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

Cancer of Pancreas Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02442323
• Other study ID #: IRB13023
• Status: Completed
• Phase: N/A
• Start date: August 9, 2013
• Est. completion date: November 30, 2020

Study information

• Verified date: January 2021
• Source: Fox Chase Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: November 30, 2020
• Est. primary completion date: August 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Cancer of Pancreas
• Pancreatic Neoplasms

Intervention

Behavioral:
• Walking Intervention
12-week walking program

Locations

Country	Name	City	State
United States	Fox Chase Cancer Center	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Fox Chase Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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