Cheville 2010.

Study characteristics
Methods	Study design: RCT Number randomized: 103; 49 to the exercise group and 54 to the control group Study start and stop dates: not reported Length of intervention: 3 weeks Length of follow‐up: 6 months
Participants	Type cancer, n (%): various: exercise group: gastrointestinal, 18 (36.7%); head and neck, 7 (14.3%); lung, 9 (18.4%); brain, 6 (12.2%); other, 9 (18.3%) control group: gastrointestinal, 21(38.9%); head and neck, 11 (20.4%); lung, 6 (11.1%); brain, 6 (11.1%); other, 10 (18.5%) Time since cancer diagnosis: not reported Time in active treatment, mean (SD) days from surgery to enrolment: exercise group: 49.1 (7.1) days control group: 42.5 (6.9) days Time in active treatment, currently receiving chemotherapy, n (%): exercise group: 29 (59.2%) control group: 34 (63.0%) Inclusion criteria: diagnosis of cancer within the last 12 months expected survival time of at least 6 months 5‐year survival probability of no more than 50% (as routinely determined by the primary radiation oncologist) treatment recommendation of radiation therapy of at least 2 weeks Eligibility criteria related to interest or ability, or both, to exercise: evaluated by a physiatrist to ensure the capacity for safe participation Exclusion criteria: previous radiation therapy recurrent disease after a disease‐free period > 6 months previous cancer diagnosis within 5 years MMSE score < 20 ECOG performance score ≥ 3 active alcohol or substance dependence (except nicotine) active thought disorder, or suicidal plans participating in another psychosocial research trial Gender, n (%): exercise group: female, 20 (40.8%); male, 29 (59.2%) control group: female, 17 (31.5%); male, 37 (68.5%) Current age, mean (SD, range) years: exercise group: 59.7 (11.49, 31.0 to 85.0) years control group: 59.4 (10.62, 36.0 to 82.0) years Age at cancer diagnosis: not reported Ethnicity/race: 100% white Education level: not reported SES: not reported Employment status, currently employed, n (%): exercise group: 28 (57.1%) control group: 29 (53.7%) Comorbidities: not reported Past exercise history: not reported On hormone therapy: not reported
Interventions	57 participants assigned to the exercise intervention, including: structured, multidisciplinary intervention including physical therapy conditioning exercises (flexibility and strengthening activities) cognitive, emotional, social, and spiritual components centered around specific topics coping strategies Type exercise (aerobic/anaerobic): anaerobic Intensity of the experimental exercise intervention: not reported Frequency: 3 times per week Duration of individual sessions: 90 minutes, with 30 minutes devoted to physical therapy conditioning exercises Duration of exercise program: 3 weeks Total number of exercise sessions: 8 sessions Format: group Facility: facility and home Professionally supervised and led by a physical therapist Adherence: 6 participants (10.9%) missed ≥ 4 sessions. Attended session rate for the entire cohort was 89.3% 58 participants assigned to control group, including: usual care Contamination of control group: not reported
Outcomes	Primary outcome: global HRQoL, measured using the Spitzer QOL Uniscale Other outcomes included: HRQoL and HRQoL domains, assessed using the LASAs of QoL, including subscales for: cognitive physical functioning EWB social (overall SWB, social support, financial well‐being, and legal concerns) spiritual well‐being physical symptoms (fatigue, pain frequency, and pain severity) distress, assessed using the Symptom Distress Scale Vigor‐Activity and Fatigue‐Inertia, assessed using the POMS–Short Form Spiritual well‐being, assessed using the Functional Assessment of Chronic Illness Therapy–Spiritual Well‐Being Outcomes were measured at baseline and at 4 weeks, 8 weeks, and 27 weeks: exercise group: n = 49 at baseline, n = 46 at 4 weeks, n = 47 at 8 weeks, n = 39 at 27 weeks control group: n = 54 at baseline, n = 54 at 4 weeks, n = 49 at 8 weeks, n = 43 at 27 weeks Subgroup analysis: cancer type and age group Adverse events: not reported
Notes	Country: US Funding: Linse Bock Foundation and the Saint Marys Hospital Sponsorship Board
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	"...randomly assigned...using a minimization procedure that balances the marginal distribution"
Allocation concealment (selection bias)	Unclear risk	Whether the treatment assignment was concealed from study personnel and participants was not described
Blinding of participants and personnel (performance bias) All outcomes	High risk	Owing to the nature of the intervention, it was not possible to conceal allocation to the intervention from the participants
Blinding of outcome assessment (detection bias) All outcomes	High risk	Allocation to the intervention was not concealed from the study personnel
Incomplete outcome data (attrition bias) All outcomes	Unclear risk	Analyses were not conducted on an ITT basis and there was substantial attrition from the trial, especially in the intervention arm. However, "...Missing data were dealt with in a number of ways. Simple imputations of missing data for the primary QOL‐related secondary endpoints was undertaken as a sensitivity analysis."
Selective reporting (reporting bias)	High risk	Data on several secondary outcomes were not reported. There were subgroup analyses which were not prespecified
Other bias	Low risk	The trial appears to be free of other problems that could put it at a high risk of bias