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Pilot randomized controlled trial of a patient-controlled cognitive-behavioral intervention for the pain, fatigue, and sleep disturbance symptom cluster in cancer.

ABSTRACT: Pain, fatigue, and sleep disturbance commonly co-occur in patients receiving treatment for advanced cancer.A pilot randomized controlled trial was conducted to assess initial efficacy of a patient-controlled cognitive-behavioral (CB) intervention for the pain, fatigue, and sleep disturbance symptom cluster.Eighty-six patients with advanced lung, prostate, colorectal, or gynecologic cancers receiving treatment at a comprehensive cancer center were stratified by recruitment clinics (chemotherapy and radiation therapy) and randomized to intervention or control groups. Forty-three patients were assigned to receive training in and use of up to 12 relaxation, imagery, or distraction exercises delivered via an MP3 player for two weeks during cancer treatment. Forty-three patients were assigned to a waitlist control condition for the same two week period. Outcomes included symptom cluster severity and overall symptom interference with daily life measured at baseline (Time 1) and two weeks later (Time 2).Eight participants dropped out; 78 completed the study and were analyzed (36 intervention and 42 control subjects). Participants used the CB strategies an average of 13.65 times (SD=6.98). Controlling for baseline symptom cluster severity and other relevant covariates, it was found that the symptom cluster severity at Time 2 was lower in the intervention group (M(Adj)=2.99, SE=0.29) than in the waitlist group (M(Adj)=3.87, SE=0.36), F(1, 65)=3.57, P=0.032. Symptom interference with daily life did not differ between groups. No significant adverse events were noted with the CB intervention.Findings suggest that the CB intervention may be an efficacious approach to treating the pain, fatigue, and sleep disturbance symptom cluster. Future research is planned to confirm efficacy and test mediators and moderators of intervention effects.

SUBMITTER: Kwekkeboom KL

PROVIDER: S-EPMC3484234 | biostudies-literature | 2012 Dec

REPOSITORIES: biostudies-literature

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Pilot randomized controlled trial of a patient-controlled cognitive-behavioral intervention for the pain, fatigue, and sleep disturbance symptom cluster in cancer.

Kwekkeboom Kristine L KL Abbott-Anderson Kristen K Cherwin Catherine C Roiland Rachel R Serlin Ronald C RC Ward Sandra E SE

Journal of pain and symptom management 20120707 6

<h4>Context</h4>Pain, fatigue, and sleep disturbance commonly co-occur in patients receiving treatment for advanced cancer.<h4>Objectives</h4>A pilot randomized controlled trial was conducted to assess initial efficacy of a patient-controlled cognitive-behavioral (CB) intervention for the pain, fatigue, and sleep disturbance symptom cluster.<h4>Methods</h4>Eighty-six patients with advanced lung, prostate, colorectal, or gynecologic cancers receiving treatment at a comprehensive cancer center wer ...[more]

PMID: 22771125

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Project description:CONTEXT:Symptom researchers have proposed a model of inflammatory cytokine activity and dysregulation in cancer to explain co-occurring symptoms including pain, fatigue, and sleep disturbance. OBJECTIVES:We tested the hypothesis that psychological stress accentuates inflammation and that stress and inflammation contribute to one's experience of the pain, fatigue, and sleep disturbance symptom cluster (symptom cluster severity, symptom cluster distress) and its impact (symptom cluster interference with daily life, quality of life). METHODS:We used baseline data from a symptom cluster management trial. Adult participants (N = 158) receiving chemotherapy for advanced cancer reported pain, fatigue, and sleep disturbance on enrollment. Before intervention, participants completed measures of demographics, perceived stress, symptom cluster severity, symptom cluster distress, symptom cluster interference with daily life, and quality of life and provided a blood sample for four inflammatory biomarkers (interleukin-1?, interleukin-6, tumor necrosis factor-?, and C-reactive protein). RESULTS:Stress was not directly related to any inflammatory biomarker. Stress and tumor necrosis factor-? were positively related to symptom cluster distress, although not symptom cluster severity. Tumor necrosis factor-? was indirectly related to symptom cluster interference with daily life, through its effect on symptom cluster distress. Stress was positively associated with symptom cluster interference with daily life and inversely with quality of life. Stress also had indirect effects on symptom cluster interference with daily life, through its effect on symptom cluster distress. CONCLUSION:The proposed inflammatory model of symptoms was partially supported. Investigators should test interventions that target stress as a contributing factor in co-occurring pain, fatigue, and sleep disturbance and explore other factors that may influence inflammatory biomarker levels within the context of an advanced cancer diagnosis and treatment.

Project description:PurposeAfter completing treatment, cancer survivors may suffer from a multitude of physical and mental health impairments, resulting in compromised quality of life. This exploratory study investigated whether two mind-body interventions, i.e., Mind-Body Bridging (MBB) and Mindfulness Meditation (MM), could improve posttreatment cancer survivors' self-reported sleep disturbance and comorbid symptoms, as compared to sleep hygiene education (SHE) as an active control.MethodsThis randomized controlled trial examined 57 cancer survivors with clinically significant self-reported sleep disturbance, randomly assigned to receive MBB, MM, or SHE. All interventions were conducted in three sessions, once per week. Patient-reported outcomes were assessed via the Medical Outcomes Study Sleep Scale and other indicators of psychosocial functioning relevant to quality of life, stress, depression, mindfulness, self-compassion, and well-being.ResultsMixed effects model analysis revealed that mean sleep disturbance symptoms in the MBB (p?=?.0029) and MM (p?=?.0499) groups were lower than in the SHE group, indicating that both mind-body interventions improved sleep. In addition, compared with the SHE group, the MBB group showed reductions in self-reported depression symptoms (p?=?.040) and improvements in overall levels of mindfulness (p?=?.018), self-compassion (p?=?.028), and well-being (p?=?.019) at postintervention.ConclusionsThis study provides preliminary evidence that brief sleep-focused MBB and MM are promising interventions for sleep disturbance in cancer survivors. Integrating MBB or MM into posttreatment supportive plans should enhance care of cancer survivors with sleep disturbance. Because MBB produced additional secondary benefits, MBB may serve as a promising multipurpose intervention for posttreatment cancer survivors suffering from sleep disturbance and other comorbid symptoms.Implications for cancer survivorsTwo brief sleep-focused mind-body interventions investigated in the study were effective in reducing sleep disturbance and one of them further improved other psychosocial aspects of the cancer survivors' life. Management of sleep problems in survivors is a high priority issue that demands more attention in cancer survivorship.

Dataset Information

Pilot randomized controlled trial of a patient-controlled cognitive-behavioral intervention for the pain, fatigue, and sleep disturbance symptom cluster in cancer.

Publications

Pilot randomized controlled trial of a patient-controlled cognitive-behavioral intervention for the pain, fatigue, and sleep disturbance symptom cluster in cancer.

Similar Datasets

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