A randomized clinical trial on the effectiveness of an intervention to treat psychological distress and improve quality of life after autologous stem cell transplantation

Abstract

Psychological distress contributes to impaired quality of life in hematological cancer patients. Stepped care treatment, in which patients start with the least intensive treatment most likely to work and only receive more intensive interventions if needed, could improve distress. We aimed to evaluate the outcome of stepped care treatment on psychological distress and physical functioning in patients treated with autologous stem cell transplantation for hematological malignancies. In the present study, we performed a randomized clinical trial with two treatment arms: stepped care and care as usual. Baseline assessment and randomization occurred during pre-transplant hospitalization. Stepped care was initiated after 6 weeks, consisting of (1) watchful waiting, (2) Internet-based self-help intervention, and (3) face-to-face counseling/ psychopharmacological treatment/ referral. Follow-up measurements were conducted at 13, 30, and 42 weeks after transplantation. Stepped care (n = 47) and care as usual (n = 48) were comparable on baseline characteristics. The uptake of the intervention was low: 24 patients started with step 1, 23 with step 2, and none with step 3. Percentages of distressed patients ranged from 4.1 to 9.7 %. Ten percent of patients received external psychological or psychiatric care. No statistically significant differences were found between stepped care and care as usual on psychological distress or physical functioning in intention to treat analyses, nor in per protocol analyses. The stepped care program was not effective in decreasing psychological distress. The low intervention uptake, probably related to the low levels of psychological distress, offers an explanation for this outcome. Future research should take into account patients’ specific care needs.Netherlands Trial Registry identifier: NTR1770.

National Institutes of Health Hematopoietic Cell Transplantation Late Effects Initiative: The Patient-Centered Outcomes Working Group Report

“…The most frequently tested interventions in randomized clinical trials include exercise (148, 157–161), cognitive behavioral therapy (149, 152, 162), and mind-body practices with stress management (161, 163–165). Multiple randomized trials of these interventions have shown small to moderate benefits in improving HRQOL, and reducing fatigue and psychological distress in HCT recipients.…”

Effects and moderators of psychosocial interventions on quality of life, and emotional and social function in patients with cancer: An individual patient data meta‐analysis of 22 RCTs

“…Of the 136 RCTs that met the inclusion criteria for the POLARIS study in the original search, 59 RCTs evaluated the effects of PSI, and 2 RCTs that evaluated the effects of physical activity combined with PSI also included a third study arm with PSI only (Figure ). PIs of 22 of the 61 eligible RCTs (response 36%) shared their data. In 1 RCT focusing on hematological cancer, we excluded patients who followed watchful waiting only ( n = 23), as they did not fit into one of the intervention categories.…”

“…PIs of 22 of the 61 eligible RCTs (response 36%) shared their data. In 1 RCT focusing on hematological cancer, we excluded patients who followed watchful waiting only ( n = 23), as they did not fit into one of the intervention categories. In 1 RCT that included patients with mixed cancer types, we excluded patients with gastrointestinal cancer as they received PSI combined with nutritional support ( n = 140).…”

Are psychological interventions effective on anxiety in cancer patients? A systematic review and meta‐analyses

“…Despite this, the majority of the clinical trials in this review included patients based on their status as a cancer patient receiving treatment, having symptoms from their cancer treatment or for the prevention of distress. In a recent study, Braamsee et al reported that patients (18.7%, N = 9/48) who dropped out of interventions did so stating that they felt they can cope well themselves …”

“…In some instances, patients even received both psychological and pharmacological treatments before being enrolled in the intervention studies. For example, 25% and 10.3% of patients received support from a mental health professional and antidepressants, making it difficult to disentangle any independent intervention benefit. In an another study, the proportion of participants taking antidepressants increased over time—from 29% at the baseline to 37% at 10 weeks of psychological intervention .…”