Table 4 RCTs and mixed-method studies

Randomised Studies

 Choratas et al. 2020

[74]

(Cyprus)

Randomised feasibility study

Cancer

N = 11 in the intervention group

N = 8 in the control group

Age: 74% (n = 14) over the age of 61

Gender: 63% (n = 12) female

Educational program: PowerPoint presentation with two video recordings and a practical exercise for patients and family caregivers. Practical parts were diaphragmatic breathing, inspirational muscle training (IMT), and use of a handheld fan

Usual care: pharmacological management by oncologists

Time points of measurements: Baseline (before Intervention), in 2 weeks, and in 4 weeks

Carer: assessed patient’s breathlessness using the mBorg scale and the effect of the educational programme by using the HADS scale for anxiety and depression and the Zarit Burden Interview (ZBI) scale for the burden they experienced

Baseline:

mBorg scale (Range: 2–9): median of 4.8 (± 1.8)

HADS scale (Range: 0–21):

- Anxiety: 7.9 (± 4.3)

- Depression 7.2 (± 4.4)

ZBI Scale (Range: 0–88):31.7 (± 11.9)

Effect of the Intervention (after 4 weeks)

Patient´s breathlessness (mBorg Scale):

- IG (− 0.6) improvement

- CG (+ 1.5) deterioration

Anxiety and Depression (HADS):

- IG (− 0,4/ + 0,1) steady

- CG (+ 3,5/ + 2,3) deterioration

Burden (ZBI):

- IG (− 2,3) improvement

- CG (+ 10,8) deterioration

 Given et al. 2006 [75]

(USA)

RCT

Cancer

N: IG 59/CG 66

Age: mean

IG: 55.3 (SD 13.76)

CG: 54.4 (SD 13.13)

Gender:44.1% male

Cognitive behavioural intervention (CBI):

strategies for managing symptoms, how to integrate assistance into daily lives, and better communicate with their patient and health care providers regarding symptom management

Standard care (no further information’s)

Time points of measurements: at baseline, after 10 and 20 weeks

(Data were analysed for baseline and 10 weeks)

Depressive symptoms: Depression scale (CES-D)

Caregivers’ reaction to assisting with symptom management: measured by (1) total number of common symptoms for which carer provided assistance;(2) total level of distress; (3) reaction score per symptom

Results are extracted only for breathlessness:

Total Number (n) of symptom assistance:

- at baseline: 65 CG

- 10 Week: 61 CG

Caregivers assisting with symptom (n):

- Baseline: 30 CG

- 10 Week 10: 16 CG

Caregiver’s Negative Reaction Score (10-point scale: 0 = no distress to 10 = worst distress):

- Baseline: 3,10

- 10 Week: 3,19

Overall: female caregivers were more responsive to the intervention

 Schunk et al. 2021 [76]

(Germany)

RCT

Any advanced life-limiting disease

N: 95 (IG: 44, CG: 51)

Age:

Gender:

Munich Breathlessness Service (MBS) short-term intervention, 2 personal contacts with palliative care specialists for exercise and positions to facilitate breathing; breathing techniques; exercise plan; assessment of need for medical aids

, 3–4 specialist respiratory physiotherapy, 2 Letters to patients, treatments within 6 weeks)

 + Standard Care: respiratory specialists, general practitioners, any disease- oriented treatment and palliative care services

Control group: gained access after a waiting time of 8 weeks + standard care

Carers completed paper-based Questionnaires:

Change in carer burden assessed with the Zarit Burden Inventory (ZBI)

T0: ZBI Sum score: mean 21.35 (SD 12.86)

ZBI sum score could only identify small effects of the intervention that were not statistically significant

Mixed-Method Studies

 Farquhar et al. 2016 [69]

(UK)

Mixed method RCT

Advanced non-malignant disease

N: 45 – 57 respondents

Total Age: 62.2 (13.39)

Female: 79% (45)

The Breathlessness Intervention Service (BIS):

Multi-disciplinary, complex intervention that is supported by a palliative care approach in theory and uses evidence-based (non-) pharmacologic interventions to help patients with advanced disease manage their respiratory distress

Standard care: specialist outpatient appointments in secondary care

Carer distress: NRS

Carer Anxiety: HADS

Brief qualitative topic-guided interviews with all patients and carers to explore their expectations and experiences of BIS

