Clinical trial NCT02442323: 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
Overall status: COMPLETED
Phase: NA
Conditions: Cancer of Pancreas
Lead sponsor: Fox Chase Cancer Center
Sponsor class: OTHER
First posted: 2015-05-13
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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.

Primary outcomes:
measure: Patient-reported outcome of quality of life
timeFrame: 14 weeks post-baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Fox Chase Cancer Center
state: Pennsylvania
Study officials:
affiliation: Fox Chase Cancer Center
name: Carolyn Y Fang, PhD
role: PRINCIPAL_INVESTIGATOR
References: