Patient-Centered Acupuncture for Pain (PCAP)

NCT02152020 | Completed DMC

• 1 other identifier: UPCC 01914
• Study Type: observational
• Target: 36
• Locations: 1 country
• Sites: 1

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.

Conditions

Cancer Survivors

Outcome Measures

Primary Outcomes (1)

• Number of Adverse Events

  12 weeks

Study Arms (1)

Cancer survivors

Behavioral: Survey

Interventions

Survey BEHAVIORAL

Cancer survivors

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Abramson Cancer Center at Penn Medicine: lead

Study Sites (1)

Abramson Cancer Center of the University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

MeSH Terms

Interventions

Surveys and Questionnaires

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Jun Mao, MD

  Abramson Cancer Center at Penn Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 29, 2014
• First Posted: June 2, 2014
• Study Start: May 1, 2014
• Primary Completion: January 1, 2015
• Study Completion: January 1, 2015
• Last Updated: January 14, 2015

Record last verified: 2015-01

Locations

US (1)