8 Weeks from baseline

Carer NRS distress due to patient´s breathlessness (0–10):

- IG: reduction (1.03-point)

- CG: 0.2-point increase

This was not statistically significant: adjusted difference of –0.42 (95% CI: –1.86 to 1.02), p = 0.56

Carer HADS-Anxiety (0–21):

IG: 1.65-point, reduction

CG: 0.15-point reduction

This was not statistically significant: adjusted difference of –1.22 (95% CI: –2.84 to 0.40), p = 0.14

Qualitative interviews: described a sense of relief from talking to someone about breathlessness during the intervention

 Farquhar et al. 2014 [70]

(UK)

Mixed-method RCT (Phase III)

Cancer

N: 39 – 41 respondents

Age: 64.6 (12.7)

Gender: 68% (28) female

The Breathlessness Intervention Service (BIS): multi-disciplinary complex intervention combining (non-) pharmacological interventions to support breathless patients with advanced disease, theoretically grounded by a palliative care approach

Standard care: specialist outpatient appointments in secondary care

Primary outcome: change in distress due to breathlessness (NRS range 0 to 10) and HADS

Qualitative interviews with patients and carers

Primary outcome: There was little change in carer distress. (No given data)

Qualitative interviews: Carer described not feeling alone by having the ability to call someone in the BIS model

 Schloesser et al. 2022 [71]

(Germany)

Mixed Methods single arm phase II study

episodic breathlessness due to any life-limiting and progressive disease

N: 16 (were named by patients)

Age: mean age 63.5; SD = 8.7

Gender: female 9 (56.3%) male 7 (43.8%)

Brief Cognitive and Behavioural Intervention:

- 1-to-2-h intervention

- Delivered by a nurse, psychologist, or a physician

- Consists of a general introduction to better understand breathlessness, as well as strategies and education

NA

Outcomes: via closed-ended questions

Safety and Acceptability: participants were asked about burdens due to the intervention and study procedure

Qualitative Interviews: to evaluate participants experiences

Outcomes were evaluated six weeks after intervention and as treated

Carer reported Outcomes:

- No carer reported any burdens due to the intervention/study procedure. The great majority of the carers were very satisfied with the intervention and the study procedure (≥ 8/10)

- Safety from carers ´perspective: no adverse effects from intervention for IC, no unexpected side effects from intervention for informal carer and no adverse effects from research for informal carer

Qualitative interviews were conducted only with patients

 Swan et al. 2019 [72]

(UK)

Mixed-method RCT

Adult respiratory outpatients with Medical Research Council breathlessness scale grade ≥ 3

14 carers were recruited and 13 (92%) completed the study

4 groups: Fan = battery-operated hand-held fan

Calming Hand (CH) = a cognitive strategy

(1) exercise advice only

(2) CH & exercise advice

(3) Fan and exercise advice

(4) fan, CH and exercise advice

All four groups received one-hour face-to-face individual training in standardised breathlessness self-management and exercise advice. All participants were given an information leaflet for use at home

CH and fan groups: received instructions how to use the interventions

Carers self-efficacy: General Self-Efficacy Scale (GSES)

Carer Assessment: Zarit burden short-form

Caregiver Outcome:

Zarit burden and GSES: Improvements in carer´ outcomes were in the fan & CH & exercise advice arm only

mean change absolute from baseline to day 28

- Zarit burden 0.25; (7.1%)

- GSES 1.75; (5%)

 Hutchinson 2022 [73]

(UK)

Mixed-method feasibility cluster randomised controlled trial

Acute-on-chronic breathlessness due to COPD or heart failure

N: 9 caregivers

Age: 28 – 67

Gender: only females

BREATHE: reassure patient and carer, check posture, exercises, airflow, technics to manage panic and fear, education of patient and carer (information booklet)

Usual care: immediate clinical assessment, reassurance, oxygen, nebulizer

Acceptability:

Fidelity: Completion rate

Safety: any adverse events

Acceptability: Qualitative and survey data showed acceptability to patients, carers and paramedics

One carer read booklet and leaflet and derived benefits. One carer read only the leaflet and dealt with two further episodes without calling the ambulance

Safety: No adverse events

Fidelity: NA for carer