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Tabel 9. Uitgangsvraag 9 – Welke meetinstrumenten zijn valide en bruikbaar in Nederland voor de effectevaluatie van oncologische revalidatie tijdens en na afronding van de in opzet curatieve behandeling en in de (ziekte- en symptoomgerichte) palliatieve fase?, Overzicht van RCT’s en gebruikte meetinstrumenten Author year Population Design, N Intervention Control Primairy outcome(s) Battaglini 2008 Breast cancer + chemo- or radiothereapy,Italy RCT N=20 F Usual care Total caloric intake (3-day food diary), %BF (skinfolds), fatigue (revised Piper Fatigue Scale Battaglini 2007 Inactive breast cancer patients, Italy Eighteen survivors of breast or colon cancer, USA RCT N=20 F Cardiovascular activity (6-12 min), followed by stretching (5-10 min), resistance training (15-30 min), and a cool-down (approximately 8 min) x 6 months 21-week exercise low to moderate intensity for 60 minutes on two days/week moderate- (40–50% HRR) intensity exercise group; low-body aerobic exercise three times a week for 10 wk Cadmus 2009 Newly diagnosed breast cancer survivors, USA RCT N=45 F Usual care Cadmus 2009 Post-treatment survivors breast cancer, USA RCT N=67 F 6-month, home-based exercise program. 30 min of moderatetovigorous physical activity 5 days per week.At the beginning of the program, each participant received an educational book, a binder containing specialized weekly informational handout and a Polar heart rate monitor (used to maintain activity at 60–80% of predicted maximal heart rate in accordance with American College of Sports Medicine guidelines Idem Idem Aerobic capacity (treadmill) comfortable walking pace (1.5–4 mph) on the treadmill, then the grade of the treadmill increased 1° every minute. Quality of Life Index for Cancer Patients Linear Analog Self-Assessment (LASA) (100-mm analog, measuring fatigue, anxiety, confusion, depression, energy, and anger) Physical activity: recorded the type, duration, and perceived intensity of any recreational/fitness activity performed on each of seven consecutive days on the 7-Day Physical Activity Log (PAL) + daily steps on a 7-day pedometer log. Exercise group participants also completed the PAL (including average heart rate from each workout) for each of the 26 weeks of the intervention. Height, Weight, % body fat: wholebody dual energy X-ray, absorptiometry scans, QOL: happiness: Fordyce Happiness Measure, Self-esteem: Rosenberg Self-Esteem Scale, Depression CES-D, Anxiety : State-Trait Anxiety Index (STAI), Stress: Cohen’s 10item Perceived Stress Scale, physical, emotional, social, and functional well-being: FACT-B, SF-36 Idem Author year Campbell 2005 Population Design, N Intervention Control Primairy outcome(s) Women undergoing chemoheapy and/or radiotherapy+ early RCT N=22 F Supervised exercise programme twice weekly for 12 weeks. Warm-up, 10–20 minutes exercise (which varied from week to week Usual care FACT-G, FACT-B, Satisfaction with Life Scale (SWLS), Revised Piper Fatigue Scale (PFS), The Scottish Physical Activity Questionnaire (SPAQ), The 12-minute walking test Burnham 2002 RCT, matched for VO2peak, QoL (15 female and 3 male, 40–65 yr of age) Secondairy outcome(s) Body composition (skinfold method); muscle strength (one repetition maximum). Low- (25–35% heart rate reserve (HRR) exercise low-body aerobic exercise three times a week for 10 wk Secondairy outcome(s) stage breast cancer, UK Cho 2006 Women with early breast cancer post treatment, post mastectomy, Korea RCT N=55 F Mean age 49.1 yr Cinar 2008 Women with modified radical mastectomy, Turkey RCT N=57 Coleman 2008 Author year Coleman 2003 (feasibility) 135 patients with multiple myeloma, USA Population RCT N=135 Design, N Patients receiving RCT N=24 10 F high-dose chemo- 14 M therapy and tandem peripheral blood stem cell transplantations for the treatment of and included walking, cycling, lowlevel aerobics, muscle-strengthening exercises, circuits etc.), a cool down and relaxation period Intervention was provided three times per week for 10 weeks consisted of psychology based education, exercise (group and home-based), and peer support group activity. Ninety