Table 2.

Randomized Intervention Trials Among Cancer Survivors Aimed at Improving Physical Function or Physical Health Outcomes Long Term

Study	Subjects	End Points	Intervention	Findings	Comment
Smoking-cessation interventions
Gritz et al128	186 individuals diagnosed with head and neck cancer	1, 6, and 12 months postintervention self-reported end points with cotinine confirmation: ever quit, point prevalence, and continuous abstinence	Control (N = 92): usual care, standardized advice to quit; intervention (N = 94): surgeon-delivered smoking-cessation counseling session postsurgery plus booster sessions at initial six monthly medical visits post-treatment	No significant differences between arms; 74% of intervention and 77% of controls reported continuous abstinence at 12-month follow-up	Attrition rate was 39%; inclusion of recent ex-smokers and delivery of minimal intervention among controls may have attenuated treatment effect
Stanislaw and Wewers131	26 hospitalized surgical oncology patient smokers	Abstinence from smoking, as determined by saliva cotinine measured at first discharge visit	Control (N = 14): usual care; intervention (N = 12): structured smoking-cessation intervention during hospitalization followed by five weekly phone calls after discharge	At first postdischarge visit, 75% of experimental-group subjects were abstinent compared with 42.9% in the usual-care group
Griebel et al127	28 hospitalized surgical oncology patient smokers	Self-reported smoking status at 6 weeks postdischarge with saliva cotinine validation	Control (N = 14): usual care; intervention (N = 14): one session, nurse-delivered minimal intervention	At 6 weeks, abstinence was noted in 21% of the intervention and 14% of the control arms	Among those who relapsed, smoking was resumed within 1 week of discharge
Schnoll et al130	435 individuals with stage I-II cancer (of any type) or stage III-IV breast, prostate, or testicular cancer or lymphoma	Smoking abstinence: 7-day point prevalence, 30-day prolonged abstinence, and 6 months prolonged abstinence	Control (N = 218): usual care; intervention (N = 217): physician-delivered, brief (< 5-minute) intervention regarding benefits of quitting, establishing quit date, discussion of nicotine-replacement therapy, provision of self-help materials and support services (1-800-4-CANCER telephone number and/or referral to a cessation program)	No significant difference in quit rates between the usual-care and intervention arms at 6 months (11.9% v 14.4%) and 12 months (13.6% v 13.3%), respectively	Higher quit rates in head, neck, or lung cancer patients who used self-help materials, attended group sessions, had a greater desire to quit, initiated smoking after age 16, and smoked < 15 cigarettes per day
Dietary interventions
Nordevang et al120	240 women with stage I-II breast cancer within 4 months of diagnosis	Baseline and 1-and 2-years follow-up: dietary intake	Control (N = 119): usual care; intervention (N = 121): individualized dietary counseling on a low-fat, plant-based diet by a trained dietitian; behavioral theory not reported	Significant changes in intervention arm v controls were: fat: −13% v −3%; vegetables: +66 v +35 g/MJ; fruit: +86 v +56 g/MJ; bread: +31 v 0 g/MJ; cereal: +11 v +4 g/MJ	Differential drop-out; at 2 years, completion rates were 2% in the intervention arm v 89% in the control arm
Chlebowski et al114	290 postmenopausal women with stage I-IIIA breast cancer	Baseline, 3 months, 6 months, and every 6 months up to 2 years: dietary assessments; serum lipids; and height, weight, and waist circumference	Individualized dietary instruction by trained dietitians (behavioral theory not reported); control (N = 147): balanced diet; intervention (N = 143): low-fat diet (< 20% total energy)	At 18 months, fat intake reduced significantly to 20.3 ± 2.4% in intervention arm v 31.5 ± 2.6% in control arm; significant weight loss of 1.46 ± 5.01 kg in intervention arm v weight gain of 1.8 ± 6.34 kg among controls	50% attrition in both groups
