Sleep/Wake Disturbances

Allison et al., 2004⁶;

Allison et al., 2004⁷

NuCare coping strategies program: self-study book and audiocassette designed to enhance personal control and teach emotional and instrumental coping responses

Training in problem solving, relaxation, coping skills, goal setting, communication, social support, and lifestyle factors

Outcomes: quality of life, anxiety, and depression

N = 66 patients with head and neck cancer; 59 completed the program and 50 gave outcome data. No age, gender, race, or ethnicity was given.

Treatment phase: active treatment and long-term follow-up

Participants chose among a small group format (n = 3), one-on-one sessions with a therapist (n = 33), or a home format without a therapist (n = 23)

Canada

Prospective, nonrandomized one-group feasibility design

McGill Model of Nursing was used; it stresses a partnership between the patient and family where situation-responsive learning about healthy behaviors and coping can occur.

The European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C-30 was used to measure quality of life and sleep.

Improvement reported in physical and social functioning and global quality of life, sleep disturbance, fatigue, and depressive symptoms.

Pilot study was not designed to test the effectiveness of the intervention.

Special training of research nurse is required.

No cost to patients

ONS Level: II (6)

Berger et al., 2002⁸

Multicomponent cognitive-behavioral therapy

Individual sleep promotion plan: sleep hygiene, relaxation treatment, stimulus control, and sleep restriction

Plan starts two days before the first treatment, is revised before each treatment, and is reinforced seven days after each treatment. Four doses and reinforcements administered.

Restrictions are delivered by RNs.

Outcomes: sleep, fatigue

N = 25 female Caucasians (mean age = 54.3 years, range = 40-65 years) with stage I or II breast cancer during adjuvant chemotherapy

Treatment phase: active treatment

Urban oncology clinics and patient homes

Midwestern United States

Prospective, repeated measures, quasi-experimental feasibility study, one group

Piper's Integrated Fatigue Model

Pittsburgh Sleep Quality Index, daily diary, and wrist actigraph

Sleep latency, efficiency, total rest, and rating of feeling refreshed on awakening were stable; time awake after sleep onset and nighttime awakenings exceeded desired levels.

The pilot study was not designed to test the effectiveness of the intervention.

Research RN training is required.

Actigraphs incur cost.

ONS Level: II (6)

Berger et al., 2003⁹

Multicomponent cognitive-behavioral therapy

Individual sleep promotion plan: sleep hygiene, relaxation, stimulus control

Sleep restriction was delivered by an RN. The plan starts two days before the first treatment, continues during chemo treatment, is revised 30, 60, and 90 days after the last treatment, and is reinforced seven days later. Three doses administered.

Outcomes: sleep, fatigue

N = 21 female Caucasians (mean age = 55.3 years, range = 43-66 years) with stage I or II breast cancer following adjuvant chemotherapy

Treatment phase: long-term follow-up

Patients' homes

Midwestern United States

Prospective, repeated measures, quasi-experimental feasibility study, one group

Piper's Integrated Fatigue Model

Pittsburgh Sleep Quality Index , daily diary, and wrist actigraph

High adherence was found except for stimulus control. Sleep latency remained stable. Sleep efficiency ranged from 82%-92%; total rest ranged from seven to eight hours per night. Night awakenings ranged from 10-11 per night.

The pilot study was not designed to test the effectiveness of the intervention.

Research RN training is required.

Actigraphs incur cost.

ONS Level: II (6)

Davidson et al., 2001¹⁰

Multimodal cognitive-behavioral therapy: group therapy, six 1-1.5 hour sessions weekly X 5 and repeated in four weeks; stimulus control therapy, relaxation training, sleep consolidation strategies, and strategies to reduce cognitive-emotional arousal were included.

Outcomes: sleep, quality-of-life role function and insomnia, fatigue

N = 14, but 12 completed the study; participants' mean age was 54.7 years. Subjects had mixed cancer diagnoses, and the mean time from diagnosis was 33.6 months.

