CancerNCT03069287
Integrating Family Caregiver Support Into Cancer Clinical Trials
A study testing Benjamin Rose Institute (BRI) Care Consultation™ Program in people with Cancer and Clinical Trials, run by Saint John's Cancer Institute at 1 site in United States.
Trial summary
The aim of this study is to assess the effects of integrating family caregiver support into cancer clinical trials on the well-being of the caregiver, the care-recipient and on the cancer clinical trial system. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer, Clinical Trials, Caregivers
- What is being tested?
- Benjamin Rose Institute (BRI) Care Consultation™ Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Jul 2018to 14 Feb 2023
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- dyad must be at least 18 years of age,
- patient is enrolled or expressed intent to enroll in a therapeutic cancer clinical trial
- caregiver is a self-identified primary caregiver,
- able to speak, read, and understand English,
- willing to participate in completion of surveys, and
- co-residence
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
John Wayne Cancer Institute at Providence Saint John's Health Center
Santa Monica, California, 90404
About this study
Official title: Feasibility and Acceptability of Integrating Family Caregiver Support Into Cancer Clinical Trials
The aim of this study is to assess the effects of integrating family caregiver support into cancer clinical trials on the well-being of the caregiver, the care-recipient and on the cancer clinical trial system.
Read the detailed description
The aim of this study is to assess the effects of integrating family caregiver support into cancer clinical trials on the well-being of the caregiver, the care-recipient and on the cancer clinical trial system. This study will allow us to examine the benefit of adding a personalized support program for the family caregiver of a patients participating in a cancer clinical trial. Findings will assist in strengthening patient/caregiver-centered care management and support programs developed to enhance the quality of life of patients with cancer and the caregivers, reduce barriers to clinical recruitment, and improve retention in clinical trials.
- Conditions
- Cancer, Clinical Trials, Caregivers
- Being tested
- Benjamin Rose Institute (BRI) Care Consultation™ Program
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Benjamin Rose Institute (BRI) Care Consultation™ ProgramBehavioural
The BRI Care Consultation™ can be delivered via face-to-face contact, telephone, mail, and/or email by a Care Consultant and caregiver who assists with daily activities, tasks, and health-related issues. BRI CareConsultation™ uses a secure, web-based Care Consultation Information System (CCIS) to guide the delivery of the intervention.
| Study group | Role | What they receive |
|---|---|---|
| Patient-caregiver dyads | Experimental | Dyads will include family caregivers and patients with a diagnosis of cancer who agreed to participate in a therapeutic clinical trial. Receives: Behavioral: Benjamin Rose Institute (BRI) Care Consultation™ Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Absolute change in the Caregiver Reaction Assessment (CRA) score
Caregiver Reaction Assessment (CRA) will be used to measure caregiver burden. The instrument was designed as a questionnaire with Likert-type responses ranging from strongly agree (1) to strongly disagree. The 24 items form 5 distinct unidimensional subscales that include: family burden (lack of family support; 5 items), financial burden (struggle with bills; 3 items), health burden (caregivers' health decline; 4 items), schedule burden (disruption of daily tasks; 5 items), and caregiving esteem (7 items), a positive subscale that measures enjoyment and importance of caregiving. A higher score on the caregiver's esteem subscale indicates a more positive effect of caregiving while higher scores on the other subscales indicate greater negative effects of caregiving in those domains
Measured: 1 year
Absolute change in the scores for the assessment domains included in the Ben Rose Institute (BRI) care consultation program
Assessment of multiple caregiver and patient domains addressed by the BRI Care Consultation program
Measured: 1 year
Secondary outcomes (2)
Absolute change in the Functional Assessment of Cancer Therapy - General (FACT-G) score
Assesses patient quality of life. There are 27 questions, each of which is answered using a 5-point scale ranging from 0 (Not at all) to 4 (Very much). Questions are phrased so that higher numbers indicate a better health state.
Measured: 1 year
Absolute change in Patient Reported Outcomes- Common Toxicity Criteria for Adverse Events (PRO-CTCAE) scores
The Patient Reported Outcome-Common Toxicity Criteria for Adverse Events (PRO-CTCAE) assesses patient quality of life. PRO-CTCAE items evaluate the symptom attributes of frequency, severity, interference, amount, presence/absence. Each symptomatic AE is assessed by 1-3 attributes. Responses for each attribute (frequency, severity, and/or interference of symptoms) are scored from 1 to 5 with 1+ mild and 5 = death.
- - Mild
- - Moderate
- - Severe
- - Life-threatening
- - Death
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2017
- Study start10 Jul 2018
- Primary completion14 Feb 2023
- Study completion14 Feb 2023
Why it stopped: Lack of funding and resources
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Saint John's Cancer Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03069287
- Sponsor's protocol ID
- JWCI-17-0102
- Status last verified
- Apr 2023
- First submitted
- 27 Feb 2017
- Last updated
- 13 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Saria MG, Courchesne N, Evangelista L, Carter J, MacManus DA, Gorman MK, Nyamathi AM, Phillips LR, Piccioni D, Kesari S, Maliski S. Cognitive dysfunction in patients with brain metastases: influences on caregiver resilience and coping. Support Care Cancer. 2017 Apr;25(4):1247-1256. doi: 10.1007/s00520-016-3517-3. Epub 2016 Dec 5.