DeWaard et al115	102 obese postmenopausal women with breast cancer (Netherlands and Poland)	Weight	Control (N = 43): usual care; intervention (N = 59): individualized dietary instruction by trained dietitians on energy-restricted (1,000-1,500 kcal/d) diet	At 1 year, median weight loss was 6 kg in intervention arm; weight loss was maintained in half the sample followed for another 2 years	Disbelief that obesity is a problem for cancer patients was a barrier to recruitment
Loprinzi et al119	107 premenopausal women starting adjuvant chemotherapy for breast cancer	Weight, waist and hip circumference, and energy intake	Control (N = 53): physician and nurse informed subject of potential for weight gain and general ways to prevent it; intervention (N = 54): individual sessions with dietitian every 4-6 weeks on energy-restricted diet (behavioral theory not reported)	At 6 months, no significant differences between the two arms in outcome measures (mean weight gain was 3.5 kg in the control arm v 2 kg in the intervention arm)	Weight gain was significantly associated with higher body mass indexes at baseline (P = .01) and prior energy restriction (P = .02) within 6 months of participation
Kristal et al118	144 postmenopausal women with stage I-II breast cancer, < 18 months postdiagnosis, ≥ 110% of ideal weight	Baseline, and 3, 6, and 12 months: dietary intake and weight	Control: usual care; intervention: trained volunteer staff (40% were dietitians) administered individualized sessions and structured group sessions on a low-fat diet using the Transtheoretical Model	At 1 year, intervention arm significantly decreased their weight (3.5 ± 0.7 kg) and fat intake, compared with controls	Did not control for the effect of exercise on weight; at 1 year, attrition was 23% in the intervention arm and 25% in the control arm
Pierce et al121	93 pre- and postmenopausal women with stage I-IIIA breast cancer within 4 years of diagnosis and not ontamoxifen	Baseline and 6- and 12-month follow-up: dietary intake, serum lipids and carotenoids, and anthropometric data	Individualized dietary counseling delivered via telephone and using Social Cognitive Theory framework: control (N = 46): balanced diet; intervention (N = 47): daily dietary goals of five vegetable servings, 16 oz of vegetable juice, three fruit servings, 15-20% energy from fat, and 30 g of dietary fiber	Significant differences in change in intake between intervention v controls: vegetables: +6.7 v +3 g/10 MJ; fruit: +4.0 v +2.5 g/10 MJ; fiber: 21 v 14 g/10 MJ; β–carotene: +1.28 v +0.99 g/10 MJ; α-carotene: +59 v +0.22 g/10 MJ; lycopene: +0.71 v +0.65 g/10 MJ	Attrition rate: 14% in intervention arm and 15% among controls
Hebert et al117	172 women diagnosed with stage I or II breast cancer within past 2 years	Baseline and 4-month and 1-year follow-up: energy intake, fat intake, complex carbohydrate intake, fiber intake, and body mass index	Control (N = 56): usual care; stress reduction (N = 51): yoga and mindfulness; Nutrition Education Program (NEP) (N = 50): individualized and group Social Cognitive Theory-based; intervention: all programs were 15 weeks in duration	Subjects in the NEP had significant decreases in their fat intake (P < .0002) and BMI (P = .003), changes that were evident at 4 months and largely maintained over the course of 1 year	8% attrition
Djuric et al116	48 women with stage I-II breast cancer diagnosed within the past 4 years and free from recurrence	Baseline and 12-month measures: weight and health status	Control (N = 16): received the National Cancer Institute's “Action Guide to Healthy Eating” and the “Food Guide Pyramid” pamphlets, Weight Watchers (WW); intervention (N = 16): encouraged to attend WW meetings; individualized counseling intervention (N = 16): one-on-one counseling (Social Cognitive Theory), weekly contacts for first 3 months, biweekly for second 3 months, and monthly thereafter	Weight change at 12 months: control v WW, +0.85 ± 6.0 v −2.6 ± 5.9 kg, respectively; individualized counseling v combination, −8.0 ± 5.5 v −9.4 ± 8.6 kg, respectively (significant difference from control)	Weight loss correlated with attendance; 19% attrition in intervention arms
