Phase II Randomized Study of Two Home-Based Interventions for Sleep-Wake Disturbances in Cancer Survivors

Active:	No
Cancer Type:	Unknown Primary	NCT ID:	NCT00993928
Trial Phases:	Phase II	Protocol IDs:	NCCTG N07C4 (primary)
Eligibility:	Cancer survivors experiencing sleep disorder, Male and Female	Study Type:	Behavioral study
Study Sponsor:	NCCTG
NCI Full Details:

Summary

RATIONALE: Following a program that uses written materials and pre-recorded mp3 devices may help improve the sleep of cancer survivors. It is not yet known which home-based program is more effective in improving the sleep of cancer survivors.

PURPOSE: This randomized phase II trial is comparing two home-based programs for improving sleep in cancer survivors.

Objectives

Primary Outcome Measures:

Change of the (3 day) sleep latency time and time to fall back asleep after awakening during the night from baseline to the end of study at week 7 [ Designated as safety issue: No ]

Secondary Outcome Measures:

Efficacy of home-based interventions on the number of awakenings after sleep, sleep quality, sleep difficulty, and sleep latency at baseline and weeks 4 and 7 [ Designated as safety issue: No ]
Percentage of participants in each group who have improved sleep per the PSQI [ Designated as safety issue: No ]
Side effects [ Designated as safety issue: Yes ]
Overall adherence rate [ Designated as safety issue: No ]

**Clinical trials are research studies that involve people. These studies test new ways to prevent, detect, diagnose, or treat diseases. People who take part in cancer clinical trials have an opportunity to contribute to scientists’ knowledge about cancer and to help in the development of improved cancer treatments. They also receive state-of-the-art care from cancer experts... Click here to learn more about clinical trials.