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Stage IIA Pancreatic CancerNCT02307539

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

A study testing Psychosocial Assessment and Care, Palliative Therapy and Quality-of-Life Assessment in people with Stage IIA Pancreatic Cancer and Stage IIB Pancreatic Cancer, run by City of Hope Medical Center at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 21 years and older
What is being tested?
Psychosocial Assessment and Care, Palliative Therapy and Quality-of-Life Assessment
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
10 participants
Where
1 siteUnited States
Study dates
Nov 2014to May 2015
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 21 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

United States1 site

  • City of Hope Medical Center

    Duarte, California, 91010

Other trials in United States

About this study

Official title: Feasibility of an Interdisciplinary Palliative Care Planning Intervention in 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.

Read the detailed description

PRIMARY OBJECTIVES:

  1. 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:

  1. 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.

Being tested
Psychosocial Assessment and Care, Palliative Therapy, Quality-of-Life Assessment, Questionnaire Administration
Medical subject headings
Pancreatic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Psychosocial Assessment and CareProcedure or surgery

    Also called Psychosocial Assessment, Psychosocial Care, Psychosocial Care/Assessment, Psychosocial Studies

    Undergo PCPI

  • Palliative TherapyOther

    Also called Comfort Care, Palliative Care, Palliative Treatment, Symptom Management

    Undergo PCPI

  • Quality-of-Life AssessmentOther

    Also called Quality of Life Assessment

    Undergo QOL assessment

  • Questionnaire AdministrationOther

    Undergo questionnaire administration

Study groups in NCT02307539
Study groupRoleWhat they receive
Supportive care (PCPI intervention)ExperimentalPatients 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.
Receives: Procedure: Psychosocial Assessment and Care; Other: Palliative Therapy; Other: Quality-of-Life Assessment; Other: Questionnaire Administration

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Reasons for refusal to participate

    Descriptive statistics will be provided.

    Measured: Up to 2 months

  2. Reasons for failure to complete study

    Descriptive statistics will be provided.

    Measured: Up to 2 months

  3. Attendance at two educational sessions

    Descriptive statistics will be provided.

    Measured: Up to 2 months

  4. Completion of intervention

    Descriptive statistics will be provided.

    Measured: Up to 2 months

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

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

    Measured: Up to 2 months

  6. 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.

    Measured: Up to 2 months

Secondary outcomes (3)

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

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

    Measured: Up to 2 months

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

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

    Measured: Up to 2 months

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

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

    Measured: Up to 2 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Dec 2014 (estimated)
  2. Study startNov 2014
  3. Primary completionMay 2015
  4. Study completionMay 2015

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
10 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02307539
Sponsor's protocol ID
14273
Other IDs
NCI-2014-02367, 14273, U24NR014637
Status last verified
Jun 2015
First submitted
2 Dec 2014
Last updated
3 Jun 2015
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A study testing Psychosocial Assessment and Care, Palliative Therapy and Quality-of-Life Assessment in people with Stage IIA Pancreatic Cancer and Stage IIB Pancreatic Cancer, run by City of Hope Medical Center at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 3 Jun 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Reasons for refusal to participate (time frame: Up to 2 months). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02307539.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jun 2015; AzTrials last refreshed its copy on 8 Nov 2026.

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