minutes of education was provide once per week for 10 weeks in a group Individual 15 sessions of physiotherapy program in physical medicine and rehabilitation department, including pendulum, wall climbing, overhead pulley, horizontal abduction, posture, wand, dorsal strengthening, and stretching exercises for levator scapula. The patients performed the exercises at home in the following 8 weeks. Exercise group received an individualized exercise prescripttion, a set of color-coded exercise stretch bands with varying resistance, and a notebook and videotape illustrating the exercises. Strength resistance training was included to strengthen muscles so patients could improve the aerobic component of the exercise program Intervention ROM of the affected shoulder joint: goniometer Psychosocial adjustment, 18-item, 4-point scale revised by Lee (1999) Quality of life: the instrument developed by Chae & Choe (2001a) on the subject of South Korean breast cancer patients domestically The HG received a form to Rom shoulder: goniometer perform the exercises by themselves after removal Lymphedema: circumferential measurements of operated and of the drains unoperated extremities were taken preoperatively and then postoperatively Function: Wingate upper extremity function questionnaire Usual care group were advised to follow the written exercise recommendations provided by their physician. The paients were generally advised to remain as active as possible and to try to walk 20 minutes per day. Number of red blood cell and platelet transfusions during transplantation Control Primairy outcome(s) Home based exercise, see above 6 Usual care, see above months Number of attempts at and total number of days of stem cell collection, time to recovery after transplantation, Weekly activity logs, aerobic capacity: 6 minute walk, Borg scale Response to intensive therapy for multiple myeloma. Exercise log, Aerobic capacity: Modified Balke protocol (min walked), Strength: 1RM, lean body weight: air displacement plethysmography, fatigue: POMS, mood: POMS, sleep measurements: Actigraph, Epworth Sleepiness Scale Secondairy outcome(s) Coleman 2003 (adherence) Courneya 2008 multiple myeloma, USA Idem Idem Mild-to-moderately RCT N=55 anemic patients with solid tumors, Canada Courneya Breast cancer 2007b (f/u) patients initiating adjuvant chemotherapy RCT N=242 Idem Idem Idem Darbepoetin alfa + exercise aerobic exercise training three times per week at 60%-100% of baseline exercise capacity for 12 weeks Darbepoetin alfa QoL: Functional Assessment of Cancer Therapy-Anemia scale (FACT-A) Resistance exercise training: thrice Usual care per week performing two sets of 8 to 12 repetitions of nine different exercises at 60% to 70% of their estimated one repetition maximum and to progress the weight by 10% when they could complete >12 repetitions QoL: FACT-AN OR Aerobic exercise training: thrice per week on a cycle ergometer, treadmill, or elliptical trainer beginning at 60% of VO2peak for 15 min and progressing to 80% of VO2peak for 45 min. Duration chemotherapy Author year Courneya 2007b (multicenter) Fatigue, Cardiorespiratory fitness (VO(2peak)), Hemo-globin (Hb) response, darbepoetin alfa dosing (full text N/A) Self-esteem, Rosenberg SelfEsteem Scale fatigue: FACT-AN anxiety: Spielberger State Anxiety Inventory depression: Center for Epidemiological Studies-Depression Scale Godin Leisure Time Exercise Questionnaire @ 6 months f/u Population Design, N Intervention Control Primairy outcome(s) Idem Idem Idem Idem Idem Secondairy outcome(s) Idem + VO2peak treadmill max test + O2 uptake Strength: estimated 1 RM Body weight: balance beam scale, Whole body fat and lean tissue: dual x-ray absorptiometry scan, Lymphedema : CulosReed 2010 Prostate cancer RCt patients receiving N=100 M androgen deprivation therapy > 6 months 16 weeks home-based portion three to five times per week at moderate intensity and weekly group sessions Wait list QoL : EORTC QLQ C30 Expanded prostate cancer index composite (EPIC) Fatigue: Fatigue severity scale (FSS) Canada Depression: center for epidemiological studies depression scale (CES-D) Godin’s leisure score index CulosReed 2007 Author