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Completed

NCT Number: NCT02442323

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Fox Chase Cancer Center

Philadelphia, Pennsylvania, 19111, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Walking Intervention

Behavioral

12-week walking program

Primary outcomes

  1. Patient-reported outcome of quality of life

    Time frame: 14 weeks post-baseline

    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.

Sponsors and collaborators

Lead sponsor

Fox Chase Cancer Center

Other

Registry information

Important dates

Study start
2013
Primary completion
2020
Study completion
2020
First posted
May 13, 2015
Registry last updated
Jan 5, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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