Treatment phase: long-term follow-up

Outpatient clinics at a major cancer center in Central Canada and the community serving the cancer center

Midwestern Canada

Repeated measure, quasi-experimental; no control group

Conceptual model was not identified.

Sleep diary and Sleep Impairment Index

Sleep improved from baseline to four weeks and to eight weeks after the intervention.

Improved sleep measures: number of awakenings, wake after sleep onset, and sleep efficiency

Limitations included a small sample size, relatively healthy participants, use of self-report only, and lack of a placebo control group. Also, the duration of effects after eight weeks was unknown.

Space to provide intervention is needed.

ONS Level: II (6)

Quesnel et al., 2003¹¹

Two-phase multimodal cognitive-behavioral therapy combined strategy: (a) over 3-10 weeks and (b) over eight weeks; eight weekly sessions lasted 90 minutes.

Establish treatment objectives, stimulus control, sleep restriction, coping strategies for fatigue, and reframing maladaptive cognitions

N = 10 women with nonmetastatic breast cancer (stages I-III), mean age = 54.3 years; women completed chemotherapy and/or radiation therapy. All had a diagnosis of chronic insomnia disorder per the Diagnostic and Statistical Manual of Mental Disorders (4th ed.). All had completed high school.

Treatment phase: long-term follow-up

One site; subjects were recruited from the community sleep laboratory and subjects' homes.

Quebec, Canada

Insomnia Severity Index, Insomnia Interview Schedule, s leep diary, self-report scales, polysomnography, and breathing parameters

Findings on sleep diaries were corroborated by objective measures.

Potential existed for influence factors, such as intragroup alliance and empathy.

Sleep improvement may be an effect of time away from cancer therapy.

A trained psychologist must administer the tests; in addition, cost is incurred by using a sleep laboratory for polysomnography.

ONS Level: II (6)

Quesnel et al., 2003¹¹

(Continued)

Outcomes: sleep, mood, fatigue, global and cognitive quality of life.

Prospective nonrandomized, repeated measures; quasi-experimental; single-case design comparing each individual over time

Cognitive Behavioral Model

Savard et al., 2005¹²

Eight weekly, 90-minute group sessions combined behavioral (stimulus control, sleep restriction), cognitive (cognitive restructuring), and educational (sleep hygiene, fatigue, and stress management) strategies.

Outcomes: sleep, medication use, psychological distress, quality of life

N = 57 women who had completed radiation and chemotherapy for stage I-III breast cancer and met Diagnostic and Statistical Manual of Mental Disorders (4th ed.) criteria for a chronic insomnia syndrome.

Treatment phase: long-term follow-up

Subjects were recruited from the community by advertisement.

Canada

Randomized clinical trial

Cognitive Behavioral Model

Insomnia Interview Schedule, Structured Clinical Interview for Diagnostic and Statistical Manual of Mental Disorders (4th ed.), sleep diary, polysomnography, and

Insomnia Severity Index

Treated patients showed a significantly greater improvement in sleep post-treatment as assessed by self-reported instruments. However, polysomnography data were not significantly more improved in treated patients. Treated patients had reduced use of sleep medication.

Limitations included a homogeneous sample (i.e., all white), with most being highly educated, and a self-selected study group.

Use of a wait-list control

A master's-level psychologist who has experience in the administration of this treatment protocol must be included.

ONS Level: II (6)

Dalton, 2004¹³

Patients received standard cognitive-based therapy, profile-tailored cognitive-based therapy, or usual care. The therapy group sessions ranged from 5-50 minutes in length.

Standard cognitive-based therapy is comprehensive cognitive and behavioral therapy that evaluates thoughts, feelings, and behaviors. It uses six to eight treatment strategies to teach patients to understand the relationship among pain, suffering, and emotions; to use symptom-coping skills, problem solving, relaxation, and self-control; and to modify cognitive distortions associated with emotional distress.

N = 131 patients (mean age = 52 years) who were experiencing cancer-related chronic pain for more than six weeks that was associated with disease progression, adjuvant therapy, or surgical exploration; 72% were female. 63% were Caucasian, and 35% were African American. Patients had at least one elevated score on the Biobehavioral Pain Profile.