year Daley 2007a N/A RCT Population Design, N Intervention Control Primairy outcome(s) Lokalised breast cancer, post treatment, UK RCT N=108 F Supervised aerobic exercise therapy or Exercise-placebo three times per week for 8 weeks Usual care QoL: FACT-G and FACT-B standard volumetric arm measurements based on water displacement. Chemotherapy completion rate was assessed as the average relative doseintensity (RDI) for the originally planned regimen based on standard formulas aerobic capacity (6-min walk test), Grip strength (grip dynamometer), flexibility (modified sit and reach). Height Weight Waist and hip circumference Blood pressure Heart rate Secondairy outcome(s) Heart rate, RPE Fatigue: revised Piper, satisfaction with life scale, Depression: Beck Depression, Inventory Physical Self-Perception Profile exercise behavior: stage of change for exercise ladder questionnaire (SOC). aerobic fitness: 8minute, single-sta- ge walking test performed on a treadmill, height weight, % body fat: bioelectrical impedance analysis muscle function: Biodex adherence: session attendance and the amount (duration, RPE, HR) of exercise Dimeo 2004 Author year Dimeo 1999 Drouin 2006 Hayes 2009 Patients who underwent surgery for lung or gastrointestinal tumours 120 days post treatment, Germany RCT N=72 51 M, 19 F mean age 55 (exerc), 60 (relax) Aerobic exercise group (stationary biking 30 min five times weekly) Progressive relaxation training group (45 min three times per week). Both interventions were carried out for 3 weeks Physical, cognitive and emotional status and somatic complaints with the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core Module (EORTC-QLQ-30) questionnaire Physical capacity: bike ergometry start 25 watts and increased by 25 watts every 3 minutes until exhaustion (wattsmax) Population Design, N Intervention Control Primairy outcome(s) Cancer patients with solid tumours receiving high dose chemotherapy followed by autologous peripheral blood stem cell transplantation Germany Twenty sedentary females with breast carcinoma during 7 wks radiation therapy, USA Women younger than 76 yr, who completed breast cancer treatment at least 6 months prior and had subsequently developed unilateral, upper-limb lymph- RCT N=59 Hospital setting Biking on an ergometer in the supine position following an interval training pattern for 30 minutes daily 50% of the cardiac reserve (duration?) Usual care Psychologic distress: POMS, SCL-90 RCT N=20 F Aerobic exercise (AE) of walking for 20 to 45 minutes, 3 to 5 times per week, at 50% to 70% of measured maximum heart rates Placebo stretching (PS) activities 3 to 5 days per week Erythrocyte measures, Physical capacity: VO2peak + modified Bruce treadmill protocol + O2 uptake RCT N=32 F 20 supervised, group, aerobic and resistance exercise sessions over 12 wk Instructed to continue habitual activities. Lymphedema status: bioimpedance spectroscopy (impedance ratio between limbs) and perometry (volume difference between limbs) Secondairy outcome(s) Headley 2004 Hwang 2008 Irwin 2009a Author year Irwin 2009b Jarden 2009 Kim 2006 Korstjens 2008 Ligibel 2008 edema, Australia Women with metastatic breast cancer beginning outpatient chemotherapy, USA Postoperative radiotherapy for breast cancer, Korea Breast cancer survivors, USA RCT N=38 F Performance of a seated exercise program using home videotape three times per week for four cycles of chemotherapy Continue any usual physical activity RCT N=40 F Supervised moderate-intensity Self-shoulder stretching exercise therapy for 50 min 3 times exercise per week for 5 weeks. Fatigue: FACIT-F QoL: WHOQOL-BREF), Fatigue: brief fatigue inventory (BFI), range of motion (ROM) of the shoulder:goniometer pain score: VAS 0-100 worst pain past week RCT N=75 F 150 min/week of supervised gym- Usual physical activity physically inactive and home-based moderateintensity aerobic exercise 6 months Body composition: dual-energy X-ray absorptiometry (DXA) % body fat,lean mass, Bone mineral density Population Design, N Intervention Primairy outcome(s) Postmenopausal breast cancer survivors, USA Allogeneic hemaopoietic cell transplantation, Denmark RCT N=75 F 150 