Multicomponent Rehabilitative Intervention

• STUDY PURPOSE: To determine if home-based, multidimensional survivorship (HBMS) programs help maintain or improve breast cancer survivors’ quality of life
• TYPE OF STUDY: Systematic review and meta-analysis

• DATABASES USED: Cochrane Breast Cancer Specialised Register, CENTRAL, PubMed, Embase, CINAHL Plus, PsycINFO, Web of Science, World Health Organization’s International Clinical Trials Registry Platform (WHO ICTRP), and ClinicalTrials.gov
• YEARS INCLUDED: (Overall for all databases) Final search results were 2006-2016
• INCLUSION CRITERIA: RCTs and quasi-RCTs using articles that appeared in peer-reviewed journal articles published in English, interventions with more than one of these components: educational, physical, and psychological interventions that were home-based, including delivery in-person, through telephone calls, Internet or multi-media, a validated instrument used to assess health related quality of life as an outcome
• EXCLUSION CRITERIA: Studies without a control group, women with stage IV breast cancer, lack of home-based component of intervention, lack of trained personnel or healthcare professional delivering intervention, lack of separate breast cancer survivors analysis, lack of quality-of-life assessments, lack of description of intervention

• TOTAL REFERENCES RETRIEVED: 29,198
• EVALUATION METHOD AND COMMENTS ON LITERATURE USED: 29,198 studies were originally found by electronic search, and 25,907 were left after duplication removal. 25,740 articles were removed after exclusion and inclusion criteria, leaving 174 articles for full-text assessment. Further screening using inclusion and exclusion left 26 studies; 25 journal articles and 1 dissertation (8 ongoing studies) (1998-2015).

• FINAL NUMBER STUDIES INCLUDED: 26
• TOTAL PATIENTS INCLUDED IN REVIEW: 2,272
• KEY SAMPLE CHARACTERISTICS: Women aged 18 years and older with a breast cancer diagnosis between stages 0-III and within 10 years of the completion of primary cancer treatment (surgery, chemotherapy, radiation therapy).

PHASE OF CARE: Survivorship

• Home-based multidimensional survivorship (HBMS) programs positively improve quality of life short-term, as measured by FACT-B and EORTC-C30 questionnaires (FACT-B: mean difference (MD) = 4.55, 95% CI [2.33, 6.78], 7 studies, 764 participants; EORTC: MD = 4.38, 95% CI [0.11, 8.64], 6 studies, 299 participants)
• HBMS may reduce anxiety, fatigue, and insomnia as measured by HADS, BFI, and ISI. HBMS programs may decrease anxiety (MD of Hospital Anxiety and Depression Scale (HADS) = -1.01, 95% CI [-1.94, -0.08], 5 studies, 253 participants). There was no evidence of improvements in depression after HBMS (MD of HADS = -1.36, 95% CI [-2.94, 0.22], 4 studies, 213 participants). HBMS programs may also decrease fatigue (MD = -1.11, 95% CI [-1.78, -0.45], 3 studies, 127 participants) and insomnia (MD = -1.81, 95% CI [-3.34, -0.27], 3 studies, 185 participants)
• Quality of life with educational, psychological, or physical intervention components showed no difference in improvement. 
• Improvement of physical, emotional, and functional quality of life was most effective with group-based intervention.

HBMS programs in breast cancer survivors were found to provide beneficial short-term improvement of breast cancer-specific quality of life and global quality of life. Also, immediately after the intervention, a reduction in anxiety, fatigue, and insomnia was assessed.

• Mostly low-quality/high-risk of bias studies
• High heterogeneity
• Low sample sizes
• Sample bias

Group-based intervention was shown to be the most effective mode of delivery toward improving physical, emotional, and functional quality of life

To examine the effects of a palliative rehabilitation program on depression, and explore the impacts and interactions between depression, inflammation, exercise, and self-efficacy.

All patients received group physiotherapy twice a week; all patients also received as treatment plan based on assessment of individual functioning and goals that was implemented during the course of the study, including support, encouragement, feedback, and guidance to motivate patients and encourage positive change. The program was provided during an eight-week period. Study measures were obtained at baseline and at the completion of the program.

• N = 80
• AGE = Not provided
• MALES: 47.5%, FEMALES: 52.5%
• KEY DISEASE CHARACTERISTICS: Multiple tumor types existed. Patients were in stage III or IV. Breast and hematological cancers were most common.
• OTHER KEY SAMPLE CHARACTERISTICS: ECOG status of 2 or better. 21.3% were taking antidepressants.

