Web-Based Stress Management for Newly Diagnosed Patients With Cancer (STREAM): A Randomized, Wait-List Controlled Intervention Study

Abstract

Purpose Being diagnosed with cancer causes major psychological distress; however, a majority of patients lack psychological support during this critical period. Internet interventions help patients overcome many barriers to seeking face-to-face support and may thus close this gap. We assessed feasibility and efficacy of Web-based stress management (STREAM [Stress-Aktiv-Mindern]) for newly diagnosed patients with cancer. Patients and Methods In a randomized controlled trial, patients with cancer who had started first-line treatment within the previous 12 weeks were randomly assigned to a therapist-guided Web-based intervention or a wait-list (control), stratified according to distress level (≥ 5 v < 5 on scale of 0 to 10). Primary efficacy end point was quality of life after the intervention (Functional Assessment of Chronic Illness Therapy-Fatigue). Secondary end points included distress (Distress Thermometer) and anxiety or depression (Hospital Anxiety and Depression Scale). Treatment effect was assessed with analyses of covariance, adjusted for baseline distress. Results A total of 222 of 229 screened patients applied online for participation. Between September 2014 and November 2016, 129 newly diagnosed patients with cancer, including 92 women treated for breast cancer, were randomly assigned to the intervention (n = 65) or control (n = 64) group. Adherence was good, with 80.0% of patients using ≥ six of eight modules. Psychologists spent 13.3 minutes per week (interquartile range, 9.5-17.9 minutes per week) per patient for online guidance. After the intervention, quality of life was significantly higher (Functional Assessment of Chronic Illness Therapy-Fatigue: mean, 8.59 points; 95% CI, 2.45 to 14.73 points; P = .007) and distress significantly lower (Distress Thermometer: mean, -0.85; 95% CI, -1.60 to -0.10; P = .03) in the intervention group as compared with the control. Changes in anxiety or depression were not significant in the intention-to-treat population (Hospital Anxiety and Depression Scale: mean, -1.28; 95% CI, -3.02 to 0.45; P = .15). Quality of life increased in the control group with the delayed intervention. Conclusion The Web-based stress management program STREAM is feasible and effective in improving quality of life.

Trial registration: ClinicalTrials.gov NCT02289014.

Figures

Fig 1.

Trial design. DT, Distress Thermometer; FACIT-F, Functional Assessment of Chronic Illness Therapy–Fatigue; STREAM, Stress-Aktiv-Mindern.

Fig 2.

Patient flow (CONSORT diagram). ITT, intention to treat; RCT, randomized controlled trial.

Fig 3.

Treatment effects. Mean changes in scores (95% CIs) postintervention (T2) for (A) quality of life (Functional Assessment of Chronic Illness Therapy–Fatigue), (B) distress (Distress Thermometer), and (C) anxiety/depression (Hospital Anxiety and Depression Scale) for the intervention and control groups and their differences (treatment effects) based on analyses of covariance with prescores (T1) as covariates.

Fig 4.

Percentage of patients with any increase or decrease or no change in total scores between T1 and T2 in (A) quality of life (Functional Assessment of Chronic Illness Therapy–Fatigue), (B) distress (Distress Thermometer), and (C) anxiety/depression (Hospital Anxiety and Depression Scale), where blue represents amelioration and gray deterioration within the respective assessment tool.

Fig A1.

Individual patients’ scores and group means for all time points. DT, Distress Thermometer; HADS, Hospital Anxiety and Depression Scale; IQR, interquartile range; FACIT-F, Functional Assessment of Chronic Illness Therapy–Fatigue.