minutes per week of Usual physical activity moderate-intensity aerobic exercise 6 months Supervised multimodal intervention Usual care exercise, psychoeducation, progressive exercise 4-6 weeks Blood levels of insulin and IGF: ELISA Newly diagnosed RCT N=41 F with breast cancer Mean age 50 yrs undergoing adjuvant therapy, South Korea Mixed cancer, post RCT N=209 treatment, Netherlands 8-week moderate intensity (60Usual care 70% VO2 peak) supervised aerobic exercise program 3 times a week Physical capacity: Bruce treadmill protocol + O2 uptake Resting HR, HRmax, BP, Post intervention: 7-day Physical Activity Questionnaire 12-week group-based multidisciplinary self-management rehabilitation program, combining physical training (twice weekly) and cognitive-behavioral therapy (once weekly) QOL: SF-36 Sedentary, oveRCT N=101 F weight breast cancer survivors, USA 16-week cardiovascular and strength training exercise intervention RCT, N=42 Hospital based Control 12-week group-based physical training (twice weekly) aerobic bicycle training (30 min) and muscle strength training (30 min)] followed by group sports (60 min). Usual care Intensity of exercise : RPE monthly calender log Aerobic capacity measured in VO(2) max: Astrand test Secondairy outcome(s) muscle strength: 1 RM, functional performance 2 min stairclimb, physical activity level: QOL, EORTC QLQ-C30 fatigue, FACT-AN psychological wellbeing HADS clinial outcomes Fasting insulin and glucose levels, weight, body composition, Daily minutes of bioelectric impedance analyzer height, weight: calibrated Scale- aerobic activity in Tronix scale circumference at the waist and hip exercise logs for the duration of the study strength: 1 RM Matthews 2007 Early-stage breast cancer post treatment, USA RCT N=36 F Author year May 2009 Population Design, N Mixed cancer, post RCT N=147 treatment, Nether- Mean age 48.8 ands yrs 12-week group-based multidiscciplinary self-management rehabilitation program, combining physical training (twice weekly) and cognitive-behavioral therapy (once weekly) McNeely 2008 Post-surgical head RCT N=52 and neck cancer 15 F, 37 M survivors, Canada Progressive resistance exercise training 12 wk supervised active and passive ROM/stretching exercises, postural exercises + 2 sets of 10 to 15 repetitions of 5 to 8 exercises, starting at 25% to 30% of their 1-repetition maximum (1RM) strength and slowly progresssing to 60% to 70% of their 1-RM strength by the end of the intervention period McNeely 2004 Mello 2003 Idem Idem Milne 2008b RCT N=20 Patients post RCT N=18 allogeneic bone marrow transplanttation, Brazil Breast cancer sur- RCT N=58 F vivors post treatment, Australia 12-week home-based walking Usual care intervention single in-person counseling visit (30 min) followed by up to five short telephonecounseling calls in weeks 1, 2, 4, 7, and 10 after randomization Intervention Control 12-week group-based physical training (twice weekly) aerobic bicycle training (30 min) and muscle strength training (30 min)] followed by group sports (60 min). Standardized therapeutic exercise protocol 12 wk supervised active and passive ROM/stretching exercises, postural exercises, and basic strengthening exercises with light weights (1-5 kg) and elastic resistance bands Idem Physical activity: Community Health Activities Model Program for Seniors Physical Activity Questionnaire (CHAMPS), Actigraph, Diet intake : 21-item diet habits questionnaire (DHQ) 19-item National Cancer Institute (NCI) all day fruit and vegetable screener, Body composition: dual X-ray absorptiometry (DEXA) Primairy outcome(s) Secondairy outcome(s) QOL: European Organization for Research and Treatment of Muscle strength 1 Cancer Quality of Life Questionnaire C30 questionnaire RM, HR peak (see Physical activity: Physical Activity Scale for the Elderly (PASE) Korstjens) Patient-rated shoulder pain: 0-100 (VAS?), shoulder disability: SPADI Idem Muscle strength: 1 RM, Shoulder ROM: goniometer, Generic QOL and fatigue: Functional Assessment of Cancer TherapyAnemia (FACTAn), Specific QOL: Neck Dissection Impairment Index (NDII) Idem 6-week exercise program with acti- Usual care ve exercise, muscle stretching and