The most common diagnoses were lymphoma and breast, colon, and lung cancers.

Treatment phase: active treatment

One inpatient and three outpatient cancer centers in the southeastern United States

Randomized, controlled trial

Brief Pain Inventory, Profile of Mood States, Karnofsky Performance Status, Medical Outcomes Study-Short Form Health Survey, Katz Index of Independence in Activities of Daily Living

Short-term outcome:

Based on the Brief Pain Inventory, interference with sleep improved immediately pre- to immediately post-intervention for the profile-tailored cognitive-behavioral therapy group.

Between-group comparison of the treatment effect over the entire study found treatment effects for interference of pain with mood and sleep. Response to the intervention decreased with time.

Poor retention was noted, with only 28 patients completing the study. The final sample size was very small.

Other concepts: fatigue, pain, b owel patterns, symptom distress, quality of life, better Karnofsky Performance Status

RNs received a two-day training course to deliver the intervention.

Space is needed to provide the intervention.

ONS Level: II (6)

Dalton, 2004¹³

(Continued)

Profile-tailored cognitive-behavioral therapy matched patients' scores on the Biobehavioral Pain Profile to specific cognitive-behavioral treatment modules, environmental influences, loss of control, healthcare avoidance, past and current experience, physiologic responsivity, and thoughts of disease progression.

Cannici et al., 1983²³

Individual muscle relaxation training over three sessions plus instructions for home practice twice daily

Outcomes: sleep

N = 30 patients (11 men and 19 women) with a mean age of 56 years (range = 21-80 years) and a variety of cancers

Groups: relaxation (n = 15) and usual care (n = 15)

Treatment phase: active treatment and long-term follow-up

Quiet office in the hospital, patient's home, or patient's hospital room

Southeastern United States

Randomized, controlled trial

No conceptual model was used.

Daily diary and questionnaire pertaining to sleep behavior the previous night for a total of nine nights

Sleep-onset latency was reduced in the relaxation group compared with the usual care group; at the three-month follow-up, differences in sleep latency were maintained. No differences were found in other sleep variables.

Sleep was measured by self-report.

Training is needed in delivering muscle relaxation.

No cost issues existed.

ONS Level: II (5)

Carlson & Garland, 2005¹⁷

Mindfulness-based stress reduction meditation program: relaxation, meditation, gentle yoga, and daily practice; eight sessions and a 52-page booklet with weekly instructions plus an audiotape of the meditations

Outcomes: sleep, mood, stress, fatigue

N = 63 patients (49 women and 14 men) with a mean age of 54 years (range = 32-78 years) and mixed cancer diagnoses and stages

Treatment phase: long-term follow-up

Outpatient setting

Canada

Prospective, repeated measures, quasi-experimental feasibility study; one group

Mindfulness conceptual model was used.

Pittsburgh Sleep Quality Index

At pretreatment, 91% of the sample had a Pittsburgh Sleep Quality Index of 5 or more and 51% had a score of 10 or more. At post-treatment, 27% reported a Pittsburgh Sleep Quality Index of more than 10. Sleep disturbance was significantly reduced, and subjective sleep quality was improved.

Limitations included a lack of a control or comparison group; also, only a subjective sleep measurement was used. The relative importance of different components of the intervention is not known.

Training in delivering the intervention is needed.

Cost is incurred for a space for the class and an instructor.

ONS Level: II (6)

Carlson et al., 2003¹⁵ ; Carlson et al., 2004¹⁶

Mindfulness-based stress reduction meditation program: relaxation, meditation, gentle yoga, and daily practice; eight sessions and a 52-page booklet with weekly instructions plus an audiotape of the meditations

Outcomes: quality of life, mood, symptoms of stress, immune and hormone parameters

Pretest: N = 59 (49 patients with stage 0, I or II breast cancer and 10 with early-stage prostate cancer)

Post-test: N = 42

Treatment phase: long-term follow-up

Outpatient setting; eight weekly, 90-minute group sessions plus a three-hour silent retreat on Saturdays on weeks 6 and 7

Canada

One group, pre- and post-test design

Mindfulness conceptual model was used.

