Multicomponent Rehabilitative Intervention

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.

To evaluate the effectiveness of a residential rehabilitation course for patients with cancer in decreasing psychological distress

Patients who had completed cancer treatment were randomly assigned to receive either usual care or a six-day residential psychosocial course. Those in the residential group had weekly rehabilitation courses in groups of 20. Course activities included education, supportive talks, physical activity, relaxation, massage, social activities, peer discussions, and dietary instruction. At the end of the course, individuals created a personal action plan to reinforce what was learned. Data were collected at baseline and at 1, 6, and 12 months after completion of the intervention.

• The study reported on a sample of 394 patients.
• Mean patient age was 61 years (range = 39–82 years).
• The sample was 64.4% female and 32.2% male.
• Patients had diagnoses of breast, prostate, or colon cancer.
• Average time since diagnosis was 15 months (range = 2.5–28.1 months).
• Of the sample, 48% were employed, 47.5% had higher than youth education, and 72% were married or cohabiting.

• Single site
• Other setting
• Denmark

Transition phase of care after initial treatment

Randomized controlled trial

• Profile of Mood States Short Form
• EORT QLC-C30

At one-month time point, findings revealed significantly more improvement in anxiety (p = 0.03), total mood disturbance (p = 0.04), emotional role function (p = 0.02), and cognitive functioning (p = 0.0009) in the control group. At the six-month time point, a significantly improved outcome for the control group was also found for depression (p = 0.005) as well as sustained improvement in anxiety (p = 0.003), total mood disturbance (p = 0.02), emotional role function (p = 0.04), and cognitive functioning (p = 0.03).

The residential rehabilitation course studied did not have a positive effect on anxiety, depression, or cognitive functioning. In this study, the control group improved more over time than those who received the intervention.

• The study had a risk of bias due to no blinding and no appropriate attentional control condition.
• This type of residential program or intervention would require training and be expensive and impractical for many individuals. It is not clear if participants incurred any costs to participate.
• Usual care was not described.
• Measurement for cognition was one item on a subjective measure.
• There was 13% attrition at time of six-month follow-up testing.

 This study suggests that an intensive residential program for cancer survivors, as examined, was of no benefit.