PubMed 27921222Saria MG, Nyamathi A, Phillips LR, Stanton AL, Evangelista L, Kesari S, Maliski S. The Hidden Morbidity of Cancer: Burden in Caregivers of Patients with Brain Metastases. Nurs Clin North Am. 2017 Mar;52(1):159-178. doi: 10.1016/j.cnur.2016.10.002.
PubMed 28189161
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility and Acceptability of Integrating Family Caregiver Support Into Cancer Clinical Trials
- ClinicalTrials.gov ID
- NCT03069287
- Acronym / sponsor ID
- JWCI-17-0102
- Conditions
- Cancer, Clinical Trials, Caregivers
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Lack of funding and resources
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Saint John's Cancer InstituteUniversity, hospital or other
- Study start
- 10 Jul 2018 (actual)
- Primary completion
- 14 Feb 2023 (actual)
- Study completion
- 14 Feb 2023 (actual)
- First posted
- 3 Mar 2017 (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 aim of this study is to assess the effects of integrating family caregiver support into cancer clinical trials on the well-being of the caregiver, the care-recipient and on the cancer clinical trial system.
Detailed description
The aim of this study is to assess the effects of integrating family caregiver support into cancer clinical trials on the well-being of the caregiver, the care-recipient and on the cancer clinical trial system. This study will allow us to examine the benefit of adding a personalized support program for the family caregiver of a patients participating in a cancer clinical trial. Findings will assist in strengthening patient/caregiver-centered care management and support programs developed to enhance the quality of life of patients with cancer and the caregivers, reduce barriers to clinical recruitment, and improve retention in clinical trials.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patient-caregiver dyads | Experimental | Behavioral: Benjamin Rose Institute (BRI) Care Consultation™ ProgramDyads will include family caregivers and patients with a diagnosis of cancer who agreed to participate in a therapeutic clinical trial. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- dyad must be at least 18 years of age,
- patient is enrolled or expressed intent to enroll in a therapeutic cancer clinical trial
- caregiver is a self-identified primary caregiver,
- able to speak, read, and understand English,
- willing to participate in completion of surveys, and
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Benjamin Rose Institute (BRI) Care Consultation™ ProgramThe BRI Care Consultation™ can be delivered via face-to-face contact, telephone, mail, and/or email by a Care Consultant and caregiver who assists with daily activities, tasks, and health-related issues. BRI CareConsultation™ uses a secure, web-based Care Consultation Information System (CCIS) to guide the delivery of the intervention. | Behavioural | Patient-caregiver dyads |
Primary outcome
Absolute change in the Caregiver Reaction Assessment (CRA) score
Time frame: 1 year
Caregiver Reaction Assessment (CRA) will be used to measure caregiver burden. The instrument was designed as a questionnaire with Likert-type responses ranging from strongly agree (1) to strongly disagree. The 24 items form 5 distinct unidimensional subscales that include: family burden (lack of family support; 5 items), financial burden (struggle with bills; 3 items), health burden (caregivers' health decline; 4 items), schedule burden (disruption of daily tasks; 5 items), and caregiving esteem (7 items), a positive subscale that measures enjoyment and importance of caregiving. A higher score on the caregiver's esteem subscale indicates a more positive effect of caregiving while higher scores on the other subscales indicate greater negative effects of caregiving in those domains
Absolute change in the scores for the assessment domains included in the Ben Rose Institute (BRI) care consultation program
Time frame: 1 year
Assessment of multiple caregiver and patient domains addressed by the BRI Care Consultation program
2 secondary outcomes
Absolute change in the Functional Assessment of Cancer Therapy - General (FACT-G) score
Time frame: 1 year
Absolute change in Patient Reported Outcomes- Common Toxicity Criteria for Adverse Events (PRO-CTCAE) scores
Time frame: 1 year
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2023.
- Background: PubMed 27921222Saria MG, Courchesne N, Evangelista L, Carter J, MacManus DA, Gorman MK, Nyamathi AM, Phillips LR, Piccioni D, Kesari S, Maliski S. Cognitive dysfunction in patients with brain metastases: influences on caregiver resilience and coping. Support Care Cancer. 2017 Apr;25(4):1247-1256. doi: 10.1007/s00520-016-3517-3. Epub 2016 Dec 5.
- Background: PubMed 28189161Saria MG, Nyamathi A, Phillips LR, Stanton AL, Evangelista L, Kesari S, Maliski S. The Hidden Morbidity of Cancer: Burden in Caregivers of Patients with Brain Metastases. Nurs Clin North Am. 2017 Mar;52(1):159-178. doi: 10.1016/j.cnur.2016.10.002.
- 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.
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 Benjamin Rose Institute (BRI) Care Consultation™ Program in people with Cancer and Clinical Trials, run by Saint John's Cancer 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 6 inclusion and 0 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: withdrawn, as of the sponsor's last update on 13 Apr 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 was withdrawn before enrolling participants, so there are no results.
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?
Absolute change in the Caregiver Reaction Assessment (CRA) score (time frame: 1 year). 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 NCT03069287, which also lists 2 linked publications.
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 13 Apr 2023.