Shum 2014.

Methods	A randomised controlled trial design (recruitment May 2011‐May 2012)
Participants	Caregivers of people with colorectal cancer recruited from the colorectal cancer clinic of Queen Mary Hospital in Hong Kong. Caregivers were caring for a family member diagnosed with colorectal cancer in the preceding four weeks, were at least 18 years old and spoke Cantonese. Domestic helpers, those who were cognitively impaired, and those who did not speak Cantonese were excluded. Caregivers age ranged from 19‐86 years; mean age in years was 54 (SD = 14.6). Most were females (n = 103, 74%) and 37 men comprised 26% of the sample. Education ranged from Illiterate (n = 14, 10%), primary (n = 37, 26%), secondary (n = 69, 49%), tertiary (n = 19, 14%), doctorates (n = 1, < 1%). Monthly family income in Hong Kong dollars (£) for the entire sample (n = 140) ranged from, less than 10,000 (769) (n = 55, 39.28%), 10,001‐20,000 (770‐1,539) (n = 42, 30%), 20,001‐30,000 (1,540‐2,307) (n = 26, 18.57%), 30,001‐40,000 (2,308‐3,079) (n = 8, 5.71%), 40,001‐50,000 (3,080‐3,846) (n = 9, 6.4%).
Interventions	Intervention: Nurse‐led, telephone, psychoeducation programme plus usual care (n = 70) Aim: To evaluate the efficacy of the programme in reducing depression, anxiety, stress and burden of care among caregivers of patient with colorectal cancer Interventionist(s): Colorectal nurse specialist Mode of delivery: Telephone Duration: Five weeks (three structured telephone calls to the caregivers at 1, 3, and 5 weeks after discharge. Each call lasted no longer than 45 minutes). Content: The calls sought to understand the caregivers’ situation and identify their problems so that information, as well as education and psychosocial support, could be provided. The interval between telephone calls and the content of the intervention followed a telecare protocol called individual support condition (Taylor 2008). Each call began with an enquiry about the patient’s and carer’s general condition. Specific caring problems or psychological issues were identified, and related information or psychological support was given to caregivers. The nurse also provided education to caregivers according to the patient’s needs at different recovery stages. Before the end of the call, the nurse asked about any additional problems and ensured that caregivers’ needs had been met. Standardisation: The content of the telephone checklists and field notes were reviewed regularly to ensure accuracy and consistency and conversations were documented. Comparison group: Caregivers received routine education on home care on discharge using an information sheet. In addition, a telephone help line number was provided (n = 70).
Outcomes	1. Quality of life: The World Health Organization Quality of Life Measure‐BREF (WHOQoLBREF) Hong Kong (HK) was used to assess quality of life and consists of 28 items covering four domains: physical health, psychological health, social relationships and environment. Higher scores indicated better quality of life. 2. Burden: The Chinese version of the Zarit Burden Scale is a 22‐item, self‐report inventory that measures carer burden. Each question was scored on a five‐point Likert scale, ranging from 0 for ‘never’ to four for ‘nearly always present’. The total score ranged from 0 to 60, with a higher score indicating greater burden. 3. Psychological health (depression, anxiety and stress): The Chinese version of the Depression, Anxiety and Stress Scale‐21 (DASS‐21) (a self‐report instrument that measures a patient’s state over the preceding week). It consists of 21 items, spread equally across three scales: depression, anxiety, and stress. Each item uses a four‐point Likert scale, ranging from 0 (‘did not apply to me at all’) to three (‘applied to me very much, or most of the time’). For depression, a score less than nine was regarded as normal, 10‐13 as mild, 14‐20 as moderate, 21‐27 as severe, and higher than 28 as extremely severe. For anxiety, a score less than seven was regarded as normal, 8‐9 as mild, 10‐14 as moderate, 15‐19 as severe, and higher than 20 as extremely severe. For stress, a score less than 14 was regarded as normal, 15‐18 as mild, 19‐25 as moderate, 26‐33 as severe, and higher than 37 as extremely severe. Outcome data were collected at week 2 (end of intervention), 4, and 8 weeks (short‐term time point) after the intervention.
Notes	Funding sources: none stated For the QoL outcome, the physical health subscale result was used in the analysis for this review. Additional information requested on the published registered trial. The author responded to the queries and emailed the linked published paper. Additional data were requested in October 2018 but these data have not been provided by the author.
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	"A person not involved in participant recruitment generated the randomisation schedule ..." (p.32) ‐ detail of method not provided.
Allocation concealment (selection bias)	Low risk	"...sequentially numbered, sealed, opaque envelopes..." (p.32)
Blinding of participants and personnel (performance bias) All outcomes	Unclear risk	Unable to blind due to nature of the intervention
Blinding of outcome assessment (detection bias) All outcomes	Low risk	"The research nurses responsible for carrying out the interviews were masked to the treatment assignment" (p.32).
Incomplete outcome data (attrition bias) All outcomes	Low risk	Details not provided in the paper, figure 1 (p.33); attrition minimal and accounted for
Selective reporting (reporting bias)	Low risk	All outcomes reported upon (Page 8, table 2&3)
Other bias	Low risk	No significant differences in baseline characteristics of the caregivers (p.4 and 5, table 1)