European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C-30 subscale for sleep disturbance

Significant improvements were reported in sleep quality.

Lack of control of the comparison group was a limitation. The relative importance of different components of the intervention is not known. Improvement in sleep was not correlated with the degree of program attendance or minutes of home practice.

Training in delivering the intervention is needed.

Cost incurred for a space for the class and an instructor.

ONS Level: II (6)

Cohen et al., 2004²⁰

Tibetan yoga: seven weekly sessions with a yoga instructor who used imagery and exercise; four aspects: controlled breathing and visualization, mindfulness, two types of posture, and daily practice

Outcomes: psychological adjustment, sleep, fatigue

N = 39 (final N = 38) patients with lymphoma who had a mean age of 51 years in both groups

Treatment phase: active treatment and long-term follow-up

Community outpatient setting affiliated with a comprehensive cancer center

Southern United States

Prospective, quasi-experimental; two groups (wait-list control

Mindfulness conceptual model was used.

Pittsburgh Sleep Quality Index

Tibetan Yoga (TY) group reported significantly lower sleep disturbances scores (total Pittsburgh Sleep Quality Index) at follow up; The TY group scores were 5.8 versus 8.1 for the wait list control group. At follow up the TY group reported better subjective sleep quality, shorter latency, longer duration, and use of fewer sleep medications

Those aspects of the intervention that helped most were unclear. The small sample was a limitation; in addition, the study did not control for time since diagnosis.

Methods of yoga taught may vary with instructor.

Training in yoga is required.

Costs are incurred for a space for the class and an instructor.

PRISM II (6)

PEP category:

effectiveness not established

de Moor et al., 2002²²

Four weekly sessions of expressive writing associated with the first four cancer vaccines

Random assignment to neutral health issues writing or expressive writing of the group's deepest thoughts and feelings

Outcomes: psychological and behavioral adjustment, symptoms of distress, perceived stress, mood, sleep

N = 42 patients (85% male) with newly diagnosed stage IV metastatic renal cell carcinoma who were four to six week postoperative; mean age was 56.4 years.

Treatment phase: active treatment

Outpatient setting

Southwestern United States

Pilot study

Randomized, controlled trial

Conceptual model was not identified.

Pittsburgh Sleep Quality Index

Statistically significant improvements in the expressive writing group were found for four of the sleep disturbance measures on the

Pittsburgh Sleep Quality Index (total score and subscales of Sleep Quality, Sleep Duration, and Daytime Dysfunction).

The small sample size was a limitation.

Generalizability was questionable because of the nature of the illness.

Space is needed for the writing to occur, prior to the injection.

ONS Level: II (6)

Fobair et al., 2002²¹

Twelve 90-minute meetings of a supportive-expressive group therapy led by a licensed clinical social worker; participants discussed problems, coping, treatment, mood, self-efficacy, relationships, pain, sleep, body image, and sexuality.

Outcomes: emotional distress, mood, self-efficacy, body image, sexuality, social support, QOL, pain, sleep

N = 20 patients with stage I-IIIA breast cancer who had a mean age of 47 years

Status post surgery

Treatment phase: active treatment

Three community settings in Northern California

One group, pre- and post-test

Conceptual model was not identified.

Quality and quantity of sleep and daytime sleepiness using a brief questionnaire based on the Structured Insomnia Interview

Patients undergoing 12 weeks of supportive group therapy showed statistically significant improvement in sleep (less waking during night).

Limitations included a small sample, lack of a c ontrol group, and a vague intervention (subjective, leader dependent).

Training required to observe for unstable emotional status.

Lesbian licensed clinical social worker familiar with supportive-expressive group therapy is needed; cost incurred for a space for the class and the instructor.

ONS Level: II (6)

Shapiro et al., 2003¹⁴

Six weekly, two-hour sessions and one-hour silent treatment session; training in meditative practices (Kabat- Zinn), sitting meditation, body scan, Hatha yoga, and "Loving Kindness" meditation

Didactic material on physical and psychological effects of stress and tools to cope with stress; control group chose a stress management technique to engage in each week and used a workbook and diary.

