Palliative Care in Improving Quality of Life in Patients With Newly Diagnosed Pancreatic Cancer

NCT02307539 | Completed DMC

• 3 other identifiers: 14273NCI-2014-02367U24NR014637
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

This pilot clinical trial studies a palliative care program in improving the quality of life of patients with newly diagnosed pancreatic cancer. Palliative care is care given to patients who have a serious or life-threatening disease, and focuses on managing disease symptoms, side effects of treatment or the disease, and improving patient quality of life. Studying a palliative care program used for other types of cancer may help doctors learn whether it can improve the quality of life of patients with pancreatic cancer.

Conditions

Stage IIA Pancreatic Cancer; Stage IIB Pancreatic Cancer; Stage III Pancreatic Cancer; Stage IV Pancreatic Cancer

Outcome Measures

Primary Outcomes (6)

• Reasons for refusal to participate

  Descriptive statistics will be provided.

  Up to 2 months

• Reasons for failure to complete study

  Descriptive statistics will be provided.

  Up to 2 months

• Attendance at two educational sessions

  Descriptive statistics will be provided.

  Up to 2 months

• Completion of intervention

  Descriptive statistics will be provided.

  Up to 2 months

• Patient satisfaction with timing, content, and delivery of PCPI

  Presented through summary statistics of data from the patient satisfaction tool.

  Up to 2 months

• Qualitative interview data

  Each interview transcript will be initially reviewed to provide a glimpse of potential domains and targets. Content analysis will be conducted on the transcribed qualitative data. Transcripts will be assigned codes. Content analysis occurring through coding consisting of line-by-line analysis with themes identified will be initiated. The research team will independently analyze selected segments of the data to verify themes. Coding will be checked and validated by the principal investigator and research team.

  Up to 2 months

Secondary Outcomes (3)

• Healthcare resource utilization, as measured by the Report of Healthcare Services Form

  Up to 2 months

• Overall cost, as measured by the Finances and Out of Pocket Costs Tool

  Up to 2 months

• Patient/family out of pocket expenses, as measured by the Finances and Out of Pocket Costs Tool

  Up to 2 months

Study Arms (1)

Supportive care (PCPI intervention)

EXPERIMENTAL

Patients receive a handbook titled "Supporting You During Cancer Treatment" with educational material on QOL issues. Patients undergo 2 education sessions on handbook material in-person or by telephone, with session 1 focusing on physical and social well-being issues and session 2 focusing on psychological and spiritual well-being issues. At the beginning of each session, patients select 3 priority topics from a list, and content is tailored to patient needs.

Procedure: Psychosocial Assessment and Care; Other: Palliative Therapy; Other: Quality-of-Life Assessment; Other: Questionnaire Administration

Interventions

Psychosocial Assessment and Care PROCEDURE

Undergo PCPI

Also known as: Psychosocial Assessment, Psychosocial Care, Psychosocial Care/Assessment, Psychosocial Studies, Psychosocial Support

Supportive care (PCPI intervention)

Palliative Therapy OTHER

Undergo PCPI

Also known as: Comfort Care, Palliative Care, Palliative Treatment, Symptom Management

Supportive care (PCPI intervention)

Quality-of-Life Assessment OTHER

Undergo QOL assessment

Also known as: Quality of Life Assessment

Supportive care (PCPI intervention)

Questionnaire Administration OTHER

Undergo questionnaire administration

Supportive care (PCPI intervention)

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Pathologically confirmed, new diagnosis of borderline resectable, locally advanced resectable/unresectable, or metastatic pancreatic cancer
• Patients who are scheduled to receive treatments (neoadjuvant therapy, surgery, adjuvant therapy, or palliative chemotherapy) at City of Hope (COH)
• All subjects must have the ability to understand and the willingness to provide informed consent

You may not qualify if:

• Subjects, who in the opinion of the investigator, may not be able to comply with the safety monitoring requirements of the study

Sponsors & Collaborators

• City of Hope Medical Center: lead
• National Cancer Institute (NCI): collaborator
• National Institute of Nursing Research (NINR): collaborator

Study Sites (1)

City of Hope Medical Center

Duarte, California, 91010, United States

Location

MeSH Terms

Conditions

Pancreatic Neoplasms

Interventions

Psychiatric Rehabilitation; Palliative Care; Patient Comfort

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Rehabilitation; Therapeutics; Health Services; Health Care Facilities Workforce and Services; Patient Care

Study Officials

• Virginia Sun

  City of Hope Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 2, 2014
• First Posted: December 4, 2014
• Study Start: November 1, 2014
• Primary Completion: May 1, 2015
• Study Completion: May 1, 2015
• Last Updated: June 3, 2015

Record last verified: 2015-06

Locations

US (1)