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Completed

NCT Number: NCT02307539

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

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.

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Key information

Age range

21 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

City of Hope Medical Center

Duarte, California, 91010, United States

About this study

PRIMARY OBJECTIVES:

I. To pilot-test an interdisciplinary Palliative Care Planning Intervention (PCPI) in pancreatic cancer. Specifically, to describe patients' satisfaction with the timing, content, and delivery of the PCPI intervention.

SECONDARY OBJECTIVES:

I. To pilot-test all selected measures for the study, including measures for healthcare resource utilization, overall cost, and patient/family out of pocket expenses.

II. The long-term objective of this pilot study is to conduct a larger PCPI intervention study for pancreatic cancer patients and evaluate its impact on quality of life (QOL), symptom intensity, healthcare resource utilization, and healthcare costs.

OUTLINE:

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.

After completion of study, patients are followed up at 1 and 2 months.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

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

Treatment and study plan

psychosocial assessment and care

Procedure

Undergo PCPI

Other names: Psychosocial Assessment, Psychosocial Care, Psychosocial Care/Assessment, Psychosocial Studies, Psychosocial Support

Palliative Therapy

Other

Undergo PCPI

Other names: Comfort Care, Palliative Care, Palliative Treatment, Symptom Management

Quality-of-Life Assessment

Other

Undergo QOL assessment

Other names: Quality of Life Assessment

Questionnaire Administration

Other

Undergo questionnaire administration

Primary outcomes

  1. Reasons for refusal to participate

    Time frame: Up to 2 months

    Descriptive statistics will be provided.

  2. Reasons for failure to complete study

    Time frame: Up to 2 months

    Descriptive statistics will be provided.

  3. Attendance at two educational sessions

    Time frame: Up to 2 months

    Descriptive statistics will be provided.

  4. Completion of intervention

    Time frame: Up to 2 months

    Descriptive statistics will be provided.

  5. Patient satisfaction with timing, content, and delivery of PCPI

    Time frame: Up to 2 months

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

  6. Qualitative interview data

    Time frame: Up to 2 months

    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.

Secondary outcomes

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

    Time frame: Up to 2 months

    Data will be summarized using descriptive statistics. Established instruments will be scored according to standard instructions, and appropriate descriptive statistics computed.

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

    Time frame: Up to 2 months

    Data will be summarized using descriptive statistics. Established instruments will be scored according to standard instructions, and appropriate descriptive statistics computed.

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

    Time frame: Up to 2 months

    Data will be summarized using descriptive statistics. Established instruments will be scored according to standard instructions, and appropriate descriptive statistics computed.

Sponsors and collaborators

Lead sponsor

City of Hope Medical Center

Other

Collaborators

  • National Cancer Institute (NCI)
  • National Institute of Nursing Research (NINR)

Registry information

Official study title

Feasibility of an Interdisciplinary Palliative Care Planning Intervention in Pancreatic Cancer

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Dec 4, 2014
Registry last updated
Jun 3, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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