• SITE: Single site  
• SETTING TYPE: Outpatient  
• LOCATION: Ottawa, Canada

• PHASE OF CARE: Late effects and survivorship
• APPLICATIONS: Palliative care

• Quasi-experimental

• C-reactive protein (CRP) as a marker of inflammation
• Six-minute walk test (6MWT)
• General Self-Efficacy Scale
• Hospital Anxiety and Depression Scale (HADS)

Completion rate for sessions was 69%. There was no change in CRP. Performance on the 6MWT increased (p < 0.001). Self-efficacy scores increased from a mean of 27.86 to 31.23 (p <  0.01). Depression scores decreased on average from 7.14 to 5.95 (p = 0.002).  Analysis showed that exercise results and self-efficacy were significant predictors of change in depression scores. Changes in the 6MWT explained 3% of the change in depression and self-efficacy explained 11%.

The multicomponent rehabilitative intervention tested here was associated with reduced depression scores. Exercise and self-efficacy were shown to be significant predictors of depression scores.

• Small sample (less than 100)
• Risk of bias (no control group)
• Risk of bias (no blinding)
• Risk of bias (no random assignment)
• Unintended interventions or applicable interventions not described that would influence results
• Measurement/methods not well described
• Measurement validity/reliability questionable
• Subject withdrawals of 10% or greater 
• Almost 50% who entered the study did not complete it; about half of these were due to disease progression.
• Authors state that use of antidepressants was not correlated with change in depression scores; however, it would not necessarily be expected that scores would decline further, and there was no subgroup analysis based on use of antidepressants.
• The measure used for exercise was a measure of stamina, not exercise intensity or regularity, so their conclusions that exercise may not be as effective for depression is not necessarily accurate.
• Mean depression score changes were not at a level that was clinically significant, and floor effects of the measure at baseline are possible.
• It is not known if participants were doing any other interventions for support.

Participation in exercise has been associated with improvement in depressive symptoms, and exercising in a group setting may enhance support and its effects on self-efficacy and mood. Findings of this study, however, showed statistically significant changes in depression, but the size of these changes on the measures used was not clinically significant. Research in this area should be aimed at individuals who have clinically relevant depressive symptoms.

To evaluate the degree to which a multi-component rehabilitation program improves symptom control and quality of life in patients with advanced cancer

The intervention was a 10-12 week program offered by a multidisciplinary team, consisting of nutritional counseling, a collaborative care plan based on patient goals, a palliative care physician specialist focused on symptom-related medical interventions, a pivot nurse for care coordination and case management, and an exercise component with semi-weekly exercise sessions with a physical therapist and a home exercise plan. Occupational therapy was provided and focused on self care, leisure, and productivity. Patients were assessed at baseline and during their final clinic visit at the end of the study.

• N = 131  
• MEAN AGE = 59.9 years (SD = 13.0 years)
• MALES: 50.4%, FEMALES: 49.6%
• KEY DISEASE CHARACTERISTICS: All had stage III and IV disease with a variety of primary tumor types including both hematologic and sold tumors.
• OTHER KEY SAMPLE CHARACTERISTICS: 38% were on current chemotherapy; most had ECOG performance status of 1 or 2.

SITE: Single site  

SETTING TYPE: Outpatient  

LOCATION: McGill University Cancer Center, Montreal, Canada

Quasi-experimental

Change in symptom severity was analyzed and Cohen’s d was used to calculate effect size. Severity of depression from ESAS declined (p <. 0001, d = 0.7); anorexia declined (p < .0001, d = .4);  pain declined (p < .0001, d = .4); physical and general fatigue declined (p < .0001, d = .7); mental fatigue declined (p < .0005, d = .4); and level of distress and difficulty coping declined (p < .0001).

The multi-component rehabilitation program provided here resulted in a significant improvement in multiple symptoms and a reduction in distress and difficulty coping.

• Risk of bias (no control group)
• Risk of bias (no blinding)
• Risk of bias (no random assignment) 
• Risk of bias (no appropriate attentional control condition)  
• Unintended interventions or applicable interventions not described that would influence results
• Subject withdrawals ≥ 10%
• Other limitations/explanation: 30% of patients withdrew from the study–the majority of these were due to death or disease progression. No information is provided about medication changes over the course of the study that might affect outcomes measured. The report states some different results in the body of the article versus tables provided.

A multi-component, multi-disciplinary rehabilitation and palliative care program can provide effective improvement of multiple symptoms in patients with advanced disease.

