Can a tailored telephone intervention delivered by volunteers reduce the supportive care needs, anxiety and depression of people with colorectal cancer? A randomised controlled trial

IntroductionInterstitial lung diseases are characterised by scarring of lung tissue that leads to reduced transfer of oxygen into the blood, decreased exercise capacity and premature death. Ambulatory oxygen therapy may be used to treat exertional oxyhaemoglobin desaturation, but there is little evidence to support its efficacy and there is wide variation in clinical practice. This study aims to compare the clinical efficacy and cost-effectiveness of ambulatory oxygen versus ambulatory air in people with fibrotic interstitial lung disease and exertional desaturation.Methods and analysisA randomised, controlled trial with blinding of participants, clinicians and researchers will be conducted at trial sites in Australia and Sweden. Eligible participants will be randomised 1:1 into two groups. Intervention participants will receive ambulatory oxygen therapy using a portable oxygen concentrator (POC) during daily activities and control participants will use an identical POC modified to deliver air. Outcomes will be assessed at baseline, 3 months and 6 months. The primary outcome is change in physical activity measured by number of steps per day using a physical activity monitor (StepWatch). Secondary outcomes are functional capacity (6-minute walk distance), health-related quality of life (St George Respiratory Questionnaire, EQ-5D-5L and King’s Brief Interstitial Lung Disease Questionnaire), breathlessness (Dyspnoea-12), fatigue (Fatigue Severity Scale), anxiety and depression (Hospital Anxiety and Depression Scale), physical activity level (GENEActive), oxygen saturation in daily life, POC usage, and plasma markers of skeletal muscle metabolism, systematic inflammation and oxidative stress. A cost-effectiveness evaluation will also be undertaken.Ethics and disseminationEthical approval has been granted in Australia by Alfred Hospital Human Research Ethics Committee (HREC/18/Alfred/42) with governance approval at all Australian sites, and in Sweden (Lund Dnr: 2019-02963). The results will be published in peer-reviewed scientific journals, presented at conferences and disseminated to consumers in publications for lay audiences.Trial registration numberClinicalTrials.gov Registry (NCT03737409).

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Thirty-year outcome of anxiety and depressive disorders and personality status: comprehensive evaluation of mixed symptoms and the general neurotic syndrome in the follow-up of a randomised controlled trial

Psychological Medicine ◽

10.1017/s0033291721000878 ◽

2021 ◽

pp. 1-10

Author(s):

Peter Tyrer ◽

Helen Tyrer ◽

Tony Johnson ◽

Min Yang

Keyword(s):

Randomised Controlled Trial ◽

Panic Disorder ◽

Controlled Trial ◽

Anxiety And Depression ◽

Term Outcome ◽

Long Term Outcome ◽

Personality Dysfunction ◽

Randomised Controlled ◽

Anxiety Depression

Abstract Background Cohort studies of the long-term outcome of anxiety, depression and personality status rarely join together. Methods Two hundred and ten patients recruited with anxiety and depression to a randomised controlled trial between 1983 and 1987 (Nottingham Study of Neurotic Disorder) were followed up over 30 years. At trial entry personality status was assessed, together with the general neurotic syndrome, a combined diagnosis of mixed anxiety–depression (cothymia) linked to neurotic personality traits. Personality assessment used a procedure allowing conversion of data to the ICD-11 severity classification of personality disorder. After the original trial, seven further assessments were made. Observer and self-ratings of psychopathology and global outcome were also made. The primary outcome at 30 years was the proportion of those with no Diagnostic and Statistical Manual of Mental Disorders (DSM) diagnosis. Data were analysed using multilevel repeated measures models that adjusted for age and gender. Missing data were assumed to be missing at random, and the models allowed all subjects to be included in the analysis with missing data automatically handled in the model estimation. Results At 30 years, 69% of those with a baseline diagnosis of panic disorder had no DSM diagnosis compared to 37–47% of those with generalised anxiety disorder, dysthymia or mixed symptoms (cothymia) (p = 0.027). Apart from those with no personality dysfunction at entry all patients had worse outcomes after 30 years with regard to total psychopathology, anxiety and depression, social function and global outcome. Conclusions The long-term outcome of disorders formerly called ‘neurotic’ is poor with the exception of panic disorder. Personality dysfunction accentuates poor recovery.

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The prevalence of anxiety and depression and its association with coping strategies, supportive care needs, and social support among women with breast cancer

Supportive Care in Cancer ◽

10.1007/s00520-021-06477-2 ◽

2021 ◽

Author(s):

Hassan Okati-Aliabad ◽

Alireza Ansari-Moghadam ◽

Mahdi Mohammadi ◽

Shiva Kargar ◽

Fariba Shahraki-Sanavi

Keyword(s):

Breast Cancer ◽

Social Support ◽

Supportive Care ◽

Coping Strategies ◽

Supportive Care Needs ◽

Anxiety And Depression ◽

Care Needs

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Hughes Abdominal Repair Trial (HART)—abdominal wall closure techniques to reduce the incidence of incisional hernias: feasibility trial for a multicentre, pragmatic, randomised controlled trial

BMJ Open ◽

10.1136/bmjopen-2017-017235 ◽

2017 ◽

Vol 7 (12) ◽

pp. e017235 ◽

Cited By ~ 2

Author(s):

Rhiannon L Harries ◽

Julie Cornish ◽

David Bosanquet ◽

Buddug Rees ◽

James Horwood ◽

...

Keyword(s):

Colorectal Cancer ◽

Randomised Controlled Trial ◽

Controlled Trial ◽

Data Monitoring Committee ◽

Feasibility Trial ◽

Abdominal Wall Closure ◽

Incisional Hernias ◽

Mass Closure ◽

Monitoring Committee ◽

Randomised Controlled

ObjectivesIncisional hernias are common complications of midline abdominal closure. The ‘Hughes Repair’ combines a standard mass closure with a series of horizontal and two vertical mattress sutures within a single suture. There is evidence to suggest this technique is as effective as mesh repair for the operative management of incisional hernias; however, no trials have compared Hughes repair with standard mass closure for the prevention of incisional hernia formation. This paper aims to test the feasibility of running a randomised controlled trial of a comparison of abdominal wall closure methods following midline incisional surgery for colorectal cancer, in preparation to a definitive randomised controlled trial.Design and settingA feasibility trial (with 1:1 randomisation) conducted perioperatively during colorectal cancer surgery.ParticipantsPatients undergoing midline incisional surgery for resection of colorectal cancer.InterventionsComparison of two suture techniques (Hughes repair or standard mass closure) for the closure of the midline abdominal wound following surgery for colorectal cancer.Primary and secondary outcomesA 30-patient feasibility trial assessed recruitment, randomisation, deliverability and early safety of the surgical techniques used.ResultsA total of 30 patients were randomised from 43 patients recruited and consented, over a 5-month period. 14 and 16 patients were randomised to arms A and B, respectively. There was one superficial surgical site infection (SSI) and two organ space SSIs reported in arm A, and two superficial SSIs and one complete wound dehiscence in arm B. There were no suspected unexpected serious adverse reactions reported in either arm. Independent data monitoring committee found no early safety concerns.ConclusionsThe feasibility trial found no early safety concerns and demonstrated that the trial was acceptable to patients. Progression to the pilot and main phases of the trial has now commenced following approval by the independent data monitoring committee.Trial registration numberISRCTN 25616490.

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