NCT02442323

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2013

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 9, 2013

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

March 18, 2015

Completed
2 months until next milestone

First Posted

Study publicly available on registry

May 13, 2015

Completed
5.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 30, 2020

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2020

Completed
Last Updated

January 5, 2021

Status Verified

January 1, 2021

Enrollment Period

7.1 years

First QC Date

March 18, 2015

Last Update Submit

January 2, 2021

Conditions

Cancer of Pancreas

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

Walking Intervention

EXPERIMENTAL

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.

Behavioral: Walking Intervention

Usual Care

NO 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.

Interventions

Walking InterventionBEHAVIORAL

12-week walking program

Walking Intervention

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fox Chase Cancer Center

Philadelphia, Pennsylvania, 19111, United States

Location

MeSH Terms

Conditions

Pancreatic Neoplasms

Condition Hierarchy (Ancestors)

Digestive System NeoplasmsNeoplasms by SiteNeoplasmsEndocrine Gland NeoplasmsDigestive System DiseasesPancreatic DiseasesEndocrine System Diseases

Study Officials

  • Carolyn Y Fang, PhD

    Fox Chase Cancer Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

March 18, 2015

First Posted

May 13, 2015

Study Start

August 9, 2013

Primary Completion

August 30, 2020

Study Completion

November 30, 2020

Last Updated

January 5, 2021

Record last verified: 2021-01

Locations

US(1)