To evaluate the effects of a rehabilitation program on quality of life (QOL), fatigue, fear of movement (kinesiophobia), distress, anxiety, depression, and physical condition.

The intervention consisted of a 12-week comprehensive rehabilitation program based on Herstel and Balans’s 12-week program. The program combined physical exercise, psychoeducation, and individual counseling. Each component consisted of 

• Physical training to enhance cardiorespiratory and muscular capacity. Physical training occurred three times a week for 60 minutes and was led by an expert physiotherapist.
• Psychoeducation to enhance self-confidence, autonomy, and coping skills. Psychoeducation occurred eight times. Each session lasted 90 minutes.
• Individual counseling to improve patients' follow-up and provide an individualized program. Individual counseling consisted of a 10-minute session at the start of the program, at the beginning of every exercise session, and at the end of the program.

The intervention was provided at no cost to patients.

• The sample was comprised of 36 patients (83% female, 17% male).  
• Mean age was 50 years (standard deviation [SD] = 12 years; range 28–75 years).
• The majority of patients (n = 27) had breast cancer.
• Patients had completed all cancer treatments, except long-term hormone treatment. Patients had received diverse treatments (i.e., chemotherapy, radiotherapy, surgery, and biotherapy) before the intervention.
• Time lapse since the last treatment varied, with a mean of nine months (SD = 14 months; range 0–60 months).
• Twenty patients were on hormone treatment during the intervention.

• Single site
• Outpatient
• University hospital in Belgium

• Patients were undergoing the transition after initial treatment phase of care.
• The study has clinical applicability for late effects and survivorship.

The study used a prospective, one-group pre-/posttest design.

• European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire (EORTC QLQ-C30), to measure global QOL and physical functioning and condition
• Functional Assessment of Cancer Therapy–Fatigue (FACT-F), to measure fatigue
• Hospital Anxiety and Depression Scale (HADS), to measure depression and anxiety
• RAND 36-Item Health Survey (RAND-36), to measure general health-related QOL
• Tampa Scale of Kinesiophobia, to measure fear of movement or injury
• Distress Barometer, to measure distress
• Tecumseh Step Test, to measure cardiorespiratory fitness

• The authors noted significant improvements in QOL (p < 0.001), physical condition (p = 0.007), fatigue (p = 0.01), and depression (p = 0.012).
• Kinesiophobia (p = 0.229), distress (p = 0.344), and anxiety (p = 0.101) did not change significantly.
• In regard to depression, HADS scores changed from 5.71 (SD = 4.7) to 4.13 (SD = 4.36). This change was statistically significant.

The rehabilitation program was associated with a positive effect on depression, fatigue, and QOL; however, weaknesses in study design may preclude making a definitive conclusion based on the study. Prospective randomized studies must determine the long-term impact and the relative contribution of the program versus spontaneous recovery. Future research should also consider the cost-effectiveness of the rehabilitation program.

• The small sample size and nature of the sample (i.e., patients with early stage breast cancer) threaten the external validity of the study.
• The study did not include an appropriate control group. The lack of control group threatens the internal validity of the study. Thus, statistically significant effects may be placebo effects or time effects.
• The study did not include information regarding the scale and range of scores and method of score computation; therefore, the credibility of analysis based on the scores is unknown.
• The authors did not report whether patients were clinically depressed and if the improvement in the depression score indicates a clinically significant change.
• For various reasons, more than half (51%) of the patients who had an intake interview did not participate in the study. This may generate problems associated with the applicability of the program to patients with cancer.

Multidisciplinary rehabilitation can be one way to manage depression and fatigue in patients with cancer.

To evaluate the effectiveness of a multidisciplinary rehabilitation program for individuals after treatment for primary brain tumors

Patients were assigned to treatment or wait-list control comparison groups according to an assessment of their needs by the clinical provider. The rehabilitation treatment team was blinded to study group assignment. The intervention included individualized 30-minute therapy sessions with social, psychological, occupational, and physical therapy in half-hour sessions two to three times a week for as many as eight weeks. The individualized intervention incorporated elements of education, health promotion, intensive mobilization, and task reacquisition programs as determined appropriate by the rehabilitation team. Study assessments were done at baseline and at three and six months. Functional independence measures were the primary outcomes of the study.

