Symptom Management and Self-Care Monitoring In Lung Transplant Candidates

Dorothy M. Lanuza, PhD, RN, FAAN, FAHA

This pilot study is designed to test the feasibility of a symptom management intervention in pre-lung transplant candidates. The primary purpose of this study is to test whether a symptom management intervention can help people who are waiting for a lung transplant (LTx) to identify and manage symptoms that they feel are most upsetting to them. Secondary purposes are to explore: 1) if the symptom management intervention helps reduce symptoms, 2) the effect that symptoms have on quality of life, 3) describe whether individuals who are in the symptom management group report greater improvement in quality of life than the routine care group

A randomized, two-group (treatment group and attention control group), longitudinal, repeated measures experimental design will be used. Approximately 40-50 subjects will be recruited. There are no major risks to subjects who participate in this study. Although the study may not benefit the subjects directly, the information obtained will be helpful in the future in improving patient care.

A letter will be sent from the LTx department to candidates describing the study and informing them if they are not interested in being contacted by the study investigators they can return an enclosed postcard. If they return the postcard to the LTx Department, their names will not be shared with the principal investigator (PI). Only contact information on candidates who do not return the postcard will be given to the PI. Then, those individuals will be contacted by a member of the research team and arrangements made to meet them at their next scheduled clinic visit. (This process was successfully used in a current study that the PI is conducting –protocol IRB # 2003-383). During the meeting, the study will be described and the subject will be asked to sign an informed consent and a copy of the consent will be given to the subject. Once the potential subjects agree to participate, the subjects will be randomly assigned to the Usual Care group or the Symptom Management Intervention group.