Moore, T.H., King, A.J., Evans, M., Sharp, D., Persad, R., & Huntley, A.L. (2015). Supportive care for men with prostate cancer: Why are the trials not working? A systematic review and recommendations for future trials. Cancer Medicine, 4, 1240–1251. 

DOI Link

Purpose

STUDY PURPOSE: To examine the effect of a variety of supportive care measures on quality of life (QOL), depression, anxiety, coping skills, and self-efficacy among men with prostate cancer in various states of care. (Note: Many more outcomes were reported among studies, but the four above were the most frequent.)

TYPE OF STUDY: Systematic review

Search Strategy

DATABASES USED: MEDLINE, EMBASE, CINAHL, CENTRAL, and PsycInfo. Reference lists of retrieved studies were reviewed for additional references. Select authors were asked for unpublished study papers. 
 
INCLUSION CRITERIA: Randomized, controlled trials and controlled trials that addressed supportive interventions in any phase of prostate cancer treatment 
 
EXCLUSION CRITERIA: Studies of participants at risk for prostate cancer, with advanced cancer, or in the final days of life; pharmaceutical trials (herbal medicines, nutritional supplements); studies of decision aids

Literature Evaluated

TOTAL REFERENCES RETRIEVED: 5,618 records
 
EVALUATION METHOD AND COMMENTS ON LITERATURE USED: Two authors screened titles and abstracts separately according to the inclusion and exclusion criteria. The authors maintained a table of numerous data extraction characteristics and decision points. Risk of bias was assessed by one author and evaluated for accuracy by another. Discrepancies and disagreements were resolved by discussion with a third review.

Sample Characteristics

  • FINAL NUMBER STUDIES INCLUDED = 26  
  • TOTAL PATIENTS INCLUDED IN REVIEW = 2,740 participants
  • SAMPLE RANGE ACROSS STUDIES: Less than 50 to over 200. Seven were pilot studies. 
  • KEY SAMPLE CHARACTERISTICS: Twenty studies were based in the USA (most were government-funded or national research groups), two were based in Canada (similar funding as in USA), and others were based in Ireland, Sweden, or Hong Kong. Other funding sources were public, private, or not described. Seven studies were rated at high risk for bias. One study included patients with breast cancer and prostate cancer in the power calculation. Control group designation, services, or support were inconsistently described across trials.

Phase of Care and Clinical Applications

PHASE OF CARE: Multiple phases of care
 
APPLICATIONS: Elder care

Results

Eight of 26 studies reported primary and secondary outcomes among a variety of measured outcomes. Studies were conducted using various measures and at various stages of treatment and for varying durations. Small numbers of trials were reported for specific interventions: two trials for buddy support, two studies for relaxation therapy, and one study for psychoeducational support.
 
Quality of Life: No significant or consistent standard mean differences or direction for QOL
 
Depressive symptoms and mood (14 trial studies) and anxiety (three trial studies) were reported together. The results were mixed. Trends were positive overall for depressive symptoms, mood, and anxiety. Confidence intervals were wide, and no positive effects on anxiety existed. One study showed a significant (p = 0.006) positive effect on depression after presurgical stress management at one week before surgery but no difference between groups on the morning of surgery.
 
Coping and Self-Efficacy: Insufficient data to determine the effect in pretreatment or during the treatment phase of care
 
Costs and Cost Analysis: Not reported in the trials reviewed

Conclusions

Most trials reported no effect of supportive care measures on the stated outcome variables. The findings indicated appropriate interventions and outcomes measures, but small samples with insufficient power contributed to lack of evidence for improvements. Recommendations included resources to support the design, conduct of trials, and reporting (CONSORT guidelines) improvements. Also included were recommendations to diversify sampling across sociodemographic profiles to include unpartnered men who may be less likely to have a social support network, address all stages of care, provide clear descriptions of usual care and control group activities, and use reliable and valid outcome measures.

Limitations

  • Mostly low quality/high risk of bias studies
  • Minimal confidence can be put in the study findings as a result of the design and analysis limitations.

Nursing Implications

The value of this systematic review is that supportive care probably works, but the evidence is lacking because of inconsistencies in study design and reporting. Clear, perhaps standardized, descriptions of the broad variety of interventions called \"supportive care\" are needed. Comparative information was not available across more than two to six trials of a particular intervention. The effect of supportive care in patients with prostate cancer can be examined by creating studies that have strong design quality and methodology. The authors’ provide important recommendations for study areas to be addressed so that results are comparable. One finding is seldom sufficient to change or influence practice.

Legacy ID

6285