• N = 106 (85 completed the six-month assessment)
• MEAN AGE = 51.4 years (range = 21–77 years)
• MALES: 43%, FEMALES: 57%
• KEY DISEASE CHARACTERISTICS: Primary brain tumors with a median time since diagnosis of 2.1 years; all received initial treatment involving surgery, chemotherapy, and/or radiation therapy; 53% of subjects in both groups had World Health Organization grade III or IV tumors and similar rates of steroid use; intervention group reported more symptoms at baseline (i.e., ataxia, cognitive impairment, seizures, paresis, visual impairment, dysphasia, dysarthria, sensory-perceptual deficits, bowel or bladder dysfunction) than the wait-list control group; proportion of patients with ataxia, dysarthria, and visual impairment was significantly larger in the intervention group
• OTHER KEY SAMPLE CHARACTERISTICS: More than 80% of participants in both groups were living with a partner, and the majority had at least a secondary level education.

• SITE: Single site  
• SETTING TYPE: Outpatient  
• LOCATION: Australia

• PHASE OF CARE: Transition phase after active treatment

Prospective trial

• Visual Analog Scale (VAS) for pain
• Cancer Rehabilitation Evaluation System Short Form (CARES-SF)
• Depression Anxiety Stress Scale (DASS)
• Functional Independence Measures (FIM) for motor skills and cognition
• Perceived Impact of Problem Profile (PIPP)

At three months, FIM Motor (self-care, sphincter, location, and mobility subscales) and FIM Cognition (communication and psychosocial subscales) scores were significantly improved in the treatment group compared to the control group. At six months, the FIM Motor (sphincter subscale) and FIM Cognition (communication, psychosocial, and cognition subscales) scores were significantly improved in the treatment group compared to the control group. There were no significant differences between groups in DASS measures of anxiety or depression from baseline to three or six months. There also were no differences observed between groups in PIPP results from baseline to three or six months, which measured the impact of functional areas also on the FIM. The greatest improvements seen were at the three-month follow-up date.

The findings of this study demonstrated that multicomponent rehabilitation can improve measures of self-care and some specific areas of motor and cognitive function.

• Baseline sample/group differences of import
• Risk of bias (no blinding)
• Risk of bias (no random assignment) 
• Risk of bias (no appropriate attentional control condition)
• Selective outcomes reporting
• Key sample group differences that could influence results
• Measurement validity/reliability questionable 
• Findings not generalizable
• Subject withdrawals ≥ 10%  
• Other limitations/explanation: Functional independence was higher at baseline in the wait-list control group by study design, because those with more obvious needs were given the intervention immediately. Therefore, the scoring of function by the control group may have been subject to a ceiling effect in the study measure. Results regarding motor and cognitive function were based on single subscales of the FIM assessment measure with no confirmatory data from a more objective measurement. It is not clear how many patients may have been receiving chemotherapy or radiation therapy during the timeframe of this study, which also could have affected outcome measurements. The fact that findings on perception of impact did not align with FIM results calls into question the overall reliability of findings. The findings are specific to patients with brain tumors and are not necessarily generalizable to other groups.

The findings of this study showed some functional benefits of multicomponent rehabilitation for patients with primary brain tumors. This study was limited by its design and the clinical nature of rehabilitation aimed to provide individualized interventions on the basis of needs assessed by care providers. This suggests that patients may benefit in the areas of self-care. The degree to which these benefits are maintained over time is not clear from this study.

To assess effectiveness of an ambulatory rehabilitation program for women with breast cancer

A sample of patients referred to a rehabilitation center was selected based on criteria of diagnosis of breast cancer, considered to be disease free. Patients were then randomly assigned to an intervention group or a control group that continued with usual activity in the community. The rehabilitation program was conducted three to five days per week for up to eight weeks and was aimed at improving activity and participation in activities. Interventions included physiotherapy, lymphedema care, occupational therapy, and clinical psychology for counseling and support. Study assessments were done at baseline and at four months after program completion.

• The study reported on a sample of 79 female patients with breast cancer.
• Median patient age was 57 years (range = 33–80).
• About half of the patients had undergone mastectomy, while 66% in the intervention group and 55% in the control group had undergone lumpectomy. More patients in the intervention group had received chemotherapy, and slightly more than 70% in both groups had received radiotherapy.
• More than half (62%) of patients were married or partnered; 63% in the intervention group versus 38% in the control group had tertiary level education.
• At baseline, depression scores were higher in the intervention group.
• Duration of disease was 2.3 years in the intervention group and 4.0 years among controls, ranging from < 1 to 24 years.

• Single site
• Outpatient setting
• Australia

Patients were undergoing multiple phases of care.