Pierce et al122	2,970 pre- and postmenopausal women with stage I-IIIA breast cancer within 4 years of diagnosis and not on tamoxifen	Baseline and 12-month follow-up: dietary intake and plasma carotenoids	Individualized dietary counseling delivered via telephone and using Social Cognitive Theory framework: control: balanced diet; intervention: daily dietary goals of five vegetable servings, 16 oz of vegetable juice, three fruit servings, 15-20% energy from fat, and 30 g of dietary fiber	Intervention arm experienced significant pre- and postintervention increases in vegetable, fruit, and fiber intakes (none in controls), changes that were validated by serum lutein, lycopene, and α- and β-carotene levels on a study subset (N = 307); % energy from fat also decreased significantly in the intervention arm
Exercise interventions
MacVicar et al106	45 women with stage II breast cancer on chemotherapy	Pre- and postintervention: peak oxygen consumption and bike stress test	Standard control (N = 16): usual care; attention control (N = 11): thrice-weekly, 10-week program of stretching and flexibility exercises; intervention (N = 18): thrice-weekly, 10-week program of interval training cycle ergometry at 60-85% of MHR	Significant 40% increase in maximum oxygen uptake and performance on stress test in the intervention arm v both control arms	Stratified on functional capacity
Winningham et al112	24 women with stage II breast cancer on chemotherapy	Pre- and postintervention: bike stress test, weight, and skinfolds	Thrice-weekly, 10- to 12- week supervised program; control (N = 12): stretching and flexibility; intervention (N = 12): interval training cycle ergometry at 60-85% MHR	Intervention arm had significant decreases in subcutaneous fat and % body fat v controls	Stratification on functional capacity
Berglund et al96	199 individuals with cancer (majority were diagnosed with breast cancer) post-treatment	Baseline and 3-, 6-, and 12-month follow-up: physical and social activities and physical strength and activities	Control (N = 101): usual care; intervention (N = 98): oncology nurse-facilitated 7-week (1- to 2-h) program that provided general information, physical skills, coping skills, and relaxation training	At 12 months, the intervention arm had significant improvements in physical status, strength, and sleep than controls; both arms had decreases in fatigue and health problems and increases in employment	Self-reported physical strength and no adherence data; multicomponent program
Dimeo et al101	70 individuals with various solid tumors post high-dose chemotherapy and bone marrow transplant	Prehospitalization and at discharge: treadmill stress test, hemoglobin concentration, and serum chemistry	Control (N = 37): usual care; supervised (N = 33): daily interval training with bed ergometer at ≤50% MHR	Intervention arm exercised on 82% of hospitalized days and had significantly greater maximum performance on the stress test after discharge than control arm	Dose of exercise was difficult to quantify because days to hospital discharge varied
Segal et al110	123 women with stage I-II breast cancer within 2 weeks of initiating adjuvant chemotherapy	Physical function, aerobic capacity, and weight	Control (N = 41): usual care; self-directed intervention (N = 40): individualized guidance via one in-person visit with exercise specialist and bimonthly telephone calls regarding warm-up, cool-down, and progressive-walking (5 d/wk) program at 50-60% VO2 maximum (concepts of Social Cognitive Theory [ie, self-monitoring and problem solving] were used); supervised intervention (N = 42): thrice-weekly exercise program with supervised warm-ups, cool-downs, and self-paced walking and structured exercise (expected to exercise at home twice weekly)	At 26 weeks, there were significant (P = .04) differences between groups regarding physical function: control: −4.1 patients; self-directed: +5.7 patients; supervised: +2.2	19.6% drop-out rate
