A Pilot Study Of A Home-Based Walking Intervention For Pancreatic Cancer Patients

Study Overview

A Pilot Study of a Home-Based Walking Intervention for Pancreatic Cancer Patients

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.

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.

Cancer of Pancreas

BEHAVIORAL: Walking Intervention

IRB13023

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2015-03-18	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2021-01-02
First Submitted that Met QC Criteria 2015-05-10	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ACTUAL) 2021-01-05
First Posted (ACTUAL) 2015-05-13	Results First Posted N/A	Last Verified 2021-01

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
Supportive Care

Allocation:
Randomized

Interventional Model:
Parallel

Masking:
None

Arms and Interventions

Participant Group/Arm	Intervention/Treatment
EXPERIMENTAL: Walking Intervention 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 conditio	BEHAVIORAL: Walking Intervention 12-week walking program
NO_INTERVENTION: Usual Care 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.

Participant Group/Arm

Intervention/Treatment

EXPERIMENTAL: Walking Intervention

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 conditio

BEHAVIORAL: Walking Intervention

12-week walking program

NO_INTERVENTION: Usual Care

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.

Primary Outcome Measures	Measure Description	Time Frame
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.	14 weeks post-baseline

Secondary Outcome Measures	Measure Description	Time Frame

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

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

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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

PRINCIPAL_INVESTIGATOR: Carolyn Y Fang, PhD, Fox Chase Cancer Center

Publications

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General Publications

No publications available

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Clinical Trial Record