Back to resultsA Pilot Study of a Home-Based Walking Intervention for Pancreatic Cancer Patients
Primary Purpose
Cancer of Pancreas
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Walking Intervention
Sponsored by
About this trial
This is an interventional supportive care trial for Cancer of Pancreas
Eligibility Criteria
Inclusion Criteria:
- Patients aged 18 years or older
- Have histologically confirmed adenocarcinoma of the pancreas (including adenocarcinoma subtypes such as signet ring carcinoma, adenosquamous carcinoma, undifferentiated/poorly differentiated carcinoma, and mucinous carcinoma)
- Have an estimated life expectancy of greater than 3 months
- Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2
- Are undergoing treatment for pancreatic cancer at Fox Chase Cancer Center
- Have borderline resectable or unresectable locally advanced disease or metastatic disease
Exclusion Criteria:
- Patients with islet cell/neuroendocrine or papillary cystic neoplasm
- Patients scheduled to undergo surgical resection for curative intent during study participation
- Patients receiving 3rd-line palliative chemotherapy
- Inability to communicate in English.
Sites / Locations
- Fox Chase Cancer Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Walking Intervention
Usual Care
Arm Description
Intervention patients will receive a 12-week home-based walking program, which includes a personalized instruction booklet and pedometer. The walking program consists of 3 phases and will be individualized for each patient based on their physical condition and baseline assessment. Patients are instructed to walk 3 to 5 times each week at home or other safe environment. Patients will be instructed on a gradual increase in walking time over the course of the intervention.
Usual care patients will receive standard of care. They will not receive any instruction on walking or other physical activity other than what is normally provided by their physician or clinical staff.
Outcomes
Primary Outcome Measures
Patient-reported outcome of quality of life
Quality of life will be measured using the FACT-Hep, a validated tool that assesses 4 components of quality of life (physical well-being, emotional well-being, social well-being, and functional well-being), as well as common symptoms associated with hepatobiliary cancers, including pancreatic cancer.
Secondary Outcome Measures
Full Information
NCT ID
NCT02442323
First Posted
March 18, 2015
Last Updated
January 2, 2021
Sponsor
Fox Chase Cancer Center
1. Study Identification
Unique Protocol Identification Number
NCT02442323
Brief Title
A Pilot Study of a Home-Based Walking Intervention for Pancreatic Cancer Patients
Official Title
A Pilot Study of a Home-Based Walking Intervention for Pancreatic Cancer Patients
Study Type
Interventional
2. Study Status
Record Verification Date
January 2021
Overall Recruitment Status
Completed
Study Start Date
August 9, 2013 (Actual)
Primary Completion Date
August 30, 2020 (Actual)
Study Completion Date
November 30, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Fox Chase Cancer Center
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Despite evidence regarding the benefits of physical activity in various cancer patient populations, the effects of a home-based walking program for pancreatic cancer patients have been under-explored. The aims of the proposed pilot project are to: (1) Assess the feasibility of implementing a 12-week, home-based walking program among pancreatic cancer patients; and (2) Examine the effects of a 12-week, home-based walking program on quality of life (QOL) and symptoms among pancreatic cancer patients.
Detailed Description
Among cancer patients, physical activity interventions can lead to improvements in QOL and reductions in fatigue and pain. While pancreatic cancer patients may have physical restrictions that limit their participation in moderate to high-intensity exercise activities, empirical evidence suggests that even low-intensity, home-based walking programs can confer benefits for cancer patients. In this pilot study, 50 patients will be randomly assigned to receive either the walking intervention program or usual care (UC). Assessments of quality of life, distress, and symptom burden will be completed at baseline (pre-intervention) and at follow-up (i.e. within 2 weeks post-intervention or approximately 12-14 weeks post-baseline). Data from the proposed pilot study will inform the development of a larger randomized trial designed to improve QOL and reduce morbidity in this patient population.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cancer of Pancreas
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
50 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Walking Intervention
Arm Type
Experimental
Arm Description
Intervention patients will receive a 12-week home-based walking program, which includes a personalized instruction booklet and pedometer. The walking program consists of 3 phases and will be individualized for each patient based on their physical condition and baseline assessment. Patients are instructed to walk 3 to 5 times each week at home or other safe environment. Patients will be instructed on a gradual increase in walking time over the course of the intervention.
Arm Title
Usual Care
Arm Type
No Intervention
Arm Description
Usual care patients will receive standard of care. They will not receive any instruction on walking or other physical activity other than what is normally provided by their physician or clinical staff.
Intervention Type
Behavioral
Intervention Name(s)
Walking Intervention
Intervention Description
12-week walking program
Primary Outcome Measure Information:
Title
Patient-reported outcome of quality of life
Description
Quality of life will be measured using the FACT-Hep, a validated tool that assesses 4 components of quality of life (physical well-being, emotional well-being, social well-being, and functional well-being), as well as common symptoms associated with hepatobiliary cancers, including pancreatic cancer.
Time Frame
14 weeks post-baseline
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients aged 18 years or older
Have histologically confirmed adenocarcinoma of the pancreas (including adenocarcinoma subtypes such as signet ring carcinoma, adenosquamous carcinoma, undifferentiated/poorly differentiated carcinoma, and mucinous carcinoma)
Have an estimated life expectancy of greater than 3 months
Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2
Are undergoing treatment for pancreatic cancer at Fox Chase Cancer Center
Have borderline resectable or unresectable locally advanced disease or metastatic disease
Exclusion Criteria:
Patients with islet cell/neuroendocrine or papillary cystic neoplasm
Patients scheduled to undergo surgical resection for curative intent during study participation
Patients receiving 3rd-line palliative chemotherapy
Inability to communicate in English.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Carolyn Y Fang, PhD
Organizational Affiliation
Fox Chase Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Fox Chase Cancer Center
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19111
Country
United States
12. IPD Sharing Statement
Learn more about this trial
A Pilot Study of a Home-Based Walking Intervention for Pancreatic Cancer Patients
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