Burnham and Wilcox97	18 breast or colorectal cancer survivors	Aerobic capacity, lower body flexibility, and body fat	Control (N = 7): usual care; low-intensity intervention (N = 7): exercise (25-35% MHR); moderate-intensity intervention (N = 7): exercise (40-50% MHR)	After 10 weeks, no difference between exercise arms but a significant difference between exercise and control arms in aerobic capacity (P < .001), lower body flexibility (P = .027), and body fat (P < .001)	14% attrition
McKenzie and Kalda107	14 breast cancer survivors with unilateral upper extremity lymphedema	Arm volume, arm circumference, and Short Form-36	Control (N = 7): usual care; intervention (N = 7): 8-week upper body resistance training and aerobic arm ergometer training	No differences in arm measures between groups but the intervention group had higher physical function (P = .05), general health (P = .048), and vitality (P = .023)
Pinto et al88	24 sedentary women with stage 0-II breast cancer	Blood pressure, heart rate, and weight	Control (N = 12): wait list; moderate aerobic exercise (N = 12): 12-week, thrice-weekly, 60-70% MHR clinicbased mixed regimen with encouragement to exercise at home at least once per week	Pre-post decreases in the intervention arm: systolic blood pressure: −13.5 (P < .05); diastolic blood pressure: −8.9 (P < .05); heart rate: −1.56 (NS); weight: −2.8 kg (NS)	25% attrition and 88% adherence in intervention arm
Segal et al111	155 men with prostate cancer scheduled for androgen deprivation	Weight, waist circumference, skinfolds, fatigue, and upper and lower body fitness	Control (N = 73) usual care; intervention (N = 82): thrice-weekly resistance training	Intervention group had improved upper (P = .009) and lower (P < .001) body fitness and less fatigue (P = .002)	No difference in body composition, weight, and anthropometric measures
Courneya et al98	108 individuals with a variety of cancers, most of whom were diagnosed within 1 year	Sit-and-reach test, skinfolds, and fatigue	Attention control (N = 48): 11 group psychotherapy sessions over 10 weeks; intervention (N = 60): psychotherapy + exercise: 11 group psychotherapy sessions and encouragement to exercise on own three to five times per week at moderate intensity (Theory of Planned Behavior)	Exercise arm demonstrated significantly better functional well-being, decreased skinfold measures, and less fatigue at follow-up	11% attrition and 84% adherence; 22% of control arm regularly exercised
Courneya et al99	53 postmenopausal women with breast cancer who completed treatment	Peak oxygen consumption and peak power output	Control (N = 28): usual care; intervention (N = 25): moderate-level thrice-weekly cycle ergometer sessions for 15 weeks (Theory of Planned Behavior)	Intervention group had significantly higher peak oxygen consumption and power output	2% attrition
Fairey et al104	53 postmenopausal women with breast cancer who completed initial treatment	Insulin resistance and IGF-1,2/IGFBP3	Control (N = 28): wait list; intervention (N = 25): thrice-weekly (15 weeks) cycle ergometer training	Significant differences in intervention v control change scores for IGF-1 (−4.9 ± 10.7 v 2.5 ± 14.8 ng/mL) and IGFBP-3 (103.4 ± 224.7 v −77.1 ± 313.5 ng/mL)	4% attrition in intervention arm/0% in control arm; 98% adherence in intervention arm
Jones et al91	450 breast cancer survivors	Frequency of exercise	Usual-care control (N = 150); physician recommendation to exercise (N = 150); physician recommendation to exercise + referral for exercise consult (N = 150)	At 5-weeks postconsult, significant differences (P = .011) were observed between arms, with the usual-care, recommendation-only, and recommendation + referral reporting 6.7 ± 8.9, 10.1 ± 10.7, and 8.2 ± 9.5 Metabolic Equivalent Task h/wk of total exercise, respectively	34.5% overall attrition; attrition was significantly higher in the control arm (42%) compared with the other two groups (29-33%)

Note: Does not include studies using quasi-experimental designs or those aimed primarily at alleviating acute, short-term, treatment-related adverse effects or those aimed solely at improving psychosocial quality of life.

Abbreviations: MHR, maximum heart rate; NS, not significant; IGF-1, insulin-like growth factor 1; IGFBP-3, insulin-like growth factor-binding protein-3.