Cancer of PancreasNCT02442323
A Pilot Study of a Home-Based Walking Intervention for Pancreatic Cancer Patients
A study testing Walking Intervention in people with Cancer of Pancreas, run by Fox Chase Cancer Center at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer of Pancreas
- What is being tested?
- Walking Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Aug 2013to 30 Nov 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Fox Chase Cancer Center
Philadelphia, Pennsylvania, 19111
About this study
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.
Read the 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.
- Conditions
- Cancer of Pancreas
- Being tested
- Walking Intervention
- Medical subject headings
- Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Walking InterventionBehavioural
12-week walking program
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 14 weeks post-baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2015 (estimated)
- Study start9 Aug 2013
- Primary completion30 Aug 2020
- Study completion30 Nov 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cancer of PancreasStudies of the same condition, open and under way.
- More trials run by Fox Chase Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fox Chase Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Carolyn Fang, PhD, Fox Chase Cancer Center
- Investigators
- Carolyn Y Fang, PhD, Principal investigator, Fox Chase Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02442323
- Sponsor's protocol ID
- IRB13023
- Status last verified
- Jan 2021
- First submitted
- 18 Mar 2015
- Last updated
- 5 Jan 2021
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study of a Home-Based Walking Intervention for Pancreatic Cancer Patients
- ClinicalTrials.gov ID
- NCT02442323
- Acronym / sponsor ID
- IRB13023
- Conditions
- Cancer of Pancreas
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Fox Chase Cancer CenterUniversity, hospital or other
- Study start
- 9 Aug 2013 (actual)
- Primary completion
- 30 Aug 2020 (actual)
- Study completion
- 30 Nov 2020 (actual)
- First posted
- 13 May 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Walking Intervention | Experimental | Behavioral: Walking InterventionIntervention 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. |
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Walking Intervention12-week walking program | Behavioural | Walking Intervention |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jan 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Carolyn Y Fang, PhD principal investigator
Fox Chase Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Walking Intervention in people with Cancer of Pancreas, run by Fox Chase Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient-reported outcome of quality of life (time frame: 14 weeks post-baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jan 2021.