Neoplasms

Respiratory Tract (Lung and Bronchial) Diseases

All Conditions

Digestive System Diseases

Gland and Hormone Related Diseases

Symptoms and General Pathology

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Rare Diseases

Lung Neoplasms

Carcinoma

Stomach Neoplasms

Pancreatic Neoplasms

Recurrence

Carcinoma, Ovarian Epithelial

Urinary Bladder Neoplasms

Uterine Cervical Neoplasms

Carcinoma, Renal Cell

Sarcoma

Rectal Neoplasms

Colonic Neoplasms

Neoplasms, Germ Cell and Embryonal

Germinoma

Ovarian Neoplasms

Urethral Neoplasms

Carcinoma, Transitional Cell

Kidney Neoplasms

Ureteral Neoplasms

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Disease Attributes

Gastrointestinal Neoplasms

Digestive System Neoplasms

Endocrine Gland Neoplasms

Gastrointestinal Diseases

Pancreatic Diseases

Endocrine System Diseases

Neoplasms, Connective and Soft Tissue

Stomach Diseases

Colorectal Neoplasms

Intestinal Neoplasms

Intestinal Diseases

Rectal Diseases

Uterine Neoplasms

Genital Neoplasms, Female

Urogenital Neoplasms

Uterine Cervical Diseases

Uterine Diseases

Genital Diseases, Female

Genital Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Urologic Neoplasms

Urinary Bladder Diseases

Urologic Diseases

Male Urogenital Diseases

Colonic Diseases

Ovarian Diseases

Adnexal Diseases

Gonadal Disorders

Adenocarcinoma

Kidney Diseases

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Urethral Diseases

Ureteral Diseases

Stomach Cancer

Pancreatic Cancer

Ovarian Cancer

Ovarian Epithelial Cancer

Renal Cell Carcinoma

Soft Tissue Sarcoma

Germ Cells Tumors

Transitional Cell Cancer of the Renal Pelvis and Ureter

Ovarian Germ Cell Tumor

Uterine Sarcoma

Urethral Cancer

Central Nervous System Germinoma

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.

educational intervention

Receive FCPCI telephone support sessions and 24 hour telephone support

telephone-based intervention

quality-of-life assessment

questionnaire administration

Betty Ferrell

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.

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

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

A Randomized Trial of a Family Caregiver Palliative Care Intervention

Analysis of covariance (ANCOVA) will be used to test group differences. Caregiver burden subscales may be tested using multivariate ANCOVA (MANCOVA).

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

ANCOVA will be used to test group differences. MANCOVA may be used to test group differences of QOL subscale scores.

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.

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.

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.

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.

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

National Cancer Institute (NCI)

American Cancer Society (ACS) National Office

City of Hope Medical Center

Carcinoma, Non-Small-Cell Lung

Carcinoma, Bronchogenic

Bronchial Neoplasms

Anti-Infective Agents

All Drugs and Chemicals

Micronutrients

Antineoplastic Agents

Vitamins

Vitamin A

Retinol palmitate

Trace Elements

Antioxidants

Protective Agents

Retinol

Participants receive vitamin A compound PO for 7 consecutive days in the absence of disease progression or unacceptable toxicity. Within 21 days of completing treatment, participants then undergo surgical resection.

Description Participants undergo surgical resection.

Participants randomized to this arm will receive 7 consecutive days of of Vitamin A compound without disease progression or unacceptable toxicities. Within 21 days of completion of treatment participants will undergo surgical resection

Vitamin A Compound

Participants randomized to this arm will receive surgical resection

Therapeutic Conventional Surgery

William J Petty, MD

This trial studies how well high dose vitamin A compound works in treating participants with non-small cell lung cancer that can be removed by surgery. Vitamin A compound may increase the number of germinal centers (immune centers that make antibodies mature) in tumor and lymph tissues which may be beneficial to patients with cancer.

PRIMARY OBJECTIVES:

I. To compare the percentage of resected cancers containing germinal centers (GCs) in patients who receive neoadjuvant vitamin A compound (vitamin A) to controls.

SECONDARY OBJECTIVES:

I. To compare the abundance of GCs in adjacent lymph nodes in patients who receive neoadjuvant vitamin A to controls.

II. To compare histopathologic responses based on tumor necrosis in lung cancer patients who receive neoadjuvant vitamin A to controls.

III. To compare overall survival of patients who receive neoadjuvant vitamin A to controls.

EXPLORATORY OBJECTIVES:

I. To describe immunophenotypic changes of monocytes including myeloid derived suppressor cells (MDSCs) in pre- and post-treatment blood samples.

OUTLINE: Participants are randomized to 1 of 2 groups.

GROUP I: Participants receive vitamin A compound orally (PO) for 7 consecutive days in the absence of disease progression or unacceptable toxicity. Within 21 days of completing treatment, participants then undergo surgical resection.

GROUP II: Participants undergo surgical resection.

After completion of study treatment, participants are followed up for 30 days.

High Dose Vitamin A Compound in Treating Participants With Resectable Non-Small Cell Lung Cancer

A Pilot Study of Neoadjuvant High Dose Vitamin A for Resectable Non-Small Cell Lung Cancer

Presence/absence of germinal centers (GCs) in resected cancer tissues from patients who receive neoadjuvant vitamin A and controls.

Measurement of GCs per unit area in adjacent lymph nodes will be assessed using semi-quantitative designation (Score of high, moderate, low, or absent) in patients who receive neoadjuvant vitamin A and controls.

Pathologic response will be defined by tumor necrosis which will be dichotomized as present or absent in patients who receive neoadjuvant vitamin A and controls

Overall survival of patients receiving neoadjuvant Vitamin A and in controls.

Wake Forest University Health Sciences

Participants receive vitamin A compound PO for 7 consecutive days in the absence of disease progression or unacceptable toxicity. Within 21 days of completing treatment, participants then undergo surgical resection.

Vitamin A Compound: Participants randomized to this arm will receive 7 consecutive days of of Vitamin A compound without disease progression or unacceptable toxicities. Within 21 days of completion of treatment participants will undergo surgical resection

Description Participants undergo surgical resection.

Therapeutic Conventional Surgery: Participants randomized to this arm will receive surgical resection

Total

Age, Continuous

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

United States

Region of Enrollment

Study Coordinator

No samples were analyzed for outcomes and the study was stopped therefore data was not collected for outcome measures

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Family Caregiver Palliative Care Intervention in Supporting Caregivers of Patients With Stage II-IV Gastrointestinal, Gynecologic, Urologic and Lung Cancers	NCT01846520	Healthy Subject Localized Trans... Metastatic Tran... Psychosocial Ef... Recurrent Bladd... Recurrent Cervi... Recurrent Colon... Recurrent Gastr... Recurrent Ovari... Recurrent Ovari... Recurrent Pancr... Recurrent Recta... Recurrent Renal... Recurrent Trans... Recurrent Ureth... Recurrent Uteri... Regional Transi... Stage II Bladde... Stage II Renal ... Stage II Urethr... Stage IIA Cervi... Stage IIA Colon... Stage IIA Gastr... Stage IIA Ovari... Stage IIA Ovari... Stage IIA Pancr... Stage IIA Recta... Stage IIA Uteri... Stage IIB Cervi... Stage IIB Colon... Stage IIB Gastr... Stage IIB Ovari... Stage IIB Ovari... Stage IIB Pancr... Stage IIB Recta... Stage IIB Uteri... Stage IIC Colon... Stage IIC Ovari... Stage IIC Ovari... Stage IIC Recta... Stage III Bladd... Stage III Pancr... Stage III Renal... Stage III Ureth... Stage IIIA Cerv... Stage IIIA Colo... Stage IIIA Gast... Stage IIIA Ovar... Stage IIIA Ovar... Stage IIIA Rect... Stage IIIA Uter... Stage IIIB Cerv... Stage IIIB Colo... Stage IIIB Gast... Stage IIIB Ovar... Stage IIIB Ovar... Stage IIIB Rect... Stage IIIB Uter... Stage IIIC Colo... Stage IIIC Gast... Stage IIIC Ovar... Stage IIIC Ovar... Stage IIIC Rect... Stage IIIC Uter... Stage IV Bladde... Stage IV Gastri... Stage IV Ovaria... Stage IV Ovaria... Stage IV Pancre... Stage IV Renal ... Stage IV Urethr... Stage IVA Cervi... Stage IVA Colon... Stage IVA Recta... Stage IVA Uteri... Stage IVB Cervi... Stage IVB Colon... Stage IVB Recta... Stage IVB Uteri... Ureter Cancer Stage IIA Lung ... Stage IIB Lung ... Stage IIIA Lung... Stage IIIB Lung...	educational int... telephone-based... quality-of-life... questionnaire a...	18 Years -	City of Hope Medical Center
High Dose Vitamin A Compound in Treating Participants With Resectable Non-Small Cell Lung Cancer	NCT03870529	Non Small Cell ... Stage I Lung Ca... Stage Ib Lung C... Stage IA Lung C... Stage IIA Lung ... Stage IIIA Lung...	Vitamin A Compo... Therapeutic Con...	18 Years -	Wake Forest University Health Sciences
High Dose Vitamin A Compound in Treating Participants With Resectable Non-Small Cell Lung Cancer	NCT03870529	Non Small Cell ... Stage I Lung Ca... Stage Ib Lung C... Stage IA Lung C... Stage IIA Lung ... Stage IIIA Lung...	Vitamin A Compo... Therapeutic Con...	18 Years -	Wake Forest University Health Sciences

Spots Global Cancer Trial Database for stage iia lung carcinoma