Outcomes: sleep

N = 63 women with a history of stage II breast cancer who had a mean age of 57 years (range = 18-80 years); women were working, retired, or on disability

Free-choice control group N = 32

Mindfulness-based stress reduction group N = 31

Treatment phase: long-term follow-up

Subjects' homes

Western United States

Randomized, controlled trial

Mindfulness conceptual model was used.

Sleep diary and a daily diary to record the activities they engaged in for stress management

Hypothesis: Sleep function is associated with psychological distress. (confirmed)

Hypothesis: Sleep efficiency would be improved after controlling for baseline distress. (not confirmed)

Hypothesis: Sleep efficiency and sleep quality would improve with mindfulness-based stress reduction. (partially confirmed)

Lack of compliance with the practice of mindfulness techniques existed; the control group was given too much leeway in their choice of activities to reduce stress.

Self-report from sleep diary was a limitation.

Personnel trained in Kabat-Zinn and Hatha yoga are needed.

ONS Level: II (6)

Simeit et al.,

2004¹⁸

Multimodal psychological sleep management program combining relaxation techniques (progressive muscle relaxation or autogenic training), sleep hygiene, co Dalton, 2004 13 Patients received standard cognitive-based therapy, profile-tailored cognitive-based therapy, or usual care. The therapy group sessions ranged from 5-50 minutes in length.

Standard cognitive-based therapy is comprehensive

N = 80 in progressive muscle relaxation group

N = 71 in autogenic training group

N= 78 in control

Mixed sample of adults with a mean age of 58 who predominantly had breast, kidney, or prostate cancer

Treatment phase: long-term follow-up

Three to four weeks' length of stay in an oncology rehabilitation clinic

Germany

Quasi-experimental design; sequential recruitment of groups, patient choice for progressive muscle relaxation or autogenic training

Conceptual model was not identified.

Pittsburgh Sleep

Quality Index (German

Translation)

No statistically significant difference was found between the progressive muscle relaxation and autogenic training groups. Improvement was noted in the intervention groups regarding sleep latency, sleep duration, sleep efficiency, sleep medication (decreased), and daytime dysfunction.

Covariates such as hormone therapy and their effects on various sleep variables

Use of a validated tool validity of German translation was not addressed.

The design was not randomized.

Staff must be trained in autogenic training, progressive muscle relaxation, and other intervention techniques.

ONS Level: II (6)

Simeit et al.,

2004¹⁸

(Continued)

cognitive and behavioral therapy that evaluates thoughts, feelings, and behaviors. It uses six to eight treatment strategies to teach patients to understand the relationship among pain, suffering, and emotions; to use symptom-coping skills, problem solving, relaxation, and self-control; and to modify cognitive distortions associated with emotional distress. gnitive techniques, and advice in stimulus control techniques; two intervention groups proceeded with two different relaxation techniques (i.e., progressive muscle relaxation and autogenic training).

Outcomes: sleep, quality of life

Smith et al., 2002²⁵

A trained RN provided 15-30 minutes of the light Swedish technique of effleurage and petrissage three times per week in the patient's hospital bed; sessions were 24 hours apart and at different times of the day and evening. The control group received 20 minutes of deliberate focused communication.

Outcomes: pain, sleep, symptom distress, anxiety

N = 41

All patients (both men and women) had a cancer diagnosis, including leukemia and lymph, lung, gastrointestinal genitourinary, head and neck, breast, and skin cancers.

Treatment phase: active treatment

Inpatients in a veteran's administration hospital

Midwestern United States

Quasi-experimental; pre- and post- intervention comparison groups (One group received massage, and the other was the control arm.)

Rogers' Science of Unitary Human Beings and Watson's Theory of Transpersonal Caring were used.

Verran and Snyder-Halpern Sleep Scale

Sleep quality remained the same.

Limitations included a small sample size and a lack of random assignment to groups. Cohorts were treated sequentially.

The sleep scale was not tested for validity and reliability with polysomnography.

