Patient-Centered Acupuncture for Pain (PCAP)

• Sponsor: Abramson Cancer Center of the University of Pennsylvania (Other)
• Overall Status: Completed
• CT.gov ID: NCT02152020
• Collaborator: (none)
• Enrollment: 36
• Location: 1
• Duration (Months): 8
• Patients Per Site Per Month: 4.5

Study Details

Study Description

Brief 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. Participants will be enrolled in either the Conventional Pain Management group or Integrative Pain Management group.

Condition or Disease	Intervention/Treatment	Phase
Cancer Survivors	Behavioral: Survey

Study Design

• Study Type: Observational
• Anticipated Enrollment: 36 participants
• Time Perspective: Prospective
• Official Title: Patient-Centered Integration of Acupuncture to Decrease Pain for Cancer Survivors
• Study Start Date: May 1, 2014
• Actual Primary Completion Date: Jan 1, 2015
• Actual Study Completion Date: Jan 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
Cancer survivors	Behavioral: Survey

Outcome Measures

Primary Outcome Measures

1. Number of Adverse Events [12 weeks]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Abramson Cancer Center of the University of Pennsylvania	Philadelphia	Pennsylvania	United States	19104

Sponsors and Collaborators

• Abramson Cancer Center of the University of Pennsylvania

Investigators

• Principal Investigator: Jun Mao, MD, Abramson Cancer Center of the University of Pennsylvania

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Abramson Cancer Center of the University of Pennsylvania
• ClinicalTrials.gov Identifier: NCT02152020
• Other Study ID Numbers: UPCC 01914
• First Posted: Jun 2, 2014
• Last Update Posted: Jan 14, 2015
• Last Verified: Jan 1, 2015

Study Results

No Results Posted as of Jan 14, 2015