treadmill walking in- and outpatient Muscle strength test: Chatillon Inc. strain-gauge dynamometer Immediate exercise group 12 weeks of supervised aerobic and resistance exercise, three times per week QoL: Functional Assessment of Cancer Therapy-Breast (FACT- Fatigue: Schwartz B) Cancer Fatigue Scale (SCFS) social physique and anxiety: Social Physique Anxiety Scale-7 items (SPAS-7), Aerobic fitness using the Aerobic Power Delayed exercise group (same therapy 12 weeks later) Index (API) cycle test. Submaximal test, starting at 25 W increased by 25 W every minute Author year Mock 2005 Population Design, N Intervention Control Primairy outcome(s) Sedentary women RCT N=119 F with Stage 0-III breast cancer receiving out-patient adjuvant chemoherapy or radiation therapy, USA Home-based moderate-intensity walking exercise program duration treatment written prescription to walk five to six times per week at a moderate pace in the target heart rate range (approximately 50–70% of maximum heart rate) Usual care Fatigue: Total Score of the Piper Fatigue Scale (PFS) Mock 2001 Monga 2007 Idem RCT N=52 Full text n/a Localized prostate cancer patients undergoing radiotherapy, USA RCT N=21 Mutri 2007 Early stage breast cancer during treatment chemoor radiotherapy, UK RCT N=203 F Payne 2008 Older women receiing hormonal treatment for breast cancer, USA RCT N=20 F 10-minute warm-up, a 30-minute Usual care aerobic segment consisting of walking on a treadmill, and a 5-10minute cool down period 3x week for 8 weeks Target HR 65% 12 week supervised group exercise Usual care programme: exercise intervention was based on guidelines for prescription of exercise for cancer patients and survivors. The classes consisted of a warm-up of 5-10 minutes, 20 minutes of exercise (for example walking, cycling, low level aerobics, muscle strengthening exercises, or circuits of specifically tailored exercises), and a cool-down and relaxation period. The exercise class lasted 45 minutes in total. Exercise at a moderate level (50-75% of age adjusted maximum heart rate). Prescribed home-based walking Usual care exercise intervention x 12 wks fFtness, modified Bruce treadmill test protocol (METS) fatigue: Piper Fatigue Scale (PFSRevised), depression: Beck Depression, QOL: FACT-P, leg strength: time it takes to stand up and sit down 5 times from an armless chair, flexibility: modified sit-and-reach test Functional assessment of cancer therapy (FACT-G) questionnaire, incl. FACT-B, FACT-F, and FACT-ES. Sleep: Pittsburgh Sleep Quality Index (PSQI), Fatigue: Piper Revised Fatigue Scale, Depression : CES-D Secondairy outcome(s) Physical functioning and activity levels: 12-min Walk Test, SF-36 Physical Activity Questionnaire (PAQ), Adherence: weekly dairies + measures above. Beck depression inventory, positive and negative affect scale, body mass index, seven day recall of physical activity (Scottish physical activity questionnaire) 12 minute walk test, assessment of shoulder mobility. Author year Pinto 2005 Population Design, N Intervention Sedentary women with breast cancer post treatment RCT N=86 F 12 weeks of PA counseling deliUsual care, Usual activity vered via telephone, as well as weekly exercise tip sheets + pedometer moderate- intensity activities at 55% to 65% of maxi-mum heart rate 12-week supervised aerobic exer- Wait list control cise program in a hospital setting Pinto 2003 Sedentary women RCT N=24 F Breast cancer post treatment Schmitz 2009 Segal 2001 Author year Control Primairy outcome(s) Secondairy outcome(s) Seven-Day Physical Activity Recall. The Seven-Day Physical Activity Recall (7-Day PAR), Physical fitness: Rockport 1-mile walk test. Objective activity monitoring: Caltrac accelerometer Stage of Motivational Readiness for PA, Mood: POMS Fatigue: 0-10 VAS, Body esteem : Body Esteem Scale Physical capacity: 50 rpm on a calibrated cycle ergometer with an increase in workload of 25W every 2 min (in watts and time) Mood: POMS, Positive and Negative Affect Scale (PANAS), Body Esteem Scale Limb volume: water displacement, circumferential measurement, Bioelectrical spectroscopy, Pain: VAS 0-10 (recall?), Pain questions from revised Brief Pain Inventory (validity?), Coordination: Nine Hole Peg Test of Finger Dexterity ROM: goniometer, Body fat (percent and total), fat free mass, and bone density: dual energy X-ray absorptiometry (DeXA) Muscle strength: 1 RM, QoL: Health and Attitudes Survey (home made) incl: Pittsburgh sleep quality index ,Relationship and body image, Fatigue symptom Inventory, SF-36, Coopersmith self-esteem inventory Life orientation test Visual analog scale (QOL), Medical outcome study social support, Temporal satisfaction with Life scale Depression survey, International physical activity questionnaire Diet history questionnaire, Demographics Menstrual tracking Medical history RCT N=295 F Female breast cancer survivors 1 to 15 years postdiagnosis among those with stable lymphedema and 1–5 years postdiagnosis for those without lymphedema at study entry. Eligible women were free of cancer at study entry and had had at least 1 lymph node removed, USA RCT N=123 Women with stages I and II breast cancer within 2 weeks of the initiation of their prescribed adjuvant therapy (radiotherapy, hormonal therapy, or chemotherapy, Canada Participants attended twice-weekly 12 months later strength training sessions for 12 months, supervised in small groups of 2–6 for the first 3 months YMCA, and then unsupervised for the remaining 9 months. Self-directed exercise, home exercise prescription and were asked to exercise five times per week for a 26-week or Supervised exercise supervised exercise program three times per week for 26 weeks in the rehabilitation Usual care QOL: SF-36, FACT-G, FACT-B Weight aerobic capacity: modified Canadian Aerobic Fitness Test (mCAFT). Population Intervention Control Primairy outcome(s) Secondairy outcome(s) Design, N Segal 2009 Segal 2003 Men with prostate N=121 M cancer receiving radiotherapy with or without androen deprivation therapy, Canada Men with prostate RCT N=155 M cancer who were scheduled to receive androgen deprivation therapy for at least 3 months after recruitment, Canada Van Weert Cancer survivors RCT N=72 M/F 2006 with different diagnoses, and cancerrelated physical and psychosocial problems, Netherlands Windsor Radiotherapy for N=66 M 2004 localized prostate carcinoma, UK 24 weeks of resistance three times Usual care per week performing two sets of eight to12 repetitions of 10 different exercises at 60% to 70% of their estimated one-repetition maximum (1 RM) or Aaerobic training: three times per week on a cycle ergometer, treadmill, or elliptical trainer beginning at 50% to 60% of their predetermined peak oxygen consumption (VO2peak) for weeks 1 to 4 and progressing to 70% to 75% for weeks 5 to 24. Fatigue: FACT-F, QOL: Prostate (FACT-P), and General (FACT-G) scales Resistance exercise program three Wait list times per week for 12 weeks: nine strength-training exercises carried out under supervision three times per week, at 60% to 70% of onerepetition maximum Fatigue: FACT-F, and disease-specific quality of life: FACT-P 15-week rehabilitation program including individual exercise, sports, psycho-education, and information full program Choose components considered relevant Health-Related Quality of Life [RAND-36 and Rotterdam Symptom Check List (RSCL)], exercise capacity (symptom limited bicycle ergometry), muscle force (hand-held dynamometry), patient preferences Hme-based, moderate-intensity, continuous walking for 30 minutes on at least 3 days of each week of radiotherapy at a target heart rate of 60-70% calculated maximum heart rate x 4 weeks Usual care Fatigue: Brief Fatigue Index, distance walked in a modified shuttle test 10 meter course, Physical activity: Scottish Physical Activity Questionnaire (SPAQ), Adherence: patient-activity diary during radiotherapy detailing the frequency and duration of the walking intervention together with the heart rate achieved / frequency and duration of everyday aerobic activity Physical fitness: maximal incremental exercise protocol on a tread-mill with O2 uptake (?protocol) body composition, DEXA scan, strength: 1 RM (estimated from 8 RM), prostatespecific antigen, testosterone, hemoglobin, and lipid levels Body weight, body mass index, waist circumference, subcutaneous skinfolds