ClinicalTrials.gg
CompletedNCT01846520Updated Oct 1, 2026

Family Caregiver Palliative Care Intervention in Supporting Caregivers of Patients With Stage II-IV Gastrointestinal, Gynecologic, Urologic and Lung Cancers

An interventional study of educational intervention and telephone-based intervention in Healthy Subject, Localized Transitional Cell Cancer of the Renal Pelvis and Ureter and Metastatic Transitional Cell Cancer of the Renal Pelvis and Ureter, sponsored by City of Hope Medical Center. Completed at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-10-01.

Sponsored by City of Hope Medical Center · Not applicable, Interventional, and Supportive care

Phase
Not applicable
Study type
Interventional
Enrollment
200
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 881 studies in Urinary Bladder Neoplasms with a site in United States — 162 open to participants now, 267 under way, 31 of them phase 3. Urinary Bladder Neoplasms · United States.

Planned enrollment
119th of 714
200 · median 46
Started
2013
with 26 others
No phase
121 of 881
32 open now
Registered
282nd of 881
by date

Among the 881 studies in Urinary Bladder Neoplasms with a site in United States, this one is the 119th largest by planned enrollment of the 714 interventional ones that give a count, is one of 27 that started in 2013, is one of 121 with no phase, and was the 282nd registered.

Urinary Bladder Neoplasms

1,798 studies on the registry are indexed under Urinary Bladder Neoplasms; 445 are open to participants now.

Browse Urinary Bladder Neoplasms studies →

Open to participants now

162 of the 881 studies in Urinary Bladder Neoplasms with a site in United States are open now. Recruiting first, the newest first:

157 more — sign in →

All 162 open studies →

A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →

Who these studies take

Of the 336 Urinary Bladder Neoplasms studies recruiting now, 256 (76%) set no upper age limit and 22 (7%) stop at 75 or younger; 22 take children under 18; 21 take healthy volunteers.

This study: 18 Years and older · all sexes · healthy volunteers too.

The full table on the hub →

This tab as a report to print or save as PDF → With an account.

Was this useful?
Watch this landscapeDownload CSVNarrow it in search →With an account: a weekly mail of what changed among 881 studies in Urinary Bladder Neoplasms with a site in United States, or all of them as a file.
02

Study 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. 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.

V. 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

03

Conditions studied

  • 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
  • Recurrent Colon Cancer
  • Recurrent Gastric Cancer
  • Recurrent Ovarian Epithelial Cancer
  • Recurrent Ovarian Germ Cell Tumor
  • Recurrent Pancreatic Cancer
  • Recurrent Rectal Cancer
  • Recurrent Renal Cell Cancer
  • Recurrent Transitional Cell Cancer of the Renal Pelvis and Ureter
  • Recurrent Urethral Cancer
  • Recurrent Uterine Sarcoma
  • Regional Transitional Cell Cancer of the Renal Pelvis and Ureter
  • Stage II Bladder Cancer
  • Stage II Renal Cell Cancer
  • Stage II Urethral Cancer
  • Stage IIA Cervical Cancer
  • Stage IIA Colon Cancer
  • Stage IIA Gastric Cancer
  • Stage IIA Ovarian Epithelial Cancer
  • Stage IIA Ovarian Germ Cell Tumor
  • Stage IIA Pancreatic Cancer
  • Stage IIA Rectal Cancer
  • Stage IIA Uterine Sarcoma
  • Stage IIB Cervical Cancer
  • Stage IIB Colon Cancer
  • Stage IIB Gastric Cancer
  • Stage IIB Ovarian Epithelial Cancer
  • Stage IIB Ovarian Germ Cell Tumor
  • Stage IIB Pancreatic Cancer
  • Stage IIB Rectal Cancer
  • Stage IIB Uterine Sarcoma
  • Stage IIC Colon Cancer
  • Stage IIC Ovarian Epithelial Cancer
  • Stage IIC Ovarian Germ Cell Tumor
  • Stage IIC Rectal Cancer
  • Stage III Bladder Cancer
  • Stage III Pancreatic Cancer
  • Stage III Renal Cell Cancer
  • Stage III Urethral Cancer
  • Stage IIIA Cervical Cancer
  • Stage IIIA Colon Cancer
  • Stage IIIA Gastric Cancer
  • Stage IIIA Ovarian Epithelial Cancer
  • Stage IIIA Ovarian Germ Cell Tumor
  • Stage IIIA Rectal Cancer
  • Stage IIIA Uterine Sarcoma
  • Stage IIIB Cervical Cancer
  • Stage IIIB Colon Cancer
  • Stage IIIB Gastric Cancer
  • Stage IIIB Ovarian Epithelial Cancer
  • Stage IIIB Ovarian Germ Cell Tumor
  • Stage IIIB Rectal Cancer
  • Stage IIIB Uterine Sarcoma
  • Stage IIIC Colon Cancer
  • Stage IIIC Gastric Cancer
  • Stage IIIC Ovarian Epithelial Cancer
  • Stage IIIC Ovarian Germ Cell Tumor
  • Stage IIIC Rectal Cancer
  • Stage IIIC Uterine Sarcoma
  • Stage IV Bladder Cancer
  • Stage IV Gastric Cancer
  • Stage IV Ovarian Epithelial Cancer
  • Stage IV Ovarian Germ Cell Tumor
  • Stage IV Pancreatic Cancer
  • Stage IV Renal Cell Cancer
  • Stage IV Urethral Cancer
  • Stage IVA Cervical Cancer
  • Stage IVA Colon Cancer
  • Stage IVA Rectal Cancer
  • Stage IVA Uterine Sarcoma
  • Stage IVB Cervical Cancer
  • Stage IVB Colon Cancer
  • Stage IVB Rectal Cancer
  • Stage IVB Uterine Sarcoma
  • Ureter Cancer
  • Stage IIA Lung Carcinoma
  • Stage IIB Lung Carcinoma
  • Stage IIIA Lung Carcinoma
  • Stage IIIB Lung Carcinoma
04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Eligibility criteria

