Healthy SubjectNCT01846520
Family Caregiver Palliative Care Intervention in Supporting Caregivers of Patients With Stage II-IV Gastrointestinal, Gynecologic, Urologic and Lung Cancers
A study testing educational intervention, telephone-based intervention and quality-of-life assessment in people with Healthy Subject and Localized Transitional Cell Cancer of the Renal Pelvis and Ureter, run by City of Hope Medical Center at 1 site in United States.
Trial summary
This randomized clinical trial studies the Family Caregiver Palliative Care Intervention in supporting caregivers of patients with stage II-IV gastrointestinal, gynecologic, urologic and lung cancers. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy Subject, Localized Transitional Cell Cancer of the Renal Pelvis and Ureter, Metastatic Transitional Cell Cancer of the Renal Pelvis and Ureter
- What is being tested?
- educational intervention, telephone-based intervention and quality-of-life assessment
- Type of treatment
- Surgery or procedure, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteUnited States
- Study dates
- 29 Oct 2013to 23 May 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
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Primary family caregivers of cancer patients with gastrointestinal (colorectal, pancreatic, gastric), gynecologic, urinary or lung cancers who are entering the City of Hope for treatment or follow-up
- Primary family caregivers of cancer patients who are diagnosed with stage II-IV disease
- Primary family caregivers of cancer patients with > 6 months prognosis
- Living within a 50 mile radius of the City of Hope
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
City of Hope Medical Center
Duarte, California, 91010
About this study
Official title: A Randomized Trial of a Family Caregiver Palliative Care Intervention
This randomized clinical trial studies the Family Caregiver Palliative Care Intervention in supporting caregivers of patients with stage II-IV gastrointestinal, gynecologic, urologic and lung cancers. Education and telephone counseling may reduce stress and improve the well-being and quality of life of caregivers of cancer patients.
Read the detailed description
PRIMARY OBJECTIVES: I. Test the effects of the Family Caregiver Palliative Care Intervention (FCPCI) on family caregivers of patients with gastrointestinal, gynecologic, urologic and lung cancers in the experimental group on caregiver burden and caregiving skills preparedness as compared to family caregivers in the control group.
II. Test the effects of the FCPCI on family caregivers of patients with gastrointestinal, gynecologic, urologic and lung cancers in the experimental group on quality of life (QOL) and psychological distress as compared to family caregivers in the control group.
SECONDARY OBJECTIVES: I. Describe family caregivers' self-care behavior, comparing the experimental and control groups.
II. Describe family caregivers' resource use, comparing the experimental and control groups.
III. Identify subgroups of family caregivers who benefit most from the FCPCI in relation to sociodemographic, health status, and patient characteristics.
IV. Describe family caregivers' satisfaction with the FCPCI.
- Describe caregiver out-of-pocket costs and the cost of the intervention.
OUTLINE: Participants are randomized to 1 of 2 arms.
ARM I: Participants receive FCPCI with an advanced practice nurse (APN), comprising 4 home education sessions once weekly followed by 4 telephone support sessions for 30 minutes once monthly and 24 hour telephone support available for 6 months.
ARM II: Participants receive usual care
- Conditions
- Healthy Subject, Localized Transitional Cell Cancer of the Renal Pelvis and Ureter, Metastatic Transitional Cell Cancer of the Renal Pelvis and Ureter, Psychosocial Effects of Cancer and Its Treatment, Recurrent Bladder Cancer, Recurrent Cervical Cancer
- Being tested
- educational intervention, telephone-based intervention, quality-of-life assessment, questionnaire administration
- Medical subject headings
- Urinary Bladder Neoplasms, Uterine Cervical Neoplasms, Colonic Neoplasms, Stomach Neoplasms, Carcinoma, Ovarian Epithelial, Pancreatic Neoplasms, Rectal Neoplasms, Carcinoma, Renal Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
educational interventionOther
Also called intervention, educational
Receive FCPCI home education sessions
telephone-based interventionBehavioural
Receive FCPCI telephone support sessions and 24 hour telephone support
quality-of-life assessmentProcedure or surgery
Also called quality of life assessment
Ancillary studies
questionnaire administrationOther
Ancillary studies
| Study group | Role | What they receive |
|---|---|---|
| Arm I (FCPCI) | Experimental | Participants receive FCPCI with an APN, comprising 4 home education sessions once weekly followed by 4 telephone support sessions for 30 minutes once monthly and 24 hour telephone support available for 6 months. Receives: Other: educational intervention; Behavioral: telephone-based intervention; Procedure: quality-of-life assessment; Other: questionnaire administration |
| Arm II (usual care) | No intervention | Participants receive usual care. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effects of Family Caregiver Palliative Care Intervention (FCPCI) on caregiver burden
Analysis of covariance (ANCOVA) will be used to test group differences. Caregiver burden subscales may be tested using multivariate ANCOVA (MANCOVA).
