Cancer SurvivorsNCT02152020
Patient-Centered Acupuncture for Pain (PCAP)
An observational study of Cancer Survivors, run by Abramson Cancer Center at Penn Medicine at 1 site in United States.
Trial summary
The objective of this study is to find out if acupuncture can improve the management of pain in cancer patients when used as part of a treatment plan that includes conventional pain medications. The investigators will enroll 36 cancer patients at Abramson Cancer Center and Penn Cancer Network sites. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer Survivors
- What is being tested?
- Survey
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 36 participants
- Where
- 1 siteUnited States
- Study dates
- May 2014to Jan 2015
- Phase
- Observational
- 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
Study population: Cancer survivors 18 years or older with pain ratings of 4 or greater on a 0-10 numerical rating scale; primary diagnosis of cancer (stages I-III); finished primary cancer treatment; Karnofsky score 60 or greater; and who have been taking pain medications daily.
Who may be able to join
- Women or men age 18 years or older
- Primary diagnosis of cancer with history of stage I, II, or III cancer
- Finished primary cancer treatments (surgery, chemotherapy, radiotherapy)
- Have a Karnofsky score of 60 or greater
- Can understand written English
- Have worst pain rated at least 4 or greater on an 11-point (0-10) numerical rating scale in the preceding week
- Have been taking pain medications daily
- Have had at least 15 days with pain in the preceding 30 days.
Who cannot join
- Women or men with metastatic (stage IV) cancer
- Unstable and progressive medical conditions as judged by the PIs or designated research nurse at the community hospitals (e.g., progressive cancer, uncontrolled heart failure) that may require hospitalization in the next 12 weeks
- Planned surgical procedures in the next 12 weeks
- Patients currently in a pain crisis as judged by the PI or designated research nurse that may warrant acute titration of medications or hospitalization
- Women who are pregnant or breastfeeding
- Unwillingness to adhere to study related procedures.
Trial locations and contacts
1 site in 1 country.
United States1 site
Abramson Cancer Center of the University of Pennsylvania
Philadelphia, Pennsylvania, 19104
About this study
Official title: Patient-Centered Integration of Acupuncture to Decrease Pain for Cancer Survivors
The objective of this study is to find out if acupuncture can improve the management of pain in cancer patients when used as part of a treatment plan that includes conventional pain medications. The investigators will enroll 36 cancer patients at Abramson Cancer Center and Penn Cancer Network sites. Participants will be enrolled in either the Conventional Pain Management group or Integrative Pain Management group.
- Conditions
- Cancer Survivors
- Being tested
- Survey
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SurveyBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Cancer survivors | Not described Receives: Behavioral: Survey |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Adverse Events
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2014 (estimated)
- Study startMay 2014
- Primary completionJan 2015
- Study completionJan 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cancer SurvivorsStudies of the same condition, open and under way.
- More trials run by Abramson Cancer Center at Penn MedicineThe 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
- Observational
- Time perspective
- Prospective
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Abramson Cancer Center at Penn Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jun Mao, MD, Principal investigator, Abramson Cancer Center at Penn Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02152020
- Sponsor's protocol ID
- UPCC 01914
- Status last verified
- Jan 2015
- First submitted
- 29 May 2014
- Last updated
- 14 Jan 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Patient-Centered Integration of Acupuncture to Decrease Pain for Cancer Survivors
- ClinicalTrials.gov ID
- NCT02152020
- Acronym / sponsor ID
- UPCC 01914
- Conditions
- Cancer Survivors
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- Abramson Cancer Center at Penn MedicineUniversity, hospital or other
- Study start
- May 2014
- Primary completion
- Jan 2015 (actual)
- Study completion
- Jan 2015 (actual)
- First posted
- 2 Jun 2014 (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.
The objective of this study is to find out if acupuncture can improve the management of pain in cancer patients when used as part of a treatment plan that includes conventional pain medications. The investigators will enroll 36 cancer patients at Abramson Cancer Center and Penn Cancer Network sites. Participants will be enrolled in either the Conventional Pain Management group or Integrative Pain Management group.
Study design
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cancer survivors | – | Behavioral: Survey |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Cancer survivors 18 years or older with pain ratings of 4 or greater on a 0-10 numerical rating scale; primary diagnosis of cancer (stages I-III); finished primary cancer treatment; Karnofsky score 60 or greater; and who have been taking pain medications daily.
Key inclusion criteria (8 listed)
- Women or men age 18 years or older
- Primary diagnosis of cancer with history of stage I, II, or III cancer
- Finished primary cancer treatments (surgery, chemotherapy, radiotherapy)
- Have a Karnofsky score of 60 or greater
- Can understand written English
Key exclusion criteria (6 listed)
- Women or men with metastatic (stage IV) cancer
- Unstable and progressive medical conditions as judged by the PIs or designated research nurse at the community hospitals (e.g., progressive cancer, uncontrolled heart failure) that may require hospitalization in the next 12 weeks
- Planned surgical procedures in the next 12 weeks
- Patients currently in a pain crisis as judged by the PI or designated research nurse that may warrant acute titration of medications or hospitalization
- Women who are pregnant or breastfeeding
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 |
|---|---|---|
| Survey | Behavioural | Cancer survivors |
Primary outcome
Number of Adverse Events
Time frame: 12 weeks
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 14 Jan 2015.
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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.
Jun Mao, MD principal investigator
Abramson Cancer Center at Penn Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cancer Survivors, run by Abramson Cancer Center at Penn Medicine 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 8 inclusion and 6 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 14 Jan 2015. 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?
Number of Adverse Events (time frame: 12 weeks). 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 14 Jan 2015.