Inclusion Criteria:

  • 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
05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
200 participants (estimated)

Study arms

  • Experimental
    Arm I (FCPCI)

    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.

    Other: educational intervention · Behavioral: telephone-based intervention · Procedure: quality-of-life assessment · Other: questionnaire administration

  • No intervention
    Arm II (usual care)

    Participants receive usual care.

Interventions

  • Othereducational intervention

    Receive FCPCI home education sessions

    Also known as: intervention, educational

  • Behavioraltelephone-based intervention

    Receive FCPCI telephone support sessions and 24 hour telephone support

  • Procedurequality-of-life assessment

    Ancillary studies

    Also known as: quality of life assessment

  • Otherquestionnaire administration

    Ancillary studies

06

What researchers measure

Primary outcomes

  1. 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).

    Time frame: Up to 6 months

  2. Effects of FCPCI on caregiving skills preparedness

    ANCOVA will be used to test group differences. Caregiver burden subscales may be tested using MANCOVA.

    Time frame: Up to 6 months

  3. 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.

    Time frame: Up to 6 months

  4. 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.

    Time frame: Up to 6 months

Secondary outcomes

  1. 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.

    Time frame: Up to 6 months

  2. 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.

    Time frame: Up to 6 months

  3. 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.

    Time frame: 3 months

  4. 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.

    Time frame: 6 months

  5. Caregiver out-of-pocket costs

    A descriptive analysis of family caregivers' costs will be conducted.

    Time frame: Up to 6 months

07

Study locations

1 site
  • City of Hope Medical Center
    Duarte, California 91010, United States
08

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Oct 2013 to primary completion in May 2019, 66 months.

Of 235 non-industry interventional studies with no phase under Urinary Bladder Neoplasms, half reached primary completion within 40 months of starting (the median), counting those still running; a quarter within 21 and three quarters within 70. This study's 66 months is above that.

Counting every sponsor, half of 244 studies reached it within 39 months; a quarter within 20 and three quarters within 69.

How these figures are worked out, and which studies are left out of them.

Registered
May 1, 2013
First posted
May 3, 2013
StartActual
Oct 29, 2013
Primary completionActual
May 23, 2019
CompletionActual
May 23, 2019
Last update
Oct 1, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Minor edits
Nothing that changes what the study is or who can join. Edited: verification date, date precision and index terms
1 update, last Oct 1, 2026
Show all 1 update
  1. Oct 1, 2026
    Minor edits only
    + 3 other changes: verification date, date precision and index terms

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

09

Registry details

Key details

Study ID
NCT01846520
Collaborators
National Cancer Institute (NCI), American Cancer Society (ACS) National Office
Responsible party
Sponsor
First posted
May 3, 2013
Start date
Oct 29, 2013
Primary completion
May 23, 2019
Completion
May 23, 2019
Last update
Oct 1, 2026

Study contacts

Betty Ferrell
principal investigator · City of Hope Medical Center

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion