Yanez, B., McGinty, H.L., Mohr, D.C., Begale, M.J., Dahn, J.R., Flury, S.C., . . . Penedo, F.J. (2015). Feasibility, acceptability, and preliminary efficacy of a technology-assisted psychosocial intervention for racially diverse men with advanced prostate cancer. Cancer, 121, 4407–4415.

DOI Link

Study Purpose

To evaluate a web-based cognitive behavioral (CB) stress reduction program

Intervention Characteristics/Basic Study Process

Participants were assigned to receive either the web-based CB program (CBSM group) or a web-based health information program (HP group). The CB program was delivered by a group facilitator according to a manual for treatment. Group web sessions were used to provide education in relaxation techniques, support management, and stress management. The health information program was provided by a group facilitator according to a manual for the intervention. The sessions provided general wellness education but did not include any of the behavioral techniques. Sessions were recorded and reviewed during weekly clinical supervision to ensure treatment fidelity. All sessions lasted for 10 weeks.

Sample Characteristics

  • N = 61   
  • MEAN AGE = 68.84 (SD = 9.23)
  • MALES: 100%  
  • CURRENT TREATMENT: Radiation, other
  • KEY DISEASE CHARACTERISTICS: Advanced prostate cancer (APC), stage 3 or 4 at diagnosis
  • OTHER KEY SAMPLE CHARACTERISTICS: Patients aged 50 years of age or older, treatment with androgen-deprivation therapy alone or in combination with radiation within the past six months, no history of surgery or chemotherapy in the past six months, no prior inpatient psychiatric treatment, a score 20 or greater on the Mini-Mental State Examination (MMSE)

Setting

  • SITE: Multi-site   
  • SETTING TYPE: Home    
  • LOCATION: Participants were recruited at Robert H. Lurie Comprehensive Cancer Center of Northwestern University and Jesse Brown VA Medical Center in Chicago; however, group interventions occurred over the Internet with participants accessing them from their homes.

Phase of Care and Clinical Applications

PHASE OF CARE: Transition phase after active treatment

Study Design

Parallel, two-group trial

Measurement Instruments/Methods

  • Feasibility/acceptability assessed through recruitment, retention, and group attendance rates
  • Efficacy evaluated using the Impact of Event Scale-Revised (IES-R) for cancer-related distress, the Patient-Reported Outcomes Measurement Information System (PROMIS) for depressive symptoms, and the Functional Assessment of Cancer Therapy-General (FACT-G) for health-related quality of life outcomes

Results

Feasibility: 31.3% enrollment rate; many refused because of significant time requirements with participation or lack of interest in the intervention. The retention rate was 85.7% at six months for the CBSM group and 86.1% for the HP group. Both groups completed most sessions (more than 70%); however, the HP group completed significantly more sessions and weekly assessments.

Acceptability: Participants in both groups reported liking the study “quite a bit”; no differences existed between groups.

Efficacy (intent to treat analysis): The CBSM group had fewer depressive symptoms than the HP group at six-month follow-up (p = 0.06) and higher scores for relaxation (p = 0.09); however, the HP group reported better social well-being on the FACT-G (p = 0.07).

Efficacy (study completers only): Significantly (p = 0.03) fewer depressive symptoms were reported in the CBSM group as well as improved relaxation (p < 0.01) at the six-month follow-up.

Conclusions

The results generally support the feasibility, acceptability, and preliminary efficacy of web-based psychosocial intervention for patients with APC. Both the CBSM and HP interventions were rated favorably. Clinically meaningful decreases in depressive symptoms and improvements in relaxation (related to functional well-being) were seen in the CBSM group at six-month follow-up, revealing that the results were evident even months after the intervention was provided.

Limitations

  • Small sample (< 100)
  • Risk of bias (no blinding)
  • Risk of bias (no random assignment)
  • Findings not generalizable
  • Subject withdrawals ≥ 10%  
  • The sample size was underpowered, which limits the detection of significant results. Participants were provided with a tablet and/or Internet as needed to complete intervention, which was not feasible for all patients, limiting its generalizability.

Nursing Implications

Web-based psychosocial interventions for men with APC have the potential to reduce symptom burden and improve health-related quality of life, specifically for patients who have computer and Internet access. Additional research is needed regarding these types of interventions in advanced disease (stages 3 and 4). Because both the CBSM and HP groups showed some improvement in this study, the positive benefits of social, group-based interventions should be explored further in this population.