Measured: Up to 6 months
Effects of FCPCI on caregiving skills preparedness
ANCOVA will be used to test group differences. Caregiver burden subscales may be tested using MANCOVA.
Measured: Up to 6 months
Effects of FCPCI on Quality Of Life (QOL)
ANCOVA will be used to test group differences. MANCOVA may be used to test group differences of QOL subscale scores.
Measured: Up to 6 months
Effects of FCPCI on psychological distress
ANCOVA will be used to test group differences. MANCOVA may be used to test group differences of QOL subscale scores.
Measured: Up to 6 months
Secondary outcomes (5)
Caregiver's self-care behavior
Qualitative analyses will be conducted on the narrative responses to the Self-Care Behaviors instrument. Self-care behaviors will be coded within each category. Results will be reviewed for consensus and validation, and any discrepancies will be resolved. Tables of coded themes with examples will be created.
Measured: Up to 6 months
Caregivers' resource use
The qualitative analysis will be conducted on the narrative responses to the Resource Use instrument. Resources will be coded within each category. Results will be reviewed for consensus and validation, and any discrepancies will be resolved. Tables of categories and codes will be created.
Measured: Up to 6 months
Identification of subgroups of family caregivers who benefit most from the FCPCI in relation to sociodemographic, health status, and patient characteristics
In four separate hierarchical multiple linear regression analyses, the 3 month outcome measure (caregiver burden, skills preparedness, psychological distress, and total QOL) will be regressed first on baseline measures for the relevant outcomes, followed by demographic and caregiver health status variables, and then by patient characteristics and severity of illness, using dummy-coding as appropriate.
Measured: 3 months
Family caregivers' satisfaction with the FCPCI
A descriptive analysis of the brief satisfaction survey item results for subjects in the experimental group will be conducted, summarizing number and percent for normal data or means and standard deviations for continuous data.
Measured: 6 months
Caregiver out-of-pocket costs
A descriptive analysis of family caregivers' costs will be conducted.
Measured: Up to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2013 (estimated)
- Study start29 Oct 2013
- Primary completion23 May 2019
- Study completion23 May 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy SubjectStudies of the same condition, open and under way.
- More trials run by City of Hope Medical 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- City of Hope Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI), American Cancer Society (ACS) National Office
- Responsible party
- Sponsor
- Investigators
- Betty Ferrell, Principal investigator, City of Hope Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01846520
- Sponsor's protocol ID
- 08176
- Other IDs
- NCI-2013-00839
- Status last verified
- Sep 2026
- First submitted
- 1 May 2013
- Last updated
- 1 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Trial of a Family Caregiver Palliative Care Intervention
- ClinicalTrials.gov ID
- NCT01846520
- Acronym / sponsor ID
- 08176
- Conditions
- Healthy Subject, Localized Transitional Cell Cancer of the Renal Pelvis and Ureter, Metastatic Transitional Cell Cancer of the Renal Pelvis and Ureter, Psychosocial Effects of Cancer and Its Treatment, Recurrent Bladder Cancer, Recurrent Cervical Cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- City of Hope Medical CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI), American Cancer Society (ACS) National Office
- Study start
- 29 Oct 2013 (actual)
- Primary completion
- 23 May 2019 (actual)
- Study completion
- 23 May 2019 (actual)
- First posted
- 3 May 2013 (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 clinical trial studies the Family Caregiver Palliative Care Intervention in supporting caregivers of patients with stage II-IV gastrointestinal, gynecologic, urologic and lung cancers. Education and telephone counseling may reduce stress and improve the well-being and quality of life of caregivers of cancer patients.