The RN must be trained in massage techniques.

ONS Level: II (6)

Weze et al., 2004²⁴

Healing touch method: a noninvasive, noncondition-specific method where hands are placed on various parts of the body for about 40 minutes; particular attention is

N = 35 (11 men, 23 women) with a mean age of 57 years (range = 24-80 years); approximately half of the sample had cancer for less than a year, and approximately half had cancer for one to five years. Cancer types were mixed, but 40% had advanced disease.

EuroQoL (EQ-5D) & visual analog scales; sleep disturbance 0-3 = sleeping too much, 4-7 sleeping well, and 8-10 = sleeping badly

A statistically significant improvement was found from pre- to post-test on sleep disturbances.

Limitations included the small sample; in addition, subjects' baseline served as their own control.

Providers must be trained in gentle touch.

ONS Level: II (6)

Weze et al., 2004²⁴

(Continued)

given to areas of pain or discomfort. Four one-hour sessions were conducted over four to six weeks (or withdrawn).

Outcomes: symptoms, quality of life

Treatment phase: active treatment and long-term follow-up

Outpatient center for complementary care

Eskdale, Cumbria

One group; pre- and post-test feasibility design

The therapeutic touch conceptual model was used.

A statistically significant improvement was found from pre- to post-test on sleep disturbances.

Limitations included the small sample; in addition, subjects' baseline served as their own control.

Providers must be trained in gentle touch.

ONS Level: II (6)

Wright et al.,

2002¹⁹

A 10-week autogenic training to revert from arousal of the autonomic nervous system to one of profound relaxation associated with the parasympathetic activity; patients were told to practice three times per week.

Outcomes: anxiety, depression, coping, sleep

N = 18 patients with a cancer diagnosis who were pain free or had pain controlled with nonopioids or mild opioids; ages ranged from 40-80 years.

Treatment phase: active treatment or long-term follow-up

Outpatient cancer center; subjects' homes

Ireland

One-group quantitative and qualitative pre- and post-test design

A coping conceptual model was used.

Qualitative interview

Qualitative remarks indicated that autogenic training was very helpful for sleep induction.

The pilot study was not designed to test the effectiveness of interventions.

Training was not well defined.

Staff must have autogenic training.

ONS Level: III (8)

Psychoeducational Intervention- PEP Weight of Evidence Category : Effectiveness Not Established

Kim et al., 2002²⁶

Educational intervention on the side effects of radiation therapy for prostate cancer; a four-minute followed by an eight-minute tape-recorded message (informational intervention vs. standard of care information) was used at treatment 1, and a different message was used at treatment 5.

Outcomes: severity of side effects from radiation

N = 152 patients receiving radiation for curative, localized prostate cancer who had a mean age of 70.8 years; 96% were Caucasian. 13% were in stage A, 66% were in stage B, and 21% were in stage C.

Treatment phase: active treatment

Eight cancer centers

Eastern United States

Randomized, controlled trial

Self-Regulation Theory and negative affectivity perspective were used.

A single-item measure of sleep was obtained at week 2 and the end of treatment.

A brief educational intervention is helpful in reducing sleep problems resulting from radiation therapy and cancer.

Baseline symptom severity was not measured.

No training is required.

Cost is incurred when developing the tape-recorded messages.

ONS Level: II (6)

Williams & Schreier, 2005²⁷

A 20-minute audiotape was used that included education about the self-care behaviors of exercise and relaxation to manage anxiety, fatigue, and sleep problems. A self-care diary mirrored the audiotape; the control group received education about side effects. Three telephone interviews, one before treatment and one and three months after treatment, were conducted.

Outcomes: fatigue, anxiety, sleep

N = 71 patients with a mean age of 50.4 years (range = 30-74 years); 85% had stage I or II breast cancer and were receiving chemotherapy regimens with cyclophosphamide.

Treatment phase: active treatment

Tertiary medical center and a satellite cancer treatment clinic

Southeastern United States

Randomized, controlled trial

Orem's Self-Care Deficit was used.

