Track topics on Twitter Track topics that are important to you
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.
- To compare the efficacy of two home-based sleep interventions as therapy for sleep-wake disturbances at baseline and at the end of week 6 in cancer survivors.
- To compare the efficacy of these interventions as therapy for sleep-wake disturbances as measured by the number of awakenings after sleep, sleep quality, sleep difficulty, and sleep latency at baseline and weeks 4 and 7 in these participants.
- To compare the efficacy of these interventions as therapy for sleep-wake disturbances as measured by the percentage of participants in each group who show improved sleep per the Pittsburgh Sleep Quality Index.
- To compare the effects of these interventions on fatigue, mood disturbance, sleep, benefit, and distress in this patient population.
- To describe the side effects associated with these interventions in these patients.
- To describe patient practice habits and adherence measured via a practice diary.
- To explore symptom clusters in this patient population and look at distress as a mediating variable. (Exploratory)
- To explore predictors of sleep quality. (Exploratory)
OUTLINE: This is a multicenter study. Patients are stratified according to current (≥ 1 per week in the past 4 weeks) pharmacological treatment, including anxiolytics, for insomnia or mood (yes vs no), current pharmacologic treatment for pain (yes vs no), sleep difficulty period (≤ 1 month vs > 1 month), and age (≤ 50 vs 51-70 vs > 70 years). Patients are randomized to 1 of 2 intervention groups.
- Group 1: Participants receive a home-based sleep intervention comprising a Sleep Hygiene Education booklet, printed stimulus-control guidelines, instructions on sleeping restrictions, and a guided-imagery pre-recorded mp3 device. Participants meet with study personnel for intervention refinement and are asked to practice behaviors consistent with the stimulus-control sheet, to read the sleep hygiene booklet one chapter per day for 7 days during the first week, and then as needed during study. They are also instructed to use the CD, with or without headphones, in a quiet and comfortable place without lights for up to 30 minutes every day for 6 weeks before bedtime. Participants are instructed to go to sleep and wake at the same time every day during study intervention.
- Group 2: Participants receive a home-based sleep intervention comprising a Sleep Hygiene Education booklet, printed stimulus-control guidelines, and a pre-recorded mp3 device containing short stories and essays. Participants meet with study personnel and are instructed to practice behaviors consistent with the stimulus control sheet, to read the sleep hygiene booklet, and use the CD as in group 1. Participants are not instructed about sleeping restrictions. They are offered the guided-imagery CD after study completion.
Patients complete a Three-Day Sleep Diary for 3 consecutive days at baseline and during weeks 4 and 7 of study intervention. Patients also complete questionnaires on Numeric Analog Sleep for Pain Scale, daily use of CD, Sleep Hygiene Practice, Pittsburgh Sleep Quality Index, Profile of Mood States, Brief Fatigue Inventory, Distress Thermometer, Side-Effect Questionnaire, and a Subject Global Impression of Change at baseline, during weeks 2 and 6, and after completion of study intervention.
Allocation: Randomized, Control: Active Control, Primary Purpose: Supportive Care
compliance monitoring, educational intervention, questionnaire administration, fatigue assessment and management, psychosocial assessment and care, quality-of-life assessment, sleep disorder therapy, stress management therapy
St. Francis Hospital and Health Centers - Beech Grove Campus
National Cancer Institute (NCI)
Published on BioPortfolio: 2014-08-27T03:18:41-0400
RATIONALE: Collecting information over time about patients' and health care providers' understanding of pain and fatigue and providing education about pain and fatigue management may impro...
RATIONALE: A multimedia educational program may help patients with newly diagnosed prostate cancer and breast cancer reduce distress, make informed treatment decisions, and improve quality...
Background: Result from an earlier study I carried out in the late 1990 showed that cancer patients were overall well informed about diagnoses, prognoses, symptoms, treatment, side-effects...
RATIONALE: Studying quality-of-life in patients having cancer treatment may identify the intermediate- and long-term effects of treatment on patients with cancer PURPOSE: This randomized...
RATIONALE: Yoga may decrease fatigue, distress, and depression, and improve sleep quality in patients undergoing chemotherapy for ovarian cancer. It is not yet known whether practicing yog...
The primary objective was to assess intensive care unit nurses' knowledge of intensive care unit delirium and delirium assessment before and after an educational intervention. In addition, nurses' per...
The nature of post-sarcoidosis fatigue syndrome (PSFS) is unknown and tools for the assessment of health quality (HQ) in these patients have not been fully assessed. The aim was to validate the Polish...
To assess the feasibility of conducting a trial of a psycho-educational intervention involving the provision of tailored information and coaching to improve management of a cancer-related symptom clus...
A time-dependent fatigue reliability assessment approach is proposed for welded details of orthotropic steel decks (OSDs) using long-term strain monitoring data. The fatigue reliability limit function...
Fatigue is a frequent symptom in patients suffering from chronic diseases, especially cancer patients. A new fatigue questionnaire was recently developed to better assess this condition, the EORTC QLQ...
Distensibility measure of a chamber such as the lungs (LUNG COMPLIANCE) or bladder. Compliance is expressed as a change in volume per unit change in pressure.
Self report questionnaire which yields 16 scores on personality traits, such as reserved vs. outgoing, humble vs. assertive, etc.
A syndrome characterized by persistent or recurrent fatigue, diffuse musculoskeletal pain, sleep disturbances, and subjective cognitive impairment of 6 months duration or longer. Symptoms are not caused by ongoing exertion; are not relieved by rest; and result in a substantial reduction of previous levels of occupational, educational, social, or personal activities. Minor alterations of immune, neuroendocrine, and autonomic function may be associated with this syndrome. There is also considerable overlap between this condition and FIBROMYALGIA. (From Semin Neurol 1998;18(2):237-42; Ann Intern Med 1994 Dec 15;121(12): 953-9)
The sum total of nursing activities which includes assessment (identifying needs), intervention (ministering to needs), and evaluation (validating the effectiveness of the help given).
Physiologic or biochemical monitoring of the fetus. It is usually done during LABOR, OBSTETRIC and may be performed in conjunction with the monitoring of uterine activity. It may also be performed prenatally as when the mother is undergoing surgery.
Sleep disorders disrupt sleep during the night, or cause sleepiness during the day, caused by physiological or psychological factors. The common ones include snoring and sleep apnea, insomnia, parasomnias, sleep paralysis, restless legs syndrome, circa...
Cancer is not just one disease but many diseases. There are more than 100 different types of cancer. Most cancers are named for the organ or type of cell in which they start - for example, cancer that begins in the colon is called colon cancer; cancer th...
Head and neck cancers
Cancer can occur in any of the tissues or organs in the head and neck. There are over 30 different places that cancer can develop in the head and neck area. Mouth cancers (oral cancers) - Mouth cancer can develop on the lip, the tongue, the floor...