QUICK TIP: LONG TERM FOLLOW-UP

Long-term follow up is important to both the patient and study results. Common study end points are time to recurrence and survival as well as long-term toxicity. Without long-term follow up end points may be never be answered and patients may not be notified of potential long-term side effects.

Once a patient is registered to a cancer clinical trial that has long term endpoints such as survival they are followed for life. It cannot be assumed that they will always have the same address, see the same physicians or have the same phone number. If thorough contact information is not obtained at baseline, patients may become lost to follow up.

The following is a list of strategies to assist with long term follow up and finding a patient if they become lost.

1) After the informed consent, and before registration, request the patient to complete a “Follow-up form.” This form should include the following:

  • Names, addresses, phone number and email of three individuals outside the patient’s home, who would be able to get in touch with patient.
  • Name, address, phone number of other physicians seen by the patient.
  • Social Security number (if allowed by institution) &/ or Driver’s License number
  • Spouse’s entire name
  • Place of employment & phone number
  • Insurance company information
  • E-mail address of patient
  • Social Networking Site

2) Signed medical release.

HIPPA regulations require the authorization to include:

  • Identification of who may make the requested use or disclosure, (individuals, organizations or class of persons)
  • Description of the personal health information that will be used or disclosed.
  • Specify to who may use the PHI or to whom the covered entity may make the requested disclosure
  • Purpose of disclosure, (e.g. screening and recruiting subjects and analyzing research data)
  • Subjects right to revoke the authorization, and description of how.
  • Whether subject must sign authorization to get treatment.
  • Explanation that once the information is disclosed, it may no longer be protected by HIPPA.
  • Notice of the covered entity’s ability or inability to condition treatment, payment, enrollment, or eligibility for benefits on the Authorization, including research-related treatment, and, if applicable, consequences of refusing to sign the Authorization.
  • The date or event when it will expire, or state at the end of the research study or that it will have no expiration date.
  • Signature of the individual and date

3) Develop a rapport with patient. Contact them before follow up is required:

  • Birthday cards
  • Holiday cards

Patient Search Sources:

  • White pages:
  • $
  • $Social Security Death Index:
  • Bureau of Traffic Safety
  • City registrar of voters
  • Local Pharmacy
  • Local Tumor Registry
  • State Vital Records Office
  • Online Obituaries:
  • U.S.Veterans Administration
  • Department of motor vehicles/Bureau of traffic safety
  • Schools, alumni associations
  • Ultimate White Pages:
  • $Find people fast:
  • Certified letters to be signed by the addressee only
  • IRS
  • National Research Council of Canada:
  • Facebook search (if within your institutions privacy policies)

$ - Fee to use these services.

Based on information from Hall, 2008; & NSABP, 2004

References:

NSABP. (2004). (Third Ed). Never Say Lost!!! A practical guide for establishing and maintaining long-term follow-up on clinical trial patients, Pittsburgh: NSABP.

Hall, T. (2008). Long-term follow-up. In Klimaszewski, A.D., Bacon, M.A., Ehrenberger, H.E., Ford, B.A.& Westendorp, J.G. (Second Ed.). Manual for Clinical Trials Nursing.(pp. 263-265). Pittsburgh: Oncology Nursing Press, Inc

U.S. Food & Drug Administration (2011). Code of Federal Regulations (Title 45, Part 164.508).Washington, DC:U.S. Government Printing Office.

Developed: 3/4/07

Revised: 1/16/08; 2/17/14, 9/5/141 of 2