Detailed description
PRIMARY OBJECTIVES: I. Test the effects of the Family Caregiver Palliative Care Intervention (FCPCI) on family caregivers of patients with gastrointestinal, gynecologic, urologic and lung cancers in the experimental group on caregiver burden and caregiving skills preparedness as compared to family caregivers in the control group.
II. Test the effects of the FCPCI on family caregivers of patients with gastrointestinal, gynecologic, urologic and lung cancers in the experimental group on quality of life (QOL) and psychological distress as compared to family caregivers in the control group.
SECONDARY OBJECTIVES: I. Describe family caregivers' self-care behavior, comparing the experimental and control groups.
II. Describe family caregivers' resource use, comparing the experimental and control groups.
III. Identify subgroups of family caregivers who benefit most from the FCPCI in relation to sociodemographic, health status, and patient characteristics.
IV. Describe family caregivers' satisfaction with the FCPCI.
- Describe caregiver out-of-pocket costs and the cost of the intervention.
OUTLINE: Participants are randomized to 1 of 2 arms.
ARM I: Participants receive FCPCI with an advanced practice nurse (APN), comprising 4 home education sessions once weekly followed by 4 telephone support sessions for 30 minutes once monthly and 24 hour telephone support available for 6 months.
ARM II: Participants receive usual care
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm I (FCPCI) | Experimental | Other: educational intervention, Behavioral: telephone-based intervention, Procedure: quality-of-life assessment, Other: questionnaire administrationParticipants receive FCPCI with an APN, comprising 4 home education sessions once weekly followed by 4 telephone support sessions for 30 minutes once monthly and 24 hour telephone support available for 6 months. |
| Arm II (usual care) | No intervention | –Participants receive usual care. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Primary family caregivers of cancer patients with gastrointestinal (colorectal, pancreatic, gastric), gynecologic, urinary or lung cancers who are entering the City of Hope for treatment or follow-up
- Primary family caregivers of cancer patients who are diagnosed with stage II-IV disease
- Primary family caregivers of cancer patients with > 6 months prognosis
- Living within a 50 mile radius of the City of Hope
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 |
|---|---|---|
| educational interventionAlso: intervention, educationalReceive FCPCI home education sessions | Other | Arm I (FCPCI) |
| telephone-based interventionReceive FCPCI telephone support sessions and 24 hour telephone support | Behavioural | Arm I (FCPCI) |
| quality-of-life assessmentAlso: quality of life assessmentAncillary studies | Procedure or surgery | Arm I (FCPCI) |
| questionnaire administrationAncillary studies | Other | Arm I (FCPCI) |
Primary outcome
Effects of Family Caregiver Palliative Care Intervention (FCPCI) on caregiver burden
Time frame: Up to 6 months
Analysis of covariance (ANCOVA) will be used to test group differences. Caregiver burden subscales may be tested using multivariate ANCOVA (MANCOVA).
Effects of FCPCI on caregiving skills preparedness
Time frame: Up to 6 months
ANCOVA will be used to test group differences. Caregiver burden subscales may be tested using MANCOVA.
Effects of FCPCI on Quality Of Life (QOL)
Time frame: Up to 6 months
ANCOVA will be used to test group differences. MANCOVA may be used to test group differences of QOL subscale scores.
Effects of FCPCI on psychological distress
Time frame: Up to 6 months
ANCOVA will be used to test group differences. MANCOVA may be used to test group differences of QOL subscale scores.
5 secondary outcomes
Caregiver's self-care behavior
Time frame: Up to 6 months
Caregivers' resource use
Time frame: Up to 6 months
Identification of subgroups of family caregivers who benefit most from the FCPCI in relation to sociodemographic, health status, and patient characteristics
Time frame: 3 months
Family caregivers' satisfaction with the FCPCI
Time frame: 6 months
Caregiver out-of-pocket costs
Time frame: Up to 6 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 2026.
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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.
Betty Ferrell principal investigator
City of Hope Medical 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 educational intervention, telephone-based intervention and quality-of-life assessment in people with Healthy Subject and Localized Transitional Cell Cancer of the Renal Pelvis and Ureter, run by City of Hope Medical 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 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: finished, as of the sponsor's last update on 1 Oct 2026. 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?
Effects of Family Caregiver Palliative Care Intervention (FCPCI) on caregiver burden (time frame: Up to 6 months). The study lists 4 primary outcomes in all. 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 2026.