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Protocol No. UW16057
Principal Investigator Costanzo, Erin
Phase Pilot/Feasibility (Cancer Control)
Age Group Adult
Sponsor Type Externally Peer-Reviewed; Institutional
Title A Pilot Randomized Control Trial of a Biobehavioral Intervention to Enhance Recovery Following Hematopoietic Stem Cell Transplant
Objective The purpose of the research is to evaluate whether behavioral (non-medication) techniques designed to improve nighttime sleep quality and increase daytime activity are helpful and are easy for stem cell transplant recipients to learn and practice regularly. We will also evaluate whether these techniques may help with mood, energy, and sleep after a transplant.
Treatment You will be randomly assigned (by chance, like the flip of a coin) to participate in either the treatment or usual care (no additional treatment).
Description If you are assigned to the treatment group you will meet with a study therapist (instructor) for approximately 45-60 minutes on three occasions to learn the techniques. The first session will take place about 3-4 weeks after your transplant, either before you are discharged from the hospital or during a clinic visit. The second and third sessions will be scheduled about 8 and 12 weeks after your transplant at the time of clinic visits to see your doctor. During the sessions, the study therapist will discuss your recent sleep and activity patterns and concerns with you in order to choose the strategies and techniques that are most likely to be helpful to you. Some of skills you may learn include good sleep habits, what to do when you are not sleeping well, pacing and timing your daytime activities when you are tired, and using a pedometer to monitor your activity level. You will be asked to practice the strategies at home after the sessions and to complete a short checklist indicating the techniques you tried each day. Both the usual care group and the treatment group the will receive the standard care provided to stem cell transplant patients. This may include medical care from your doctor and referrals to health psychology, social work, or other specialists to treat any problems with mood, energy, and sleep. You will be asked to complete a packet of questionnaires about your physical and psychological well-being before your transplant and about 9 and 18 weeks after your transplant. We will also ask you to wear a watch-like instrument for one week at the same time points (before your transplant and about 9 and 18 weeks after your transplant) to measure rest and activity levels.
- Autologous transplant recipients with multiple myeloma or lymphoma (both Hodgkin's and Non-Hodgkin's types)
- Allogeneic transplant recipients undergoing ablative transplants will also be eligible to participate
- Those receiving nonablative regimens (a small proportion of allogeneic transplant recipients at UWCCC) will be excluded
- Participants who develop treatment complications or disease recurrence after being enrolled in the study may continue to participate if they are able to do so
Applicable Disease Sites Hematologic cancers, other; Leukemia; Lymphoma; Multiple Myeloma
Therapies Involved Not Applicable
Participating Institutions UW Hospital and Clinics