PRIME
- Status last verified
- Jan 2023
- First submitted
- 13 May 2022
- Last updated
- 20 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Gudenkauf LM, Li X, Hoogland AI, Oswald LB, Lmanirad I, Permuth JB, Small BJ, Jim HSL, Rodriguez Y, Bryant CA, Zambrano KN, Walters KO, Reblin M, Gonzalez BD. Feasibility and acceptability of C-PRIME: A health promotion intervention for family caregivers of patients with colorectal cancer. Support Care Cancer. 2024 Feb 28;32(3):198. doi: 10.1007/s00520-024-08395-5.
PubMed 38416143
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- C-PRIME: Caregiver Protocol for Remotely Improving, Monitoring, and Extending Quality of Life
- ClinicalTrials.gov ID
- NCT05379933
- Acronym / sponsor ID
- C-PRIME / MCC-21751
- Conditions
- Stress, Quality of Life, Sleep Disturbance
- Keywords
- Family Caregiver, Well-being
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- H. Lee Moffitt Cancer Center and Research InstituteUniversity, hospital or other
- Study start
- 11 May 2022 (actual)
- Primary completion
- 15 Nov 2022 (actual)
- Study completion
- 15 Nov 2022 (actual)
- First posted
- 18 May 2022 (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.
The purpose of this study is to test an intervention to improve health promoting behaviors in family caregivers of patients receiving cancer therapy
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| C-PRIME | Experimental | Other: Remote health coaching to improve self-care behaviorsParticipants will wear an activity tracker for 8 weeks. During the 8 weeks of the study, participants will complete weekly survey questions about health and well-being and engage in weekly, 15-20 minute telephone/videoconference coaching sessions with a health coach. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Eligible family caregivers will be:
- An unpaid family member or friend who provides assistance and support with healthcare of a non-institutionalized patient receiving some form of treatment for stage III or IV colorectal cancer at Moffitt Cancer Center
- Age 18+ years
- English or Spanish speaking
- Able to complete questionnaires and engage in short discussions with coaches
Key exclusion criteria (1 listed)
- Participants who do not meet the study inclusion criteria
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 |
|---|---|---|
| Remote health coaching to improve self-care behaviorsParticipants will be asked to wear an activity tracker, complete brief surveys, and participate in weekly health coaching sessions remotely for 8 weeks | Other | C-PRIME |
Primary outcome
Percentage of Participants Who Agree to Participate (Acceptability)
Time frame: 12 Months
The study will be deemed acceptable if at least 50% of eligible family caregivers agree to participate
Percentage of Participants Who Provide Data (Feasibility)
Time frame: 12 Months
The study will be deemed feasible if at least 75% of family caregivers who participate provide data for at least 50% of study days
2 secondary outcomes
Self Care Behaviors - Primary Efficacy
Time frame: 8 Weeks
Quality of Life -Secondary Efficacy
Time frame: 8 Weeks
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 20 Jan 2023.
- Derived from this study: PubMed 38416143Gudenkauf LM, Li X, Hoogland AI, Oswald LB, Lmanirad I, Permuth JB, Small BJ, Jim HSL, Rodriguez Y, Bryant CA, Zambrano KN, Walters KO, Reblin M, Gonzalez BD. Feasibility and acceptability of C-PRIME: A health promotion intervention for family caregivers of patients with colorectal cancer. Support Care Cancer. 2024 Feb 28;32(3):198. doi: 10.1007/s00520-024-08395-5.
- Individual participant dataSharing planned: No
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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.
Brian Gonzalez, PhD principal investigator
Moffitt Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Remote health coaching to improve self-care behaviors in people with Stress and Quality of Life, run by H. Lee Moffitt Cancer Center and Research Institute 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 7 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 20 Jan 2023. 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?
Percentage of Participants Who Agree to Participate (Acceptability) (time frame: 12 Months). 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 NCT05379933, which also lists 1 linked publication.
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 20 Jan 2023.