A randomized, single-blind, controlled trial design was used.

• Depression Anxiety Distress Scale
• Perceived Impact of Problems Profile
• Cancer Rehabilitation Evaluation System Short Form
• Functional Independent Measure (FIM)

Out of 42 patients, 31 completed the rehabilitation program. Over the study period, more patients in the treatment group showed a decrease in depression scores compared with the control group (p = 0.02). Intervention group patients also showed significant differences in impact profile scores (p = 0.05). There were no differences between groups in anxiety or FIM scores.

Findings suggest that comprehensive multidisciplinary rehabilitation may improve depression among women with breast cancer.

• The study had a small sample size, with less than 100 participants.
• The study had baseline sample/group differences of import that could have influenced results.
• Risk of bias existed due to no blinding, no appropriate attentional control condition, and sample characteristics.
• Subject withdrawals were ≥ 10%.
• Of the intervention group patients, 26% did not complete the rehabilitation program, leading to the question of practicality and acceptability of this approach for patients.
• Intervention group patients were more depressed at baseline; other studies have shown that interventions for depression tend to work better for individuals who actually have clinically relevant depression. It is not known if there could have been a floor effect in measurement used.
• Intervention group patients were more educated. 
• More control group patients had symptoms such as phantom breast sensations and phantom breast pain, which might have influenced findings.
• Given differences in the prevalence of some demographic factors, it is surprising that differences were not significant. 
• There was a very broad range of time since diagnosis, suggesting very broad differences in the sample that were not taken into account.

Some patients may benefit from a multidisciplinary rehabilitation program after breast cancer treatment. This study provides some evidence in support of this approach, but has several limitations. Further research is needed to determine the benefit versus cost of such programs.

To examine the effects of inpatient and outpatient rehabilitation (i.e., physical therapy, psycho-oncological treatment, patient education, medical treatment, group sessions) on quality of life and psychosocial outcomes

Patients who had radical prostatectomy participated in inpatient and/or outpatient rehabilitation within 14 days after completion of acute oncology treatment

• N = 714   
• AGE = 57 years (SD = 4.4)
• MALES: 100%  
• KEY DISEASE CHARACTERISTICS: Prostate cancer stages T1–4, pN0, M0; average KPS 79 (SD = 8.7)
• OTHER KEY SAMPLE CHARACTERISTICS: Patient who had radical prostatectomy aged 18–64 years and were employed. Excluded those with excessive psychological or physical distress or cognitive limitations as assessed by rehabilitation physicians, those who were unable to speak and read German, and those who were diagnosed with a second cancer requiring treatment.

• SITE: Multi-site   
• SETTING TYPE: Multiple settings    
• LOCATION: Four clinics in Germany

PHASE OF CARE: Transition phase after active treatment

• Quasiexperimental repeated measures design with convenience sampling from inpatient and outpatient treatment areas
• No blinding

• European Organization for Research and Treatment of Cancer (EORTC) Quality of Life (QLQ)-C30: Two items for subjective cognitive function
• EORTC QLQ-Prostate-specific 25 (PR25)
• Hospital Anxiety and Depression Scale (HADS)

Subjects reported similar cognitive function scores at baseline and one year after rehabilitation. Cohen’s d  was 0.51 and 0.54 respectively (both p < 0.001). They reported higher cognitive function at the end of rehabilitation (F [df 1.8, 1238.2] = 138.1, p < 0.001). Quality of life was higher at a one-year follow-up (p < 0.001). Anxiety was lower at the end of rehabilitation for inpatient and outpatient rehabilitation groups (p < 0.001). Depression was lower at end of rehabilitation and sustained at a one-year follow-up (p = 0.008).

The effect of structured rehabilitation on outcomes in this study was unclear, and no clear differences in outcomes based on whether patients received inpatient or outpatient rehab services were observed.

• Risk of bias (no control group)
• Risk of bias (no blinding)
• Risk of bias (no random assignment) 
• Risk of bias (no appropriate attentional control condition)  
• Risk of bias (sample characteristics)
• Unintended interventions or applicable interventions not described that would influence results
• Intervention expensive, impractical, or training needs
• Subjective cognitive function measure was limited; objective measures of cognitive function were not used.  
• Because rehabilitation was given as part of standard medical care, many other factors could have influenced the results.

Rehabilitation, whether provided in an inpatient or outpatient setting, improved patients’ perception of quality of life, depression, anxiety, and cognitive function by the end of rehabilitation. Perceived improvements in quality of life and depression persisted at one year after treatment.