Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01846520
Other study ID # 08176
Secondary ID NCI-2013-00839
Status Completed
Phase N/A
First received
Last updated
Start date October 2013
Est. completion date May 23, 2019

Study information

Verified date January 2020
Source City of Hope Medical Center
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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. Education and telephone counseling may reduce stress and improve the well-being and quality of life of caregivers of cancer patients.


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


Recruitment information / eligibility

Status Completed
Enrollment 200
Est. completion date May 23, 2019
Est. primary completion date May 23, 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Related Conditions & MeSH terms

  • Carcinoma
  • Carcinoma, Ovarian Epithelial
  • Carcinoma, Renal Cell
  • Carcinoma, Transitional Cell
  • Colonic Neoplasms
  • Germinoma
  • Healthy Subject
  • Kidney Neoplasms
  • Localized Transitional Cell Cancer of the Renal Pelvis and Ureter
  • Lung Neoplasms
  • Metastatic Transitional Cell Cancer of the Renal Pelvis and Ureter
  • Neoplasms, Germ Cell and Embryonal
  • Ovarian Neoplasms
  • Pancreatic Neoplasms
  • Psychosocial Effects of Cancer and Its Treatment
  • Rectal Neoplasms
  • 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
  • Sarcoma
  • 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 Lung Carcinoma
  • 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 Lung Carcinoma
  • 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 Lung Carcinoma
  • 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 Lung Carcinoma
  • 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
  • Stomach Neoplasms
  • Ureter Cancer
  • Ureteral Neoplasms
  • Urethral Neoplasms
  • Urinary Bladder Neoplasms
  • Uterine Cervical Neoplasms

Intervention

Other:
educational intervention
Receive FCPCI home education sessions
Behavioral:
telephone-based intervention
Receive FCPCI telephone support sessions and 24 hour telephone support
Procedure:
quality-of-life assessment
Ancillary studies
Other:
questionnaire administration
Ancillary studies

Locations

Country Name City State
United States City of Hope Medical Center Duarte California

Sponsors (3)

Lead Sponsor Collaborator
City of Hope Medical Center American Cancer Society (ACS) National Office, National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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). Up to 6 months
Primary Effects of FCPCI on caregiving skills preparedness ANCOVA will be used to test group differences. Caregiver burden subscales may be tested using MANCOVA. Up to 6 months
Primary 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. Up to 6 months
Primary 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. Up to 6 months
Secondary 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. Up to 6 months
Secondary 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. Up to 6 months
Secondary 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. 3 months
Secondary 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. 6 months
Secondary Caregiver out-of-pocket costs A descriptive analysis of family caregivers' costs will be conducted. Up to 6 months
See also
  Status Clinical Trial Phase
Completed NCT01434290 - Radiation Therapy in Treating Patients With Prostate Cancer Phase 2
Completed NCT00830635 - Multimedia Educational Program for Patients With Early-Stage Prostate Cancer or Breast Cancer N/A
Completed NCT00466830 - Psychological and Social Factors That May Increase the Risk of Developing Chronic Pain After Surgery in Women With Breast Cancer N/A
Completed NCT00951626 - A Standardized Nursing Intervention Protocol for HCT Patients N/A
Withdrawn NCT00397501 - BBBD Followed By Methotrexate and Carboplatin With or Without Trastuzumab in Treating Women With Breast Cancer That Has Spread to the Brain Phase 1/Phase 2
Completed NCT01417507 - Natural History of Brain Function, Quality of Life, and Seizure Control in Patients With Brain Tumor Who Have Undergone Surgery N/A
Completed NCT01217424 - Reflexology or Aromatherapy Massage in Relieving Symptoms in Patients With Cancer N/A
Completed NCT00956475 - Quality of Life in Younger Leukemia and Lymphoma Survivors Phase 1
Withdrawn NCT00873600 - Outpatient Health Care Program for Older Patients Receiving Chemotherapy for Newly Diagnosed Breast Cancer or Colon Cancer N/A
Completed NCT00932997 - Survivorship Booklets With or Without Individual Telephone Sessions in Increasing Knowledge About the Impact of Breast Cancer in African American and Latina Breast Cancer Survivors N/A
Completed NCT00400699 - Radiation Therapy Outreach Program for Minority or Low-Income Patients With Newly Diagnosed Cancer N/A
Completed NCT00915889 - Psychosocial Support for African-American, Latina-American, or European-American Cervical Cancer Survivors N/A
Completed NCT00410579 - Patient-Reported Outcomes in Long-Term Survivors of Colon and Rectal Cancers N/A
Completed NCT00363909 - Citalopram in Treating Postmenopausal Women With Hot Flashes Phase 3
Completed NCT00713505 - Educational and Skills Training Program for Parents of Childhood Cancer Survivors Who Have Neurobehavioral Dysfunction N/A
Withdrawn NCT00770419 - Perceptions of Burden in Patients With Late-Stage Cancer and Their Caregivers N/A
Recruiting NCT00503646 - Communication and Intimacy-Enhancing Therapy for Men With Early Stage Prostate Cancer and Their Partners N/A
Completed NCT00755313 - Effects of Chemotherapy on the Brain in Women With Newly Diagnosed Early-Stage Breast Cancer N/A
Completed NCT00372840 - Printed Education Materials in Patients Who Are Finishing Treatment for Stage I, Stage II, or Stage IIIA Breast Cancer, Colorectal Cancer, Prostate Cancer, or Chest Cancer N/A
Completed NCT00085176 - Neurobehavioral Complications in Children Who Were Previously Treated With Steroids and Intrathecal Therapy for Acute Lymphoblastic Leukemia N/A