A modified self-care diary measured the number of side effects, severity of each side effect, number of self-care behaviors performed for each side effect, and the effective of each self-care behavior.

More women in the control group reported difficulty sleeping at baseline; both groups experienced increased severity of sleep disturbance between the first and second self-care diary.

Control was lacking regarding how much and what kind of information was given to women at the time of treatment; the use of the self-care audiotapes may have been insufficient. In addition, the trial had a small sample size.

ONS Level: II (6)

Coleman et al., 2003³⁰

A home-based exercise program was used that included aerobic and resistance training. The exercise group received an individualized exercise prescription, with strength levels and aerobic capacity at first testing versus usual care.

Outcomes: exercise, fatigue, mood, sleep

N = 24 Caucasian patients (10 women, 14 men) who had a mean age of 55 years; patients were on high-dose chemotherapy and were receiving peripheral blood stem cell transplant for multiple myeloma (with bone involvement).

Treatment phase: active treatment

Outpatients at a cancer research center

Midwestern United States

Pilot feasibility; randomized, controlled trial

Cardiovascular training conceptual model was used.

A wrist actigraph was used to measure latency, minutes of sleep at night, percent time asleep at night, number of nighttime awakenings, frequency of daytime naps, minutes of sleep during the daytime, and total minutes of sleep during each 24-hour period. The Epworth Sleepiness Scale also was used.

Feasibility of individualized exercise program for patients receiving aggressive treatment for multiple myeloma was supported.

The small sample size was a limitation.

The study had a 42% attrition rate; equal attrition was noted in both groups.

Valid and reliable sleep latency is difficult to determine from actigraphy.

The test is time consuming and a burden to patients.

An exercise testing facility is needed.

ONS Level: II (6)

Mock et al., 1997²⁸

A self-paced progressive home-based exercise program (walking exercise versus usual care) was used. Individualized walking was based on age, level of fitness, and history of exercise. The program was a brisk, incremental, 20-30-minute walk, followed by a 5-minute slow walking cool down, four to five times per week for six weeks.

Outcomes: exercise, fatigue,

N = 46 females who had a mean age of 49 years; 87% were Caucasian, and 72% had stage I breast cancer and were undergoing radiation therapy.

Treatment phase: active treatment

Two university teaching hospitals

Instructions were given at the institution, but the intervention was carried out at home.

Southeastern United States

Randomized, controlled trial; two-group, pre- and

post-test experimental design

Symptom Assessment Scale, Piper Fatigue Scale, 12-minute walk test, and sociodemographic information

Women who exercised regularly reported less difficulty sleeping than the control group.

Caution: Maintain safety while exercising

Exercise physiologist consultation is needed. RNs must be trained in delivering the intervention.

The study should be supervised by a principal investigator.

ONS Level: II (6)

Mock et al., 1997²⁸

(Continued)

physical functioning, emotional distress, sleep

The Roy Adaptation Model was used.

Young-McCaughan et al., 2003²⁹

Subjects met twice a week for 12 weeks for exercise and education.

Outcomes: exercise tolerance, activity, sleep, quality of life

N = 62 patients (31 men, 31 women) who had a mean age of 55 years; subjects had mixed ethnicity and varying cancer diagnosis and stages. Therapy included surgery, chemotherapy, radiation therapy, immunotherapy, and endocrine and hormonal therapy.

Treatment phase: active treatment or long-term follow-up

Two major military medical centers

Inpatient and outpatient settings

Southwestern United States

Prospective feasibility study with repeated measures

The Roy Adaptation Model and Cardiac Rehabilitation Model were used.

Wrist actigraphy was used to measure the duration of sleep, percentage of night spent asleep, average length of a sleep episode, number of awakenings. Cancer Rehabilitation Evaluation System-short form (CARES-SF) sleep item also was used.

No improvement was found in sleep patterns per actigraphy; improved subjective rating was noted.

This was a feasibility study; therefore, no control group was used. The small sample size and missing actigraphy data were limitations.

Cost is incurred for actigraphs, and staff must be trained in the exercise measurement.

ONS Level: II (6)